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113 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- women of good physical and mental health
- under 37 years old, with regular menstrual cycles of 25-35 days
- normal basal FSH and LH levels
- BMI less than 30 kg/m2
- presence of both ovaries and intact uterus
- absence of polycystic ovaries
- endometriosis, or gynaecological / medical disorders and a negative result in a
screening for sexually transmitted diseases
- all patients signed a written informed consent form
- no patient had received any hormone therapy for at least 60 days preceding the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 35 Years | Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days | NCT01468441 | Contradiction |
885 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Male and female Patients aged ≥50 and ≤85 years.
2. Patients with a history of clinically symptomatic OA of the knee for ≥ 6 months.
3. Index knee joint pain rated ≥60 mm on a 100 point Pain Visual Analogue Scale (VAS).
4. Patient must have a diagnosis of idiopathic OA according to the American College of
Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and
fulfilment of at least 2 of the 3 criteria:
- Age of ≥50 years Stiffness lasting <30 minutes after getting up in the morning
- Crepitus
5. Radiographic evidence of grade III knee OA based on the Kellgren and Lawrence (KL)
radiographic entry criteria for OA.
- Grade III: Anteroposterior weight-bearing knee radiograph demonstrates definite
joint space narrowing, multiple osteophyte formations, some sclerosis, and possible
deformity of bony ends.
6. Patients with normal liver & renal function defined as:
- Serum Alkaline phosphatase levels up to 1.5 of ULN (Upper Limit of Normal).
- Serum AST and ALT levels up to 2.5 of ULN.
- Serum creatinine levels up to 1.5 of ULN.
- Blood Urea Nitrogen levels up to 1.5 of ULN.
7. Female Patients must not be of childbearing potential (defined as postmenopausal for
at least 1 year or surgically sterile [bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy])
8. Patients must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin,
acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy,
acupuncture) starting from the screening visit until completing participation in the
study.
9. Abstinence from any home-based remedies or any other form of topical products intended
for knee joint pain relief for the entire study duration.
10. Patient must be willing to avoid unaccustomed physical activity (eg, starting a new
weight lifting routine) for the duration of the study starting from the screening
visit.
11. Ability to read and provide written, personally signed, and dated informed consent to
participate in the study.
12. An understanding, ability, and willingness to fully comply with study procedures and
restrictions.
Exclusion Criteria:
1. Patients who have any contraindications to MRI, such as, but not limit to:A metal
device affected by MRI (e.g. any type of electronic, mechanical, or magnetic implant;
cardiac pacemaker; aneurysm clip(s); implanted cardiac defibrillator); - Have history
of orbit trauma by a potential ferromagnetic foreign body (metal slivers, metal
shavings, other metal objects) for which they sought medical attention; - Have
claustrophobia; - Have difficulty fitting into the MRI knee coil due to greater than
normal thigh diameter.
2. Any other lower limb dis-functionality of lower limb other than the knee that, in the
opinion of the Investigator, could interfere with pain and functional assessments
related to the knee.
3. Patients who has a history of total or partial knee replacement, arthroplasty, or
other knee surgery on either knee.
4. Patients who has had significant injury, as judged by the Investigator, involving the
target knee within the 6 months before screening.
5. Patients who has used opiates or corticosteroids within 30 days before screening for
the target knee or who requires treatment with chronic opiates or corticosteroids or
had intra articular injections of corticosteroids, hyaluronic acid, or visco
supplements to a knee to be treated within the 3 months before Screening.
6. Patients who has a history of significant hypersensitivity, intolerance, or allergy to
ibuprofen, any NSAIDs, aspirin, or acetaminophen.
7. Known sensitivity to the investigational product or any excipients of the drug
product.
8. Patients who has a history of chronic inflammatory disease (such as rheumatoid
arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions
that may affect the target joint or the functional and pain assessments (eg,
osteonecrosis, chondrocalcinosis).
9. Patients has any clinically significant unstable cardiac, respiratory, neurological,
immunological, hematological, or renal disease, or any other condition that, in the
investigator's opinion, could compromise the Patient's welfare, ability to communicate
with the study staff, or otherwise contraindicate study participation.
10. Patients has any other clinically significant laboratory finding at screening that in
the investigator's opinion contraindicates study participation.
11. Presence of uncontrolled hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm
Hg).
12. Uncontrolled diabetes defined as fasting blood glucose (FBG) > 125 mg/dL.
13. Patients with heavy alcohol consumption, defined as - For men: More than 14 standard
alcoholic drink (SAD)/week or more than 4 SAD in a day. - For women: More than 7
SAD/week or more than 3 SAD in a day.
(NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which
is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9%
alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry
or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
14. Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a
2-hour time frame.
15. Individuals having a history (in past 2 years) of smoking or currently smoking or
using any form of smokeless tobacco.
16. Patients without access to telephone and/or ability to gain technology access.
17. Patients who participated in another human trial within last 90 days prior to
screening.
18. Any condition that could, in the opinion of the investigator, preclude the Patient's
ability to successfully and safely complete the study or that may confound study
outcomes.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years | To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint. | NCT04833946 | Entailment |
3,638 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- You must be between 18-45 years old
- You have Heavy Periods
Exclusion Criteria:
- You are pregnant
- You are currently using hormonal contraception or hormonal therapy
- You have a history of pelvic inflammatory disease (and have not had a normal pregnancy
since)
- You had an infected abortion within the last three months
- You have abnormal or cancerous cells of the cervix or uterus
- You have an actine infection in your genital organs
- Known or suspected breast cancer
- Active liver disease or tumors
- Allergy to levonorgestrel or norethindrone
- You currently have deep vein thrombosis, pulmonary embolism, or history of these
conditions
- you currently have active or recent (within the past year) arterial thromboembolic
disease (such as a stroke or myocardial infarction) these conditions
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding | NCT01391052 | Entailment |
512 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | - INCLUSION CRITERIA:
1. Female
2. Between 18 and 28 years of age (inclusive)
3. Reported menarche between the ages of 11 and 14 years
4. Gynecological age of less than or equal to 14 years
5. A history of self-reported regular menstrual cycles when not on contraceptive
medication of between 25 and 35 days (inclusive) at prescreen and knowledge of
date of onset of menses before the screening visit
6. A BMI of 18.5 to 27 kg (Summation)m(2) and a weight >= 93 lbs.
7. Agrees to use barrier contraception method for the duration of the study
8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study
interventions
9. Agrees to abstain from donating blood during the study and within 30 days of
completing the study
10. Is willing and able to fulfill the requirements of the protocol and to provide
informed consent
11. Able to speak and read English
12. Lives within 50 miles of the Clinical Research Unit
EXCLUSION CRITERIA:
1. Currently lactating or pregnant or planning on becoming pregnant for the duration of
the study
2. Has ever given birth
3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg
(4.4 lbs)
4. > 4 hours per week of aerobic exercise for the past 3 months
5. Has initiated training for an athletic sport or event in the past 3 months that, in
the opinion of the investigator, may interfere with the results of the study
6. Currently using hormone-based contraception, including those administered orally,
vaginally, via injection, sub-dermally, or transdermally
7. Current use of medications or supplements that may interfere with the results of the
study, including:
i.Steroids
ii.Hormone-based contraception
iii.Sleeping pills
iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and
other-the-counter extracts)
v.Stimulants (e.g. Ritalin)
vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive
medications
8. Current use of recreational drugs (alcohol intake will be monitored and excluded
during the two intervention periods)
9. Unable to consume food containing dairy or nuts
10. Has currently or has a history of any of the following: autoimmune, heart, liver,
renal disease, diabetes, or another health condition deemed by the PI to be a
contraindication to study participation. History of thyroid disorder is permissible if
the patient is biochemically euthyroid on replacement.
Additional Eligibility Criteria to be Met Prior to Start of Intervention(s):
Criteria 1 Habitual energy intake between 35-55 kcal/kg LBM*day
Criteria 2 VO2max less than or equal to 40 ml/kg/min with the option to increase this at
the discretion of the PI, depending on the current and past exercise level of the
participant
Criteria 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory.
Criteria 4 Ovulation confirmed in the cycle before each study intervention by self-reported
positive urine test, ultrasound and/or progesterone blood-levels
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 28 Years | CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study) | NCT02858336 | Contradiction |
141 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Adult males 18 years of age or older
- Currently is being treated for hypogonadism with testosterone therapy using injectable
testosterone.
- Must not have erythrocytosis (defined as a hematocrit of 52% or higher) attributable
to other medication or medical condition
- Agree not to initiate any other treatment for erectile dysfunction (ED), including
herbal and over- the-counter (OTC) medications, for the duration of the study.
- Must not already be taking finasteride or other 5-alpha reductase inhibitor
Exclusion Criteria:
- Men not currently using testosterone supplementation therapy or men on non-injectable
testosterone therapy
- Prior history of anabolic steroid use, but have not used for at least 6 months
- Prior history of testosterone use, but have not used for at least 6 months
- Men who are already taking finasteride
- Untreated or inadequately treated hypothyroidism
- Significant history of allergy and/or sensitivity to the drug products or excipients,
including sensitivity to testosterone and/or finasteride
- Current use of any medications, herbal, and/or nutritional supplements that can
interfere with testosterone level
- Currently receiving treatment with cancer chemotherapy or anti-androgens
- Any contraindication to testosterone therapy or finasteride
- History of luteinizing hormone-releasing hormone antagonist or agonist treatment
- History of clomiphene treatment in 6 months prior to Visit 1
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| H-36731: Finasteride in Management of Elevated Red Blood Cells | NCT02548117 | Contradiction |
420 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
To be eligible to participate in this study, all of the following criteria must be met:
- An Independent Ethics Committee (IEC)-approved written Informed Consent Form is signed
and dated by the subject
- Subject is considered reliable and capable of adhering to the protocol (eg, able to
understand and complete diaries), visit schedule, or medication intake according to
the judgment of the Investigator
- Subject is male or female, 18 to 55 years of age (inclusive)
- Female subjects must have a negative pregnancy test in urine at the Screening Visit
and a negative serum pregnancy test on Day -1, and be of nonchildbearing potential,
defined as being:
1. Postmenopausal (for at least 2 years before the Screening Visit), verified by
serum follicle-stimulating hormone (FSH) level >40 mIU/mL at the Screening Visit,
or
2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
salpingectomy), or
3. Congenitally sterile
- Contraception methods for male subjects and their female partners:
1. Male subject with a partner of childbearing potential must be willing to use a
condom when sexually active
2. The female partner of childbearing potential of a male subject must be willing to
use at least 2 effective methods of contraception, including a barrier method
(eg, male condom, female condom, or diaphragm with spermicide) during the study
period.
Both sexes must use the above mentioned contraception methods (condoms for males) during
the study and for 20 weeks after the last administration of the Investigational Medicinal
Product (IMP) (anticipated 5 half-lives).
- Subject is of normal weight as determined by a body mass index (BMI) of 18.0 to 30.0
kg/m^2 (inclusive), with a body weight of at least 50 kg
- Subject has clinical laboratory test results within the reference ranges of the
testing laboratory
- Subject has Blood Pressure (BP) and pulse within normal range in a supine position
after 5 minutes rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse:
40 to 90 beats per minute - all inclusive)
- Subject's ECG is considered "normal" or "abnormal but clinically nonsignificant" (as
interpreted by the Investigator)
Exclusion Criteria:
Subjects are not permitted to enroll in the study if any of the following criteria is met:
- Subject has a known hypersensitivity to any components of the Investigational
Medicinal Product (IMP)
- Subject is considered anti-high-affinity immunoglobulin E (IgE) receptor nonresponsive
if CD63 induction on basophils is <10 %
- Subject has cardiovascular or cerebrovascular disease, including hypertension, angina,
ischemic heart disease, transient ischemic attacks, stroke, and peripheral arterial
disease sufficient to cause symptoms and/or require therapy to maintain stable status
- Subject has diabetes mellitus of any type requiring insulin
- Subject has
1. an active infection (eg, sepsis, pneumonia, abscess)
2. history of latent, chronic, or recurrent infections (eg, tuberculosis [TB],
recurrent sinusitis, genital herpes, urinary tract infections) or at risk of
infection (surgery, trauma, infection requiring antibiotics, history of skin
abscesses) within 3 months before IMP administration
3. experienced a significant episode of gastroenteritis (defined as loose stools
associated with abdominal pain and/or fever) during the 7 days before IMP
administration
When in doubt, the Investigator should confer with the Sponsor's Study Physician.
- Subject has a history of positive TB test or evidence of possible TB or latent TB
infection at the Screening Visit (QuantiFERON® Gold Test)
- Subject has received live attenuated vaccination within 3 months or any other type of
vaccine within 4 weeks before the Screening Visit or intends to have such a
vaccination during the course of the study
- Subject who has any of the following hematology values at the Screening Visit:
Hemoglobin; for women <11 g/dL; for men <13 g/dL Absolute Neutrophil Count (ANC) <1.5
x 109/L (<1000/mm^3)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects | NCT02207595 | Contradiction |
1,195 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Histologically or cytologically documented malignant pleural effusion and/or malignant
ascites OR morphological diagnosis of malignant pleural effusion and/or malignant
ascites by CT or ultrasound
2. Histologically confirmed cancer
3. Malignant pleural effusion and/or malignant ascites clinically judged as not
responsive to conventional systemic therapy(ies) for primary malignancy
4. Adequate liver and renal function as defined below:
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
6. Life expectancy of > 12 weeks
7. Willing and able to provide written, signed informed consent after the nature of the
study has been explained, and prior to any research-related procedures
8. Females of childbearing potential must have a negative serum pregnancy test at
screening and be willing to have additional serum pregnancy tests during the study.
9. Willing and able to comply with all study procedures
Exclusion Criteria:
1. Presence of > grade 3 active infection or gastric bleeding at the time of screening
2. Change in chemotherapy regimen within 28 days before Day 1 of study drug
administration
3. Concurrent use of any investigational product (IP) or investigational medicine within
28 days before Day 1 of study drug administration
4. Symptomatic interstitial lung disease or inflammatory pneumonitis
5. Concurrent disease or condition which, in the opinion of the Investigator, would pose
a risk to patient safety or interfere with study participation or interpretation of
individual patient results
6. Breastfeeding at screening or planning to become pregnant (self or partner) at any
time during study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites | NCT03736122 | Entailment |
4,756 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- HHIE-S score over 8
- Indication of comorbid psychological suffering/distress (defined as total score above
0 on PHQ9/GAD7 or below 1sd on QOLI)
Exclusion Criteria:
- No computer with internet connection
- Unability to understand written content
- Incomplete screening procedure
- A health condition that needs immediate care
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 110 Years | Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss | NCT02877329 | Entailment |
4,906 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Males and females age 19 up to, and including, 49 years of age at the time of the
first dose of study drug
- Weight less than 89 kg
- Written informed consent obtained from the volunteer
- Healthy by medical history and physical examination
- Sexually active females, unless surgically sterile or at least two years
post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding
pregnancy (including oral, injectable, transdermal, abstinence, use of a condom by the
sexual partner or sterile sexual partner) for 3 months before the first dose of study
drug, and must agree to continue using such precautions through the study period of 84
days. Cessation of birth control after this point should be discussed with a
responsible physician. Sexually active males, unless surgically sterile, must likewise
use an effective method of birth control (condom or abstinence) and must agree to
continue using such precautions through Study Day 84 after their dose of study drug.
- Use of common over-the-counter medications such as topical corticosteroids,
decongestants, antihistamines, analgesics, and antacids is permitted unless, in the
opinion of the investigator, it would interfere with either the volunteer's ability to
complete the study or interpretation of the study results.
- Ability to complete the follow-up period of 84 days
- Willing to forego other forms of experimental treatment during the study period of 84
days
- Willing to forego vigorous activity 1 - 2 days before dosing, and before each study
visit.
Exclusion Criteria:
- Acute illnesses or evidence of significant active infection, such as fever greater
than or equal to 38.0 C (100.5°F) at the start of the study
- Use of prescription medications, other than oral contraceptives, in the 28-day period
before Study Day 0
- Any blood donation or significant loss of blood within 6 months of time of entry into
the study
- History of immunodeficiency or receipt of immunosuppressive drugs
- History of allergy or reaction to any component of the MEDI-528 formulation
- History of substance abuse that, in the opinion of the investigator, may compromise
the ability of the study subject to complete the study and follow-up period
- Evidence of any systemic disease, neurologic abnormality, lymphadenopathy, or
splenomegaly upon physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- Receipt of immunoglobulins or blood products within 60 days of entering the study
- Receipt of any investigational drug therapy or standard vaccine therapy, other than
vaccination for influenza, within 60 days of the first dose of study drug through
Study Day 84 (use of licensed agents for indications not listed in the package insert
is permitted)
- Receipt of MEDI-528 in any previous clinical study
- At Screening (must be within 21 days before study dose administration) any of the
following: Hgb, total WBC, platelet count, Na, K, C1, CO2, AST, ALT, BUN, glucose,
amylase, lipase, creatinine, or troponin out of the normal range; other abnormal
laboratory values in the screening panel that, in the opinion of the principal
investigator, are judged to be clinically significant
- Clinically significant abnormality, as determined by the investigator, on 12-lead
electrocardiogram at the time of initial screening
- Clinically significant abnormalities noted on baseline brain MRI
- Elective surgery planned during the study period through Study Day 84
- Pregnancy (sexually active females must have a negative serum pregnancy test on the
day of the first dose of study drug, before dosing)
- Nursing mother
- The presence of any condition or concern which, in the opinion of the investigator,
may interfere with the conduct or interpretation of the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 49 Years | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528 | NCT00116168 | Contradiction |
5,884 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. males and females (of non-childbearing potential. ie-surgically sterile, or willing to
use an approved form of birth control) between the ages of 18 and 70 who speak and
write in English,
2. chronic cough (> 8 wks/another article used > 6 wks) with symptom severity criteria of
2 or greater on the Fisman Cough Severity Score and 3 or greater or the Fisman Cough
Frequency Score, and,
3. failure to respond to post nasal drip therapy.
Exclusion Criteria:
1. abnormal chest x-ray,
2. patients taking H2 blockers within the previous 3 days or PPI's within the previous 7
days,
3. failure to respond to past PPI therapy given for cough that lasted at least 12 weeks,
4. use of an investigational drug within the past 30 days,
5. previous surgical antireflux or non-surgical endoscopic anti-reflux procedure (ex.,
Stretta or endoscopic sewing device),
6. previous aerodigestive malignancy,
7. current smokers, or ex-smokers (defined as those who quit smoking less than 3 months
prior to study enrollment or those who have quit, but have a 20 pack year smoking
history),
8. upper respiratory infection within 8 weeks prior to study enrollment,
9. current use of a B- blocker, ACE-I, or anticholinesterases at time of enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | The Utility of Nexium in Chronic Cough and Reflux Disease | NCT00287339 | Contradiction |
6,102 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria
1. Ages 14-75
2. Must be able to read and write in English
3. Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in
both nostrils
Exclusion Criteria
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates in past 12 hours
- Currently experiencing any of the CDC COVID-19 symptoms:
- Fever
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- New loss of taste or smell
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
Subject must be at most 75 Years | A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit | NCT04720235 | Contradiction |
5,588 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- overweight/obese adults
- body mass index: 27-35 kg/m2
- individuals not prescribed medications over the past 6 months that could interfere
with the study outcomes (i.e. statins or metformin)
Exclusion Criteria:
- smokers
- those on an energy restricted diet
- breakfast skippers
- pregnant/lactating women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 55 Years | The Effect of Eating Pulses for 8 Weeks on Satiety and Metabolic Syndrome Risk Factors in Overweight Individuals | NCT00604448 | Contradiction |
5,107 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- postmenopausal woman >age 45 of any racial origin
- Participants will have received at least 4 prior denosumab treatments and be within 7
months from their last denosumab injection
- Participants are willing to participate for the duration of the study and have no
physical or psychological illness that would prohibit them from participating.
- Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria.
Osteoporosis will be defined by bone mineral density T-Score < -2.5 at lumbar spine
(at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck.
Osteoporosis will also be defined clinically in women with osteoporotic fractures
within the preceding 5 years, including clinical vertebral or nonvertebral fractures
or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a
DXA BMD T-Score < -1.5 at one or more skeletal sites.
Exclusion Criteria:
- Use of drugs other than denosumab (within the preceding 3 months) known to affect
skeletal or calcium homeostasis.
- Fewer than 2 evaluable lumbar vertebrae
- A history of a symptomatic renal stone within the past 2 years or history of multiple
symptomatic renal stones within the preceding 10 years
- Skeletal Disorders other than osteoporosis, including hypercalcemia,
hyperparathyroidism, or Paget's Disease
- History of external or internal radiation therapy
- Estimated GFR below 30 ml/min
- Any contraindications to receipt of Abaloparatide or Denosumab
- History of any cancer in past 5 years (except basal/squamous skin cancer)
- Unexplained elevation of Serum Alkaline Phosphatase
- History of atypical femoral fracture
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
| Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone | NCT04467983 | Contradiction |
4,819 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Male and female patients diagnosed as Cushing syndrome (CS) caused by ACTH-producing
pituitary adenoma or cortisol producing adrenal adenoma
- Age between 18 and 70 years
Exclusion Criteria:
- Chronic glucocorticoid use
- CS caused by ectopic ACTH producing tumors
- CS caused by adrenocortical carcinoma
- Pseudo CS
- Patients with Raynaud phenomenon
- Patients with collagen tissue disease
- Patients who use drugs that affect the metabolism of fibrinolysis (such as oral
contraceptives)
- Employees at work at risk of microtrauma (such as gardeners, farmers)
- Skin diseases with nail fold involvement (such as dermatitis, psoriasis)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients | NCT04433819 | Contradiction |
829 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Adults of either sex 30 to 75 years of age, inclusive, with a diagnosis of nonfamilial
hypercholesterolemia or mixed hyperlipidemia as one of the following:
- TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250
mg/dL
- TG between 150 mg/dL and 500 mg/dL and LDL-C > 130 mg/dL);
2. Subject must be free of any clinically significant disease, other than nonfamilial
hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study
evaluations;
3. A wash-out period of 2 weeks will be applied to patients prior treated with
lipid-lowering medication;
4. Subject must be willing to adhere to protocol requirements, and provide written
informed consent;
5. Female of child-bearing potential must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation.
Exclusion Criteria:
1. Patients with secondary dyslipidemia caused by diabetes mellitus, hypothyroidism,
obstructive liver disease, chronic renal failure or drugs which can increase LDL-C
level (e.g. retinoids, cyclosporine A and phenothiazines) or decrease HDL-C level
(e.g. progestins, androgens, β-blockers, probucol and anabolic steroid)
2. Patients with lifestyle that may interfere treatment efficacy, such as alcoholism or
drinking habits more than 3 times per week, late dinner, late night supper, frequent
oversea business traveler, frequent social gathering, and patients who cannot
anticipate a diet control and lifestyle changes;
3. Patients with diabetes or history of coronary artery disease (has had myocardial
infarction, cardiac intervention, cerebrovascular accident/stroke or transient
ischemic attack less than 6 months prior to Visit 1);
4. Patients with hypertension that is uncontrolled defined as 2 consecutive measurements
of sitting blood pressure of systolic >140 mmHg or diastolic > 90 mmHg at Visit 1;
5. Patient has a known hypersensitivity to Antroquinonol or related compounds;
6. Patient with uncontrolled intercurrent illness including, but not limited to, acute
decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may
require IV therapy), right heart failure due to severe pulmonary disease, diagnosed
peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit
1, or psychiatric illness/social situations that would limit compliance with study
requirements;
7. Patients with a history of heart transplant or who are on a transplant list or with
left ventricular assistance device (LVAD device);
8. Patients with documented ventricular arrhythmia with syncopal episodes within the past
3 months prior to visit 1 that remained untreated;
9. Patients with confirmed severe primary pulmonary, renal (eGFR<30 ml/min/1.73 m2) or
hepatic (Child-Pugh B/C classification) disease;
10. Patients who can't stop current lipid lowering drug treatments based on investigator's
judgement;
11. Patients with any malignancy, treated or untreated, within the past 5 years of Visit 1
whether or not there is evidence of local recurrence or metastases, with the exception
of localized basal cell carcinoma of the skin or carcinoma in situ of the cervix;
12. Female patient during pregnancy, lactation or breastfeeding;
13. Patient has any other life-threatening complications;
14. Patient who is considered unreliable as to medication compliance or adherence to
scheduled appointments, or inappropriate for inclusion determined by the
investigators;
15. Any other reasons addressed by the investigators.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 Years | Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia | NCT02719028 | Entailment |
1,246 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Lung lesion being evaluated for surgery during initial consultation with a thoracic
surgeon
Exclusion Criteria:
- Age < 18 years old
- Inability to consent for the study
- Chest wall anatomy precluding PULC
- Inability to sit upright
- Medications including Warfarin (Coumadin) or Clopidogrel (Plavix) in patient requiring
pleural fluid aspiration
- Active cutaneous infection overlying proposed puncture site
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Pleural Ultrasonography in Lung Cancer | NCT01141946 | Entailment |
1,444 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months
duration, as documented by the prevalence of aspiration on fluoroscopic swallow study.
- Must be receiving 100% of nutritional requirements by enterogastric tube.
- 18 years of age and older, acceptable forms of documentation for verification of age
include birth certificate, passport, and/or driver's license.
- Diminished upper esophageal sphincter opening defined as less than .55 cm for
individuals under 65 years of age and less than .40 cm for individuals over 65 years
of age on fluoroscopic swallow study.
- Failure of > 3 months of dysphagia therapy within 3 months of study enrollment.
- No documented history of noncompliance with feeding recommendations.
- Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test
Score (AMTS) score greater than 6.
- Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by
a Block and Box Test (BBT).
- Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb
weight off of a table and keep it elevated for 10 seconds.
- Ability to understand the informed consent and comply with follow-up, as evidenced by
appropriate questions, responses, and comments during the initial evaluations and a
normal Abbreviated Mental Test Score.
- Bilateral vocal fold mobility or unilateral vocal fold immobility in which the
individual is able to attain complete glottic closure as evidenced on endoscopy.
Exclusion Criteria:
- Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration.
- Esophageal phase dysphagia as defined as personal history and/or documented diagnosis
of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive
peptic esophagitis, and/or systemic disease affecting the esophagus.
- Able to safely consume any food or liquid by mouth, as documented by fluoroscopic
swallow study.
- Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals
under 65 years of age and greater than .40 cm for individuals over 65 years of age on
fluoroscopic swallow study.
- Currently pregnant, as evidenced by a positive result on a pregnancy test if the
patient is within child bearing age (younger than 60 years of age).
- 17 years of age and younger, acceptable forms of documentation for verification of age
include birth certificate, passport, and/or license.
- Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3
months of study enrollment.
- Lack of manual dexterity to operate swallowing expansion device as determined by a
Block and Box Test (BBT) score below the normal limits per age, sex, and hand.
- Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.
- Lack of cognitive ability to operate swallowing expansion device or provide informed
consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6.
- Active tumor involving the cricoid or laryngeal cartilage.
- Known allergic reaction to titanium as evidenced by personal history of allergic or
adverse reaction to titanium.
- Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as
documented by recent imaging study or abnormal physical examination.
- Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
- A documented history of noncompliance with recommendations to take nothing by mouth.
- Patients with an insensate larynx. Laryngeal sensation will be assessed with
laryngopharyngeal sensory testing. An insensate larynx is defined as a
laryngopharyngeal sensory threshold < 6 mmHg air pulse pressure or a complete absence
of the laryngeal adductor reflex on palpation of the arytenoid with a flexible
laryngoscope.
- Patients with a current, at the time of evaluation, and/or history of Zenker's
diverticulum.
- Patients with sialorrhea at the time of evaluation with or without oral commissure
incompetence.
- Patients with profound xerostomia at the time of evaluation.
- Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
- Patients with a current, at the time of evaluation, and/or history of
immunosuppression, as defined by the patient having a diagnosed immunodeficiency
disorder or on immunosuppressive medication.
- Patients with a current, at the time of evaluation, and/or history of coagulopathy, as
defined by the patient having a diagnosed coagulation disorder or on anticoagulation
medication (e.g., baby aspirin, over-the-counter non-steroidal anti-inflammatories,
herbal agents, and warfarin, etc.) that cannot be temporarily stopped for the
procedure.
- Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical
marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications
that may affect safe patient use of the swallowing device.
- Patients taking antifibrotic medications.
- Patients with bilateral vocal fold immobility in any position, as evidenced on
endoscopy.
- Patients with unilateral vocal fold immobility and unable to attain complete glottic
closure, as evidenced on endoscopy.
- Patients with current, at the time of evaluation, and/or documented history of
subglottic stenosis, as evidenced on endoscopy.
- Patients with current, at the time of evaluation, and/or documented history of airway
obstruction, as evidenced on endoscopy.
- Patients with a life expectancy < 2 years.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients | NCT02296528 | Contradiction |
6,863 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Patients having a consultation in the Research and Resources Memory Center of Amiens
(RRMC) ,
- patients registered in the Alzheimer National Bank and having an Alzheimer Disease
based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy
body disease based on revised criteria of McKeith et al 2020
- patients having a complete neuropsychological evaluation including a visual inspection
time.
- patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to
have an adequate ocular exam's quality.
- patients having an available MRI in the CHU's database including a 3DT1 sequence
- patients having a visual acuity better than 5/10, spherical refraction of +/- 5D, an
astigmatism < 3D and an applanation IOP <22mmHg
Exclusion Criteria:
- Any other neurocognitive disorder
- Any other optical neuropathy including glaucoma
- All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)
- Diabetes mellitus
- Uncontrolled hypertension blood pressure
- Any ophthalmological conditions interfering with a good ocular examination or OCT
quality (cataract, corneal opacity..)
- Severe dementia preventing a good ophthalmological examination
- Not consenting patient
- Patient with guardianship or curatorship having symptoms preventing a good
ophthalmological examination (agitation, unstable ocular fixation)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers | NCT04794634 | Contradiction |
6,583 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Hemophilia patients with moderate (factor level 1-3%) or severe (factor level <1%)
severity
Exclusion Criteria:
- Platelet count less than 100,000 /mm3 or other bleeding tendency
- Hemophilia patients who have FVIII inhibitor >0.6 BU (modified Nijmogen method)
- Hemophilia patients who have no bleeding symptoms
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 20 Years | Comparison of Different Prophylaxis Regimens for Moderate to Severe Hemophilia A Pediatric Patients | NCT02727647 | Contradiction |
5,054 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Confirmed osteoporosis or osteopenia by a referring physician and/or medical history
and physical exam OR osteopenia on plain film
- Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old
- Pain not responsive to standard medical therapy
- Current rating for pain intensity of at least 3 on a scale of 0 to 10
Exclusion Criteria:
- Evidence or suspicion of malignant tumor or spinal canal compromise
- Concomitant hip fracture
- Local or systemic infection
- Uncorrectable bleeding diatheses
- Surgery within the previous 60 days
- Lack of access to telephone
- Inability to communicate in English
- Dementia
- Pregnancy
- Abnormal renal function or anticipated venography
- Conscious sedation is contraindicated for subject
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Vertebroplasty for the Treatment of Fractures Due to Osteoporosis | NCT00068822 | Contradiction |
2,896 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- clinically definite or probable ALS according to El Escorial criteria
- life expectancy of more than 1 year
- INR ≤2 before liposuction
- lack of treatment with immune-suppressants and/or corticosteroids within min. 20 days
prior to recruitment
- constant riluzole treatment (50 mg/bid) throughout the study period
- compliance with treatment regimen e.g. will and possibility to attend check-up visits
- Polish citizens
Exclusion Criteria:
- primary haematological disease, including hypercoagulable states
- Presence of comorbidity that would stand in the way of neurosurgical treatment-
- previous history of a spinal-cord surgery at the clinically affected level
- previous/current history of neoplasm or comorbidity that could impact upon patient's
survival
- PEG
- pregnancy /lactation
- noninvasive/invasive mechanical ventilation at time of recruitment
- alcohol abuse, cocaine amphetamine, etc.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Intraspinal Transplantation of Autologous ADRC in ALS Patients | NCT03296501 | Entailment |
4,899 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria: ASA 1-2 patients programmed for elective surgery, normal neurologic
examination -
Exclusion Criteria: neurologic illness, receiving drugs that affect Central Nervous System
during the last 48 hours
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?. | NCT03140982 | Contradiction |
3,740 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
community-dwelling, physician diagnosed osteoarthritis of the knee, willingness to exercise
regularly, willingness to perform 3 testing sessions over a 6-month period, ability to
exercise safely at a moderate level of intensity, knee osteoarthritis by clinical criteria,
WOMAC Scores as follows:
PAIN:"mild" pain on 2 items or "moderate" pain on 1 item; PHYSICAL FUNCTION: "mild"
difficulty in 4 items or "moderate" difficulty in 2 items -
Exclusion Criteria:
age<50,inability to exercise and ambulate independently, physical limitation secondary to a
condition that is not modifiable by exercise (e.g., active cancer), knee replacement (past
or scheduled), total hip joint replacement less than 6 months ago, current participation in
regular conditioning exercise, participation in another research study,
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Exercise and Physical Fitness for Persons With Knee Osteoarthritis | NCT00265447 | Contradiction |
1,337 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Ages 3 to <9 years
- Short stature with height >2.25 Standard Deviation below the mean
- Prepubertal (Tanner stage I) at commencement of trial
- Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone
secretion
- Signing informed consent forms
Exclusion Criteria:
- Intra Uterine Growth Retardation
- Growth retardation associated with malignancy, severe chronic disease, genetic
syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with Growth Hormone
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 9 Years | Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature | NCT00458263 | Contradiction |
4,534 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 21-40 years of age
- BMI >18, <30
- Serum P4 ≥ 3 ng/ml on single sample collected between days 18-25 of self-reported
menstrual cycle
- Flexible schedule allowing morning blood draws on less than 48 hour notice
- In good general health
- Commit to remain on stable diet during study period (no changes to normal dietary
habits)
- Commit to using non-hormonal contraceptive methods during study period except those
prescribed in the experimental protocol
- No objections to taking study drugs
- No objections to refraining from intercourse the night before any sampling and willing
to using condoms during vaginal intercourse.
Exclusion Criteria:
- Oral contraceptive use or other hormone supplement within the preceding 2 months
- Women with current cervical infection
- Evidence of abnormal cervical cytology
- Use of Paragard IUD for contraception
- Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera®)
- Contraindications to study drugs
- Current or past pregnancy within the previous 6 months or currently trying to conceive
- Desiring to conceive in the next 8 months
- Breastfeeding in the past 2 months
- Diagnosed Diabetes or Metabolic Syndrome
- Current or previous use of cholesterol lowering drugs within the preceding 12 months
- Diagnosed Polycystic Ovary Syndrome
- History of, or self-reported, substance abuse
- Smoker
- Previous infertility treatment excluding male factor issues
- Use of an investigational drug within the past 2 months
- History of excisional or ablative treatment procedure on cervix (ie. LEEP,
Cryotherapy, Cold Knife Cone)
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Regulation of Cervical Mucus Secretion | NCT02969590 | Contradiction |
6,777 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients with medical diagnosis of congenital coagulopathies: hemophilia A, hemophilia
B, or von Willebrand's disease
- Patients over 18 years of age
- Patients in a prophylactic or on demand regimen with FVIII / FIX concentrates
- Patients that have accepted the informed consent document.
Exclusion Criteria:
- Patients with neurological or cognitive disorders that prevent the comprehension of
the questionnaires
- Patients without capacity to walk autonomously or with orthosis
- Patients without access to digital media to complement the measuring instruments.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Pain in Patients With Congenital Coagulopathies | NCT03499522 | Entailment |
6,309 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
All consecutive patients referred to the Emergency Unit of the "V. Cervello" Hospital, in
Palermo, Italy, for clinical symptoms suggestive of suspected COVID-19 infection.
In details, we consider patients referred for one or more of the following manifestations:
respiratory symptoms, fever, taste or smell loss.
To be included their records must include:
- detailed clinical history
- radiological findings (High-resolution CT, HRCT)
- results of viral RNA research for SARS-COV2, by PCR on nasopharyngeal swab, repeated
two times (at the admission and again after 48 hours from the admission in the
Emergency Unit)
- laboratory results regarding routine hemato-chemical assays
- oxygen therapy
- treatment used.
Exclusion Criteria:
- age <18 years
- incomplete medical records with respect to the parameters sought
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 95 Years | Comparison Between Positive and Negative COVID-19 Pneumonia | NCT04507893 | Entailment |
3,989 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Subject has both clinical and radiographic findings consistent with osteoarthritis of
the knee:
1. Subject has clinical findings including (but not limited to) tenderness to
palpation, swelling/effusion, stiffness, chronic limited range of motion.
2. Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 2 to 3 using
the Kellgren-Lawrence grading scale.
- Failed conservative care over the past 3 months of at least 2 conservative treatments
including oral pain medication [analgesics, steroids and/or non-steroidal
anti-inflammatory drugs (NSAIDs)] and structured physical therapy or exercise program
prescribed by physical therapist, chiropractor provider or physician specifically for
the treatment of knee osteoarthritis.
- Subject has a BMI less than 40 kg/m2
- Subject is willing and able to provide informed consent and participate in all
procedures and follow-up evaluations necessary to complete the study.
- Subject must have a VAS pain score of 4 or greater on a 100-mm scale.
- All subjects of reproductive age or capacity must use adequate contraception
(abstinence, surgically sterilized, postmenopausal, or consistently use an effective
contraception method) during the study.
- Subject agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine,
collagen, hyaluronic acid) during the study without reporting the use to the study
team.
Exclusion Criteria:
- Subject has a diagnosis of knee osteoarthritis (OA) defined as Grade 4 on the
Kellgren-Lawrence grading scale.
- Subject has active infection at the injection site.
- Subject has symptomatic OA of the contralateral knee or of either hip (VAS≥40) that is
not responsive to acetaminophen (Tylenol®) and/or Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs, e.g. Ibuprofen) and requires other therapy.
- Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any
other disorders that is the primary source of their knee pain, including but not
limited to:
osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
- Subject has documented history of gout or pseudo-gout.
