id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
1,972 | 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... | DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the stomach
- Locally advanced or metastatic disease
- Measurable disease
- At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
- No known symptomatic brain metastases
- No bone metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin less than 2 times normal
- AST and ALT no greater than 2.5 times normal
- Alkaline phosphatase no greater than 2.5 times normal
Renal
- Creatinine less than 1.6 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular
- No serious cardiac failure within the past 12 months
- No myocardial infarction within the past 12 months
- No cardiac insufficiency
- No angina
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled serious infection
- No significant brain or psychiatric disorders
- No intolerance to cortisone or polysorbate 80
- No other prior malignancy except curatively treated basal cell skin cancer or
carcinoma in situ of the cervix
- No other illness or medical condition that would preclude study participation
- No peripheral neuropathy greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 21 days since prior participation in another clinical study
- No other concurrent experimental medication
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 75 Years | Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach | NCT00075465 | Entailment |
129 | 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:
- Peripubertal (Tanner stage 1 to 5) girl, age 8-16 years
- Obesity (BMI-for-age ≥ 95th percentile)
- Generally healthy (save for exogenous obesity)
- Ability and willingness of subject/parents to provide informed assent/consent
Exclusion Criteria:
- Age < 8 or > 16 y
- Greater than 4 y post-menarche
- Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome,
leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
- Pregnancy or lactation
- Virilization
- Total testosterone > 150 ng/dl, which suggests the possibility of a virilizing
neoplasm
- DHEAS greater than twice upper limit of age-appropriate normal range
- 17-OHP greater than 250 ng/dl, which suggests the possibility of congenital adrenal
hyperplasia (if postmenarcheal, the 17-OHP will be collected during the follicular
phase, or > 60 if oligomenorrheic) NOTE: If a 17-OHP > 250 ng/dl is confirmed on
repeat testing, an ACTH stimulation test will be offered, with a post-ACTH 17-OHP <
1000 ng/dl being required for study participation
- History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before
age 8)
- Fasting glucose > 125 mg/dl or hemoglobin A1c > 7.0%
- Abnormal TSH or prolactin
- Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired
growth, striae)
- Hematocrit < 36% or hemoglobin < 12 g/dl
- Significant and current cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring systemic intermittent corticosteroids;
etc.)
- Abnormal liver enzymes, age-specific alkaline phosphatase, or a bilirubin > 1.5 times
upper limit of normal
- Abnormal sodium, potassium, bicarbonate concentrations, or elevated creatinine
concentration
- Weight less than 34 kg is an exclusion criterion (to ensure safe blood withdrawal)
- Subjects using restricted medication (see restrictions below) are excluded unless the
subject's primary care provider approves stopping the medication
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 16 Years | Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls | NCT00928759 | Contradiction |
2,692 | 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:
- Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head
and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease
with left ventricular dysfunction (systolic ejection fraction < or = 30%)
Exclusion Criteria:
- Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic
instability Cardiac biomarker instability Need for surgical procedure interfering with
placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical
need for IABP ASA score > or = 5 Pregnancy Inability to provide 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.
| ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery | NCT01253356 | Entailment |
136 | 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:
- Men ages 60 and older
- Serum testosterone between 150-300 ng/dL
- Symptoms suggestive of androgen deficiency
Male
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Anastrozole Administration in Elderly Hypogonadal Men | NCT00136695 | Contradiction |
787 | 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:
- Knee pain and osteophytes on radiographs OR
- Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes
or less, and crepitus (cracking sound) during motion
- Experiences chronic pain for 6 months or longer
- Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
- If female, is not pregnant or breast feeding, and not currently attempting to
conceive; if of childbearing potential, use of a highly effective method of birth
control (as determined by Pl)
- Able to walk at least ½ a city block a day, and agrees to try and slowly increase that
over the course of study
- Able to read and speak English and provide informed consent
- Able to understand and comply with all data collection methodology including
electronic diary
- Subject agrees to 1) continue their stable drug regimen with no changes during the
course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day)
for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours
before testing.
Exclusion Criteria:
- Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake
blockers for mood disorders
- Subject is allergic to SSRIs, SNRIs, or milnacipran
- Subject has severe or untreated psychiatric disturbance (e.g. mania, depression,
anxiety, substance dependence)
- Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or
heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or
digoxin during the trial
- Subject has a clinical diagnosis of fibromyalgia
- Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic
disease [creatinine>1.5 ml/dl; AST or ALT> 3x normal limit], uncontrolled
hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g.
polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders,
uncontrolled seizure disorder or urinary retention)
- Subject has cardiac implants
- Subject has a knee replacement
- Subject plans to start new pain treatments or therapies during the study (e.g. new
pain medication, injections, PT, surgery)
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 | Milnacipran for Chronic Pain in Knee Osteoarthritis | NCT01510457 | Entailment |
4,019 | 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:
1. Male or female higher than 18 and less or equal to 65 years of age
2. an active life-style, professional or regular casual sport player (people who plays
sport or trains themselves at least 2-3 times per week).
3. diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee
X-ray at Screening or an X-ray performed within 6 months prior to screening. The
radiograms must be classified as a Kellgren and Lawrence Grade I-III for
osteoarthritis of the knee.
4. a knee VAS pain score, within 48 hours before the visit.
5. patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks
prior to Baseline except for acetaminophen.
Exclusion Criteria:
1. Major injury to the contralateral knee or other weight-bearing joint if it would
interfere with the study assessments.
2. Surgical procedure of the studied joint within the previous 12 months prior to
Screening.
3. Ligament reconstruction in the target knee within 1 year
4. Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
5. Intra-articular or local peri-articular corticosteroid injections to the study
joint/knee within the previous 3 months prior to screening or to any other joint
(beside the study joint) or soft tissue area within the previous month prior to
Screening.
6. Any corticosteroid within the previous month. Steroid inhalants are permitted if the
patient has been on a stable regimen for the past month prior to Screening and remains
on this regimen throughout the course of the trial.
7. Intra-articular hyaluronan in the studied joint within the previous 6 months prior to
Screening.
8. History of allergic reaction to an intra-articular Hyaluronic acid injection
9. Use of glucosamine- or chondroitin sulfate-containing products unless the patient is
on stable doses for at least 4 months prior to Screening and willing to remain on
these stable doses throughout the course of the trial.
10. Patients with X-ray findings of acute fractures, severe loss of bone density,
avascular necrosis and/or severe deformity.
11. Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on
standing X-ray.
12. Symptomatic osteoarthritis of either hip, contralateral knee or spine that may
interfere with functional assessment of the signal knee.
13. Clinically significant medio-lateral and/or anterior-posterior instability.
14. Osteonecrosis of either knee.
15. If patients are receiving or performing physical therapy at Screening, this physical
therapy regimen has not been stable during the one-month preceding Screening and the
patient is not willing to maintain the same regimen throughout the course of the
trial.
16. Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV
large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
17. Hemiparesis of the lower limbs
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 | Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome | NCT04661111 | Entailment |
1,229 | 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:
- Referral to pulmonary or interventional radiology services for large-volume
thoracentesis
- Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis
of:
- Chest radiograph: effusion filling >= 1/3 the hemithorax, OR
- Computed tomography (CT)-scan: maximum anteroposterior (AP) depth of the effusion
>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm,
including atelectatic lung completely surrounded by effusion, OR
- Ultrasound: effusion spanning at least three rib spaces with depth of >= 3 cm
Exclusion Criteria:
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the
study including:
- Coagulopathy, with criteria left at the discretion of the operator
- Hemodynamic instability with systolic blood pressure < 90 mmHg or heart rate >
120 beats/min, unless deemed to be stable with these values by the attending
physicians
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- Referral is for diagnostic thoracentesis only
- Manometry felt to be clinically indicated
- Inability to assume or maintain a seated position for the procedure
- Presence of multiple loculations on bedside pre-procedure ultrasound
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.
| Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis | NCT02677883 | Entailment |
499 | 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. Women younger than 39 at the time of cryopreservation
2. Regular menstrual cycles of at least 26 days and at most 32 days.
3. Women with no more than 3 failed prior embryo transfers
4. Patients with embryos cryopreserved 48 hours after ovum pick up
Exclusion Criteria:
1. Women with known uterine malformations or significant myomas
2. Women with elevated Progesterone of at least 1.5 ng/mL for the duration of more than
72 hours before embryo transfer can be performed
3. Women suspected of having endometrial pathology based on previous treatment cycles
i.e. "thin endometrium", polyps, adhesions
4. Women whose embryos did not survive the thawing process, i.e. no embryos available for
transfer after thawing
5. Women without follicular development
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Natural Cycle/Progesterone Fortified Protocol for Endometrial Preparation for Frozen/Thawed Embryo Transfer | NCT02749344 | Contradiction |
7,005 | 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 to moderate Alzheimer's disease or related dementia,
- type 2 diabetes
- sleep disturbance as determined by a score ≥ 5 on the PSQI
Exclusion Criteria:
- insulin-dependent diabetes,
- urinary incontinence
- obstructing cataracts
- macular degeneration
- blindness
- severe sleep apnea or
- restless leg syndrome (RLS)
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.
| Light and the Effect on Metabolic Syndrome and Alzheimer's Disease | NCT03777722 | Entailment |
6,534 | 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 diagnosed with hemophilia A and B
- Medical diagnosis of hemophilic arthropathy
- Chronic joint pain
- Over 18 years
- On prophylactic treatment or on demand with FVIII / FIX concentrates
Exclusion Criteria:
- Patients with neurological or cognitive disorders that impede the understanding of the
questionnaires
- Painless patients
- Amputee, epileptic or seriously impaired vision patients
- Patients receiving physiotherapy treatment at the time of the study
- Patients who have not signed the informed consent document.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Movement Visualization in Patients With Hemophilic Arthropathy | NCT04237766 | Contradiction |
1,419 | 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:
- patients with suspicion of OD associated with aging (>70 years), neurodegenerative
diseases or stroke.
Exclusion Criteria:
- Patients with suspicion that they will not be able to compliment the protocol,
patients participating or have participated in a clinical study the last 4 weeks and
patients with alcoholic or drugs dependence
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 70 Years old.