- Subject has a known allergy to local anesthetics.
- Subject has autoimmune disease or a known history of having Acquired Immunodeficiency
Syndromes (AIDS) or Human Immunodeficiency Virus (HIV).
- Subject has diagnosis of hematologic, renal, hepatic, or coagulation abnormalities
based on medical history and laboratory results.
- Subject has received any of the following to the target knee:
1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to
screening;
2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to
screening;
3. Has had or is planning to have major surgery in the target knee within 26 weeks
of treatment; or
4. History of unicondylar or total knee arthroplasty.
- Subject is currently participating in another clinical trial or has used an
investigational drug, device or biologic within 12 weeks prior to treatment.
- Subject has a history of immunosuppressive use or chemotherapy in the last 12 months.
- Subject has had prior radiation to the index knee.
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).
- Subject is breast feeding or pregnant or plans to become pregnant within 12 weeks of
treatment.
- Subject has any significant medical condition that, in the opinion of the
Investigator, would increase the chances of an adverse event and/or would interfere
with protocol evaluation and participation.
- Subject is a worker's compensation patient.
- Subject has taken pain medication <48 hours prior to the injection or has received
pain medicine other than acetaminophen and/or NSAIDs for conditions unrelated to OA of
the index knee.
- Subject has a history of alcohol or substance abuse.
- Physical or IA injection exclusion criteria include:
1. Frank mechanical symptoms such as locking, intermittent block to range of motion,
or loose body sensations (meniscal displacement or IA loose body),
2. Knee surgery on index knee within 12 months or on contralateral knee within 6
months, and/or
3. Acute injury to the knee within 3 months.
- Subject has uncontrolled, unstable diabetes mellitus with HbA1C =/>8%.
- History within preceding 5 years of solid organ or hematologic transplantation or
diagnosis of non-basal cell malignancy.
- History within the preceding 6 months of septic arthritis in the affected knee or
sepsis/bacteremia.
- History within the preceding 3 months of infection requiring antibiotic treatment .
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Study of AlloGen® Liquid Intra-articular Injection for Knee Osteoarthritis | NCT04835389 | Entailment |
6,721 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Main Inclusion Criteria:
- Ethnic Chinese
- is of any age
- has a documented diagnosis of severe or moderately severe hemophilia A (congenital
FVIII deficiency: baseline Factor VIII (FVIII) ≤ 2%)
- has documented and verified >50 exposure days (EDs) to FVIII (recombinant or plasma
derived)
- is receiving on-demand treatment with FVIII at the time of enrolment in this study
- has negative history of inhibitor development
- is HIV negative or HIV positive with stable disease and CD4+ count ≥ 200 cells per
mm^3
- is negative for Hepatitis C virus (HCV); Or participant is HCV positive with chronic
stable hepatitis as assessed by investigator
Main Exclusion Criteria:
- has prior history of hypersensitivity or anaphylaxis associated with receipt of FVIII
- is diagnosed with other bleeding disorder(s) other than hemophilia A, including but
not limited to thrombocytopenia (platelet count < 100000 /mL)
- has been exposed to an investigational product (IP) within 30 days prior to the
screening visit or is scheduled to participate in another clinical study involving an
IP or investigational device during participation in the study
- is planned, or likely to have surgery during the study period
- has end-stage renal failure or evidence of a severe or uncontrolled systemic disease
as judged by the investigator
- has active hepatic disease (alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) levels > 5 times the upper limit of normal)
- has clinical or laboratory evidence of severe liver impairment including (but not
limited to) a recent & persistent international normalized ratio (INR) >1.4, and/or
the presence of splenomegaly and/or significant spider angioma on physical exam,
and/or a history of esophageal hemorrhage or documented esophageal varices
- is a family member of the investigator or site staff
Male
No healthy subjects accepted to join the trial.
| China ADVATE PTP Study | NCT02170402 | Contradiction |
2,317 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Clinical diagnosis of Duchenne muscular dystrophy
Exclusion Criteria:
- Inability to follow verbal instructions
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 25 Years | Relationship Between PFTs and Pdi in DMD | NCT03335384 | Entailment |
4,224 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- male 18-50 years
- oligozoospermia: < 5 million spermatozoa/mL;
- asthenozoospermia: < 32% progressive motile spermatozoa;
- teratozoospermia: < 4% normal forms.
Exclusion Criteria:
- azoospermia
- smoke
- use drugs
- use drugs with proven fertility toxicity
- exposition to any environmental or occupational toxic substances
- exposition to radiation or heat
- orchitis secondary to mumps
- sexually transmitted diseases
- history of cryptorchidism
- previous testicular torsion
- genitourinary anomalies
- alterations of the epididymis or deferens
- inguinal surgery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility | NCT03864198 | Contradiction |
404 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Be healthy on the basis of medical history (screening only), physical examination,
vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1
(predose)
- Be healthy on the basis of clinical laboratory tests performed at screening. If the
results of the serum chemistry panel, hematology, or urinalysis are outside the normal
reference ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant. This
determination must be recorded in the participant's source documents and initialed by
the investigator
- All female participants (regardless of childbearing potential), must have a negative
serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a
negative urine pregnancy test on Day -1 of each treatment period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for at least 1 month after the last study drug
administration
- A man, who is sexually active with a woman of childbearing potential and has not had a
vasectomy, must agree to use an adequate contraception method as deemed appropriate by
the investigator (for example, abstinence, vasectomy, barrier method, partner using
effective contraception)
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, hepatic (Child-Pugh Score greater than or equal to [>=] 7)
or renal insufficiency (estimated glomerular filtration rate [eGFR] less than [<] 60
milliliter per minute per 1.73 meter square [mL/min/1.73m^2] based on the modified
diet renal disease [MDRD] formula at screening only), thyroid disease, neurologic
(including seizure disorders) or psychiatric disease (depression or anxiety disorder
in remission is acceptable), infection, or any other illness that the investigator
considers should exclude the participant or that could interfere with the
interpretation of the study results. Significant past gastrointestinal medical
history, or any disease/surgery that would with interfere drug absorption
- Clinically significant abnormal values for hematology, clinical chemistry (including
thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at
admission to the study site. It is expected that laboratory values will generally be
within the normal range for the laboratory, though minor deviations, which are not
considered to be of clinical significance to the investigator, are acceptable
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at
screening or at admission to the study site though minor deviations, which are not
considered to be of clinical significance to the investigator are acceptable
- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, oral contraceptives, and hormonal replacement
therapy within 14 days before the first dose of the study drug is scheduled. Or has
used any systemic herbal medications or dietary supplements including products
containing Hypericum perforatum (for example, St. John's Wort) from 21 days before the
first dose of study drug is scheduled
- Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within
14 days or a period less than 5 times the drugs half-life; whichever is longer, before
the first dose of the study drug is scheduled
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants | NCT03682380 | Contradiction |
3,923 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
Patellofemoral Osteoarthritis group: 1) age 35-70 years, 2) have been diagnosed with knee
osteoarthritis in one or both knees with symptoms primarily in the anterior knee, 3)
radiographic evidence of ≥ Grade 1 osteophytes or joint space narrowing at the
patellofemoral joint according to the Osteoarthritis Research Society International (OARSI)
grading scale (0 = none, 1 = mild/possible, 2 = moderate/definite, 3 = severe), 4) pain
produced by ≥ 2 of the following: descending steps, ascending steps, sit-to-stand,
squatting, kneeling, prolonged knee flexion, increased activity (e.g., hiking), morning
stiffness < 30 minutes, stiffness after sitting ≥ 30 minutes, history of patellar
subluxation or dislocation in the past.
Control group: 1) age 35-70 years, 2) no known diagnosis by a physician of knee
osteoarthritis, 3) pain free in the lower extremities at the time of enrollment into the
study and for 1 week prior to enrollment.
Exclusion Criteria:
Patellofemoral Osteoarthritis (PFOA) group: 1) the presence of other conditions that may
cause knee pain (e.g., patellar tendonitis, rheumatoid arthritis), 2) neurologic or
musculoskeletal conditions that may alter lower extremity kinematics (e.g., multiple
sclerosis, hip arthritis/arthroplasty), 3) history of a fracture of the knee, 4) pregnancy,
5) knee injections within the past 3 months, 6) inability to understand English.
Control group: 1) all previously listed exclusion criteria for the PFOA group, 2) knee pain
produced by 2 or more of the following: descending steps, ascending steps, sit-to-stand,
squatting, kneeling, prolonged knee flexion, or a history of patellar subluxation or
dislocation in the past.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 70 Years | Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study | NCT02825238 | Entailment |
3,015 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Males and females between the ages of 50-90 with a molecular documentation of a
fragile X premutation, diagnosed with FXTAS.
2. stable current pharmacological treatment regimen for at least 4 weeks.
3. English speaking (the intervention is currently only available in English)
4. Clinically significant hypertension.
5. Normal or corrected to normal vision and hearing.
Exclusion Criteria:
1. Significant medical and behavioral problems that would interfere with the study (e.g.
not being able to sit and play a computer game for 10 minutes)
2. Participants who plan to initiate or change pharmacologic or non-pharmacologic
interventions during the course of the study
3. Individual is non-verbal (has no spoken language)
4. English is not the primary language.
5. Clinically critical Hypertension that requires medical attention
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years | Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia | NCT03816540 | Contradiction |
2,103 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Key Inclusion Criteria:
1. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the
past 7 years prior to study participation.
2. HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25%
honeycombing.
3. FVCpp value ≥50% and ≤80%.
4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and
≤90%.
5. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but
discontinued at least 1 week prior to screening, unless neither treatment is available
in the host country.
Key Exclusion Criteria:
1. Previous exposure to pamrevlumab.
2. Evidence of significant obstructive lung disease.
3. Female subjects who are pregnant or nursing.
4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
study.
5. Interstitial lung disease other than IPF.
6. Sustained improvement in the severity of IPF.
7. Other types of respiratory diseases including diseases of the airways, lung
parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
8. Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart
failure or pulmonary hypertension, or cancers.
9. Acute IPF exacerbation during Screening or Randomization.
10. Recent use of any investigational drugs or unapproved therapies, or approved or
participation in any clinical trial.
11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | NCT04419558 | Entailment |
6,391 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- For the patients:
- Any woman or man requesting a home visit and having symptoms characteristic of
viral infection, with initial manifestation within the previous 48-72 hrs. Such
symptoms may include sudden fever onset, accompanied by one or more of the
following symptoms: dry cough, sore throat, nasal congestion, headache,
musculoskeletal pain, perspiration, fatigue, malaise, blurry vision, loss of the
sense of smell.
- For the people cohabiting with patients:
- Any woman or man cohabiting with study patients.
Exclusion Criteria:
- Children and adolescents under the age of 18 years;
- Pregnant women;
- Persons suffering from a pre-existing condition preventing them from autonomously
providing informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Assessment of the Clinical Effectiveness of a Herbal Extract (Cretan IAMA) in Patients With Viral Respiratory Infections, Including COVID-19, in Primary Healthcare Settings, and Co-assessment of Its Prophylactic Effect in People Cohabiting With These Patients | NCT04705753 | Entailment |
1,185 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a
diagnostic thoracentesis.
Exclusion Criteria:
- Inability to provide informed consent by the patient or the surrogate to enroll for
the planned study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | iSTAT Comparison Study, IRB3785 | NCT02208895 | Entailment |
712 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Subject must be able to wear the investigational device so that there is adequate PEMF
exposure to the knee.
2. Subject must have a body mass index ≤ 45 at the time of consent.
3. Subject must be at least forty (≥ 40) years of age of age at the time of consent.
4. Subject must have an established diagnosis of primary femorotibial OA in the target
knee by modified American College of Rheumatology criteria for at least 6 months and
at least one of the following:
i. Stiffness less than 30 min ii. Crepitus (noise or cracking on knee motion)
5. Subject must have symptomatic Kellgren-Lawrence (K-L) Grades 1-3 OA by radiograph (PA
flexion) within 90 days of screening, where the K-L grades are defined as:
Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2:
definite osteophytes and definite narrowing of joint space; Grade 3: moderate multiple
osteophytes and definite narrowing of joint space and some sclerosis and possible
deformity of bone contour
6. Subject must have a visual analog pain score between 4 cm and 8 cm on a 10 cm scale in
the target knee at the time of screening.
7. Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm
confirmed by radiograph.
8. Subject must be ambulatory.
9. Subject must NOT have had arthroscopy within 8 weeks of randomization.
10. Subject must NOT have had viscosupplementation within 8 weeks of randomization.
11. Subject must NOT have had NSAIDs within 1 week of randomization (low-dose aspirin as
cardioprotective prophylaxis is permitted).
12. Subject must be willing to discontinue corticosteroids administered by any route
except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
13. Subject must be willing to take acetaminophen (up to 3000 mg/day) as pain medication
for the duration of the study. Other pain medications may be allowed during the course
of the study if the subject meets specific criteria.
14. Subject must be willing to STOP taking any pain medications 24 hours prior any
scheduled study visit.
15. Subject must NOT have participated in a clinical study within the past 12 weeks that
required the use of an investigational device, drug or biologic.
16. Subjects must be proficient in English.
17. Subject must be willing and able to sign an informed consent document.
18. Subjects must be willing and able to comply with all study procedures for the duration
of the clinical study.
Exclusion criteria:
1. Subjects who have a body mass index > 45 at the time of consent.
2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint
infection, Lyme disease, SLE, etc.).
3. Subjects with a diagnosis of secondary arthritis (acromegaly, Charcot's arthropathy,
hemochromatosis, Wilson's disease, ochronosis, etc.).
4. Subjects with confounding factors such as ipsilateral hip OA or chronic pain syndromes
(fibromyalgia, Crohn's disease, ulcerative colitis, interstitial cystitis).
5. Subjects who have had an injury or an acute traumatic injury to the index knee within
6 months of screening will be excluded.
6. Subjects who have had treatment of the target knee with intra-articular injections of
steroids within 8 weeks of screening.
7. Subjects who have had intra-articular injections of hyaluronic acid within 8 weeks of
screening.
8. Subjects who plan to have surgery on the target knee within the study period.
9. Subjects who have used electrotherapy or acupuncture for OA of the target knee within
4 weeks of screening.
10. Subjects with significant and clinically evident mal-alignment of the target knee (>
10 degrees varus or valgus in the target knee).
11. Subjects with surgical metallic hardware in the target knee.
12. Subjects with pain in any other area of the lower extremities or back that is equal to
or greater than the pain in the target knee.
13. Subjects who have contraindications to MRI and X-rays, for example, implanted
electrical devices (cardiac pacemakers, deep brain stimulators).
14. Subjects with a current malignancy or who have received treatment for malignancy with
the last 5 years, with the exception of resected basal cell carcinoma and squamous
cell carcinoma of the skin.
15. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of
chronic substance abuse (> 5 years).
16. Subjects with skin breakdown or infection in the area where the study device will be
placed.
17. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart
failure, etc.) that have not been well-controlled for at least 3 months prior to
screening.
18. Subjects who have any ongoing litigation for worker's compensation.
19. Subjects with any condition, in the opinion of the Investigator that might interfere
with the evaluation of the study objectives.
20. Subjects who are unwilling or unable to adhere to the follow up schedule and
procedures.
21. Subjects who are pregnant.
22. Subjects who are prisoners.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee | NCT02436590 | Contradiction |
4,782 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion criteria: • Patients with acquired single sided sensorineural deafness due to
cochlear damage.
- Age: 18-70 years old.
- Onset of SSD within 6 months to 10 years before Study inclusion.
- Normal hearing on the contralateral ear (Hearing thresholds 0.125-2 kHz 25 dB HL or
better, 4-8 kHz 35 dB HL or better, 100% speech discrimination at 80 dB SPL).
- Regular middle ear function on the hearing ear.
- Regular structure of the cochlea and the cochlear nerve (as demonstrated by MRI, MRI
scans are included in the basic assessment of SSD and are no study-specific
investigations).
- Fluency in the German language.
- Subject is willing to comply with all study requirements.
- Impairment in daily life as a consequence of SSD (communication problems, annoyance by
tinnitus perception).
- Subject is not participating in another ongoing research study related to the SSD.
- Subject does not have unrealistic expectations, regarding the outcome of the
intervention.
- Subject has had a trial with conventional acoustic measures in SSD (CROSS, BAHA).
Exclusion criteria: • Uncertainty of correct diagnosis of SSD.
- Retrocochlear cause of SSD (Deafness due to lesions of the acoustic nerve or central
auditory pathways).
- Active middle ear infections.
- Ossification of the cochlear that prevents electrode insertion.
- Tympanic membrane perforation.
- Psychiatric comorbidities such as depression or cognitive deficits.
- Severe coexisting illness with a medium survival of less than 5 years.
- Exposure to radiation with a cumulative effective dose of 5 mSV within the last 5
years (including the ongoing year).
- Increased risk profile for general anesthesia due to cardiovascular comorbidity.
- Metallic implants constituting an exclusion criterium for MEG procedures of the brain.
- Pregnancy (a pregnancy test will be performed in women in the reproductive age group
before study enrolment and before postoperative PET scan) and lactation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Single-sided Deafness and Cochlear Implants | NCT01749592 | Entailment |
3,806 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50,
and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee
during the last year (equal to or more than 28 separate or consecutive days).
- Have no previous diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout.
- Have no history of using disease-modifying anti-rheumatic drugs or gout medications.
- Have no prior knee replacement surgery, and not on a waiting list for total knee
replacement surgery.
- Have no history of acute injury to the knee in the past 6 months.
- Have not had surgery in the back, hip, knee, foot or ankle joints in the past 12
months.
- Have an email address and daily access to a computer with internet connection.
- Be able to attend a 2-hour education session at the Mary Pack Arthritis Centre.
Exclusion Criteria:
- Have a body mass index of equal to or greater than 40
- Have received a steroid injection in a knee in the last 6 months
- Have received a hyaluronate injection in a knee in the last 6 months
- Use medication that may impair activity tolerance (e.g. beta blockers)
- Are at risk when exercising, as identified by the Physical Activity Readiness
Questionnaire (PAR-Q)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Feasibility of a Wearable-enabled Intervention for Promoting Physical Activity in People Knee OA | NCT02313506 | Entailment |
3,313 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- all patients attending assuit university hospital clinics complaining of pigmentary
skin lesions
Exclusion Criteria:
- no exclusion criteria
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Dermoscopy in Diagnosis of Pigmentary Skin Lesions | NCT03542539 | Entailment |
5,696 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion criteria:
All the children who consulted for the first time because of their short stature, in
pediatric endocrinology at the Montpellier University Hospital between January 2017 and
December 2018
Exclusion criteria:
Patient already undergoing specialized medical follow-up due to his small size Major
patient
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients | NCT04754516 | Entailment |
1,874 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- patients undergoing ESD for gastric neoplasms
Exclusion Criteria:
- (1) history of acid suppressive medication within 1 week prior to the procedure; (2)
known gastrointestinal disorders, such as peptic ulcer disease, which might impact
epigastric pain assessment; (3) current or regular use of pain medication; (4) history
of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation
during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or
psychological disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Pain After Endoscopic Submucosal Dissection | NCT02254889 | Entailment |
4,216 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Subjects who are able to understand this study and comply with all study procedures,
are able to be trained and use the device correctly at screening and willing to
provide written informed consent before screening.