| Effect of Oral Menthol on the Swallow Response of Patients With Oropharyngeal Dysphagia Associated With Neurological Diseases and Aging | NCT03050957 | Contradiction |
3,794 | 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:
- Age 35 to 80
- Subjects of childbearing potential and their partners must use effective contraception
- OA based on the ACR criteria
- OA of the knee ≥ 6 months prior to Screening
- OA knee pain which required NSAID or other therapy for ≥ 15 days
- Pain on Movement in the contralateral knee be ≤ 20 mm
- Radiographic evidence of OA by Kellgren-Lawrence score of 2 or 3 taken 6 months prior
to Screening
- Moderate to severe OA pain defined as POM score between 50 mm and 90 mm
- Baseline WOMAC pain subscale score ≥ 9
- No change in physical activity and/or therapy for the past 3 months
- Provide written informed consent and comply with the trial
Exclusion Criteria:
- Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit
- Inflammatory skin condition over the target knee
- Extreme pain in the target knee characterized by POM score of > 90 mm
- Mild pain in the target knee, characterized by POM score of < 50 mm
- > 30 mm POM score variability in Days -2 to -1 from Baseline visit
- Baseline POM score of > 20 mm for the contralateral knee or any other significant
joint or general pain at Baseline visit
- Excessive effusion in the target knee
- Heat and/or redness in comparison to the contralateral knee
- Knock-kneed or bow-legged defined by valgus or varus deformity of ≥ 15 degrees
- Acute or chronic injury other than OA
- Radiographic evidence of OA by Kellgren-Lawrence score of 0, 1 or 4
- Open surgery of the target knee within the last year
- Arthroscopic surgery of the target knee within the last 6 months
- Surgery of the target knee requiring insertion of a medical device or surgical
hardware
- Use of prohibited concomitant medications/therapies during the 7-day washout period or
planned use during the 14-day treatment period including:
1. Prescription medications to treat pain, OTC and natural supplements
2. Muscle relaxants unless on a stable dose ≥ 30 days prior to Screening
3. Nutraceuticals unless on a stable dose ≥ 3 months prior to Screening
4. Sedative hypnotics unless on a stable dose ≥ 30 days prior to Screening
5. Devices or therapeutic treatments for knee pain or ambulation
6. Systemic corticosteroids
7. Other Investigational Drugs
8. Chemotherapeutic drugs
9. Immunotherapy
10. Topical products applied to the target knee
11. Cyclosporine (except ophthalmic), lithium, methotrexate
12. Anti-depressants or medications acting on the central nervous system, unless on a
stable dose for depression ≥ 3 months prior to Screening
13. Narcotics or previous history of chronic narcotic use
14. Rescue Medication within 48 hours of Baseline, Day 7 or Day 14 visits
- Intraarticular steroids in the target knee within the previous 3 months or in any
other joint within the previous 30 days
- Intraarticular hyaluronate within the previous 6 months or in any other joint within
the previous 30 days
- Systemic corticosteroids within the prior month
- Documented history of inflammatory joint disease
- BMI over 35
- Uncontrolled psychiatric conditions
- Cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or
neurological disease or prior surgery
- Uncontrolled hypertension
- Diabetes with an HbA1c level > 8
- Known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis
C Virus (HCV)
- Cancer within the past 5 years, except for treated basal cell or squamous cell
carcinoma of the skin
- Any other medical conditions, diseases or prior surgeries
- Interventional and/or surgical procedure during the 28 days following randomization
- Change in level of physical activity during the 28 days following randomization
- Active infection or fever ≥ 38°C within 3 days of Baseline visit
- Known sensitivity to Investigational Drug
- Women planning to become pregnant during the 28-day trial
- Participation in any Investigational Drug or device trial within 30-day prior to
Baseline visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 Years | Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee | NCT01768975 | Entailment |
264 | 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. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed
consent/assent and in good general health;
2. History of regular menstrual cycles defined as occurring every 21-35 days when not
using hormones or prior to recent pregnancy or spontaneous or induced abortion;
3. Sexually active with a male partner who has not had a vasectomy;
4. Reasonably expect to have coitus at least once monthly during the study period;
5. In a mutually monogamous relationship of at least 3 months duration;
6. Seeking to avoid pregnancy for the duration of the study;
7. Willing to use the study drug as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Subjects who are age 21 or older, at time of informed consent, must have a normal
papanicolaou test (Pap) or atypical squamous cells of undetermined significance
(ASC-US) with negative high risk human papilloma virus (HPV) test result within the
appropriate screen timeframe per American Society for Colposcopy and Cervical
Pathology (ASCCP) guidelines, and prior to the study IUD insertion. Alternatively, the
subject must have had a colposcopy performed within the appropriate screen timeframe,
and prior to the study IUD insertion that showed no evidence of dysplasia requiring
treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease by clinical evaluation;
10. Able and willing to comply with all study tests, procedures, assessment tools
(including e-diary) and follow-up;
11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI). Unemancipated subjects under 18 years
old must provide assent and have written parental consent documented on the consent
form consistent with local legal requirements;
12. Plan to reside within a reasonable driving distance of a research site for the
duration of the study.
13. Subject agrees not to self-remove VeraCept
Exclusion Criteria:
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle;
2. Subject who anticipates separation from her partner for more than a 6-month period
during use of VeraCept;
3. A previously inserted intrauterine device (IUD) that has not been removed by the time
the study IUD is placed;
4. History of previous IUD complications, such as perforation, expulsion, or pregnancy
with IUD in place;
5. Pain with current IUD;
6. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and
has not had 2 normal menstrual cycles since the last injection;
7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 60 months of study participation;
8. Exclusively breastfeeding before return of menses; lactating women will be excluded
unless they have had 2 normal menstrual periods prior to enrollment;
9. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including
bleeding 4 weeks post-septic abortion or puerperal sepsis;
10. Severely heavy or painful menstrual bleeding;
11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal Pap smear requiring evaluation or treatment;
12. Any history of gestational trophoblastic disease with or without detectable elevated
ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;
13. Any congenital or acquired uterine anomaly that may complicate study drug placement,
such as:
- Submucosal uterine leiomyoma
- Asherman's syndromes
- Pedunculated polyps
- Bicornuate uterus
- Didelphus or uterine septa
14. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the
investigator, are likely to cause issues during insertion, retention or removal of the
IUD;
15. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study drug placement;
16. Untreated acute cervicitis or vaginitis within the past 3 months;
17. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
18. Subjects who have an established immunodeficiency;
19. Known intolerance or allergy to any components of VeraCept including intolerance or
allergy to nickel, titanium, or copper, and including Wilson's Disease;
20. Currently participating or planning future participation in a research study of an
investigational drug or device during the course of this investigational study.
Subject must have waited at least 30 days from exiting their last study prior to
informed consent in this study;
21. Subject has been enrolled in a previous VeraCept study;
22. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;
23. Any general health, mental health or behavioral condition that, in the opinion of the
investigator, could represent an increased risk for the subject or would render the
subject less likely to provide the needed study information;
24. Study staff or a member of the immediate family of study staff.
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD | NCT03633799 | Contradiction |
6,699 | 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:
- Male
- At least 6 years of age and not more than 65 years of age.
- Signed and dated Informed Consent Form and Patient Authorization for Release of
Information approved by the appropriate Institutional Review Board (IRB) prior to
screening and enrollment. If the subject is a minor (i.e., less than 18 years of age)
both he and his parent or legal guardian must sign and date the informed consent.
- Diagnosis of severe hemophilia A
- Levels of Factor VIII less than 0.01 IU/mL.
- Treatment with cryoprecipitate, Factor VIII concentrates, and/or whole blood, for at
least 150 cumulative exposure days (CEDs) prior to enrollment.
- No treatment with cryoprecipitate, Factor VIII concentrate, or any other blood
product, for at least 72 hours prior to screening.
- No previous diagnosis with inhibitors to Factor VIII at any detectable titer.
- Subjects must never have been diagnosed with nonspecific inhibitors of coagulation.
- Negative test for the presence of Factor VIII inhibitors at screening and enrollment.
- CD4 counts greater than or equal to 400 cells/µL.
- Vaccination against hepatitis A and hepatitis B, or evidence of antibodies against
hepatitis A and hepatitis B. (A subject who has no prior immunity against hepatitis A
will be offered a course of vaccination for hepatitis A.)
- Karnofsky Performance Score of at least 50.
Exclusion Criteria:
- Any immunosuppressive medications including intravenous immunoglobulins at the time of
enrollment.
- Clinical signs or symptoms of an infection, such as fever, chills or nausea during
screening or enrollment.
- History of frequent reactions to Factor VIII concentrates (e.g., chills or headaches).
- Prior treatment with Alphanate® (Solvent-Detergent/ Heat-Treated).
- Immunocompromised (including HIV+ status or has an impaired immune system due to
disease or treatment).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 65 Years | Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A | NCT00323856 | Contradiction |
173 | 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:
- Hypogonadal male between 18 and 65 years of age, inclusive;
- Able to understand and provide signed informed consent;
- Have documented total serum testosterone levels ≤300 ng/dL;
- Are currently being treated with any form of a topical testosterone replacement
therapy for at least three months, or are treatment-naive.
Exclusion Criteria:
- In the opinion of the Investigator, significant intercurrent disease of any type, in
particular liver, kidney, heart disease, stroke, or psychiatric illness;
- History of pituitary or hypothalamic tumors or history of any malignancy (including
breast and prostate cancers) excluding basal cell or squamous cell carcinoma of the
skin curatively treated by surgery;
- Prostatomegaly or history of abnormal PSA levels (>10.0 ng/mL). If PSA is >10 ng/mL, a
recent negative biopsy must be documented (within the last 12 months);
- History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous
6 months or nasal fracture that caused a deviated anterior nasal septum surgery,
mucosal inflammatory disorders, specifically Sjogren's syndrome;
- Use of any form of intranasal medication delivery other than periodic short-term (less
than 3 days) use of sympathomimetic decongestants;
- History of severe adverse drug reactions to testosterone therapies;
- History or current evidence of abuse of alcohol or any drug substance;
- Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic
steroids, or other sex hormones;
- Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth
hormone within the previous 12 months;
- Treatment with drugs that interfere with the metabolism of testosterone, such as
anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole,
spironolactone, or testolactone;
- Poor compliance history;
- Participation in any other research study during the conduct of this study or 30 days
prior to the initiation of this study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ | NCT02937740 | Entailment |
2,676 | 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:
- Elective laparoscopic repair for one or more incisional hernias in the midline (at
least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone),
using a synthetic mesh
- Horizontal fascial defect between 3 and 8 cm
- Age between 25 and 75 years
- American Association of Anesthesiologist score between I and III
- Body mass index < 33 kg/m^2
Exclusion Criteria:
- Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient
from climbing stairs or shopping for groceries
- Existing stoma
- Postoperative complications requiring intervention
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 75 Years | Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair | NCT02320071 | Entailment |
4,067 | 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:
- A diagnosis of osteoarthritis of the index hip or knee based on American College of
Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the
Central Reader
- Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib,
diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or
ketoprofen) as described in the protocol along with a history of insufficient pain
relief from, inability to tolerate or contraindication to taking acetaminophen and,
tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol
specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening
period
- WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
- Be willing to discontinue all non study pain medications for osteoarthritis and not
use prohibited pain medications throughout the duration of the study
- Female subjects of childbearing potential must agree to comply with protocol specified
contraceptive requirements
Exclusion Criteria:
- Subjects exceeding protocol defined BMI or body weight limits
- History of other diseases specified in the protocol (eg, inflammatory joint diseases,
crystalline diseases such as gout or pseudogout) that may involve the index joint and
that could interfere with efficacy assessments
- Radiographic evidence of protocol specified bone or joint conditions in any screening
radiograph as determined by the central radiology reviewer
- A history of osteonecrosis or osteoporotic fracture
- History of significant trauma or surgery to a knee, hip or shoulder within the
previous year
- Planned surgical procedure during the duration of the study
- Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to
severe pain that may confound assessments or self evaluation of osteoarthritis pain
- Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
- Considered unfit for surgery based upon American Society of Anesthesiologists physical
classification system for surgery grading, or subjects who would not be willing to
undergo joint replacement surgery if required
- Contraindications to magnetic resonance imaging
- History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or
diclofenac) the subject could be randomized to receive or any of its excipients or
existence of a medical condition or use of concomitant medication for which the use of
this NSAID is contraindicated
- History of intolerance or hypersensitivity to acetaminophen or any of its excipients
or existence of a medical condition or use of concomitant medication for which the use
of acetaminophen is contraindicated
- Use of prohibited medications without the appropriate washout period prior to
Screening or Initial Pain Assessment Period
- History of cancer within 5 years of Screening, except for cutaneous basal cell or
squamous cell cancer resolved by excision
- Subjects with signs and symptoms of clinically significant cardiac disease as
described in the protocol
- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis
of stroke with residual deficits that would preclude completion of required study
activities
- History, diagnosis, or signs and symptoms of clinically significant neurological
disease such as but not limited to peripheral or autonomic neuropathy
- History, diagnosis, signs or symptoms of any clinically significant psychiatric
disorder
- History of known alcohol, analgesic or drug abuse within 2 years of Screening
- Previous exposure to exogenous NGF or to an anti-NGF antibody
- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG fusion protein
- Poorly controlled hypertension as defined in the protocol or taking an
antihypertensive that has not been stable for at least 1 month prior to Screening
- Evidence of protocol defined orthostatic hypotension at Screening
- Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined
limits
- Presence of drugs of abuse in screening urine toxicology panel
- Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
- Participation in other investigational drug studies within protocol defined time
limits
- Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling
or unable to follow protocol required contraceptive requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that in the judgment of the investigator, would make the subject
inappropriate for entry into this 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.
| Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee | NCT02528188 | Entailment |
6,000 | 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:
- Patient has an established diagnosis of GERD according to the investigator, or an
occurrence of at least 1 typical GERD symptom (i.e., heartburn or regurgitation) at
least once a week during the last 3 months.