2. Subjects judged to be healthy by the principal or sub investigator, based on medical
history and clinical evaluation.
3. Male and female subjects ≥ 40 to ≤ 80 years of age at the time of informed consent.
4. Subjects whose body mass index (BMI) is ≥ 18.0 and < 30.0 kg/m2 during the screening
visit．
5. Subjects able to produce a peak inspiratory flow rate of at least 30.00L/min at
screening using the investigational device attached to an electronic flow meter.
6. Subjects who have smoked within 12 months before admission cannot be entered the
study.
7. Subjects judged to have normal lung function. Specifically, with percent predicted
forced expiratory volume in 1 second (%FEV1) ≥ 80% and forced expiratory volume in 1
second (FEV1)/forced vital capacity (FVC) ratio ≥70%.
8. Male subjects are eligible to participate if they agree to the following during the
treatment period and for at least 3 months (a spermatogenesis cycle) after the last
dose of study intervention.
- Refrain from donating sperm.
- Must agree to use a male condom and should also be advised of the benefit for a
female partner to use a highly effective method of contraception as described in
Appendix 2, as a condom may break or leak when having sexual intercourse with a
woman of childbearing potential who is not currently pregnant.
9. Female subjects who agree to use of appropriate contraception measures from time of
screening until 3 months after the last dose of study drug, except for female subjects
who are surgically sterile by bilateral oophorectomy for at least 6 weeks with
appropriate documentation or who are post-menopausal (defined as at least 6 months of
spontaneous amenorrhea in woman > 45 years with serum follicle-stimulating hormone
(FSH) levels > 40 mIU/mL at screening, or at least 12 months of spontaneous amenorrhea
in woman > 45 years)
Exclusion Criteria:
1. Subjects deemed by the principal or sub investigator to be ineligible for the study
due to history of, or concurrent and clinically significant metabolic or endocrine,
hepatic, renal, haematological, respiratory, cardiovascular, gastrointestinal,
urological, immunological, neurological or psychiatric disorders, or any malignant
neoplasms at any diagnosed stage.
2. Radiation exposure, including that from the present study, excluding background
radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv
in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
as defined in the Ionising Radiation Regulations 2018, shall participate in the study.
3. Subjects who have a history of clinically relevant respiratory disease, diseases
affecting respiratory function, E.N.T. diseases, or lung surgery.
4. Subjects who have had an upper respiratory infection in the last 7 days which could
affect inhalation/absorption of study medication.
5. Subjects who use regular medication (prescribed and/or over the counter) or have used
any medication (excluding non-prescription drugs, vitamins, and dietary or herbal
supplements which do not interfere with respiratory function according to their
labelling) within 14 days before admission; exceptions may be permitted on a case by
case basis if considered not to interfere with the aims of the study and agreed by the
investigator and sponsor's medical monitor.
6. Subjects with a history of lactose intolerance, intolerance to dairy products, or a
history of gluten intolerance.
7. Subjects with a history of serious adverse reaction or serious hypersensitivity to the
active ingredient or excipients in any drug.
8. Subjects with a history of drug and/or alcohol addiction within the past 2 years
before screening or a positive test for drugs or alcohol at screening or admission
visit.
9. Regular alcohol consumption in males of > 21 units per week, or females of > 14 units
per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
10. Subjects with a positive result on any of the tests for the serologic detection of
human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen
(HBsAg), and hepatitis C antibody.
11. Female subjects who are pregnant, breast-feeding, have a positive pregnancy test
result during the screening assessment or admissions; or intending to become pregnant
during the study period or within 3 months after the last dose of study treatment.
12. Subjects who have donated > 400 mL of blood within 3 months before screening, > 200 mL
within 4 weeks before screening, or who donated blood between screening and admission.
13. Subjects who have been exposed to an investigational drug within 90 days prior to
study drug administration.
14. Subjects who have previously received pirfenidone (Esbriet®, Pirespa®) in any form, or
S 770108.
15. Subjects who are study site employees or immediate family members of a study site
employee, or sponsor employees.
16. Subjects who are ineligible for the study for any other reason, as judged by the
investigator or sub investigator.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device | NCT04631354 | Contradiction |
2,087 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | IPF :
INCLUSION CRITERIA
1. Age 18-85 years
2. IPF diagnosed according to ATS/ERS/JRS/ALAT criteria
3. Patient gave informed consent
NON INCLUSION CRITERIA
1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema,
tuberculosis sequelae, prior lung surgery
2. Obstructive ventilatory disorder
3. Counterindication to pulmonary function testing
4. Women : Pregnancy or milking
5. Lack of health insurance
Controls :
INCLUSION CRITERIA
1. Volunteers aged 18-85 years, free of any respiratory disease
2. Volunteer gave informed consent
Secondary EXCLUSION CRITERIA Abnormal PFT : Total lung capacity or FEV1/VC ratio < Lower
Limit of Normal
Non-IPF ILD :
INCLUSION CRITERIA
1. Age 18-85 years
2. Radiological interstitial pneumonia, on 2 tests performed >3 months apart
3. PINS histology OR sarcoidosis histology OR clinical diagnosis of drug-induced lung
disease OR diagnosis of auto-immune disease
4. Patient gave informed consent
NON INCLUSION CRITERIA
1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema,
tuberculosis sequelae, prior lung surgery
2. Obstructive ventilatory disorder
3. Counterindication to pulmonary function testing
4. Women : Pregnancy or milking
5. Lack of health insurance
Uncharacterized ILD :
INCLUSION CRITERIA
1. Age 18-85 years
2. Radiological interstitial pneumonia, on 2 tests performed >3 months apart
3. Patient gave informed consent
NON INCLUSION CRITERIA
1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema,
tuberculosis sequelae, prior lung surgery
2. Obstructive ventilatory disorder
3. Counterindication to pulmonary function testing
4. Women : Pregnancy or milking
5. Lack of health insurance
Secondary EXCLUSION CRITERIA Final diagnosis other than either IPF or non-IPF interstitial
pneumonia.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Conducting Airways in Lung Fibrosis (VACFI) | NCT01777373 | Entailment |
5,873 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male or female subjects aged 18-80 years old (females of childbearing potential should
be on highly effective contraceptive methods)
- Mentally capable to provide informed consent in English
- Present to the Northwestern Medical Group GI practice or the Washington University
Division of Gastroenterology with symptoms of GERD (heartburn, regurgitation, and
non-cardiac chest pain)
- Have failed an appropriate compliant trial of PPI therapy with a GERD-Q score ≥8.
- Able to undergo endoscopy, ambulatory reflux monitoring, manometry, PPI therapy
cessation and trial of dexlansoprazole therapy. Subjects with Los Angeles
Classification Grade A (mild) or B esophagitis and symptomatic, non-erosive disease
will be enrolled.
Exclusion Criteria:
- Participation in a concurrent clinical trial or completed another trial within past 8
weeks.
- Active severe erosive esophagitis (Los Angeles Grade C or D), long-segment Barrett's
esophagus (Zap score of 4)
- Eosinophilic esophagitis
- Prior gastrointestinal surgery of the esophagus and/or stomach
- Current treatment with dexlansoprazole
- Current signs or symptoms of heart disease. All patients with non-cardiac chest pain
are required to have a cardiologist evaluation as standard of care work up in the
evaluation of non-cardiac chest pain.
- Subjects with clinically abnormal results of the screening ECG and/or chemistry panel
(particularly prolonged QTc interval or hypomagnesaemia) excluded from the
dexlansoprazole trial. Subjects with sensitivities or allergies to the metals
contained in the Bravo capsule including chromium, nickel, copper, cobalt, and iron.
- Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with
well-controlled hypertension, diabetes and a remote history of ischemic heart disease
that is deemed stable, as judged by the investigator can be included.
- History of drug addiction, drug abuse or alcoholism.
- Current neurologic or cognitive impairment, which would preclude ability to obtain
informed consent.
- Pregnant patients.
- Patients with Cirrhosis (Childs Classification A-C).Special vulnerable populations
including children, prisoners, institutionalized individuals.
- Bleeding disorder or requirement of NSAID/aspirin during monitoring period.
- Drugs that affect gastrointestinal symptoms (H2 blockers, antacids, metoclopramide,
domperidone, erythromycin, anticholinergics [bentyl, levsin, belladonna etc.]).
Antidepressants can be continued at stable dose.
- Drugs listed on the Dexilant label including antiretrovirals (Rilpivirine-containing
products, Atazanavir, Nelfinavir, Saquinavir, etc), Warfarin, Methotrexate, Drugs
Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib,
nilotinib, mycophenolate mofetil, ketoconazole/itraconazole), Tacrolimus, CYP2C19 or
CYP3A4 Inducers or inhibitors.
- Patients found to have achalasia, a spastic disorder, hypercontractile disorder or
functional obstruction at the esophagogastric junction will be excluded. Subjects with
a history of structuring or narrowing upon endoscopy (Subjects with no such history
will be enrolled; however, if such features are noted upon endoscopy during the study,
these subjects will not undergo MI testing).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Effectiveness of Physiologic Testing in PPI Non-Responders | NCT03202537 | Contradiction |
971 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. BMI ≥ 25 and ≤ 29.9 kg/m2.
2. With unilateral or bilateral OA of the knee for at least greater than 3 months, as
presented by pain in the knee at least for last 3 months.
3. Post-menopausal females (LMP at least 12 months prior to the screening).
Exclusion Criteria:
1. History of osteoarthritis for more than 3 years.
2. Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg
3. FBS>140 mg/dl.
4. Smokers or chronic alcoholics.
5. Participants planning to travel in the next 56 days or engage in any non-routine
activity that is likely to strain the knees.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Effect of LANCONONE in Weight-bearing Joint Pain | NCT03658369 | Entailment |
1,052 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Syncopal and/or near syncopal episodes at least twice within the prior 3 months
Exclusion Criteria:
- Neurological disease
- Structural heart disease
- Metabolic and psychiatric illness
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope | NCT00143754 | Contradiction |
5,914 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria: -
1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements
2. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any procedures
3. Has persistent typical gastroesophageal reflux disease (GERD) symptoms (heartburn
and/or acid regurgitation) for at least 6 months and a frequency of GERD symptoms is
at least 4 days within the past 7 days prior to the screening visit
4. Meets one of the following diagnoses verified by the screening endoscopy
1. Has macroscopically normal esophageal mucosa on endoscopy and may thereby be
eligible for assignment to the nonerosive reflux disease (NERD) study group
2. Has evidence of erosive esophageal reflux disease on endoscopy, Los Angeles (LA)
classification grades B-D, and thereby may be eligible for assignment to the
erosive esophagitis (EE) study group
5. Is able and willing to record GERD symptoms in a subject diary and has completed the
diary at least for 7 consecutive days during the screening period
6. Male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 30 days after last dose
7. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent throughout the duration of the study
8. All female participants of childbearing potential must have a negative urine pregnancy
test at Screening and a negative urine pregnancy test at Day -1. Participants who have
had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of
menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level >40 IU/L or
absence of menses for >2 years) are not required to use birth control
Exclusion Criteria:
1. Has received any investigational compound within 30 days prior to Screening
2. Known hypersensitivity to any proton pump inhibitor (including lansoprazole,
omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of
dexlansoprazole
3. Use of a H2 blocker or a PPI other than dexlansoprazole during screening and
throughout the study. Previous use of Dexlansoprazole before screening
4. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
5. Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug
6. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring
of mucosal tissue near the lower esophageal sphincter)
7. Co-existing diseases affecting the esophagus, (eg, esophageal varices, scleroderma,
viral, fungal infection or esophageal stricture), history of radiation therapy or
cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy
to the esophagus
8. Chronic use (>12 doses/month) of non-;steroidal anti-inflammatory drugs (NSAIDs)
including COX 2 NSAIDs within 30 days prior to screening period and throughout the
study, however, low dose aspirin up to 325 mg per day is allowed
9. In the judgment of the investigator, participant has clinically significant abnormal
hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening
10. Has a history or clinical manifestations of significant organ failure which would
preclude their successful completion of the study
11. Participants using drugs with significant anticholinergic effects such as tricyclics
who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study
12. Participants with known biliary disease
13. Participants with the need for continuous anticoagulant therapy
14. Participants with cancer (except basal cell and squamous cell carcinoma of the skin)
within 3 years prior to Screening
15. Any condition that may require inpatient surgery during the course of the study
16. Has abnormal laboratory values that suggest a clinically significant underlying
disease or condition that may prevent the subject from entering the study; or subject
with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase
(ALT) and/or Aspartate Aminotransferase (AST) >2.0X the upper limits of normal, or
Total Bilirubin >2.0 mg/dL with AST/ALT elevated above normal values
17. Known to have acquired immunodeficiency syndrome (AIDS)
18. Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory
condition
19. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
20. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of endoscopy
22. Has received blood products within 3 months prior to the first dose of study drug 23.
History of alcohol abuse [>21 units (1 unit = 12 oz beer, 1.5 oz hard liquor, or 5 oz wine)
per week] or illegal drug use or drug addiction in the 12 months prior to Screening 24.
Participants who, in the opinion of the investigator, are unable to comply with the
requirements of the study or are unsuitable for any reason 25. is required to take excluded
medications 26. If female, the participant is pregnant or lactating or intending to become
pregnant before, during, or within 1 month after participating in this study; or intending
to donate ova during such time period 27. If male, the participant intends to donate sperm
during the course of this study or for 30 days thereafter
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease | NCT02351960 | Contradiction |
1,270 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Patients with pleural diseases
Exclusion Criteria:
- Patients with other lung diseases
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases | NCT03153501 | Entailment |
4,092 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International
Classification of Sleep Disorders, third edition (ICSD-3) criteria
2. Patients aged ≥16 to <65 years at the time of obtaining informed consent
3. Outpatients
Exclusion Criteria:
1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome,
periodic limb movement disorder)
2. Patients with organic brain diseases (including neurodegenerative diseases or
cerebrovascular disorders) or epilepsy
3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar
disorder, schizophrenia)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 64 Years | A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy | NCT03267303 | Entailment |
6,175 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Clinical suspicion of a new episode of acute respiratory tract infection.
2. Patient is admitted to hospital
3. Primary reason for hospital admission is clinical suspicion of a new episode of ARI
4. Onset of the following symptoms within the last 7 days: i. Sudden onset of
self-reported fever OR temperature of ≥ 38°C at presentation AND ii. At least one
respiratory symptom (cough, sore throat, runny or congested nose, dyspnea) AND iii. At
least one systemic symptom (headache, muscle ache, sweats or chills or tiredness)
OR
Laboratory confirmed SARS-CoV-2 infection at the time of eligibility check.
Exclusion Criteria:
1. Inability to obtain consent from patient or surrogate
2. Previous enrollment in current study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19 | NCT04364711 | Contradiction |
1,616 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Have completed protocol SSC-710 and received either DCVax-001 plus poly ICLC, poly
ICLC only or sterile saline. If less than 6 volunteers who originally received placebo
(poly ICLC only or sterile saline) under protocol SSC_710 are willing to participate
and are found eligible to participate in this proposed study, new volunteers can be
enrolled as long as they are eligible according to the remaining inclusion and
exclusion criteria below.
- Healthy adult males and females, as assessed by a medical history, physical exam, ECG,
and laboratory tests;
- Age of at least 18 years of age on the day of screening and no greater than 62 years
at time of vaccination;
- Willing to comply with the requirements of the protocol and available for follow-up
for the planned duration of the study (screening plus 12 months);
- In the opinion of the principal investigator or designee, has understood the
information provided. (Written informed consent needs to be given before any
study-related procedures are performed);
- Amenable to HIV risk reduction counseling, committed to maintaining behavior
consistent with low risk of HIV exposure through the last required protocol clinic
visit;
- Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of
sexual behaviors within the 12 months prior to enrollment defined as follows:
- Sexually abstinent OR
- Had two or fewer mutually monogamous relationships with partners believed to be
HIV-uninfected and who did not use illicit drugs (illicit drug use or abuse that
includes any injection drugs, methamphetamines (crystal meth), heroin, cocaine,
including crack cocaine or chronic marijuana abuse) OR
- Had two or fewer partners believed to be HIV-uninfected and who did not use illicit
drugs (as defined above) and with whom he/she regularly used condoms for vaginal and
anal intercourse;
- If sexually active female, willing to use one effective method of contraception
(combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine
Device (IUD); condoms; anatomical sterility in self or partner) at least until 3
months after last immunization. All female volunteers must be willing to undergo urine
pregnancy tests at time points as indicated in the Schedule of Procedures.
Exclusion Criteria:
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant abnormality on history or examination including history of
immunodeficiency or autoimmune disease; use of systemic corticosteroids
immunosuppressive anticancer, or other medications considered significant by the trial
physician within the last 6 months
- Any clinically significant acute or chronic medical condition requiring care of a
physician (e.g., diabetes, coronary artery disease, myopericarditis, grand-mal
epilepsy, rheumatologic illness, malignancy, substance abuse) that in the opinion of
the investigator would preclude participation
- History of clinically significant eczema or chronic urticaria
- Any laboratory value outside of reference range, with the exception of any
non-clinically significant Grade I elevations of liver function tests (AST, ALT,
direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined
by the Principal Investigator or his designee
- Baseline ECG with features that would interfere with interpretation of
myo/pericarditis including significant repolarization abnormality, bundle branch
block, and AV block
- Within the 12 months prior to enrollment, the volunteer has had excessive daily
alcohol use or frequent binge drinking or chronic marijuana abuse or any other use of
illicit drugs
- Within the 12 months prior to enrollment, the volunteer has a history of
newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus
type 2 (HSV2), pelvic inflammatory disease (PID), mucopurulent cervicitis,
epididymitis, proctitis, lymphogranuloma venereum, chancroid, hepatitis B (surface
antigen, HbsAg) or hepatitis C (HCV antibodies);
- If female, pregnant, planning a pregnancy during the 3-month follow up period after
last immunization, or lactating
- Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days
prior to study vaccination
- Prior use of medications for HIV PrEP
- Receipt of an investigational product (not vaccine-related) within the last 12 months.
Receipt of a non-HIV experimental vaccine(s) within the last 5 years in a prior
vaccine trial. Exceptions may be made for vaccines that have subsequently undergone
licensure by the FDA. For subjects who have received control/placebo in an
experimental vaccine trial, or who have received an experimental vaccine(s) greater
than 5 years ago, eligibility for enrollment will be determined by the investigators
on a case-by-case basis.
- History of severe local or systemic reaction to vaccination defined as:
- Local: extensive, indurated redness and swelling involving most of the major
circumference of the arm, not resolving within 72 hours;
- Systemic: fever > 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal edema,
circulatory collapse, convulsions or encephalopathy within 72 hours
- History of immediate type hypersensitivity reaction to eggs or egg products
- Major psychiatric illness
- In the opinion of the investigator, unlikely to comply with protocol
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 62 Years | A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR | NCT01889719 | Contradiction |
2,075 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- diagnosis of mild COPD OR healthy control subjects
- 40-80 years old
- able to perform all study procedures
- Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years
(for healthy control subjects)
Exclusion Criteria:
- allergy to atrovent
- history of asthma, atopy or nasal polyps
- Oxygen desaturation < 80 % during exercise
- recent history of CAD (under a year) or any significant diseases that could contribute
to dyspnea or exercise limitation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD) | NCT00202176 | Entailment |
4,322 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Completion of the written informed consent process.
2. Men or WNCBP age 18 to 55 years, in good health as determined by past medical history,
physical examination, vital signs, electrocardiogram, and laboratory tests at
screening.
3. Male subjects agree to use acceptable methods of contraception if the male subject's
partner could become pregnant from the time of the first administration of study
medication until 130 (90+40) days following administration of the investigational
medicinal product. One of the following acceptable methods of contraception must be
utilized:
- Condom and occlusive cap (diaphragm or cervical/vault caps)
- Surgical sterilization (vasectomy with documentation of azoospermia) and a
barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- The subject's female partner uses oral contraceptives (combination
estrogen/progesterone pills), injectable progesterone or subdermal implants and a
barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- The subject's female partner uses medically prescribed topically-applied
transdermal contraceptive patch and a barrier method (condom or occlusive cap
[diaphragm or cervical/vault caps].
- The subject's female partner has undergone documented tubal ligation (female
sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm
or cervical/vault caps].
- The subject's female partner has undergone documented placement of an
intrauterine device or intrauterine system. In addition, a barrier method (condom
or occlusive cap [diaphragm or cervical/vault caps].
- True abstinence: when this is in line with the preferred and usual lifestyle of
the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception. Abstinent subjects have to agree to use 1 of the above-mentioned
contraceptive methods, if they start sexual relationships during the study and
for up to 100 days after the last dose of study drug.
4. Women subjects must be of non-childbearing potential (WNCBP) as per one of the
following definitions:
- Natural (spontaneous) post-menopausal defined as being amenorrhoeic for at least
12 months without an alternative medical cause with a screening follicle
stimulating hormone level consistent with local laboratory levels for
post-menopause.
- Premenopausal with irreversible surgical sterilization by hysterectomy and/or
bilateral oophorectomy or salpingectomy at least 6 months before screening (as
determined by subject medical history).
5. Haematology, clinical chemistry and urinalysis results at screening that are within
the local laboratory reference range or, if outside the range, not clinically
significant as judged by the Investigator. More specifically, serum creatinine,
hepatic transaminase enzymes (AST ALT), and total bilirubin (unless the subject has
documented Gilbert syndrome) should not exceed the upper laboratory norm and
haemoglobin must be equal to or higher than the lower limit of the normal range.
6. Total body weight greater than 50 kg and a body mass index (BMI) within the range of
18 to 32 kg/m2 (inclusive).
7. Non-smoker or ex-smoker for more than 90 days prior to screening, or smoke no more
than 5 cigarettes per day as determined by history. Must be able to abstain from
smoking during the inpatient stay.
8. Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures.
9. Agree to stay in contact with the study site for the duration of the study and up to 2
weeks following the end of study visit, provide updated contact information as
necessary, and have no current plans to move away from the study area for the duration
of the study.
Exclusion Criteria:
1. Male subjects with a female partner(s) who is (are) pregnant or lactating from the
time of the administration of study medication.
2. Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been
sterilized by vasectomy or other means.
3. Evidence or history of clinically significant haematological, renal, endocrine,
pulmonary, gastrointestinal (including gallbladder), cardiovascular (including a
family history of long QT syndrome or sudden death), hepatic, psychiatric, neurologic,
or allergic disease (including drug or food allergies, anaphylaxis or other severe
allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the
time of dosing).
4. History of malignancy of any organ system (other than localised basal cell carcinoma
of the skin), treated or untreated, within the past five years, regardless of whether
there is evidence of local recurrence or metastases.
5. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the Investigator, would make the subject
inappropriate for entry into this study.
6. Any surgical or medical condition possibly affecting drug absorption (e.g.
cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or
excretion.
7. Previous splenectomy.
8. A history of photosensitivity.
9. Subject positive for any of the following
- Anti-human immunodeficiency virus 1 or 2 antibodies (anti-HIV1 or anti-HIV2 Ab)
(ELISA)
- Hepatitis B surface antigen (HBsAg)
- Anti-hepatitis B core antibodies (anti-HBcAb)
- Anti-hepatitis C antibodies (anti-HCV)
10. Resting vital signs (measured after 5 minutes in the supine position) at screening,
pre-dose (Part A) or pre-inoculation (Part B) outside of the following study-specific
normal ranges:
- tympanic body temperature < 38.0 °C
- 90 < SBP < 140 mmHg
- 50 < DBP < 90 mmHg
- 40 < pulse rate < 100 bpm
11. Symptomatic postural hypotension at screening, irrespective of the decrease in blood
pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood
pressure ≥20 mmHg 2 minutes after changing from a supine to standing position.
12. A history of clinically significant ECG abnormalities, or any of the following ECG
abnormalities at screening, pre-dose (Part A and B) or pre-inoculation (Part B):
- PR >210 ms
- QRS complex >120 ms
- QTcF >450 ms
- Second or third degree atrioventricular block
- Incomplete, complete or intermittent bundle branch block
- Abnormal T wave morphology
- Left ventricular hypertrophy with repolarisation abnormalities
- Right ventricular hypertrophy.
13. Presence of acute infectious disease or fever (i.e. tympanic body temperature ≥38.5
ºC) within five days prior to the first dose of study medication (Part A) or the
inoculation administration (Part B).
14. Use of prescription or non-prescription drugs, herbal and dietary supplements within
14 days or 5 half-lives (whichever is the longer) prior to the first dose of study
medication (Part A) or the inoculation administration (Part B). [As an exception,
paracetamol may be used at doses of up to 1 g/day (Part A) or 2 g/day (Part B), or
ibuprofen up to 1.2 g/day (Part B). Limited use of other non-prescription medications
not believed to affect subject safety or the overall results of the study, may be
permitted on a case-by-case basis following approval by the sponsor.]
15. Recipient of any vaccination within 28 days prior to the first dose of study
medication (Part A) or the inoculation administration (Part B).
16. Urine drug screen at screening, pre-dose (Part A) or pre-inoculation (Part B) positive
for any drug as listed in Section 9.2.4 unless there is an explanation acceptable to
the medical Investigator (e.g. the subject has stated in advance that they consumed a
prescription or over the counter product which contained the detected drug) and/or the
subject has a negative urine drug screen on retest by the pathology laboratory.
17. Ingestion of any poppy seeds within the 24 hours prior to the screening blood test.
18. A positive alcohol breath test at screening, pre-dose (Part A) or pre-inoculation
(Part B).
19. History of regular alcohol consumption exceeding a weekly intake of more than 21 units
for males and more than 14 units for females (one unit is equivalent to 8-10 g of
ethanol, 285 ml of beer or lager, one glass [125 ml] of wine, or 25 ml of spirits)
within 6 months of screening.
20. History of drug habituation, or any prior intravenous usage of an illicit substance.
21. Participation in any investigational product study within 12 weeks or five half-lives
(whichever is longer) prior to the first dose of the study medication.
22. Intake of grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g.
Seville oranges, pomelos) within 28 days prior to the first dose of the study
medication.
23. Excessive consumption of beverages containing xanthine bases (e.g. more than 400 mg of
caffeine per day, equivalent to approximately 4 cups of coffee).
24. Pregnant or nursing (lactating) women.
25. Participation in any research study involving blood sampling (more than 450 ml/ unit
of blood), or blood donation to the Australian Red Cross Blood Service (ARCBS) or
other blood bank during the 8 weeks prior to IMP administration (Part A) or
inoculation (Part B).
26. Blood donation (excluding plasma donation) of any volume, within 1 month prior to
screening.
27. Medical requirement for intravenous immunoglobulin or blood transfusions.
28. Subject with poor peripheral venous access.
29. Subject unwilling or unable to comply with the restrictions described in this
protocol.
30. Any subject who, in the judgment of the Investigator, is likely to be noncompliant
during the study, or unable to cooperate because of a language problem or poor mental
development.
31. Any subject who is the Investigator or any sub-investigator, research assistant,
pharmacist, study coordinator, or other staff thereof, directly involved in conducting
the study.
32. Recent (within the last three years) and/or recurrent history of autonomic dysfunction
(e.g. recurrent episodes of fainting, palpitations, etc.).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A | NCT02783820 | Entailment |
6,500 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Must be a healthy, post-pubescent male or female 18 years of age or older with
moderate to severe erythematotelangiectatic and papulopustular rosacea, defined as 10
to 40 papules and pustules
- Must have presence of moderate to severe erythema
- Must have presence of telangiectasia
- Must have a diagnosis or findings consistent with a diagnosis of
erythematotelangiectatic rosacea and papulopustular rosacea
- Must understand and voluntarily sign an informed consent form
- Must be ale to adhere to the study visit schedule and other protocol requirements
- Must be able to restrict diet in order to avoid foods/drinks that are known triggers
that would exacerbate the signs/symptoms of rosacea
- Must have within normal range for routine blood laboratory tests
- Females of childbearing potential must have a negative urine pregnancy test at
screening and if sexually active must agree to use two(2) forms of contraception
(adequate forms of contraception are outlined in the protocol)
- Females of childbearing potential must agree to serum pregnancy tests every 4 weeks
while on study medication
- Males (including those who have had a vasectomy) must agree to use barrier
contraception (latex condoms) when engaging in sexual activity with females of
childbearing potential while on study medication and for 84 days after taking the last
dose of study medication
Exclusion Criteria:
- Inability to provide voluntary consent
- Diagnosis of acne vulgaris or perioral dermatitis
- Use of topical acne or rosacea treatments within 4 weeks of baseline
- Use of systemic retinoids within 90 days of baseline
- Known or suspected excessive alcohol intake (which in the opinion of the investigator
will exacerbate the signs and symptoms of rosacea)
- Use of any investigational medication within 4 weeks prior to start of study drug or 5
pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- A known sensitivity to tetracyclines
- Currently taking clinically significant concomitant drug therapy
- Use of any acne or rosacea treatment during the course of the study or within four
weeks of starting the study medication, including azelaic acid, topical or systemic
retinoids, sulfa drugs, erythromycin, cephalosporins, quinolones, tetracycline,
benzoyl peroxide products, as well as pulse dye laser, intense pulsed light and
photodynamic therapy
- Current use and inability to discontinue use of PDE 4 inhibitors, theophylline,
systemic steroids (oral or inhaled), penicillin antibiotics, niacin greater than 500
mg/day, chronic use of NSAIDS, or use of any medication that in the opinion of the
investigator affects the severity of rosacea
- Long-term use (greater than 14 days) of topical or systemic anti-inflammatories in the
4 weeks prior to baseline and during the study. Chronic use of aspirin at
sub-analgesic doses (less than 325 mg once daily) is acceptable for patients requiring
platelet aggregation inhibition
- Use of topical or systemic corticosteroids 4 weeks prior to baseline and during the
study
- Patients with ocular rosacea and/or blepharitis/meibomianitis who required treatment
by an ophthalmologist
- Patients who had surgeries that bypassed or excluded the duodenum
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study
- Pregnant or breastfeeding women, or women of childbearing potential who are not using
an adequate form of birth control as described in the inclusion criteria
- Initiation of a hormonal method of birth contraception within 4 months of baseline,
discontinuation during the course of the study, or change in the product within 4
months of baseline during the study
- Subject is a woman who is perimenopausal whos symptoms cause flushing that may affect
the rosacea
- Systemic fungal infection
- History of active mycobacterial infection with any species within 3 years prior to
screening, subjects with mycobacterium tuberculosis infection more than 3 years prior
to screening are allowed if successful treatment was completed at least 3 years prior
to randomization and is documented and available for verification
- Latent mycobacterium tuberculosis infection as indicated by a positive purified
protein derivative (PPD) skin test. Subjects with a positive PPD skin test and
documented completion of treatment for latent TB are eligible. Subjects with a
positive PPD skin test and not treated or no documentation of completion of treatment
are ineligible
- History of incompletely treated mycobacterium tuberculosis infection as indicated by:
a)subject's medical records documenting incomplete treatment for mycobacterium
tuberculosis b)subject's self reported history of incomplete treatment for
mycobacterium tuberculosis
- History of recurrent bacterial infection (at least 3 major infections resulting in
hospitalization and/or requiring intravenous antibiotic treatment within the past 2
years)
- Clinically significant abnormality on the chest x-ray at screening, chest x-rays
performed within 3 months prior to start of study drug are acceptable
- Any clinically significant abnormality on 12-lead electrocardiogram at screening
- History of congenital or acquired immunodeficiency (common variable immunodeficiency
(CVID) Hepatitis B surface antigen positive or Hepatitis B core antibody positive at
screening
- History of human immunodeficiency virus (HIV) infection
- Antibodies to hepatitis C at screening
- Malignancy or history of malignancy (except for treated/cured basal cell skin
carcinoma) greater than 3 years prior to screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Open Label Pilot Study of Apremilast in Treatment of Rosacea | NCT01045551 | Entailment |
4,479 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Age 18-35
- Normal menstrual periods (24-35 days)
- Good general health
- Willing to use a non-hormonal form of contraception for the entire study (Acceptable
forms of contraception include condoms, spermicide, sexual contact with a sterilized
partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- Willing and able to return to clinic for bi-weekly blood tests
Exclusion Criteria:
- Pregnant or breast feeding
- Polycystic ovarian disease
- Gastrointestinal conditions (i.e.gastric ulcer)
- Currently using birth control
- Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or
Sulfa-drugs
- Diabetes
- Cardiac disease or hypertension
- Moderate to severe heartburn (GERD)
- Obesity (BMI greater than 30)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle | NCT00614406 | Contradiction |
6,696 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:
1. Male Chinese subjects 6 years or older (weight >20 kg) with severe hemophilia A
(factor VIII activity <1%) previously treated with > 150 exposure days to any
FVIII-containing products.
2. Subjects should not have received an infusion of any FVIII products for at least 3
days (at least 72 hours) before the administration of Xyntha on Day 1.
3. Subjects must be in a non bleeding state before the administration of Xyntha on Day 1.
4. Evidence of a personally or legally acceptable representative (legally acceptable
representative is only applicable to pediatric subjects) signed and dated informed
consent document indicating that the subject has been informed of all pertinent
aspects of the study.
5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Exclusion Criteria:
Subjects with any of the following characteristics/conditions will not be included in the
study:
1. Current FVIII inhibitor or history of FVIII inhibitor (defined as > upper limit of
normal (ULN) of the local reporting laboratory).
2. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing) or clinical findings at Screening.
3. Diagnosed with any other bleeding disorder in addition to hemophilia A.
4. Documented Human Immunodeficiency Virus (HIV).
5. Subjects anticipating elective surgery or other invasive procedure within 1 month
following study entry.
6. Treatment with immunomodulatory therapy within 30 days or 5 half lives whichever is
longer, prior to study entry or planned use for the duration of study participation.
7. Subjects with known hypersensitivity to the active substance or to any of the
excipients of Xyntha.
8. Subjects with a known hypersensitivity to Chinese Hamster Ovary cell (CHO cell)
proteins.
9. Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat, if deemed necessary: significant hepatic or renal impairment (alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, or total
bilirubin >2 x ULN or serum creatinine >2 x ULN), prothrombin time >1.5 x ULN,
platelet count <80,000 L. Subjects with Gilbert's disease may be enrolled.
10. Unwilling or unable to follow the terms of the protocol.
11. Any condition which may compromise the subject's ability to comply with and/or perform
study related activities or that poses a clinical contraindication to study
participation, in the opinion of the investigator or sponsor.
12. A positive urine drug screen.
13. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
(150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor)
within 6 months of screening.
14. Treatment with an investigational drug within 30 days or 5 half lives preceding Day 1,
whichever is longer.
15. Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg
(systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the
average of the three BP values should be used to determine the subject's eligibility.
16. Screening supine 12 lead ECG demonstrating QTcF >450 or a QRS interval >120 msec msec.
If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTcF values should be used to determine the
subject's eligibility.
17. Blood donation (excluding plasma donations) of approximately 500 mL or more within 56
days prior to dosing.
18. History of sensitivity to heparin or heparin induced thrombocytopenia.
19. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.
20. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.
21. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
22. Subjects with history of infection within 1 week prior to study entry.
23. Male subjects with partners currently pregnant and male subjects able to father
children who are unwilling or unable to use a highly effective method of contraception
as outlined in this protocol for the duration of the study and for at least 28 days
after the last dose of investigational product.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A | NCT02461992 | Contradiction |
1,192 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Subject is ≥ 18 years old.
2. Subject has a symptomatic malignant pleural effusion requiring intervention. For an
effusion to be defined as malignant, at least one of the following must be true:
- There is histocytological confirmation of pleural malignancy
- The effusion is an exudate (as per Light's criteria) in the context of
histocytologically proven malignancy elsewhere, with no other clear cause for
fluid identified
3. Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea
that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
4. Subject is willing and able to provide written informed consent.
5. Subject is willing and able to meet all study requirements, including attending
follow-up visits or receiving trial-related telephone calls.
6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an
indwelling pleural catheter
7. Negative pregnancy test if appropriate
Exclusion Criteria:
1. Subject has significant trapped lung (>20%), or a proximal bronchial obstruction which
is likely to lead to trapped lung.
2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3*
or more.
3. Subject is pregnant, planning to become pregnant, or is lactating.
4. Subject has a history of empyema.
5. Subject has a history of chylothorax.
6. Subject has an uncorrected coagulopathy.
7. Subject is allergic to device materials.
8. Subject has evidence, in the opinion of the Chief Investigator, of either on-going
systemic or pleural infection.
9. Subject has had a lobectomy or pneumonectomy on the side of the effusion.
10. Subject has undergone a previous attempt at pleurodesis which has failed.
11. Subject has previously been diagnosed with a serious immunodeficiency disorder.
12. Subject has bilateral pleural effusions, with both being at least moderate in size
(greater than 1/3 of the hemithorax on chest x-ray).
13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely
to be futile.
14. Subject has a mediastinal shift of ≥2cm toward the side of the effusion.
15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the
ipsilateral chest.
16. Subject has any clinical condition, diagnosis, or social circumstance that, in the
opinion of the Chief Investigator, would mean participation in the study would be
contraindicated.
17. Subject has no access to a telephone
18. No details of blood values (full blood count, clotting screen, urea and electrolytes,
liver function) from within the last 10 days * Patients who have a performance status
of 3 may be considered for the trial if the removal of their fluid would likely
improve their performance score by 1 or more.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions | NCT02227732 | Entailment |
10 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Agrees to written as well as audio-visual informed consent.
2. Ability to understand the risks/benefits of the protocol
3. Male between 35-65 years of age.
4. Diagnosed with Symptomatic hypogonadism
Exclusion Criteria:
1. Uncooperative Subjects
2. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.
3. Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of
normal; elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L
or1.2mg/dl)
4. Patients suffering from CAD
5. History of malignancy
6. History of hypersensitivity to any of the investigational drugs
7. Receiving any other testosterone booster therapy/medication/supplement within the last
2 months
8. History of coagulopathies
9. High alcohol intake (>2 standard drinks per day)
10. History of psychiatric disorder that may impair the ability of subjects to provide
written informed consent.