- Patient has presented at least 1 typical GERD symptom (i.e., heartburn or
regurgitation) in the week preceding the study visit.
Exclusion Criteria:
- Exclusively atypical digestive or non-digestive symptoms (e.g., epigastralgia,
respiratory disturbances, thoracic manifestations, etc.)
- Current or recent (less than 1 year) history of gastric or duodenal ulcer
- History of surgery of the upper digestive tract
- Tumor of the superior digestive tract or ENT system;
- Pregnant or breastfeeding woman
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.
| Observational Study (This Means That no Drug is Tested) in Patients Suffering of Gastroesophageal Reflux Disease. | NCT01601379 | Entailment |
1,433 | 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:
- Symptom of dysphagia
- Esophageal findings consistent with ineffective esophageal motility (IEM), defined as
per the Chicago Classification as ≥50% ineffective swallows. Ineffective swallows
include both failed swallows, defined by an average distal contractile integral (DCI)
<100mmHg*cm*sec, and weak swallows, defined by an average DCI >100 but <450mmHg*cm*sec
- Normal endoscopy
- If female of childbearing potential, a negative urine pregnancy test administered 1
day prior to taking the study medication (prucalopride)
- Able to provide informed consent
Exclusion Criteria:
- Clinical evidence (on history, physical exam, or investigations) of significant
cardiovascular, respiratory, gastrointestinal, hepatic, hematological, renal,
neurological, or psychiatric comorbidities that may interfere with the objectives of
the study and/or pose safety concerns, including pregnancy and breastfeeding
- History of cardiovascular disorder including myocardial infarction, life-threatening
arrhythmias, pacemaker or defibrillator
- Estimated GFR <30, documented within 6 months preceding study entry
- Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal
reference ranges
- Uncontrolled gastroesophageal reflux disease on pH testing (DeMeester score >14.7)
- Established esophageal motility disorder, including but not limited to achalasia,
spastic disorders, Esophagogastric junction (EGJ) outflow obstruction, and absent
contractility
- History of gastrointestinal surgery, including hiatal hernia repair and/or
fundoplication, or any major surgery in the 3 months preceding study entry
- Use of narcotics or prokinetic treatments that cannot be stopped prior to study entry
- Use of laxatives that cannot be stopped prior to study entry
- Use of tricyclic antidepressants at a dose of >25 mg daily (stable doses of SSRIs/
SNRIs are permitted)
- Use of macrolide antibiotics (non-macrolide antibiotics are permitted)
- Participation in clinical trial with prokinetic treatment in the 30 days preceding
study entry
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 | Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study | NCT03244553 | Contradiction |
1,838 | 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 are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy
sampling
Exclusion Criteria:
- Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases
- Patients without informed consent
- Patients with other malignant tumors
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 | Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner | NCT04327050 | Entailment |
2,315 | 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
- Able to walk >170 m
- Absence of hepatic insufficiency
- Absence of renal insufficiency
Exclusion Criteria:
- Dependent upon wheelchair
- Body weight >60kg
- Liver failure
- Kidney failure
- Surgery scheduled during the year following the first visit
Male
No healthy subjects accepted to join the trial.
| Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy | NCT00296621 | Entailment |
907 | 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
- Current symptoms of chronic (6 months), stable pain and/or stiffness in one or both
knees during weight-bearing activities
- Involved joint is primary factor limiting physical or functional activity
- Radiographic signs of mild or moderate arthritis
- Mild joint space narrowing (at least 2mm remaining)
Exclusion Criteria
- Current participation in a regular exercise program
- Existing medical condition that would preclude increased physical activity
- Subjective complaint of instability (giving way)
- Ligamentous instability greater than Grade I
- Knee flexion contracture greater than 15 degrees
- Asymptomatic osteoarthritis of both knees, incapacitating arthritis, or inflammatory
arthritis
- Major reconstructive surgery on a lower extremity joint
- Multiple major joint involvement
- Any condition which severely limits local ambulation, such as amputation or stroke
- Gait aids used majority of time for ambulation
- Cannot use step-over-step techniques in either ascending or descending stair
conditions
- Not able to undergo MRI scan (e.g., cardiac pacemaker)
- Dementia or inability to give informed consent as determined by a Folstein Mini Mental
score greater than 24
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.
| Aerobic Exercise Intervention for Knee Osteoarthritis | NCT00049816 | Entailment |
6,988 | 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 (Alzheimer's disease):
- Meet the criteria for probable Alzheimer's disease with amnestic presentation as
described in the NIA-AA criteria (McKhann 2011)
- The diagnosis has been made by either a neurologist, psychiatrist or a geriatrician at
the memory clinic at Rigshospitalet or Zealand University Hospital
- The participant is between 50 and 90 years old
- The MMSE score is between 16-28
- The participant does not wear a hearing aid
- The participant is a native Danish speaker
- The participant has at least attended school for 7 years
- The participants' hearing and vision is sufficient to participate in
neuropsychological tests
- The participants' general condition of health allows that the participant can
cooperate with the trial
- The participant does not suffer from psychiatric diseases (except mild depressive
symptoms or mild depression) or neurological diseases that affect the brain other than
Alzheimer's disease
- The treatment with anti-dementia medication or SSRI drugs have been given in stable
dose for at least 3 months up to the inclusion and the doctor including the
participant estimates that treatment will not change within the next 6 months
- No overuse of alcohol or intake of illegal drugs within the last 2 years
- The participant has previously undergone a CT or MRI scan, which is compatible with
Alzheimer's disease
- The participant does not have any contraindications for MRI or MRI contrast
- The participant is living with another person, who is willing to take part in the
trial, and who is together with the person long enough to observe the behavior (if any
epileptic activity should arise)
Exclusion Criteria (Alzheimer's disease):
- Diagnosis of epilepsy prior to the diagnosis of Alzheimer's disease was made
- Other focal pathology in the hippocampus for example hippocampal sclerosis
- The person living with the participant is not able to participate (e.g. due to a
serious disease or disability) in the clinical visits or able to register behavior
suspected of epilepsy
- The participant is living in a nursing home
- The participant is treated with antiepileptic medication, tricyclic antidepressants or
antipsychotics
- Daily or nearly daily intake of medication known to have an anticholinergic or an
adrenergic effect, which is suspected to affect the cognitive abilities or the EEG
- Large brain infarctions or more than 4 lacunar infarcts
- The participants is suffering from uncontrollable movements of the face as for example
oral dyskinesia
Inclusion Criteria (Lewy body dementia):
- Meet the criteria for Lewy body dementia as described in dementia with Lewy body
consortium (McKeith 2017)
- The diagnose has been made by either a neurologist, psychiatrist or a geriatrician at
the memory clinic at Rigshospitalet or Zealand University Hospital
- The participant is between 50 and 90 years old
- The MMSE score is between 16-28
- The participant does not wear a hearing aid
- The participant is a native Danish speaker
- The participant has at least attended school for 7 years
- The participants' hearing and vision is sufficient to participate in
neuropsychological tests
- The participants' general condition of health allows that the participant can
cooperate with the trial
- The participant does not suffer from psychiatric diseases (except mild depressive
symptoms or mild depression) or neurological diseases that affect the brain other than
Lewy body dementia
- The treatment with anti-dementia medication or SSRI drugs have been given in stable
dose for at least 3 months up to the inclusion and the doctor including the
participant estimates that treatment will not change within the next 6 months
- No overuse of alcohol or intake of illegal drugs within the last 2 years
- The participant does not have any contraindications for MRI or MRI contrast
- The participant is living with another person, who is willing to take part in the
trial, and who is together with the person long enough to observe the behavior (if any
epileptic activity should arise)
Exclusion Criteria (Lewy body dementia):
- Diagnosis of epilepsy prior to the diagnosis of Lewy body dementia was made
- Other focal pathology in the hippocampus for example hippocampal sclerosis
- The person living with the participant is not able to participate (e.g. due to a
serious disease or disability) in the clinical visits or able to register behavior
suspected of epilepsy
- The participant is living in a nursing home
- The participant is treated with antiepileptic medication, tricyclic antidepressants or
antipsychotics
- Daily or nearly daily intake of medication known to have an anticholinergic or an
adrenergic effect, which is suspected to affect the cognitive abilities or the EEG
- Large brain infarctions or more than 4 lacunar infarcts
- The participants is suffering from uncontrollable movements of the face as for example
oral dyskinesia
Inclusion Criteria (Healthy controls):
- Normal cognition as evaluated at the clinical examination
- The participant is a native Danish speaker
- The participant has at least attended school for 7 years
- The participants' hearing and vision is sufficient to participate in
neuropsychological tests
- The participants' general condition of health allows that the participant can
cooperate with the trial
- The participant does not suffer from psychiatric diseases (except mild depressive
symptoms or mild depression) or neurological diseases that affect the brain
- The participant does not have any contraindications for MRI or MRI contrast
Exclusion Criteria (Healthy controls):
- The participants is suffering from uncontrollable movements of the face as for example
oral dyskinesia
- The participant is suffering from epilepsy or receives anti-epileptic medication
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 | Epileptic Activity in Patients With Alzheimer's Disease and Lewy Body Dementia | NCT04436341 | Entailment |
2,024 | 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 who underwent upper endoscopy
Exclusion Criteria:
- Age < 20 or > 70
- Severe systemic disease or advanced chronic liver disease
- Medication history of NSAID, PPI, H2 blockers or antibiotics
- History of H. pylori eradication therapy
- History of gastric surgery
- Recent history of upper GI bleeding
- Gastric or duodenal ulcer (including old scar change) during endoscopy
- Anemia (Hemoglobin level < 10mg/dL)
- Pangastritis
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 70 Years | Detection of Helicobacter Pylori Infection by High Resolution Endoscopy | NCT01434992 | Entailment |
6,138 | 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:
- Patients with COVID 19 PCR positive
Exclusion Criteria:
- Patients less than 18 years of age .
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 | Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital | NCT04481360 | Contradiction |
5,145 | 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:
- Voluntary written informed consent, and who were willing and able to make reasonable
efforts to observe all clinical trial requirements were to be enrolled
- Subjects were to be postmenopausal (naturally or surgically) women, from 60 to 85
years of age (inclusive) at entry
- Screening BMD of the total hip and/or spine had to be equal to or lower than 2.5 SD
T-score for subjects without an asymptomatic fracture or equal to or lower than -2.0
SD T-score for subjects with an asymptomatic fracture
- Subjects were to have a Body Mass Index (BMI) = 34 kg/m^2.
Exclusion Criteria:
Subjects with any of the following conditions were not to be enrolled into the trial:
- Recent acute vertebral fracture (diagnosed within the last year) documented by spinal
radiograph requiring medication for osteoporosis treatment, in the judgment of the
investigator
- More than two prevalent asymptomatic vertebral fractures at baseline
- Screening BMD of the total hip or spine lower than -4 SD T-score
- Unsuitable anatomy on spinal radiographs (lumbar and thoracic vertebrae) e.g.,
excessive scoliosis
- Not ambulatory
- History or presence of any malignancy within the past five years except for
nonmelanoma skin cancer. Subjects with ever history of ovarian cancer or estrogen
dependent tumors particularly breast or endometrial cancer were to be excluded
- Trans vaginal ultrasound (TVUS) endometrial double wall thickness >4 mm
- Unexplained abnormal vaginal bleeding in the past year prior to screening
- Abnormal cervical Papanicolaou (Pap) smear (including low grade squamous
intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL),
atypical squamous cells of undetermined significance (ASCUS), atypical glands of
undetermined significance (AGCUS))
- Mammography finding that was suspicious of malignancy
- Bone disease other than osteoporosis such as Paget's disease, osteomalacia,
hyperparathyroidism, or bone metastases
- Treatment with anabolic steroids, calcitonin, raloxifene, tamoxifen, or calcitriol
within the last six months prior to screening BMD or spinal X-ray measurements.
- Treatment with systemic estrogen and/or progestin within the last three months prior
to screening BMD or spinal X-ray measurements (occasional use of estriol containing
vaginal cream was allowed)
- Treatment with bisphosphonates for one month or more within the last year
- Ever use of estrogen and/or progestin containing implants
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 85 Years | Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468) | NCT00519857 | Contradiction |
5,834 | 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:
Each patient must meet all of the following criteria to be eligible for enrollment in this
study:
- Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18
years old at the Screening Visit.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
regurgitation) while taking standard proton pump inhibitor (PPI) therapy.
- Patient has evidence of pathological acid reflux.
- Female patients must not be pregnant and must agree to avoid pregnancy for the
duration of the study.
- Patient must comply with study procedures.
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the
study:
- Patient has a history of complete lack of GERD symptom response to PPI therapy.
- Patient has a significant medical or surgical history including conditions that would
impact drug absorption or metabolism (such as bowel obstruction, poorly controlled
diabetes, gastroparesis, hiatal hernia).
- Patient reports pain or burning behind the breastbone or in the center of the upper
stomach as his or her predominant symptom at the Screening Visit.
- Patient has received an investigational drug during the 30 days before the Screening
Visit, or is planning to receive another investigational drug or use an
investigational device at any time during the study.
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
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 Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors | NCT03561090 | Contradiction |
289 | 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:
- Undergoing FET treatment cycles
- Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at
baseline
- endometrial thickness >=8mm during the stimulated IVF cycle and FET cycle
Exclusion Criteria:
- Pregnancy in previous IVF or FET cycles
- Presence of hydrosalpinx not surgically corrected prior to FET
- Presence of endometrial polyp or fibroid distorting uterine cavity
- IVF cycles carried out for preimplantation genetic diagnosis
- Arrange for blastocyst transfer
- Use of donor oocytes
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles | NCT02197832 | Contradiction |
2,238 | 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:
- Diagnosed with gout
Exclusion Criteria:
- Participated in other clinical study within 12 weeks prior to enrollment, and received
an investigational product (including placebo)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients | NCT02290210 | Entailment |
1,668 | 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:
- Be seen as a clinical patient in one of the participating Integrative Medicine (IM)
clinics and willing to participate in the Registry
- Be 18 years of age or older
- Have access to a computer with internet connection and a valid email address
- Be willing to be contacted in the future by study investigators
Exclusion Criteria:
- Not being seen by a provider for clinical purposes, but only involved in an education
program or one-time activity
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Registry for Integrative Medicine Interventions Effectiveness | NCT01754038 | Entailment |
3,717 | 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:
- primary knee osteoarthritis
- synovitis
- pain
Exclusion Criteria:
- other inflammatory conditions
- hepatic insufficiency
- renal insufficiency
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 100 Years | Methorexate and Knee Osteoarthritis | NCT04326894 | Contradiction |
6,636 | 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 has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
- Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1
BU (Bethesda or Nijmegen method)
- Subject has been prescribed ADVATE by their treating physician
- Subject may be of any age
- Subject or parent/legally authorized representative has provided written informed
consent
Exclusion Criteria:
- None
Male
No healthy subjects accepted to join the trial.
| ADVATE Post Authorization Safety Surveillance | NCT00214734 | Contradiction |
930 | 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:
- Symptomatic unilateral knee tibiofemoral OA
- Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both
knees on a recent 3 months time X-Ray
- Knee pain within the last 24 hours before assessment more than 40mm on VAS
- Pain on most days in the last month
Exclusion Criteria:
- Knee pain equal or more than 80mm on a 100mm VAS.
- Pain in the contra lateral knee; more than 30mm on a 100 VAS.
- Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of
Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
- Any condition that may interfere with the measure of pain in the targeted knee
- Concomitant meaningful synovial fluid effusion
- Post trauma OA
- Gross ligamentous instability of the knee
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis | NCT01365260 | Entailment |
3,664 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Men and women ≥50 years of age.
- Symptoms of leg/buttock/groin pain, with or without back pain, that are exacerbated by
lumbar extension and relieved in flexion.
- Diagnosis of neurogenic intermittent claudication (NIC) (defined as a feeling of
paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking
or standing) secondary to lumbar spinal canal stenosis at 1-2 lumbar levels (between
L1 and L5), confirmed by dynamic X-Ray (showing sagital instability or rocking), and
CT and/or MRI (showing central spinal canal narrowing and/or foraminal narrowing).
- Has completed at least 6 months of conservative therapy, which may include but is not
limited to, epidural steroid injections, oral steroids, NSAIDS, analgesics, physical
therapy, spinal manipulation, bracing.
- Appropriate candidate for lumbar surgical treatment using posterior approach.
- Subject can walk independently 15 meters or more.
- Subject is able to understand the risks and benefits of participating in the study.
- Subject understands and has signed the study informed consent form.
- Subject is physically and mentally willing and able to comply with the requirements of
the study procedure and scheduled follow-up visits and testing.
Exclusion Criteria:
- Severe symptomatic lumbar spinal stenosis at ≥2 level, requiring surgical
intervention.
- Prior lumbar spine surgery at any level.
- Unremitting pain in any spinal position or axial back pain only without
leg/buttock/groin pain.
- Evidence that subject's symptoms are due to vascular claudication OR has significant
peripheral vascular disease.
- Significant instability of the lumbar spine at any level OR defined as translation of
more than 3mm or 10 degrees of angular motion between flexion and extension on upright
lateral radiographs.
- Subject has an ankylosed segment at the affected level.
- Significant scoliosis, defined as Cobb angle >25°.
- Cauda equina syndrome.
- Fixed motor deficit or known peripheral neuropathy demonstrated clinically.
- Subject has degenerative neurologic disease.
- Subject has any mass lesions.
- Any evidence of spinal or systemic infection.
- Subject has a history of spinous process fracture or pars interarticularis fractures
or pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or
hips
- Subject has history or radiographic evidence of 1 or more osteoporotic fractures in
the spine.
- Subject has severe osteoporosis of the spine, defined as bone mineral density (BMD) in
the spine more than 2.5 SD below the mean of adult normals.
- Subject is paraparetic.
- Subject has a bleeding disorder.
- Active systemic disease such as HIV, hepatitis, etc.
- Subject is immunologically suppressed, or has received or is receiving 7.5 milligrams
prednisone (or equivalent) daily for more than six months immediately prior to
enrollment.
- Extreme morbid obesity, defined as BMI >35 kg/m2.
- Diagnosis of lumbar spinal stenosis which requires a direct neural decompression or
surgical intervention other than those required to implant the experimental device.
- Subject is not able to undergo MRI or tolerate closed MRI scan.
- Known or suspected history of alcohol and/or drug abuse.
- Life expectancy less than one year.
- Active rheumatoid arthritis.
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.
| Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis | NCT01053364 | Contradiction |
6,494 | 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 include:
1. Fitzpatrick skin type II or III
2. Age greater than or equal to 18 years
3. Individuals without a history of rosacea
Exclusion criteria include:
1. Women who are pregnant or lactating
2. Use of topical prescription medications or procedures to the face within one month of
enrollment
3. Skin conditions that might interfere with interpretation of procedure results (at the
discretion of the investigator)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Genetic Basis of Rosacea Study (Control) | NCT02749786 | Entailment |
4,929 | 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:
- Patients with clinical diagnosis of E.T. for at least a year by a movement disorder
neurologist
- A +2 or worse action or kinetic tremor of one or both upper limbs involving at least
the forearm and/or hand
- Ages 18 to 95 years old
Exclusion Criteria:
- (+) sensory loss in the upper extremities
- dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing
wounds, abrasions, acne, pustules, abscesses, or skin rash)
- known history of sensitivity to cold (i.e., cold urticaria)
- known peripheral vascular disease
- Raynaud's phenomenon
- scleroderma
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 95 Years | Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor | NCT01093027 | Entailment |
6,595 | 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:
- Males, age 18 to 65 years
- Subjects with Severe hemophilia A with a documented plasma FVIII level of <1%
- >/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records
Exclusion Criteria:
- Evidence of current or past inhibitor antibody
- History of any congenital or acquired coagulation disorders other than hemophilia A
- Platelet count <75,000/mm3
- Abnormal renal function (serum creatinine >2 times the upper limit of the normal
range)
- Active liver disease verified by medical history or persistently elevated alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of
normal or severe liver disease as evidenced by, but not limited to any of the
following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein
hypertension including presence of otherwise unexplained splenomegaly and history of
esophageal varices
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222 | NCT01653639 | Contradiction |
3,212 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Exclusion Criteria:
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
No condition on gender to be admitted to the trial.
Subject must be at least 20 Years old.
| A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | NCT02503189 | Entailment |
2,303 | 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:
- Genetically confirmed dystrophin mutation compatible with DMD phenotype. Specifically,
gene deletion test positive (missing one or more exons) in the central rod domain
(exons 25-60) of dystrophin, where reading frame can be predicted as 'out-of-frame' OR
showing complete absence of dystrophin by muscle biopsy.
- Ages between 3 years and < 7 years
- Steroid-naïve
- Signed informed consent
Exclusion Criteria:
- Treatment with CoenzymeQ10, creatine, amino acid supplements within 3 months of study
entry
- Treatment with cardiac medications: beta-blockers, digoxin, and carvedilol
- Existing medical condition or physical disability that would alter subject's motor
development
- Existing medical condition that precludes the use of corticosteroids
- Inability to swallow sample tablet in bite of soft food*
- Investigator assessment that participant or family will not be compliant with
treatment or study procedures
- Been on investigational DMD medication for the past 6 months
Male
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 6 Years | A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy | NCT02036463 | Contradiction |
1,921 | 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... | DISEASE CHARACTERISTICS:
- Histologically proven stage II-IV adenocarcinoma of the stomach including cardia
carcinoma types II and III
- Locally resectable disease
- No distant metastases except M1 lymph nodes
- No evidence of peritoneal carcinomatosis
- Free tumor cells in lavage at laparoscopy allowed
- No uncontrolled bleeding of the primary tumor
- No gastric outlet syndrome or complete tumor stenosis that would require total
parenteral nutrition
PATIENT CHARACTERISTICS:
Age:
- 18 to 69
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- Prothrombin rate at least 70%
Renal:
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No prior atrial or ventricular arrhythmias
- No prior congestive heart failure
- No myocardial infarction within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior or concurrent neoplasm except curatively treated nonmelanoma skin
cancer or carcinoma in situ of the cervix
- No active infection
- No allergy to protocol drugs
- No dementia or significantly altered mental status
- No other serious medical condition that would prevent compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No filgrastim (G-CSF) within 48 hours prior to chemotherapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
- No prior stent implantation
- No prior laser therapy
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 69 Years | Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer | NCT00004099 | Entailment |
1,111 | 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
- Males and females between 18 and 85 years of age at screening.
- Body weight is ≥45 kg at screening.
- Diagnosed with oHCM per the following criteria:
- Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence
of other cardiac disease.
- Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable
with a positive family history of HCM or with a known disease-causing gene
mutation).
- Adequate acoustic windows for echocardiography.
- Has LVOT-G during screening as follows:
- Resting gradient ≥50 mmHg OR
- Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
- LVEF ≥60% at screening.
- New York Heart Association (NYHA) Class II or III at screening.
- Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on
stable doses for >4 weeks prior to randomization and anticipate remaining on the same
medication regimen during the study.
Exclusion Criteria
- Aortic stenosis or fixed subaortic obstruction.
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM
(eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LV systolic dysfunction (LVEF <45%) at any time during their clinical
course.
- Documented history of current obstructive coronary artery disease (>70% stenosis in
one or more epicardial coronary arteries) or documented history of myocardial
infarction.
- Has been treated with septal reduction therapy (surgical myectomy or percutaneous
alcohol septal ablation) or has plans for either treatment during the study period.
- Has been treated with disopyramide or antiarrhythmic drugs that have negative
inotropic activity within 4 weeks prior to screening.
- Paroxysmal atrial fibrillation or flutter documented during the screening period.
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg,
direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months
prior to screening. (This exclusion does not apply if atrial fibrillation has been
treated with anticoagulation and adequately rate-controlled for >6 months).
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
months prior to screening.
- Has received prior treatment with CK-3773274 or is currently receiving mavacamten.
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 | REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM | NCT04219826 | Entailment |
1,359 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- children aged 24 months - 11 years old inclusive
- patients with constipation defined as:
- ≤ 2 spontaneous complete bowel movements per week (over the previous 14 days),
and one or more of the following:
- 1/4 or more of bowel movements with straining
- 1/4 or more of bowel movements with hard or lumpy stools
- patients in whom these symptoms have been present for ≥ 3 months
- new patients or those whose management is unsatisfactory on current laxative treatment
- patients of either sex
- patients of any ethnic origin
- hospital in-patients or outpatients.
Exclusion Criteria:
Patients with:
- history of bowel washout within the last 2 months
- intestinal perforation or history of obstruction
- recent history of urinary tract infection (within last month)
- Hirschsprungs disease
- paralytic ileus
- toxic megacolon
- severe inflammatory conditions of the intestinal tract
- clinically uncontrolled renal/hepatic/cardiac disease(s)
- clinically uncontrolled endocrine disorder(s)
- any other severe unstable co-existing disease
- hypersensitivity to macrogol or other constituents of Movicol
- encopresis
- patients who have taken any investigational drug in the last three months
- patients or patients whose parents would in the opinion of the investigator be unable
to comply with the requirements of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
Subject must be at most 11 Years | An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children | NCT00403897 | Contradiction |
2,999 | 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. | 1. Inclusion criteria for children or adults with ID of unknown etiology (index case)
In order to be eligible to participate in this study, an individual must meet all the
following criteria:
- Age:
1. Between 0 and 5 years with stringent criteria (severe delayed development in
terms of motor skills, language, and/or sociability) OR
2. ≥ 6 years: patients with ID, whatever the severity (but with proven ID by ad
hoc neuropsychological testing) and the associated manifestations
- Without any obvious diagnosis identified during a genetic consultation in one of
the participating center (i.e., an obvious syndrome with ID with well-known
molecular diagnosis is excluded);
- Provision of signed and dated of "participant" consent form;
- Stated willingness to comply with all study procedures and availability for the
duration of the study.
Patient with a social security in compliance with the French law (Provisions relating
to research involving the human person provided for in Articles L 1121-1 et seq. of
the French Public Health Code).
2. Inclusion criteria for biological parents
- Provision of signed and dated of both parents consent form.
3. Non-inclusion criteria
- An individual, who presents any condition which in the investigator's opinion
makes it undesirable for the subject to participate in the trial or which would
jeopardize compliance with the protocol, will not be eligible;
- Patients with isolated learning disabilities;
- One or both parents with ID;
- Parent placed under judicial protection (tutelle, curatelle et sauvegarde de
justice) ;
- Patient with a known etiological diagnosis (non-genetic, previously proven Fra-X
syndrome, know chromosomal anomaly, known pathogenic or probably pathogenic
variant identified in an ID gene by any technique).
- For patient concerning by biobank project: hypersensitivity to local anesthesia
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Genome Sequencing Strategies for Genetics Diagnosis of Patients With Intellectual Disability | NCT04154891 | Contradiction |
273 | 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:
- Infertile women who underwent the first GnRH antagonist IVF/ICSI-ET (Embryo Transfer)
cycle with an available ART outcome
- Used Cetrotide in a fixed or flexible antagonist protocol
- Age not more than 35 years old
- Baseline serum Follicle-stimulating hormone (FSH) level not more than 10
milliinternational unit per milliliter (mIU/ml)
- Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2)
- Normal uterine cavity
Exclusion Criteria:
- Previously underwent 3 or more IVF/ICSI cycles
- The total dose of Gonadotropin used was more than 2500 IU in current cycle
- Administration of daily 0.125 milligram (mg) Cetrotide
- Received an agonist trigger
- Use of clomiphene citrate or letrozole during cycles
- Presence of endometriosis Grade 3 to 4, confirmed or suspected
- Presence of uni-or-bilateral hydrosalpinx
- Known history of recurrent miscarriages
Female
No healthy subjects accepted to join the trial.
Subject must be at most 35 Years | A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment | NCT02889380 | Contradiction |
4,941 | 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:
Patient foreseen to undergo DBS for Parkinson's disease or Essential Tremor according to
routine criteria of the center.
For Parkinson Disease:
- Person is between 18 and 75 years of age
- Established diagnosis of idiopathic Parkinson's disease with progression of symptoms
for a minimum of 2 years.
- Person has a history of at least 30% improvement on the UPDRS therapy in L-dopa
(levodopa), except in the case of tremor dominant patient
- Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on /
off, dyskinesia on)
For Essential Tremor:
- Person is between 18 and 80 years of age
- Established diagnosis of Essential Tremor for a minimum of 2 years
- Functional disability due to tremor was not adequately controlled by medication for at
least 3 months prior to implant.
Person has given his/her written consent
Exclusion Criteria:
- Person suffering from an active major psychiatric disorder
- Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment
- Presence of major co-morbidity or medical condition that may affect participation to
the study
- Presence of an electrical or electromagnetic implant (e.g., cochlear implant,
pacemaker)
- Person with a previous surgery for the treatment of Parkinson's disease or Essential
Tremor
- Person with a previous brain ablation procedure
- Person who suffers from epilepsy
- Person who is pregnant: a pregnancy test will be performed in patients of childbearing
age
- Person with coagulopathies
- Abuse of drugs or alcohol
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 | Evaluation of Directional Recording and Stimulation Using spiderSTN | NCT02894567 | Entailment |
6,459 | 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:
- Male or Female
- 18 years of age and older
- Female subjects of childbearing potential must have a negative urine pregnancy test at
Baseline
- Female subjects of childbearing potential must practice a reliable method of
contraception throughout the study
- Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or
4
- Able to understand and comply with the requirements of the study and sign Informed
Consent/Health Insurance Portability and Accountability Authorization forms
Exclusion Criteria:
- Female subjects who are pregnant, breast feeding or who are of childbearing potential
and not practicing a reliable method of birthcontrol
- History of hypersensitivity or idiosyncratic reaction to any component of the test
medications
- Subjects who have not completed the proper wash-out periods for prohibited medications
and/or procedures
- Medical condition that contraindicates the subject's participation in the study
- Alcohol or drug abuse is evident within the past 5 years
- History of poor cooperation, non-compliance with medical treatment, unreliability
- Participation in an investigational drug study within 30 days of the Baseline 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 85 Years | Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study | NCT02147691 | Entailment |
546 | 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:
- Premenopausal women, 18-50 years, inclusive.
- Cyclic abnormal uterine bleeding (heavy or prolonged).
- Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
the first 8 days of menses.
- Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
- Endometrial biopsy without evidence of malignancy or atypical or non-atypical
hyperplasia.
Exclusion Criteria:
- History of uterine surgery that would interfere with the study endpoints.
- Known coagulation disorder including bleeding disorder or clotting disorder.
- History of, or current uterine, cervix, ovarian, or breast cancer.
- Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
or total bilirubin two times or greater than the upper limit of normal range.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas | NCT02147158 | Contradiction |
447 | 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:
- Women with poor response to ovarian stimulation. The definition of poor response was
based on the presence of at least one of the following criteria: Age > 40 years old,
day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3
oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less
than 500 pg/ml on the day of HCG.
Exclusion Criteria:
- All other women that do not fulfill the above mentioned criteria
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response. | NCT02237755 | Contradiction |
2,757 | 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:
- age ≥18 years
- unilateral inguinal hernia
- no previous intraabdominal operations
- no history of neurological diseases
Exclusion Criteria:
- recurrent inguinal hernia
- bilateral inguinal hernia
- history of chronic pain syndrome
- preoperative ASA classification IV-V
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Electrocoagulation Employment During TAPP Inguinal Hernia Repair | NCT03566784 | Entailment |
1,671 | 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:
- Health volunteers 18 years and above; equal numbers of males and females to address
Sex As a Biological Variable (SABV); and in sinus rhythm.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedures being performed (all
subjects should be able to understand the informed consent form and any other
documents that subjects are required to read).
Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Any other condition that would increase the risk of participation in the study in the
opinion of the site Investigator.
- A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
- Upper extremity arteriovenous hemodialysis shunt.
- Wrist distortion or pain from arthritis.
- Prior trauma or surgery at the radial artery monitoring 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.
Subject must be at most 90 Years | Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices | NCT04835857 | Entailment |
2,287 | 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:
1. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
upper limit of normal, and genetic mutation known to be causative for Duchenne
muscular dystrophy .
2. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
upper limit of normal and genetic or biopsy confirmation of Duchenne muscular
dystrophy in a primary relative (e.g. brother or maternal uncle).
3. De-identified, genetic studies will be reviewed by collaborator Kevin Flanigan, MD
prior to enrollment of subjects.
4. Age at entry: one month through 30 months.
Exclusion Criteria:
- Prior treatment with corticosteroids
Male
No healthy subjects accepted to join the trial.
Subject must be at least 1 Month old.
Subject must be at most 30 Months | Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy | NCT02167217 | Contradiction |
2,086 | 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:
- Idiopathic Pulmonary fibrosis will be diagnosed by presence of UIP pattern. Other
forms of ILD will be diagnosed using HRCT by presence of Reticular abnormality
Honeycombing with or without traction Extensive ground glass abnormality.
- Profuse micronodules.
Exclusion Criteria:
- Patients who refused to participate in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis | NCT03171870 | Entailment |
3,121 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Age 18 years or above with primary Sjogren's disease (as defined by the American
European Consensus Group Criteria), and complaint of chronic cough.
- Able to give consent and anticipated ability to adhere to the study procedures.
Exclusion Criteria:
- Diagnosis of COPD, emphysema, asthma, chronic bronchitis, other clinically significant
lung disease that is likely to cause cough. Interstitial lung disease associated with
Sjogren's is not excluded.
- Cigarette use of greater than 20 pack years or regular use within 6 months
- Allergy or intolerance to Pulmozyme.
- Acute respiratory infection or other acute respiratory illness during the prior month.
- LCQ greater than 17 and VAS less than 3 cm at baseline (Visit 1).
- Pregnancy or breast feeding.
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.
| Pulmozyme for Sjogren's Associated Cough | NCT01357447 | Contradiction |
1,497 | 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:
Adults with Osteoarthritis:
- Age 50-80
- radiographic evidence of knee osteoarthritis (OA participants)
- self-report current non-smoker
- willing and able to walk for 30 minutes a day three days a week for six weeks at a
location that is within 30 minutes from University of Maryland Baltimore
- speaks English
Healthy Controls:
- Age 50-80
- self-reports no osteoarthritis
- self-report current non-smoker
- willing and able to walk for 30 minutes a day three days a week for six weeks at a
location that is within 30 minutes from University of Maryland Baltimore
- speaks English
Exclusion Criteria:
- unable to pass the evaluation to sign consent
- diagnosis of rheumatoid arthritis
- diagnosis of gout
- diagnosis of heart failure
- diagnosis of chronic obstructive pulmonary disease
- diagnosis of diabetes
- diagnosis of Parkinson's disease
- diagnosis of Alzheimer's disease
- diagnosis of autoimmune disease
- currently taking long-term steroid medications such as methotrexate
- weight less than 110 lbs.