11. Any medical condition, where the investigator feels participation in the study could
be detrimental to the subjects overall well-being.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study | NCT02702882 | Contradiction |
4,942 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- For PD patients
- Adults ≥ 18 years old.
- Patients with Parkinson's disease diagnosed according to the UKPDSBB criteria
with predominantly feature of rest tremor that intractable to medically
treatment.
- Informed consent For other tremor patients
- Adults ≥ 18 years old.
- Patients with essential tremor diagnosed according to the TRIG criteria for
essential tremor or patients with dystonic tremor diagnosed according to the
proposed definition in which their symptoms shared similar trait of medically
intractable tremor.
- Informed consent
Exclusion Criteria:
- For PD patients
- Patients with a history of cardiac arrhythmia, renal failure, hepatic failure,
and pregnancy as well as those who had history of seizure or had the risk for
tended to become seizure such as those who had focal brain lesions, encephalitis,
and stroke patients.
- Patients with a history of hand surgery and implanted screws or wires in hand
area that supposed to place a surface EMG or EMS, as well as those patients who
were implanted for electrical devices such as cardiac pacemaker, pulse generator
of deep brain stimulation,and intrathecal baclofen pump.
- Patients who cannot avoid the medication that may potentiate or attenuate tremor
such as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone
supplement.
For other tremor patients
- Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and
pregnancy as well as those who had history of seizure or had the risk for tended to
become seizure such as those who had focal brain lesions, encephalitis, and stroke
patients.
- Patients with a history of hand surgery and implanted screws or wires in hand area
that supposed to place a surface EMG or EMS, as well as those patients who were
implanted for electrical devices such as cardiac pacemaker, pulse generator of deep
brain stimulation, and intrathecal baclofen pump.
- Patients who cannot avoid the medication that may potentiate or attenuate tremor such
as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone supplement.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation | NCT02370108 | Entailment |
898 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Adult patients 30 years or older with medial compartment knee Osteoarthritis
(unilateral) and Grade 4 Kellgren-Lawrence39 radiographic changes presenting for
treatment of knee pain.
- Range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees
of extension.
- Subtalar and forefoot motion permitting foot/ankle eversion with weight bearing.
- Sufficient shoe toe box height to allow space for the insole and therefore comfort and
compliance.
- Passive laxity of medial capsule and collateral ligament by knee extension test.
Exclusion Criteria:
- All other forms of knee arthritis other than OA.
- Knee Instability- medial pseudo-opening of greater than grade 1 or detectable
Anterior-posterior instability.
- Less than Grade 4 Kellgren-Lawrence radiographic changes in the medial compartment of
the knee39.
- Grade 2 or greater Kellgren-Lawrence radiographic39 involvement of the patellofemoral
or lateral compartment.
- Inadequate knee range of motion
- Balance problems requiring the use of a walker or wheel chair - ambulation with aid
- Diabetics with peripheral neuropathy
- Knee surgery within the past year
- Intraarticular steroid injection or visco supplementation within 6 months
- Stiff subtalar or forefoot joints - clinical test
- Inadequate shoe toe box depth to accommodate the test or control inserts
- Charcot joint
- Fixed contracture of the medial capsule and/or collateral ligament- clinical test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 100 Years | Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee | NCT02254473 | Entailment |
457 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Pre-menopausal infertile woman, aged 18 to 40 years inclusive, who wishes to conceive
- Regular, spontaneous menstrual cycle of 25-35 days
- Body mass index (BMI) ≤ 28
- FSH ≤ 10 IU/L (follicular phase, days 2-5)
- Prolactin (PRL) within the normal ranges
- Evidence of both ovaries by ultrasound scan
- Women undergoing IVF-Embryo Transfer (ET) or ICSI, down regulated with Gonadotropin
releasing hormone analogues (GnRHa) (daily dose) under controlled ovarian
hyperstimulation (COH) with FSH
- Washout > 90 days from last dose of clomiphene or gonadotrophin, before ongoing COH
cycle
- Only one previous IVF-ET or ICSI cycle (in the last 9 months preceding the ongoing COH
cycle) resulted in a hypo-response properly documented (from 6 to 12 oocytes with a
total FSH dose ≥ 4000 IU)
- Negative pregnancy hCG test (urine or blood sample) before the ongoing COH cycles
- Willing and able to comply with the protocol for the duration of the study
- Written informed consent before applying any procedure related to the study protocol,
which is not part of routine medical care, with the understanding that consent may be
withdrawn by the subject at any time, without prejudice on their future medical care
Exclusion Criteria:
- Oligo/Anovulatory cycles (World Health Organization [WHO] I and II)
- Male partner azoospermia (assessed within the last 12 months)
- Follicular phase (day 2-5) FSH > 10 IU/L even if only once observed in the medical
history
- Abnormal cervical cytology (assessed within the last 12 months)
- History of unexplained gynecologic hemorrhage
- Any contraindication to pregnancy
- Known allergy to gonadotrophin
- Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus,
epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular
disease, serious corticoid-dependent asthma) which constitutes a contraindication to
gonadotropin use
- Any medical condition which, according to the investigator's judgement, may affect the
absorption, distribution, metabolism or excretion of the drug. In case of doubt,
inclusion of the subject in question should be discussed with the Medical Responsible
of Serono
- Known Human Immunodeficiency Virus (HIV) positivity
- Any substance abuse or history of drugs or alcohol abuse within the past 5 years
- Prior inclusion in the present study or simultaneous inclusion in a clinical study of
another drug
- Refusal or inability to comply with the protocol
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle | NCT01071200 | Contradiction |
3,392 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Aged 18-90 years at the time of enrollment in the study
- Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing
in other ear
- Fluent in English
- Willingness to comply with all study requirements
Exclusion Criteria:
- Scuba dives or sky dives
- Underwater swimming or dives into the water
- Handicaps that would restrict participation in all the evaluations
- Hearing loss of neural or central origin
- Unrealistic expectations regarding benefits and limitations inherent in the devices
- Chemotherapy within the last six months
- Compromised immune system
- Radiation to head or neck
- Perforated tympanic membrane
- History of cholesteatoma
- Active outer or middle ear pathology
- High levels of anticoagulant therapy
- Insulin-dependent and/or uncontrolled diabetes
- Contact dermatitis
- Bleeding disorder
- Unwillingness or inability to comply with all study requirements
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Post-market Study to Capture Information Regarding Performance of Lyric2 | NCT01861704 | Contradiction |
6,744 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
Inclusion Criteria for Arms A, B, and C:
- Diagnosis of severe congenital hemophilia A or hemophilia A with FVIII inhibitors
- Aged 12 years or older at the time of informed consent
- Body weight ≥40 kilograms (kg) at the time of screening
- Participants without FVIII inhibitors (<0.6 Bethesda unit per milliliter [BU/mL]) who
completed successful immune tolerance induction (ITI) must have done so at least 5
years before screening and have no evidence of inhibitor recurrence (permanent or
temporary)
- Documentation of the details of episodic therapy (FVIII or bypassing agents) and of
number of bleeding episodes for at least the last 24 weeks and ≥5 bleeds in the last
24 weeks prior to study entry
- Adequate hematologic, hepatic, and renal function
- For women of child bearing potential: agreement to remain abstinent or use a protocol
defined contraceptive measure during the treatment period and for at least 5
elimination half-lives (24 weeks) after the last dose of study drug
Inclusion Criteria for Arm D:
- Diagnosis of congenital hemophilia A of any severity and documented history of
high-titer inhibitor (i.e., ≥5 BU/mL)
- Children <12 years old at time of informed consent
- Body weight >3 kg at time of informed consent
- Requires treatment with bypassing agents
- Adequate hematologic, hepatic, and renal function
- For female participants who are of childbearing potential, follow the same
contraception criteria as listed above for Arms A, B, and C
Exclusion Criteria:
Exclusion Criteria for Arms A, B, and C:
- Inherited or acquired bleeding disorder other than hemophilia A
- At high risk for thrombotic microangiopathy, in the investigator's judgment
- History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the
investigator's judgment
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which anti-thrombotic
treatment is not currently ongoing) or signs of thromboembolic disease
- Other conditions that may increase risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Known human immuno-deficiency virus (HIV) infection with cluster of differentiation 4
(CD4) count <200 cells/microliter (cells/mcL) within 24 weeks prior to screening.
Participants with HIV infection who have CD4 >200 cells/mcL and meet all other
criteria are eligible
- Use of systemic immunomodulators at enrollment or planned use during the study, with
the exception of anti-retroviral therapy
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study, may pose additional risk, or would, in the
opinion of the investigator, preclude the participant's safe participation in and
completion of the study
- Planned surgery (excluding minor procedures such as tooth extraction or incision and
drainage) during the study
- Receipt of: Emicizumab in a prior investigational study; An investigational drug to
treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
administration; A non-hemophilia-related investigational drug concurrently, within
last 30 days or 5 half-lives, whichever is shorter
- Pregnant or lactating, or intending to become pregnant during the study
Exclusion Criteria for Arm D:
- Inherited or acquired bleeding disorder other than hemophilia A
- Ongoing (or plan to receive during the study) ITI therapy or prophylaxis treatment
with FVIII
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which anti-thrombotic
treatment is not currently ongoing) or signs of thromboembolic disease
- Other diseases that may increase risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
- At high risk for thrombotic microangiopathy, in the investigator's judgment
- Use of systemic immunomodulators at enrollment or planned use during the study
- Planned surgery (excluding minor procedures such as tooth extraction or incision and
drainage) during the study
- Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood
products (or any standard-of-care treatment for a life-threatening condition)
- Receipt of: Emicizumab in a prior investigational study; An investigational drug to
treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
administration; A non-hemophilia-related investigational drug concurrently, within
last 30 days or 5 half-lives, whichever is shorter
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study, may pose additional risk, or would, in the
opinion of the investigator, preclude the participant's safe participation in and
completion of the study
- Pregnant or lactating, or intending to become pregnant during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants | NCT03315455 | Contradiction |
1,542 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Enrolled in residency for ear, nose and throat training or medical student interested
in ear, nose and throat training.
Exclusion Criteria:
- Not enrolled in ENT training program or interest in ENT training.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Validation/Dissemination Of A Temporal Bone Dissection Simulator | NCT00887185 | Contradiction |
775 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Those aged 20-60 years old
2. There are at least three pains in the unilateral or bilateral knee joints (up and down
steps, squats, running, squatting, jumping, walking, and sedentary for a long time),
and the pain lasts for at least one month.
3. Visual pain score (VAS) ≧30 (mm) for unilateral or bilateral knee joints
4. Non-steroidal anti-inflammatory drugs, analgesics, and Chinese herbal medicines for
the treatment of knee joint pain
5. Non-severe degenerative arthritis (Kellgren-Lawrence scale knee arthritis grade 2 or
less)
Exclusion Criteria:
1. thighs, knee joints, calf areas, those who have undergone surgery or are expected to
have surgery, those who have been traumatized within the last month, and those who
have wounds, ulcers, infections or other skin diseases within two weeks
2. Pregnancy
3. BMI value is greater than 27 KG/m2
4. People with cardiovascular disease or hemophilia
5. Patients with gout, rheumatism and rheumatoid arthritis
6. Diabetic patients with knee arthritis, patients with dry arthritis
7. Patients with malignant tumors
8. Those who are allergic to Vaseline products
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 60 Years | The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy | NCT03821194 | Contradiction |
1,189 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- any patients with Benign or Malignant Respiratory Diseases and agree to included in
the study
Exclusion Criteria:
- Patients with renal failure, hepatic failure, severe cardiopulmonary compromise,
coagulopathy or hemodynamically unstable were excluded
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 70 Years | Survivin and Fibulin-3 in Benign and Malignant Respiratory Diseases | NCT04413292 | Entailment |
4,651 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Speak, read, and understand English or Spanish and is willing and able to provide
written informed consent on an IRB-approved form prior to the initiation of any study
procedures;
2. Healthy, premenopausal female age 18-47;
3. History of menstrual events that occur in regular cycles
4. Agreement not to attempt to become pregnant
5. Agrees to use double-barrier contraception during the study and for 30 days after
discontinuation of study medication. Acceptable double-barrier methods are: male
condom with spermicide; male condom with diaphragm; diaphragm containing spermicide
plus additional intra-vaginal spermicide;
6. Has a negative pregnancy test at the Screening visit. An exception for the pregnancy
test requirement will be granted for subjects reporting surgical sterilization in
medical history
7. Normal laboratory values or clinically insignificant findings at screening as
determined by the Investigator;
8. Subject is willing to remain in the clinic overnight for PK assessment on Days 0 and 8
9. Ability to complete the study procedures in compliance with the protocol.
Exclusion Criteria:
1. Subject is a post-menopausal woman, defined as either; six (6) months or more
(immediately prior to screening visit) without a menstrual period, or prior
hysterectomy and/or oophorectomy
2. Subject is pregnant or lactating or is attempting or expecting to become pregnant
during the study
3. Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x
ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).
4. Received an investigational drug in the 30 days prior to the screening for this study
5. Women with a history of PCOS
6. Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
DHEA or hormonal products for at least 2 weeks prior to screening and during the
study.
7. Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the
preceding 10 months.
8. Has an IUD in place
9. Women currently using narcotics
10. Women currently taking spironolactone
11. Infectious disease screen is positive for HIV or Hepatitis A, B or C.
12. Clinically significant abnormal findings on screening examination or any condition
which in the opinion of the investigator would interfere with the participant's
ability to comply with the study instructions or endanger the participant if she took
part in the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 47 Years | Comparison of Two Formulations of Proellex for Oral Administration | NCT02141061 | Entailment |
1,460 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Diagnosed with hypertension
- Proficient in English
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control | NCT04485637 | Entailment |
5,022 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Men and women, aged 18 to 80
- Diagnosis of essential tremor according to the criteria of the Consensus Statement of
the Movement Disorders Society (MDS)
- Patients with significant disability related to their essential Tremor, despite
well-conducted medical treatment
- Stable drug therapy for at least 30 days prior to inclusion
- Contraindication or refusal of deep brain stimulation
- Patient receiving Social Security or Universal Medical Coverage or any equivalent plan
- Person who voluntarily and knowingly agreed to participate in the study (signing of a
written consent)
Exclusion criteria :
- Other neurological disorder, in particular previous history of multiple stroke or
cerebral hemorrhage, intracranial aneurysm in the last 6 months
- Inability to stop anticoagulant or antiplatelet therapy or any other medication that
may increase the risk of bleeding during the 2 weeks prior to the procedure
- Current state of health causing bleeding and / or abnormal coagulopathy
- Unstable cardiac pathology or severe hypertension that cannot be controlled by
medication (diastolic blood pressure> 100 with drugs).
- Previous medical history of brain tumor
- Active epilepsy in the year preceding the inclusion
- Contraindications to magnetic resonance imaging such as non-compatible implanted metal
devices (including pacemakers), size limits, etc.
- Known hypersensitivity to local anesthetics (Xylocaine 20mg / ml)
- Important claustrophobia that cannot be managed with mild medication
- Inability to maintain prolonged stationary supine position necessary for treatment
(3-4 hours)
- Woman of childbearing age without means of contraception
- Pregnant or lactating woman
- Major persons subject to a measure of legal protection (guardianship, curators or
under the protection of justice)
- Subject in exclusion period of another biomedical research or participating in any
other biomedical stimulation or therapeutic trial
- Patients under AME (state medical aid) (except if exemption from affiliation)
- Presence of implants in the brain or skull
- Patient cannot communicate with the doctor during the treatment procedure
- Subjects with behavior compatible with the abuse of ethanol or psychoactive substances
- Cerebrovascular disease (multiple stroke or stroke within 6 months)
- Patients who have taken CNS (Central Nervous System) medications within the last 6
months (eg, CNS stimulants, sympathomimetics)
- Significant healing in an area on the path of the planned energy path to the treatment
area
- Recourse to neurosurgical treatments for essential tremor (deep brain stimulation or
gamma knife
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Transcranial Ultrasound Therapy of Essential Tremor | NCT04074031 | Entailment |
2,254 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Known history of gout
Exclusion Criteria:
- History of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic
arthritis)
- History of another crystal induced arthritis (ex. pseudogout)
- Any contraindication to receiving an MRI (ex. pacemaker)
- Allergy to gadolinium contrast dye
- Inability to give informed consent
- Pregnant women
- Erosive changes on initial screening x-ray of index joint
- Serum Creatinine > 1.8 mg/dL at screening visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs | NCT00584311 | Entailment |
6,984 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria
1. Male or female subjects aged 55-80 years at the time of signing the Informed Consent
Form.
2. Subjects (or subject's legally acceptable representative) and caregiver(s) who can
sign an Informed Consent to participate in the study. Same caregiver(s) must assist
the subject throughout the entire duration of the study.
3. Subjects who have a diagnosis of probable Alzheimer's disease according to the NIA-AA
(National Institute of Aging and Alzheimer's Associations, 2011) criteria with mild to
moderate dementia (stage 4 - 5) at screening.
4. Subjects who have mild-to-moderate cognitive impairment with MMSE Score of 16-26 at
screening.
5. Subjects who have an MRI (either 1.5T or 3T) or CT scan performed after onset of
symptoms and prior to randomization with findings consistent with the diagnosis of
dementia due to Alzheimer's disease and without any other clinically significant
comorbid pathologies.
6. Subjects who have one (or more) identified adult study partner(s) who, in the opinion
of the investigator, has sufficient contact with and knowledge about the subject as to
be able to report knowledgeably about the subject's safety, compliance and adherence,
cognition, function, and behavior.
Exclusion Criteria
1. Subjects who are female who are pregnant, nursing, or of childbearing potential and
not practicing effective contraception.
2. Subjects who have signs of delirium.
3. Subjects who have had a cortical stroke within the preceding 2 years.
4. Subjects who have any diagnosis of dementia other than that related to Alzheimer's
Disease, including concomitant vascular dementia.
5. Subjects who have a PET scan performed after onset of symptoms with negative amyloid
results.
6. Subjects with a history of myocardial infarction, unstable angina, New York Heart
Association (NYHA) class III or IV heart failure or stroke within the last 12 months.
7. Subjects with uncontrolled hypertension (systolic blood pressure >160mm Hg or
diastolic blood pressure > 95mm Hg) or hypotension (systolic blood pressure <90mm Hg
or diastolic blood pressure <50mm Hg).
8. Subjects who have clinically significant renal impairment (creatinine > 1.5x ULN) or
hepatic impairment (AST or ALT > 2.5x ULN or total bilirubin > 1.5x ULN).
9. Subjects who have history of cancer or malignant tumor within 5 years prior to
screening with the exception of:
1. Basal or squamous cell carcinoma of the skin or cervical dysplasia which has been
adequately treated.
2. In situ Grade 1 cervical cancer, fully treated at least 2 years prior to
screening and without recurrence.
3. Prostate cancer, confined to the prostate gland, which has been adequately
treated (surgery and/or radiation) with normal or low and stable PSA levels for 2
years prior to screening.
10. Subjects who have history of untreated thyroid disorder or a seizure disorder.
11. Subjects who are being treated, or likely to require treatment during the study, with
any medications prohibited by the study protocol.