- direct employee of the PI
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 80 Years | Biologic Mechanisms for Pain Variation After Physical Activity in Osteoarthritis | NCT03344913 | Entailment |
6,939 | 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:
- Alzheimer's disease
- Able to communicate
Exclusion Criteria:
- Active major psychiatric disorders
- Acute or unstable chronic medical conditions
- Blindness
- Deafness
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 87 Years | Alzheimer's Disease Reminiscence Quality of Life | NCT01295957 | Entailment |
5,012 | 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:
- Greater than 18 of age
- Meet the diagnostic criteria for essential tremor with visible upper limb tremor
- Must be either on stable medications to treat tremor for 30 days, or no medications to
treat tremor
Exclusion Criteria:
- History of seizures
- History of chronic pain conditions
- Any metal in their body above their shoulders
- Use of medications that lower seizure threshold including:
- broad classes of drugs such as tricyclic antidepressants
- anti-psychotics
- neuroeptics
- thyroid medications and stimulants
- Use of any medications that cause tremor, Pregnancy
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 to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor | NCT02763865 | Entailment |
3,886 | 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:
1. Patients aged 18 years or older with moderate to severe knee effusion associated with
underlying osteoarthritis (Outerbridge grade II or higher) that undergo therapeutic
aspiration
2. Patients with symptomatic primary total knee arthroplasty without infection (as
verified by prior aspiration) with moderate to severe effusion electing for
therapeutic arthrocentesis. Must be minimum of 3 months from index surgery to be
included.
Exclusion Criteria:
1. Patients with effusion related to trauma or another underlying condition (ie.
fracture, ligamentous injury, hemarthrosis)
2. Patients with known history of gout or with synovial fluid samples testing positive
for urate of calcium pyrophosphate crystals
3. Patients with knee effusion associated with septic arthritis or periprosthetic knee
infection as determined from knee arthrocentesis.
4. Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
5. Patients with revision knee arthroplasty, unicompartmental arthroplasty or other
repair/reconstruction surgery
6. Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple
sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
7. Patients with symptomatic hip pain
8. Patients with active cancer in the area
9. Patients with pacemakers
10. Patients who are pregnant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis | NCT04146649 | Entailment |
103 | 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:
- Constitutional delay of growth and puberty
- Age 14 years or more
- mean testicular volume 2.5 ml or more and less than 4 ml
- serum testosterone level less than 5 nM OR
as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean
testicular volume is less than 2.5 ml OR
as above, but tanner stage G2 and testosterone level less than 3 nM
Exclusion Criteria:
- Chronic diseases
- Primary or secondary hypogonadism
- Chromosomal anomalies
- Chronic medication that potentially adversely affects bone mineralization (excluding
inhaled corticosteroid treatment)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 17 Years | Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment | NCT01797718 | Contradiction |
3,958 | 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:
- Kellgreen and Lawrence (KL) classification for I to III or painful IV osteoarthritis
(with the use of orthoses for analgesia, in this case).
- Capacity to understand and agree to the consent form and questionnaires and
evaluations.
Exclusion Criteria:
- Patients who had undergone previous non-medical therapeutic treatment for OA of the
hands;
- Who had undergone some surgical procedure in the region or were involved in another
clinical trial;
- Patients with rheumatoid arthritis or other rheumatologic disease, any neurological
problems.
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 80 Years | Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises. | NCT03173989 | Entailment |
965 | 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. | Key Inclusion criteria:
• Osteoarthritis of the hand
Key Exclusion Criteria:
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
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 Diclofenac Sodium Gel in Hand Osteoarthritis | NCT00171665 | Entailment |
4,821 | 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:
In the three groups:
- Age > 18
- Cushing's disease medical history: histology confirming an ACTH staining adenoma, or
ACTH-dependant Cushing syndrome with MRI confirmation of pituitary adenoma, or
pituitary secretion of ACTH confirmed with petrosal sinus gradient
- Written informed consent
- Hair length ≥ 3 cm
In patient group:
- Persistent CD diagnosed on usual criteria in expert centers including overt
hypercortisolism with at least 2 UFC > 1.5 N prior to the start of medical treatment
- Previous treatment with pasireotide, cabergoline, metyrapone, ketoconazole (alone or
in association) AND hypercortisolism considered as controlled for at least 3 months
based on 2 normal UFC.
In remission control group:
o Patients cured of CD and having recovered a normal pituitary function for at least 12
months following pituitary surgery (normal UFC associated to: cortisol suppression
following dexamethasone suppression test, or normal LNSC, or midnight serum cortisol < 200
nmol/L)
In bilateral surrenalectomy control group:
o Patients with previous CD, treated with bilateral adrenalectomy and receiving weight
adjusted doses of hydrocortisone for at least 6 months. Last daily dose of Hydrocortisone
should be administered no later than 5 pm.
Exclusion Criteria:
In the three groups:
- Renal Failure (Cl < 30 mL/min)
- Non-compliant patients
- Hair length < 3 cm
- Severe depression and psychosis
- Drug addiction and active alcoholism
- Myocardial infarction or cerebrovascular accident < 3 months
- Intense physical activity (marathon runner)
- Night-shifters
- Obesity with BMI > 35 kg/m2
- Type 1 diabetes
- Type 2 diabetes with HbA1C > 9 %
In patient group:
- Patients receiving mifepristone and/or mitotane
- Patients treated with anticortisolic agents during the titration process
- Patients requiring additional hydrocortisone supplementation or exogenous
corticosteroids
- Pituitary radiotherapy < 5 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.
| Hair Cortisol and Cushing's Disease | NCT04201444 | Contradiction |
5,954 | 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:
- history of obesity exceeding 5 years
- documented previous weight loss attempts,
- body mass index (BMI)) of 40-50 kg/m2
- age of 18-60 years.
Exclusion Criteria:
- contraindications to pneumoperitoneum
- large esophageal hiatal hernia
- pregnancy,
- drug or alcohol abuse,
- psychological disorders (e.g., bulimia, depression)
- hormonal or genetic obesity-related disease
- previous gastric surgery
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 | Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux | NCT02618044 | Contradiction |
2,773 | 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:
- Age above 18 and below 80
- Male or female patients
- Unilateral inguinal hernia
- First occurrence hernia
Exclusion Criteria:
- Inguino-scrotal hernia
- Recurrent inguinal hernia
- Incarcerated hernia
- Bilateral inguinal hernia
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 | Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair | NCT00960011 | Entailment |
2,427 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | DISEASE CHARACTERISTICS:
- Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following
criteria:
- Stage III or IV disease
- Grade 1, 2, or 3 disease requiring systemic first-line treatment
- No transformation to diffuse large cell lymphoma
- At least 1 bidimensionally measurable lesion meeting 1 of the following criteria:
- Lymph nodes > 1.5 cm x 1.0 cm by physical exam or CT scan
- Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm
(e.g., skin lesions or nodules) by physical exam
- Must have a medical indication for treatment, as indicated by 1 of the following:
- Presence of constitutional symptoms that are attributed to lymphoma (e.g., B
symptoms, including night sweats, fever, weight loss, fatigue, or pain)
- Lymphadenopathy that requires treatment based on presence of associated symptoms,
potential threat to organ function (e.g., ureteric compromise from
retroperitoneal disease), or degree of enlargement (i.e., > 5 cm)
- Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow
involvement by lymphoma or from splenomegaly and hypersplenism)
- Immune-related complications of lymphoma that require therapy
- Rate of disease progression for which observation is deemed inappropriate
- No history of any other lymphoproliferative disorder or evidence of transformation to
an aggressive histology lymphoma
- No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Platelet count ≥ 75,000/mm^3*
- Absolute neutrophil count ≥ 1,000/mm^3*
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma)
- Able (i.e., sufficiently fluent) and willing to complete the quality of life
questionnaires in either English or French
- Inability (illiteracy in English or French, loss of sight, or other equivalent
reason) to complete the questionnaires will not make the patient ineligible for
the study
- No history of other malignancies, except for the following:
- Adequately treated nonmelanoma skin cancer
- Curatively treated in situ cancer of the cervix
- Ductal carcinoma in situ of the breast (as long as radiation limitation is not
exceeded)
- Other solid tumors curatively treated with no evidence of disease for > 5 years
- No history of allergic reactions attributed to compounds containing boron or mannitol
- No history of an unusual or severe allergic reaction to rituximab or similar agent
- No pre-existing neuropathy ≥ grade 2
- No known HIV infection
- No other serious illness or medical condition that would preclude study participation,
including any of the following:
- Active, uncontrolled bacterial, fungal, or viral infection
- Significant cardiac dysfunction
- Cardiovascular disease NOTE: *Exceptions will be allowed for values below these
thresholds in patients with marrow involvement by lymphoma or lymphoma-related
hypersplenism
PRIOR CONCURRENT THERAPY:
- No prior systemic therapy for lymphoma
- No prior bortezomib, cyclophosphamide, or vincristine
- At least 4 weeks since prior radiotherapy that involved ≤ 25% of functioning bone
marrow and recovered
- Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy or if the
irradiated field is not a significant marrow-bearing area
- At least 2 weeks since prior major surgery
- No other concurrent anticancer therapy, investigational agents, corticosteroids
(except for physiologic replacement or antiemesis), cytotoxic chemotherapy, or
immunotherapy
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.
| Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma | NCT00428142 | Contradiction |
1,458 | 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:
- Patients aged 18-90 presenting with dysphagia or food impaction
- Ability to undergo esophagogastroduodenoscopy and biopsies
- No significant cardiopulmonary disease, or other contraindication to EGD
Exclusion Criteria:
- Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or
bleeding disorder or elevated INR
- Inability to provide informed consent
- Esophageal varices
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 | Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia | NCT00256529 | Entailment |
2,090 | 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:
- >18 years of age
- Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required
as the symptom of dyspnea, not cancer itself, is targeted)
- If diagnosed with lung cancer, must have completed definitive treatment more than 6
months prior
- At least moderate dyspnea defined by a BDI score of 6 or less in the Self-
Administered Computerized Versions of the Baseline and Transition Dyspnea
Indexes(SAC-BDI/TDI)13,14 (This cutoff score is close to the score of 5.7 used to
define "moderate dyspnea" in the publication that validated the instrument and is
selected by attending physicians in the Pulmonary Service as a good indication of
"moderate dyspnea" in clinical practice. A typical person with BDI of 6, for example,
would be a 52 year old woman who has to pause when walking because of dyspnea and/or
has eliminated doing an activity because of dyspnea).
- Able to safely complete the Six Minute Walk Test (6MWT)15 as per attending physician's
clinical judgment.
- Respiratory functions clinically stable for the preceding 3 months and expected to be
stable for the next 3 months as determined by project PIs and other Pulmonary Medicine
faculty.
Exclusion Criteria:
- Life expectancy less than 6 months
- Any cause of dyspnea that is determined by the investigators as readily reversible by
other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia
Hb<9.0, etc.)
- Non-English speaking
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.
| Breath Training Exercise for the Reduction of Chronic Dyspnea | NCT01831388 | Entailment |
205 | 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. Males between 18-75 years of age
2. Two screening serum testosterone values less than 300 ng/dL
3. One or more symptoms of testosterone deficiency
Exclusion Criteria:
1. Previous use of the investigational product
2. Use of any investigational product within 30 days prior to screening and during the
study
3. BMI less than 18 kg/m^2 or more than 35 kg/m^2
4. Prostatic mass(es)
5. Generalized skin irritation or skin disease
6. Lower urinary tract obstruction
7. Myocardial infarction or cerebrovascular accident in the last 6 months
8. Unstable angina or congestive heart failure
9. Thromboembolic disorders
10. Sleep apnea
11. Hyperparathyroidism or uncontrolled diabetes
12. Untreated moderate to severe depression
13. History of testicular, prostate, or breast cancer
14. HIV, Hepatitis B, or Hepatitis C positive
15. PSA more or equal to 3 ng/mL
16. Use of any medications that could be considered anabolic
17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens,
or human Growth Hormone
18. Chronic use of any drug of abuse
19. Involvement in a sport in which there is a screening for anabolic steroids
20. Not willing to use adequate contraception during the study
21. Partner is pregnant and/or breast feeding
22. Partner has a history of breast, uterine or ovarian cancer
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel | NCT01665599 | Entailment |
2,005 | 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:
- Histologically proven adenocarcinoma of the stomach, the esophagus or the cardia (with
or without signet ring cells; intestinal, diffuse or mixed form).
- Locally advanced (non resectable) or metastatic disease.
- Measurable disease (at least one measurable tumor) according to the RECIST V1.1
criteria (the tumor should not be located in a previous field of radiation).
- Absence of previous palliative chemotherapy. Previous neo-adjuvant or adjuvant
chemotherapies (alone or combinated with radiotherapy) are authorized, including
biotherapy (except anti-EGFR or anti-c-Met / HGF), if it has been stopped at least 12
months before inclusion.
- Previous radiotherapy authorized if stopped at least 14 days before randomization and
if at least one measurable target outside the radiation area is present.
- No major surgery ≤ 28 days, or minor surgery ≤ 14 days, prior to randomization
- Sites of disease evaluated within 28 days prior to randomization with
thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI plus Chest X-ray).
- Age ≥ 18 years.
- Patient general status : ECOG 0-1.
- Life expectancy ≥ 3 months.
- Hemoglobin > or = 9 g/L - (transfusion authorized if necessary), PNN ≥ 1,5.109/l,
platelets ≥ 100.109/l.
- Hepatic transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 ULN in case of
hepatic metastases), alkaline phosphatase ≤ 2.5 ULN (≤ 5 ULN in case of hepatic
metastases), total bilirubinemia ≤ 1.5 ULN)
- Creatinine clearance (calculated or measured) ≥ 50 ml / min, serum creatinine > 1.5
ULN
- Prothrombin time (PT) ≥ 60 %, INR < 1,5 (except if anticoagulant therapy)
- Magnesemia and calcemia ≥ Lower Limit of Normal (LLN)
- Negative Pregnancy test for women of child-bearing age.
- Information given to the patient and signed informed consent.
- Public Health insurance coverage.
- Sample of tumour (primitive or metastatic) available.
Exclusion Criteria:
- Known brain or leptomeningeal metastases.
- Positive HER2 Status (IHC 3+ or IHC2+/FISH or CISH+) .
- contraindication, allergy or hypersensitivity to ANY OF the study treatments.
- Prior Treatment with EGFR inhibitor or HGF / c-Met inhibitor.
- Patient already included in another clinical trial testing an experimental drug.
- Peripheral edema > grade 2.
- Proteinuria > 1 g/24h
- Clinically significant cardiovascular disease (such as unstable angina pectoris,
severe congestive heart failure, uncontrolled severe cardiac arrhythmia) within 12
months prior to randomization.
- Thrombosis or ischemic vascular event during the last 12 months (deep venous
thrombosis, pulmonary embolism, STROKE or established cerebral infarction, myocardial
infarction).
- Medical history or signs of interstitial pneumopathy or pulmonary fibrosis.
- Peripheral neuropathy > grade 1.
- Clinically significant hemorrhage of the upper gastrointestinal tract (requiring blood
transfusion or hemostatic interventional procedure.
- Actively evolutive inflammatory bowel disease or any other intestinal disease causing
chronic diarrhea (≥ grade 2).
- Any uncontrolled concomitant disease (e.g., uncontrolled diabetes) or medical history
(e.g., organ transplantation) which, according to the opinion of the investigator, may
interfere with the interpretation of the study results.
- Any comorbidity or situation which, according to the opinion of the investigator,
could increase the risk of toxicity (e.g., Dihydropyrimidine dehydrogenase
deficiency).
- Chronic or active HIV, HBV or HCV infections.
- Severe and\or not healed wound.
- Any active infection requiring systemic treatment, or any uncontrolled infection
within 14 days before randomization.
- Other concomitant malignancy or history of cancer (except carcinoma in situ of the
cervix, or non melanoma skin cancer, with curative intent treatment), except when
considered in complete remission for at least 5 years before randomization.
- Pregnant women or women who might become pregnant during the study (or who plan to
become pregnant within 6 months after the last administration of a study drug) or
lactating women.
- Men or women who have the age of procreation and who do not abide with the use of a
highly efficient contraceptive means (according to the current institutional
standards) or, alternatively, the use of abstinence during the study treatment and
until 6 months after last administration of the study drugs.
- Patient unwilling to comply with the medical follow-up required by the trial because
of geographic social or psychological reasons.
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.
| MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma | NCT01443065 | Entailment |
1,961 | 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:
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee
on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs
are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- patients whose previous history of chronic shoulder pain
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
- Enlarged or bulky regional lymph node envelop important vessels
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of predicted values
- Difficulty of understanding V A S(Visual Analogues Score).
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 75 Years | The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy | NCT03482609 | Entailment |
5,115 | 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:
1. Ages Eligible for Study: 65-75 Years
2. Genders Eligible for Study: Woman
3. Accepts Healthy Volunteers: NO
4. Study Population: Female patients with hip fracture. -
Exclusion Criteria:
1. Malignancy or benign ovarian cysts
2. Known chronic or systemic diseases
3. Hormone therapy in the previous 3 months
4. Bone metabolism and drug therapy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 75 Years | Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture | NCT02750046 | Contradiction |
6,587 | 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:
1. severe hemophilia A (FVIII<1%);
2. male, any age;
3. high responders (peak inhibitor levels > 5 BU);
4. any inhibitor level at study enrolment;
5. ability and willingness to participate in the study;
6. at least one of the following risk factors for ITI failure:
- peak inhibitor titer > 200 BU
- titer at ITI start > 10 BU
- age > 7 years
- time between inhibitor occurrence and ITI > 2 years
7. absence of high risk of cardiovascular, cerebrovascular or other thromboembolic events
as deemed by the treating clinician.
Exclusion Criteria:
1. concomitant systemic treatment with immunosuppressive drugs;
2. concomitant experimental treatment;
3. previous ITI attempt;
4. previous history of myocardial infarction and/or cerebral stroke.
Male
No healthy subjects accepted to join the trial.
| Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive | NCT01051544 | Contradiction |
2,514 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Must have employee status at the National Institutes of Health.
Age greater than 18 years.
Able to understand and sign consent.
Patients who are wheelchair bound and are unable to have images of their back and lower
extremities taken safely will be excluded from photography since this portion of the
examination requires an ability to stand. However, they will still be eligible to
participate in the skin cancer screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles | NCT00005781 | Contradiction |
4,426 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria for Tennis Elbow patients:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 90 days of follow up
- Pain when pressure applied to the epicondyl
- Pain upon forced movement of both epicondylien muscles
- Absence of pain upon forced movement of an epitrochlear muscle
- Absence of one or more skeletal-muscle problem on the homolateral arm felt by the
patient to be just as problematic as his/her tennis elbow
- at least one consult for pain treatment associated with tennis elbow (on the same
elbow)
Inclusion Criteria for healthy volunteers:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- No pain when pressure applied to the epicondyl
- No pain upon forced movement of both epicondylien muscles
- No neck pain
- No skeletal-muscle problems in the arms during the 3 months preceding the study
Exclusion Criteria for Tennis Elbow patients:
- The patient is included in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
- The patient is breastfeeding
- Absence of one or more skeletal-muscle problem on the homolateral arm felt by the
patient to be just as problematic as his/her tennis elbow
Exclusion Criteria for Health Volunteers:
- The subject is included in another study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection, under tutorship or curatorship
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- Presence of one or more skeletal-muscle problems in the arms within the 3 months
preceding the study
- Pain when pressure applied to the epicondyl
- Pain upon forced movement of both epicondylien muscles
- Consultation for any kind of treatment for elbow pain
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain | NCT01390454 | Contradiction |
750 | 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:
- high cardiovascular risk defined as patients with: Documented cardiovascular disease
(CVD), clinical or unequivocal on imaging. Documented clinical CVD includes previous
acute myocardial infarction, coronary revascularization and other arterial
revascularization procedures, stroke and TIA, aortic aneurysm and PAD. Unequivocally
documented CVD on imaging includes plaque on coronary angiography or carotid
ultrasound; DM with target organ damage or with a major risk factor such as smoking or
marked hypercholesterolaemia or marked hypertension.
- History of statin intolerance, demonstrated by: trial of ≥2 statins with intolerance
of any dose or to increase statin dose above the total maximum doses because of
intolerable: Myopathy or myalgia (muscle pain, ache, or weakness without CK
elevation), or Myositis (muscle symptoms with increased CK levels), or Rhabdomyolysis
(muscle symptoms with marked CK elevation) and Resolution or improvement of symptoms
when the statin dose was decreased or discontinued
- patients with LDL-C >55 mg/dL
- end-stage renal disease on chronic hemodialysis
- Participant is willing and able to give informed consent for participation in the
study.
Exclusion Criteria:
- secondary hypercholesterolemia (i.e. hypothyroidism, Primary biliary cholangitis, etc)
- Use of drugs or dietary supplements that can impact on cholesterol value (i.e.
progestinic, red yeast rice, niacin >200 mg/d, lipid-regulating drugs - eg, fibrates or
derivatives, ezetimibe, bile-acid sequestrants, stanols, or stanol esters - )
- Previous treatment with evolocumab or any other anti-PCSK9 therapy
- Inability to provide informed consent or to attend follow-up visits
- Unreliability as a study participant based on judgment of investigator's knowledge of
the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to
the protocol, psychosis)
- Current enrollment in another investigational device or drug study or <30 d since
ending another investigational device or drug study
- serum triglycerides level > 400 mg/dL at baseline
- Pregnancy, breastfeeding, or inadequate birth control in premenopausal female subjects
- Laboratory values at screening CK >3 × ULN; AST or ALT >2 × ULN
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 | Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia | NCT04659525 | Contradiction |
5,135 | 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:
1. Ambulatory women older than 60 years of age. Self declared as African Americans.
2. 20 nmol/L < serum 25(OH)D level < 65 nmol/L.
3. Willingness to take study drug and participate for four years in the trial.
4. Willingness to refrain from the use of self-administered supplements during the trial.
Exclusion Criteria:
1. Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
2. BMD total hip below - 2.5 standard deviation (using NHANES III adult young white men
and women as the point of reference) or history of osteoporotic fracture.
3. Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment
on DXA.
4. Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or
anabolic steroids during 6 months prior to entry.
5. Use of systemic corticosteroids (oral or IV) within the last year at an average dose
of greater than 5 mg per day of oral prednisone or equivalent for a period of three
months or more prior to screening.
6. Hypercalcemia (serum calcium > 10.6 mg (dl) or history of primary hyperparathyroidism.
7. History of chronic liver disease, chronic renal insufficiency, Parkinson's, metabolic
bone disease, hematologic tumors, rheumatologic disease requiring steroids,
malabsorption or new diagnosis or active treat-ment of cancer 12 months prior to
inclusion.
8. Use of medications that influence bone metabolism (e.g. anticonvulsants).
9. Significant deviation from normal in either: history, physical examination or
laboratory tests as evaluated by the Principle Investigator. Participants with a
history of hypercalciuria, nephrolithiasis and active sarcoidosis will also be
excluded.