12. Subjects who have participated in any investigational drug or device trial within the
previous 30 days or five half-lives of the investigational drug at screening,
whichever one is longer.
13. Subjects who have any other clinically significant abnormal result in laboratory tests
such as abnormally low B12 or high TSH levels, as determined by the Investigator.
14. Subjects with any current psychiatric diagnosis other than AD if, in the judgment of
the investigator, the psychiatric disorder or symptom is likely to confound
interpretation of drug effect, affect cognitive assessments, or affect the subject's
ability to complete the study.
15. Subjects whose treatment with FDA-approved AD medication (donepezil, galantamine,
memantine, rivastigmine or their combinations) has not been stable for at least 3
months prior to screening. Treatment and dosing should remain stable, with no changes
throughout the trial.
16. Subjects who are currently receiving (or unable to stop use for at least 21 days [3
weeks] prior to receiving the first dose of the AR1001 and throughout the study)
prescription or non-prescription medications or other products known to be moderate or
potent inhibitors/inducers of CYP3A4.
17. Subjects who have had any intake of grapefruit, grapefruit juice, Seville oranges,
Seville orange marmalade, or other products containing grapefruit or Seville oranges
within 7 days of the first administration of the AR1001 and throughout the study.
18. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the
study.
Extension Phase Continuation Criterion
1. Subjects enrolled in AR1001-ADP2-US01 and completed 26 weeks of assigned dosing.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years | Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease | NCT03625622 | Entailment |
5,479 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Group 1
- Any patient suspected of having GCA, that is to say in practice patients in whom a
doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy
or an imagery (Angio-CT, Angio-MRI, PET- to scan
- Patient over 50 years old
- Patient able to chew a chewing gum for 4 minutes Group 2
- Patients free from GCA
- Age matched (± 3 years)
- Patient able to chew a chewing gum for 4 minutes
Exclusion Criteria:
- Group 1
- Patients known to have a temporomandibular joint pathology
- Patients who started corticosteroid therapy Group 2
- Patients known to have temporomandibular joint pathology
- Patients who started corticosteroid therapy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort | NCT04010097 | Contradiction |
4,679 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
Parts 1 & 2:
- Healthy young male subject aged 18 to 45 years inclusive
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subjects must be non-fertile, or must practice an adequate contraceptive method
to prevent pregnancies.
Part 3:
- Healthy elderly male subject aged 55 years or older, or healthy pre-menopausal female
subject aged 18 to 45 inclusive.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subject must be non-fertile, or must practice adequate contraceptive methods.
- Female subjects must be of non-child bearing potential, i.e. surgically sterilized or
practice adequate (double barrier) non-hormonal contraceptive methods.
Part 4:
- Healthy pre-menopausal female subject aged 18 to 45 inclusive.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Female subjects must be of non-child bearing potential, i.e. surgically sterilized or
practice adequate contraceptive methods.
- Females having a regular menstruation cycle with a duration between 25 up to 30 days.
Exclusion Criteria:
Parts 1 & 2:
- Male subjects with out-of-range Testosterone levels in serum at screening.
- Subjects with any history of cancer.
- Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal.
- A QTc interval of > 430 ms after repeated measurements.
- Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months
prior to admission to the Clinical Unit.
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
Part 3:
- Pregnancy within 6 months before screening assessment or breast feeding 3 months
before screening.
- Male subjects with out-of-range T levels in serum at screening.
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
Part 4:
- Pregnancy within 6 months before screening assessment or breast feeding 3 months
before screening.
- Use of any hormonal interfering contraceptives in the 3 months before admission (for 3
consecutive menstruation cycles) OR any evidence of unovulatory menstrual cycles.
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects | NCT02368912 | Entailment |
6,892 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Key Inclusion criteria:
- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical
criteria for probable AD dementia or prodromal AD (consistent with the NIAAA
diagnostic criteria and guidelines for mild cognitive impairment)
- Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid
PET scan
- Demonstrated abnormal memory function
- MMSE score greater than or equal to 22 (≥ 22)
- Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
- Availability of a reliable study partner who accepts to participate in study
procedures throughout the 2 years duration of study
- If receiving symptomatic AD medications, the dosing regimen must have been stable for
3 months prior to screening and until randomization
- For enrollment in the China extension, patients must have residence in mainland China,
Hong Kong, or Taiwan and be of Chinese ancestry
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods
Key Exclusion criteria:
- Any evidence of a condition other than AD that may affect cognition
- History of schizophrenia, schizoaffective disorder, major depression, or bipolar
disorder
- History or presence of clinically evident systemic vascular disease that in the
opinion of the investigator has the potential to affect cognitive function
- History or presence of clinically evident cerebrovascular disease
- History or presence of posterior reversible encephalopathy syndrome
- History or presence of any stroke with clinical symptoms within the past 12 months, or
documented history within the last 6 months of an acute event that is consistent with
a transient ischemic attack
- History of severe, clinically significant CNS trauma
- History or presence of intracranial mass (e.g., glioma, meningioma) that could
potentially impair cognition
- Presence of infections that affect brain function or history of infections that
resulted in neurologic sequelae
- History or presence of systemic autoimmune disorders that potentially cause
progressive neurologic disease with associated cognitive deficits
- At risk for suicide in the opinion of the investigator
- Alcohol and/or substance abuse or dependants in past 2 years
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- Any contraindications to brain MRI
- Unstable or clinically significant cardiovascular, kidney or liver disease
- Uncontrolled hypertension
- Unstable or clinically significant cardiovascular disease
- Abnormal thyroid function
- Patients with evidence of folic acid deficiency
Exclusion for Open-Label Extension (OLE):
- Discontinued from study treatment during the double-blind treatment period
- Received any other investigational medication during the double-blind treatment period
or after the end of double-blind treatment
- Participation in the OLE deemed inappropriate by the investigator
- Presence of ARIA-E findings at the Week 104 MRI scan
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years | Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) | NCT03444870 | Entailment |
3,022 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Males and females aged 6 to 12 years on day 1 of treatment.
- Clinical diagnosis of DS (full trisomy 21 or translocated) confirmed by chromosomal
analysis (karyotyping) (Cohort I) or molecular diagnosis for FXS (mutations or
premutations on the fragile mental retardation 1 gene-Fmr1 of the X chromosome)
(Cohort II). A karyotype will be performed if not available in DS population. FXS
molecular diagnosis will be performed if not available in FXS population.
- A body-weight under 50 kg.
- Parent or legal guardian/representative and caregiver willing to give written informed
consent.
- Mental age ≥ 3 years (Brunet-Lézine scale C version, picture naming and receptive
vocabulary of the WPPSI-IV)
- Study participants must have sufficient vision and hearing to participate in study
evaluations. Mild hearing loss will be allowed.
- Availability of parent/caregiver to accompany the subject to clinical visits, provide
information about the subject's behavior and symptoms and ensure compliance with the
medication schedule.
- Subjects must be able to understand basic instructions. Naming and comprehension tasks
of the WPPSI-IV will be used as an evaluation
Exclusion Criteria:
- Study participants with a current Diagnostic and Statistical Manual of Mental
Disorders (DSM-5) diagnosis of any primary psychiatric diagnosis (including autism
spectrum disorder). For secondary diagnoses, such as attention deficit hyperactivity
disorder, depression and conduct disorder, individuals under a fixed regime of
medication (a regime that does not change in the 6 weeks prior to enrollment) are
allowed as long as they are considered stable and their medication does not interfere
with the progression of the study.
- Personal history of infantile spasms, of epilepsy, of severe head trauma or Central
Nervous System (CNS) infections (e.g. meningitis), with the exception of a single
isolated febrile seizure.
- Subjects with past history of seizures from primary causes (such as West syndrome and
Lennox-Gastaut syndrome) or secondary causes.
- Clinical history of moderate or severe Obstructive Sleep Apnea (OSA) as defined by
Apnea-Hypopnea Index (AHI) (>15 events per hour not well controlled by positive airway
pressure therapy with stable settings) for at least 3 months prior to screening visit.
- Subjects with thyroid disease that is not controlled (elevated basal
Thyroid-stimulating hormone (TSH) > 10 microU/mL) by thyroid hormone respective
therapy.
- Evidence of active, clinically significant, and unstable gastrointestinal, renal,
hepatic, endocrine or cardiovascular system disease.
- Cardiovascular, Systolic Blood Pressure (SBP) and/or Diastolic Blood Pressure (DBP)
outside the 95th percentile for age; resting heart rate above 100 bpm.
- Cardiovascular, ECG: clinically relevant ECG abnormalities at screening. Auscultation
is mandatory part of cardiovascular examination.
- Clinically significant abnormalities in laboratory test results at screening unless
acceptable by the investigator.
- Life-threatening illness or major surgery in the 3 months prior to the study.
- Concomitant disease or condition or any clinically significant finding at screening
that could interfere with the conduct of the study, or that would, in the opinion of
the investigator, could lead to an unacceptable risk to the subject in this study.
- Patients with risk factors of liver dysfunction such as previous history of liver
disease, previous clinically significant hepatic abnormalities in laboratory testing,
previous allergy or intolerance with liver disorders or any clinically significant
abnormalities in hepatic laboratory testing at screening
- Participation in other clinical trials in the last 3 months prior to the study.
- Concomitant use of unapproved medication.
- Current intake of vitamin supplements, catechins or products containing EGCG (i.e.
TEAVIGO, Mega Green Tea capsules Life Extension or Font-UP Grand Fontaine
Laboratories) for at least 3 months previous to the screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 12 Years | Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS) | NCT03624556 | Contradiction |
6,379 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Documentation of Covid-19 infection based on laboratory evidence of positivity by RT-
PCR.
2. Patients who have no clinical symptoms (fever, cough and dyspnea).
3. Patients who have mild clinical symptoms that could include fever, cough, sore throat,
malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath
(dyspnea).
4. Screening laboratory values within institutional normal range or judged to be not
clinically significant by clinical investigator.
5. Ability and willingness of subject to give written informed consent.
6. Negative pregnancy test on the day prior to each vaccination.
7. Willingness to use adequate contraception by study participants.
Exclusion Criteria:
1. History of respiratory and cardiovascular diseases, hematologic disease (e.g.,
cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus,
porphyria cutanea tarda).
2. Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal,
hepatic, renal or neurologic disease, which in the opinion of the investigator will
compromise ability to participate in the study.
3. Pregnancy and breast-feeding.
4. Prior or current systemic cancer chemotherapy.
5. Investigational agents and immunomodulators (cyclosporine, hematological growth
factors, systemic corticosteroids, interleukins or interferons) within 90 days prior
to study entry.
6. Anaphylaxis or allergy to vaccine components.
7. Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements.
8. Any other serious diseases other than Covid-19 infection including current or recent
(within 5 years) cancers.
9. Subjects who are immunocompromised or immunosuppressed due to disease or medications.
10. Women who are lactating.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | NCT04428073 | Entailment |
3,304 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- The investigators included healthy mothers with singleton pregnancies and documented
prenatal care who were admitted before term (28-34) weeks gestation to the hospital's
delivery room with early uterine contractions and entering stage 1 of an anticipated
spontaneous vaginal delivery or term infants born at 38-42 weeks of gestation.
Exclusion criteria:
- Mothers who showed signs of fetal distress during labor, or required Cesarean
(C)c-section, or had fetuses withand estimated fetal weights < 10th percentile for
gestational age and children diagnosed with
- Genetic anomalies, congenital heart malformations, gastrointestinal disturbances
and central nervous system dysfunction
- Age < 9 months, Age > 9 months month at onset of study
- Considered medically unstable
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 9 Months old.
Subject must be at most 12 Months | Melatonin Production Delay in Preterm Infants | NCT00775723 | Contradiction |
5,209 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- 45 - 75 year old Caucasian, Hispanic or Asian women
- one year post-menopausal if older than 50 years
- three years post-menopausal if between the ages of 45 - 50 years
- body mass index less than or equal to 30
- T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of
lumbar spine or hip
- have at lease two spinal vertebrae evaluable by DXA analysis
Exclusion Criteria:
- bisphosphonate therapy within the last two years
- estrogen replacement hormones or SERMS within last one year
- no more than one week of PTHrP, PTH, or an analog of PTH within the last year
- an atraumatic bone fracture within the last 6 months
- significant or active diseases of any organ system
- history of malignancy
- anemia with a hematocrit less than 34%
- significant drug or alcohol abuse
- having received any investigational drug within the last 90 days
- taking any medication that may interfere with skeletal metabolism, such as
phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide
- abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin
D less than 20 ng/ml or PTH greater than 65 pg/ml
- African-Americans for this particular study - although future studies are planned
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 75 Years | Comparison Study of PTHrP and PTH to Treat Osteoporosis | NCT00853723 | Entailment |
2,859 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Probable laboratory-supported, probable, or definite ALS, as defined by El Escorial
Revised ALS diagnostic criteria 34
- Disease duration ≤ 18 months
- No swallowing difficulty (4 at ALSFRS-R swallowing subscore)
- Able to perform reproducible pulmonary function tests
- Forced vital capacity ≥70% of normal
- Stable on riluzole treatment for 3 months in the lead-in period
- Able to perform reproducible pulmonary function tests
- Signed informed consent
Exclusion Criteria:
- Treatment with edaravone
- Other causes of neuromuscular weakness
- Presence of other neurodegenerative diseases
- Significant cognitive impairment, clinical dementia or psychiatric illness
- Severe cardiac or pulmonary disease
- Other diseases precluding functional assessments
- Other life-threatening diseases
- At the time of screening, any use of non-invasive ventilation (e.g. continuous
positive airway pressure, non-invasive bi-level positive airway pressure or
non-invasive volume ventilation) for any portion of the day, or mechanical ventilation
via tracheostomy, or on any form of oxygen supplementation
- Gastrointestinal disorder that is likely to impair absorption of study drug from the
gastrointestinal tract
- Has taken any investigational study drug within 30 days or five half-lives of the
prior agent, whichever is longer, prior to dosing
- Any clinically significant laboratory abnormality
- Other concurrent investigational medications
- Active peptic ulcer
- Previous surgery or infections of small intestine
- Patients unable to easily swallow the treatment pills at time of enrolment
- Occurrence of frequent biliary colic, biliary infections, severe pancreatic
abnormalities
- Subjects who weigh 88 lbs (40 kg) or less at screening
- Aspartate aminotransferase or alanine aminotransferase concentrations more than 3
times the upper limit of normal
- Creatinine clearance 50 ml/min or less
- Previous exposure to bile acids
- Any clinically significant neurological, haematological, autoimmune, endocrine,
cardiovascular, neoplastic, renal, gastrointestinal, or other disorder that, in the
Investigator's opinion, could interfere with the subject's participation in the study,
place the subject at increased risk, or confound interpretation of study results
- Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive TUDCA or that the subject is unable or unlikely to comply with
the dosing schedule or study evaluations
- The patient is sexually active and is not willing to use highly effective
contraception during the study and up to 90 days after the day of last dose
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS | NCT03800524 | Entailment |
6,178 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Adult ≥ 18 years old.
2. SARS-CoV-2 infection confirmed.
3. Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT
chest.
4. Hospitalized patients who received at least one administration of Remdesivir therapy
(Dose: 200mg day one then 100mg daily for up to 10 days).
Exclusion Criteria:
1. Presences of chronic renal failure > 4 stage, GFR < 30ml/min.
2. ALT/AST > 5 times than normal values.
3. Pregnant women.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience | NCT04728880 | Contradiction |
2,490 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Healthy subjects (volunteers) with age-related impaired twilight and night
- Age 50 to 70, men or women
- Written informed consent
- Full visual acuity (vision ≥ 0.7) according to DIN Standard condition
- Refraction ≤ +/-6.0 in the highest main step
- Age-related findings in the ophthalmologic examination (anterior chamber and eye
ground)
- Normal intraocular pressure (10-20 mmHg)
Exclusion Criteria:
- Diabetes mellitus
- Epilepsy
- Abnormal visual acuity or eye ground (e.g. clouding of the lens)
- Age related vision problems
- Glaucoma and macular degeneration
- Disease of the retina
- Consumption of anthocyan preparations during the past six months
- Opthalmologic pathology: cataract, visus < 0.7, retinal pathology, maculopathy,
intraocular pressure (> 21 mmHg), known acute or chronic eye disease, use of hard
contact lenses, eye surgery performed within the last 12 months
- Any serious disorder that might interfere with his/her participation in this study and
the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus,
anamnestic indications of diabetic microangiopathy or polyneuropathy, renal
insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension
> 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino
- Any treatment that might interfere with the evaluation of the test drug, in particular
drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis,
ethambutol, chlorpromazine or phenothiazine derivatives such as thioridazine,
periciazine, perphenazine)
- Known hypersensitivity to any of the ingredients of the study drug
- Drug and alcohol abuse
- Pregnancy, lactation, women of childbearing potential who do not use an established
contraceptive
- Participation in another trial within the past 30 days
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 70 Years | Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision | NCT02194127 | Entailment |
222 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Total serum testosterone concentrations < 300 ng/dL at baseline
Exclusion Criteria:
- Presence or history of prostate cancer
- Elevated PSA > 3.5 ng/mL
Additional inclusion and exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 68 Years | Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism | NCT00962637 | Entailment |
461 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Can provide informed consent
- Women ages 21-35 with known HIV status
- If HIV negative must have had an HIV test within the last 3 months
- Intend to stay in Lilongwe region for the duration of the study
- Desire to prevent pregnancy for at least the next six months
- Desires to use LoFemenal for contraception
- Has no known history of infertility
- Has intact uterus and at least one ovary
- Has regular monthly menses defined by menses occurring every 21-35 days
- Has not used another form of systemic hormonal contraception within the last six
months.
- Has no contraindications to the combined oral contraceptive LoFemenal which include;
any thrombophlebitis or thromboembolic disorders; cerebral-vascular or coronary-artery
disease (current or history); thrombogenic valvulopathies; thrombogenic rhythm
disorders; major surgery with prolonged immobilization; diabetes with vascular
involvement; headaches with focal neurological symptoms; uncontrolled hypertension;
known or suspected carcinoma of the breast or personal history of breast cancer;
carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia;
undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice
with prior pill use; hepatic adenomas or carcinomas or active lever disease, as long
as liver function has not returned to normal; known or suspected pregnancy.
Exclusion Criteria:
- Hemoglobin < 10 mg/dL.
- Body mass index < 18.6 kg/m^2.
- Using any drugs known to interfere with cytochrome P450 system (such as rifampicin,
phenytoin, carbamezapine, among others)
- In the opinion of the PI or study staff the individual cannot complete the study
- Cannot be adherent to other medications.
Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:
- Must be on antiretroviral therapy which includes nevirapine for at least three
consecutive months immediately prior to enrollment into the study
- Must report adherence to medication and medical visits
- Must be willing to use a barrier or backup method of contraception.
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 35 Years | Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi | NCT00998725 | Contradiction |
3,611 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Woman aged 18 to 65, consultant in general medicine. (Any patient meeting the
inclusion criteria may choose to answer the questionnaire in the waiting room of
general practitioners selected by lot.)
Exclusion Criteria:
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Prevention of Cystitis. | NCT03744338 | Entailment |
2,026 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- At least one measurable lesion according to RECIST criteria
- Histologically or cytologically confirmed NSCLC of adeno histology
- Locally progressed or metastasized on or after first-line chemotherapy. The imaging
evidence of disease progression can be either chest X ray, CT or MRI assessment on
measurable lesions. If no measurable lesion is available, evaluable lesions are acce
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy | NCT00836160 | Entailment |
6,883 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Diagnosis of mild-moderate Alzheimer disease (AD)
- Mini-Mental State Examination (MMSE) 16-26
- Study partner available who has frequent contact with the participant
- Good visual and auditory acuity for neuropsychological testing
- Education including completion of at least six grades
- Must read and speak English fluently
- Antidepressants permitted, if stable for 4 weeks prior to screening (and participant
is not currently depressed and does not have a history of major depression within the
past 1 year)
- Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening
Exclusion Criteria:
- Any significant neurologic disease other than AD
- History of Diabetes Mellitus type I or II
- Any contraindications to MRI or PET studies
- Major depression, bipolar disorder as described within the past 1 year.
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past 2 years
- Any significant systemic illness or unstable medical condition, which could lead to
difficulty complying with the protocol
- Current use of specific psychoactive medications
- Investigational amyloid lowering therapies are prohibited two months prior to
screening and for the duration of the trial. Other investigational agents are
prohibited one month prior to screening and for the duration of the trial.
- History of brain cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years | A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease | NCT02912936 | Contradiction |
6,573 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Subject is expected to survive 6 months from the date of screening, If female and of
child-bearing potential, subject has a negative serum pregnancy test prior to surgery
and agrees to not breast feed her child (if applicable) for duration of study
treatment and completion of study follow-up visits, If subject is a sexually active
male or a sexually active female of child-bearing potential, subject agrees to use a
medically accepted form of contraception from the time of consent to completion of all
follow-up study visits
Exclusion Criteria:
- pregnant females
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered | NCT02264730 | Contradiction |
2,746 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Informed consent
- Diagnosis of primary, unilateral or bilateral, reducible groin hernias
- Medically fit for general anesthesia
- Comprehension and use of French language
- Installed in the geographical region without foreseeable move for two years
Exclusion Criteria:
- Female gender, recurrent hernia
- Ongoing chronic pain syndrome, other than hernia origin
- Coagulation disorders, prophylactic or therapeutic anticoagulation, un able to stop
platelet antiaggregation therapy 10 days before surgery
- Previous pelvic surgical procedures contraindicating laparoscopic technique
- American Society of Anesthesiology Class 4 and 5 patients
- Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
- Mentally ill patients
- Presence of local or systemic infection
- Life expectancy < 2 years
- Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 70 Years | Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy | NCT00625534 | Entailment |
4,114 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
General and Demographic Criteria:
- Age of 18 to 50 years
- Weight less than or equal to 115 kg
- Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site
(CRS) and willingness to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of this study;
completes a questionnaire prior to enrollment with verbal demonstration of
understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent until
completion of the last study visit
- Good general health as shown by medical history, physical exam, and screening
laboratory tests
HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling
- Assessed by the clinic staff as being at "low risk" for HIV infection [low risk
guidelines are found on the protocol home page on the HVTN Members' site
(https://members.hvtn.org/protocols/hvtn116)] and committed to maintaining behavior
consistent with low risk of HIV exposure through the last required protocol clinic
visit
Laboratory Inclusion Values:
Hemogram/CBC
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female,
greater than or equal to 13.0 g/dL for volunteers who were born male
- White blood cell count equal to 2,500 to 12,000 cells/mm^3
- Total lymphocyte count greater than or equal to 800 cells/mm^3
- Remaining differential either within institutional normal range or with site physician
approval
- Platelets equal to 125,000 to 550,000/mm^3
Chemistry
- Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
alkaline phosphatase less than 1.25 times the institutional upper limit of normal;
creatinine less than or equal to institutional upper limit of normal
Virology
- Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug
Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally
available assays that have been approved by HVTN Laboratory Operations.
- Negative hepatitis B surface antigen (HBsAg)
- Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive
Urine
- Normal urine:
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
microscopic urinalysis with red blood cells levels within institutional normal
range)
Reproductive Status:
- Volunteers who were born female: negative serum or urine beta human chorionic
gonadotropin (β-HCG) pregnancy test performed prior to initial biopsy for groups 1-3
and prior to initial infusion for groups 4-5 on the day of enrollment. Persons who are
NOT of reproductive potential due to having undergone bilateral oophorectomy (verified
by medical records), are not required to undergo pregnancy testing.
Reproductive Status:
United States:
A volunteer who was born female must:
- Agree to consistently use effective contraception (see the protocol for more
information) for sexual activity that could lead to pregnancy from at least 21 days
prior to enrollment through the last required protocol clinic visit. Effective
contraception is defined as using the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Any other contraceptive method approved by the HVTN 116 Protocol Safety Review
Team (PSRT)
- Successful vasectomy in the male partner (considered successful if a volunteer
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity postvasectomy);
- Or not be of reproductive potential, such as having had a bilateral oophorectomy, or
tubal ligation;
- Or be sexually abstinent.
South Africa:
A volunteer who was born female must:
- Agree to consistently use effective contraception (see the protocol for more
information) for sexual activity that could lead to pregnancy from at least 21 days
prior to enrollment through the last required protocol clinic visit. Effective
contraception for participants in South Africa is defined as using 2 methods of birth
control.
ONE barrier contraceptive method:
- Condoms (male or female)
- Diaphragm or cervical cap
PLUS ONE of the following methods:
- Intrauterine device (IUD),
- Hormonal contraception, or
- Successful vasectomy in the male partner (considered successful if a volunteer reports
that a male partner has [1] documentation of azoospermia by microscopy, or [2] a
vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity
postvasectomy), or
- Any other contraceptive method approved by the HVTN 116 PSRT
Or not be of reproductive potential, such as having had a bilateral oophorectomy, or tubal
ligation;
Or be sexually abstinent.
- Volunteers who were born female must also agree not to seek pregnancy through
alternative methods, such as artificial insemination or in vitro fertilization until
after the last required protocol clinic visit
Mucosal Specimen Collection
- Volunteers 21 years of age and older who were born female: Pap smear (verified by
medical records) is required within:
- the 3 years prior to enrollment with the latest result reported as normal or
ASCUS (atypical squamous cells of undetermined significance), OR
- the 5 years prior to enrollment, with the latest result reported as normal, or
ASCUS with no evidence of high risk HPV.
- If no Pap smear was done within the last 3 years (or within the last 5 years, if
high risk HPV testing was performed), the volunteer must be willing to undergo a
Pap smear with the result reported (verified by medical records) as normal or
ASCUS prior to sample collection.
- Willing to have mucosal secretions and tissue biopsies collected
- Willing to abstain from sexual intercourse for the required period after each biopsy
collection
Exclusion Criteria:
General
- Blood products received within 120 days before first infusion, unless eligibility for
earlier enrollment is determined by the HVTN 116 PSRT
- Investigational research agents received within 30 days before first infusion
- Intent to participate in another study of an investigational research agent or any
other study that requires non-HVTN HIV antibody testing during the planned duration of
the HVTN 116 study
- Pregnant or breastfeeding
- Active duty U.S. military personnel with the potential of being deployed during the
study
Vaccines and Other Injections
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 116 PSRT will determine eligibility
on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 6 months in a prior vaccine
trial. Exceptions may be made for some vaccines and vaccine trials. For volunteers who
have received an experimental vaccine(s) less than 6 months ago, eligibility for
enrollment will be determined by the HVTN 116 PSRT on a case-by-case basis.
- Live attenuated vaccines other than influenza vaccine received within 10 days before
first infusion or scheduled within 10 days after first infusion (e.g., measles, mumps,
and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- Previous receipt of humanized or human mAbs whether licensed or investigational
Immune System
- Immunosuppressive medications received within 30 days before first infusion. (Not
exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; or [3]
topical corticosteroids for mild, uncomplicated dermatitis)
- Serious adverse reactions to VRC01 and VRC01LS formulation components such as sodium
citrate, sodium chloride, and L-arginine hydrochloride, including history of
anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema,
and/or abdominal pain
- Autoimmune disease (Not exclusionary: mild, well-controlled psoriasis)
- Immunodeficiency
Clinically Significant Medical Conditions
- Untreated or incompletely treated syphilis infection
- Clinically significant medical condition, physical examination findings, clinically
significant abnormal laboratory results, or past medical history with clinically
significant implications for current health. A clinically significant condition or
process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated infusions or blood draws, including perceived
inability to establish venous access
- A condition that requires regular use of any anticoagulant medications (not
including aspirin or NSAIDs),
- A condition that requires active medical intervention or monitoring to avert
grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with
reactions to study product, or
- Any condition specifically listed among the exclusion criteria below.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence, assessment of safety or reactogenicity, or a volunteer's ability to give
informed consent
- Psychiatric condition that precludes compliance with the protocol. Specifically
excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
or history of suicide attempt or gesture within the past 3 years.
- Current anti-tuberculosis (TB) prophylaxis or therapy
- Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as
defined in the most recent National Asthma Education and Prevention Program (NAEPP)
Expert Panel report).
- Exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses moderate/high dose inhaled corticosteroids, or
- In the past year has either of the following:
- Greater than 1 exacerbation of symptoms treated with oral/parenteral
corticosteroids;
- Needed emergency care, urgent care, hospitalization, or intubation for asthma.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
- Thyroidectomy, or thyroid disease unless well controlled (normal T3/T4/TSH) with
medication
- Hypertension:
- If a person has been found to have elevated blood pressure or hypertension during
screening or previously, exclude for blood pressure that is not well controlled.
Well-controlled blood pressure is defined as consistently less than or equal to
140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without
medication, with only isolated, brief instances of higher readings, which must be
less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg
diastolic. For these volunteers, blood pressure must be less than or equal to 140
mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
- If a person has NOT been found to have elevated blood pressure or hypertension
during screening or previously, exclude for systolic blood pressure greater than
or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or
equal to 100 mm Hg at enrollment.
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
- Malignancy (Not excluded from participation: Volunteer who has had malignancy excised
surgically and who, in the investigator's estimation, has a reasonable assurance of
sustained cure, or who is unlikely to experience recurrence of malignancy during the
period of the study)
- Seizure disorder: History of seizure(s) within past three years. Also exclude if
volunteer has used medications in order to prevent or treat seizure(s) at any time
within the past 3 years.
- Asplenia: any condition resulting in the absence of a functional spleen
- History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- For those undergoing rectal biopsies, a rectal condition, such as an active infection
or inflammation of the colorectal area (e.g., an HSV-2 outbreak or inflamed
hemorrhoids or colitis/diarrhea), internal hemorrhoids, or any other condition noted
during screening rectal exam via anoscope or in medical history that in the opinion of
the clinician represents a contraindication to mucosal sampling
- For those undergoing vaginal and cervical biopsies, any condition noted during pelvic
exam via speculum or in medical history that in the opinion of the clinician
represents a contraindication to mucosal sampling
- An active genital tract condition, such as an active infection or inflammation of the
genital tract (e.g., genital sores or ulcers, penile or abnormal vaginal discharge,
genital warts that are symptomatic or requiring treatment) or any other condition that
in the opinion of the clinician represents a contraindication to mucosal sampling
- Hysterectomy
- Menopause
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults | NCT02797171 | Contradiction |
5,568 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Prepubertal patients,
- Male/female,
- Ages 3-14 yrs,
- Being treated with growth hormone for the conditions of growth hormone deficiency,
idiopathic short stature, and small-for-gestational age with failure to catch up to
the normal growth curve by age 2 years.
Exclusion Criteria:
- Patients being treated with growth hormone for other conditions such as Turner
syndrome, chronic renal failure, or Prader-Willi syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 14 Years | Constructing an Insulin-Like Growth Factor-based Prediction Model | NCT00263445 | Contradiction |
5,185 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Subject has provided informed consent prior to any study-specific
activities/procedures
- Ambulatory postmenopausal women.
- Age 55 years or older
- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar
spine, total hip, or femoral neck.
Exclusion Criteria:
- Administration of osteoporosis treatments or bone active treatments within specific
timeframes
- Vitamin D deficiency
- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism;
hypo/hyperthyroidism, unless stable and well-controlled)
- Contraindications to denosumab therapy (e.g., hypocalcemia)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 100 Years | A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis | NCT02157948 | Entailment |
5,988 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.
- Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
- GerdQ≥8
- The subject will not have endoscopy within 4 weeks after enrolment.
- Ability to provide informed consent, adhere to the study visit schedule, and complete
all study assessments and complete the patient diary by his/herself.
Exclusion Criteria:
- If participating in any interventional clinical trial.
- Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia,
hematemesis, melena).
- Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive
drug within 2 weeks before screening.
- The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and
famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics
during the upcoming 4 weeks (study duration).
- Previous gastroesophageal surgery.
- Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
- Peptic ulcer
- Diabetes
- Cerebral vascular disease
- Zollinger-Ellison syndrome
- Scleroderma
- Hiatus hernia women
- Pregnant or lactating women
- Any other subjects were not suitable to this study in the opinion of the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease. | NCT02606851 | Entailment |
4,793 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. Participants will be adults who utilize English as their primary language.
2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6
months (to ensure stability of hearing loss), but no greater than 10 years.
3. Contralateral ear with normal, or near-normal, hearing.
4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss,
defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000,
2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the
CNC Word Test at 60 dBA under earphones, less than or equal to 20%
5. Better ear (contralateral ear): normal or near-normal hearing defined as pure-tone
thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer
than 40 dB HL at 4000 Hz with monosyllabic word understanding, as measured using the
CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.
6. Willingness to comply with all study requirements.
7. Patent cochlea and normal cochlear anatomy.
Exclusion Criteria:
1. Medical or psychological conditions that contraindicate undergoing surgery.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of
the electrode array.
3. Unrealistic expectations on the part of the candidate and/or candidate's family,
regarding the possible benefits, risks, and limitations that are inherent to the
surgical procedure(s) and prosthetic devices.
4. Unwillingness or inability of the candidate to comply with all investigational
requirements.
5. Active middle ear infection.
6. Tinnitus primary motivation for implantation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants | NCT03929809 | Entailment |
1,517 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- English speaking
- Able to read, comprehend, and complete the consent form
- Aged 18 to 80, and,
- Meet one of the following:
- Patients with heartburn or regurgitation undergoing a screening EGD, who undergo
WATS3D sampling and forceps biopsies for suspicion of BE, or
- Patients with known BE with or without dysplasia undergoing a surveillance EGD with
WATS3D biopsies and forceps biopsies, or
- Patients who have undergone endoscopic eradication therapy(including, but not limited
to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency
ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD
following the establishment of complete eradication of intestinal metaplasia (CEIM)
with accompanying WATS3D sampling and forceps biopsies.
Exclusion Criteria:
- Patients meeting any of the following criteria will be excluded from this study:
- Patients who on their enrollment endoscopy have a visible highly suspicious lesion,
such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted
biopsy will be excluded from the study.Patients requiring a targeted biopsy on
follow-up endoscopies will be allowed to remain in the study.
- Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on
their initial evaluationfor routine care will be excluded from this study. Subsequent
endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or
both forceps and WATS3D biopsies.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry | NCT02988934 | Entailment |
1,091 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be
enrolled in the study.
Inclusion criteria:
- age between 18 and 60 years
- 3 syncopal episodes at least of likely CNS in the previous 2 years
- marked cardioinhibitory response to HUT or documented asystolic pauses at internal
loop recorder registration [7].
Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV
block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.
Exclusion criteria:
- documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection
fraction lower than 50%)
- documented tachyarrhythmias as possible causes of symptoms
- channelopathies (Brugada syndrome, LQT or SQT syndrome)
- ventricular preexcitation
- symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement
- pregnancy in women
- previous cardiac pacemaker implantation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope | NCT01814228 | Contradiction |
2,893 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | - A clinical diagnosis of probable or definite lab-supported ALS, either SALS or FALS,
according to modified El Escorial criteria.
- Males or females, 21 to 80 years of age.
- Patients receiving treatment with Rilutek® (riluzole) must be on a stable dose for at
least 30 days immediately prior to enrollment.
- Women of childbearing potential must be non-lactating and surgically sterile or using
an effective method of birth control (double barrier or oral contraception) and have a
negative pregnancy test. Women will be considered menopausal if they have not had a
menstrual cycle (period) for two years.
- Disease duration less than five years since symptom onset.
- At least 5 of 10 testable upper extremity muscle groups of MRC grade 4 or better.
- The patient must have given informed consent that has been approved by the appropriate
Institutional Review Board (IRB).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis | NCT00069186 | Entailment |
2,023 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Newly diagnosed histologically or cytologically gastric adenocarcinoma. (Siewert III
acceptable: the bulk of tumor should be in stomach; gastric tumors with extension to
the gastroesophageal junction are permitted.) Patients with T1-T2N1-2 and T3N0-2
disease are eligible (stage I-III). Patients with T1-2N0, N3, T4, or M1 disease are
not eligible.
- T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with contrast.
- Medically eligible to receive CAPOX chemotherapy
- At least 19 years of age
- ECOG performance status ≤ 2
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin > 9 g/dL
- Creatinine clearance > 50 mL/min
- The effects of the various chemotherapy agents used in this study on the
developing human fetus are unknown. For this reason, women of childbearing
potential and men must agree to use adequate contraception (hormonal or barrier
method of birth control, abstinence) prior to study entry and for the duration of
study participation. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she must inform her treating physician
immediately. Men treated or enrolled on this protocol must also agree to use
adequate contraception prior to the study, for the duration of the study, and one
month after completion of the study
- Ability to understand and willingness to sign an IRB approved written informed
consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.
- Prior surgery to the esophagus or stomach.
- Siewert I-II GE junction tumor
- Any active malignancy within 2 years that may alter the course of gastric cancer.
(Apparently cured localized malignancy or advanced, but indolent malignancy with
significantly more favorable prognosis are allowed).
- Currently receiving any other investigational agents.
- Metastatic disease, including gross peritoneal carcinoma
- Presence of ascites
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to capecitabine, oxaliplatin, or other agents used in the study.
- Contraindications to MRI (e.g., non-compatible implantable device or metallic foreign
bodies).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris,
or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
they have a history of AIDS-defining opportunistic infection within the 12 months
prior to registration. Concurrent treatment with effective ART according to DHHS
treatment guidelines is recommended. Recommend exclusion of specific ART agents based
on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent
strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be
contraindicated).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| MR-guided Pre-operative RT in Gastric Cancer | NCT04162665 | Entailment |
1,215 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Adult patients over 18 years of age
- Patients presenting with a lung or pleural nodule or mass presumed to be resectable on
pre- operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of
consent.
Exclusion Criteria:
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Patients with a history of anaphylactic reactions to OTL38
- Patients with a known allergy to Benadryl
- At-risk patient populations:
- Homeless patients
- Patients with drug or alcohol dependence
- Children and neonates
- Patients unable to participate in the consent process.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Intraoperative Imaging of Pulmonary Nodules by OTL38 | NCT02602119 | Entailment |
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