10. Participation in another investigational trial 30 days prior to screening.
11. Spinal disease that affects interpretation of bone densitometry like scoliosis with a
Cobb angle greater than 15o, history of surgery at lumbosacral spine.
12. Bilateral hip replacement.
13. Currently smoking more than 10 cigarettes daily.
14. Body width on DXA > 25 cm.
15. Patients who are deemed unsafe to perform muscular function testing as evaluated by
the investigator.
---------- Study participants should live close to the study site, as this study
requires multiple visits over a four year period.
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
| Vitamin D and Osteoporosis Prevention in Elderly African American Women | NCT01153568 | Contradiction |
302 | 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:
- Unexplained and mild male factor infertile patients
- Minimum 2 follicles >16 mm at the day of HCG
- First 3 cycles
Exclusion Criteria:
- Basal FSH >12 mIU/L
- Total antral follicle count<6
- Severe male factor infertility
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 37 Years | Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development | NCT00993902 | Contradiction |
4,435 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- The duration of symptoms over 3 months
- Primary conservative treatment (physiotherapy, NSAID, ...) has been tried
Exclusion Criteria:
- Significant systemic diseases
- Any surgical operation of the particular elbow
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.
| The Effect of Platelet Rich Plasma on Lateral Epicondylitis | NCT01851044 | Contradiction |
4,033 | 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:
- Patients of both sexes and over 40 years of age diagnosed with unilateral or bilateral
symptomatic OA of the knee who met the criteria of the American College of
Rheumatology (ACR).
- Patients who were rated grade II or III on the Kellgren and Lawrence (K&L)
radiological scale [19].
- Patients with symptomatic OA with a global mean pain in the knee >40 mm on a Visual
Analogue Scale (VAS) for pain assessment.
Exclusion Criteria:
- Women who were pregnant or breastfeeding
- Patients who were grade I or IV on K&L radiological scale.
- Patients who have had a prosthesis replaced in the 12 months prior to inclusion.
- Obesity
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human | NCT03736109 | Entailment |
4,128 | 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. | - HEALTHY VOLUNTEER INCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:
- 18 to 75 years of age
- Enrolled without regard to gender, race, or ethnicity
- NIH employees or non-employees eligible
- Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process
- Able and willing to complete the informed consent process
- Able and willing to arrange to have another person drive them home after the procedure
- Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the
procedure
- Willing to donate blood and respiratory tract samples for storage to be used for
future research
- In good general health without clinically significant medical history
- Physical examination without clinically significant findings
- Screening laboratory tests without clinically significant abnormalities:
1. Complete blood count with differential
2. Serum chemistries including creatinine, blood urea nitrogen, glucose, liver
enzymes and function tests, electrolytes
3. HIV test and hepatitis serologies (HBsAg; HCV) if status is unknown
4. Prothrombin time, partial thromboplastin time
5. Urinalysis
6. Female subjects must have negative urine pregnancy test within 1 week of
participation and continue birth control practices prior to participation
7. Chest radiograph (CXR) (if the subject has not had a CXR or computerized
tomography [CT] scan of the chest within the prior7 days)
8. Pulse oximetry
9. Electrocardiogram (ECG)
10. Treadmill exercise stress test (as indicated for history of angina or
abnormalities on ECG)
HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:
- Less than 18 or greater than 75 years old
- A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less
than a year.
- Positive HIV status. Subjects must have a negative FDA-approved HIV blood test. [Note:
Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a
negative HIV polymerase chain reaction (PCR) test result will be sufficient for
eligibility screening of subjects with positive HIV ELISA that is due to prior
participation in an HIV vaccine study]
- Acute or chronic hepatitis based on viral hepatitis serologies
- Pregnancy or breastfeeding
- Any active medical problems especially bleeding disorders, significant bruising or
bleeding difficulties with intramuscular (IM) injections or blood draws, use of
anticoagulants, or pulmonary disorders including asthma
- History of allergic reaction to lidocaine, sedative medications like Valium Trademark
or Versed Trademark, or narcotic medications like morphine or fentanyl
- Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or
long-acting beta-agonists within the past three months. (Note that use of
corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute
uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is
not excluded).
- Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs
(NSAIDs) within 7 days of procedure
- Any medical, psychiatric, social condition, occupational reason or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer s ability to give informed consent
PATIENT INCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES
1. 18 to 75 years of age inclusive
2. Known or suspected respiratory infections or infection susceptibility
3. Enrolled without regard to gender, race, or ethnicity
4. Must be enrolled in a concurrent NIH protocol and under the care of a primary
physician outside of the NIH
5. Able and willing to complete informed consent process
6. Able and willing to arrange to have another person drive them home after the procedure
7. Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the
procedure
8. Willing to donate blood and respiratory tract samples for storage to be used for
future research
PATIENT EXCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES
1. Less than 18 or greater than 75 years old
2. History of recent/acute clinically significant pulmonary compromise. This will be
defined by the following criteria:
1. New lung infection or change in status of chronic lung infection or significant
new findings on chest x-ray or CT scan
2. Asthma that is unstable or required emergent care, urgent care, hospitalization,
or intubation during the past two years, or that required the use of oral or
parenteral corticosteroids during the past two years
3. Clinically significant reactive airway disease that does not respond to
bronchodilators
4. Unstable chronic lung disease such as Chronic Obstructive Pulmonary Disease
(COPD) or pulmonary fibrosis
5. History of pulmonary hypertension
6. Requirement of supplemental oxygen at rest
3. Unstable angina or uncontrolled heart failure or rhythm disturbance
4. Significant kidney or liver disease
5. Significant anemia with a hemoglobin of less than 7.5 grams/dl.
6. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions), significant bruising or bleeding
difficulties with IM injections or blood draws, or use of anticoagulant medications
7. Use of platelet inhibitors including aspirin and NSAIDs within 7 days of procedure or
clopidogrel (Plavix TM) within 14 days of procedure or the inability to safely stop
platelet inhibitors for 7-14 days prior to procedures
8. History of allergic reaction to lidocaine, sedative medications like Valium TM or
Versed TM, or narcotic medications like morphine or fentanyl
9. Pregnancy or breastfeeding
10. Any medical, psychiatric, social condition, occupational reason or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer's ability to give informed consent
HEALTHY VOLUNTEER INCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:
- Greater than or equal to 10 years old
- Enrolled without regard to gender, race, or ethnicity
- NIH employees or non-employees eligible
- Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process
- Able and willing to complete the informed consent process
- Willing to donate blood and respiratory tract samples for storage to be used for
future research
- Stable vital signs
HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY , Nasal Nitric Oxide
Measurement, and Nasal Potential Difference Measurement:
- Less than 10 years old
- History of frequent colds or significant uncontrolled hay fever symptoms, recent or
active upper respiratory tract infection, such as a cold or sinusitis, or chronic
sinus infection or congestion
- History of turbinectomy or significant nasal pathology that would preclude obtaining
mucosal scrape biopsies or other measures
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions), significant bruising or bleeding
difficulties with IM injections or blood draws, or use of anticoagulant medications
- The use of nasal steroids in the past 6 weeks
- Any medical, psychiatric, social condition, occupational reason, or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer s ability to give informed consent
PATIENT INCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY, Nasal Nitric Oxide Measurement, and
Nasal Potential Difference Measurement
- Greater than or equal to 10 years old
- Known or suspected infections or infection susceptibility
- Enrolled without regard to gender, race, or ethnicity
- Must be enrolled in a concurrent NIH protocol and under the care of a primary
physician outside of the NIH
- Able and willing to complete informed consent process
- Willing to donate blood and respiratory tract samples for storage to be used for
future research
PATIENT EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY, Nasal Nitric Oxide Measurement, and
Nasal Potential Difference Measurement:
- Less than 10 years old
- Significant uncontrolled hay fever symptoms or recent or active upper respiratory
tract infection, such as a cold or sinusitis
- History of turbinectomy or significant nasal pathology that would preclude obtaining
mucosal scrape biopsies or other measures
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions), significant bruising or bleeding
difficulties with IM injections or blood draws, or use of anticoagulant medications
- Any medical, psychiatric, social condition, occupational reason, or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer's ability to give informed consent.
Healthy Volunteer Inclusion Criteria for Sputum Induction and Exhaled Breath Condensate
Collection
1. greater than or equal to 10 years old
2. Enrolled without regard to gender, race, or ethnicity
3. NIH employees or non-employees eligible
4. Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process
5. Able and willing to complete the informed consent process
6. Willing to donate blood and respiratory tract samples for storage to be used for
future research
7. Stable vital signs
Healthy Volunteer Exclusion Criteria for Sputum Induction and Exhaled Breath Condensate
Collection
1. < 10 years old
2. History of asthma or reactive airways disease
3. Any medical, psychiatric, social condition, occupational reason, or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer s ability to give informed consent
PATIENT INCLUSION CRITERIA FOR SPUTUM INDUCTION and Exhaled Breath Condensate Collection:
1. greater than or equal to 10 years old
2. Known or suspected infections or infection susceptibility
3. Enrolled without regard to gender, race, or ethnicity
4. Must be enrolled in a concurrent NIH protocol and under the care of a primary
physician outside of the NIH
5. Able and willing to complete informed consent process
6. Willing to donate blood and respiratory tract samples for storage to be used for
future research
PATIENT EXCLUSION CRITERIA FOR SPUTUM and Exhaled Breath Condensate Collection:
1. <10 years old
2. Significant uncontrolled asthma or reactive airways disease
3. Any medical, psychiatric, social condition, occupational reason, or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a volunteer s ability to give informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 75 Years | Collection of Lung Fluid and Tissue Samples for Research | NCT00471250 | Contradiction |
767 | 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:
- ≥65 years
- diagnosis of chronic benign joint pain
- polypharmacy (>5 drugs or active ingredients, of which 2 or more had been prescribed
for pain)
Exclusion Criteria:
- severe cognitive deterioration (GDS> 5)
- allergy to or fear of animals
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| AAI in Elderly Patient With Chronic Pain | NCT04079985 | Contradiction |
1,014 | 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:
- Patients of both sexes and over 40 years of age diagnosed with unilateral or bilateral
symptomatic OA of the knee who met the criteria of the American College of
Rheumatology (ACR).
- Patients who were rated grade II or III on the Kellgren and Lawrence (K&L)
radiological scale [19].
- Patients with symptomatic OA with a global mean pain in the knee >40 mm on a Visual
Analogue Scale (VAS) for pain assessment.
Exclusion Criteria:
- Women who were pregnant or breastfeeding
- Patients who were grade I or IV on K&L radiological scale.
- Patients who have had a prosthesis replaced in the 12 months prior to inclusion.
- Obesity
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human | NCT03736109 | Entailment |
4,171 | 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:
- sedentary adults diagnosed with functional class II and II CHF in accordance with the
New York Heart Association (NYHA);
- in stage B or C according to American College of Sports Medicine guidelines;
- with left ventricle ejection fraction lower than 45% (evaluated by echocardiogram in a
period ≤ 1 year);
- cardiomegaly confirmed by increased left ventricle end-diastolic (LVDD) and
end-systolic diameter (LVESD) associated with a cardiac index (CI) >0.5 according to
chest X-rays;
- inspiratory muscle weakness (MIP <70% of predicted values);
- clinical stability with no change in medication for at least three months and
sedentary (no regular physical activity performed in the previous six months or not
accumulating 30 minutes or more of moderate physical activity - 3 to 6 METs - on most
week days).
Exclusion Criteria:
- patients exhibiting unstable angina, myocardial infarction or prior heart surgery up
to three months before beginning the investigation;
- orthopedic, infectious or chronic metabolic diseases;
- treatment with steroids, hormones or chemotherapy;
- ratio between forced expiratory volume in one second and forced vital capacity
(FEV1/FVC) < 70% of predicted, characterizing an obstructive respiratory disorder;
- respiratory diseases, smokers and ex-smokers with a history of cigarettes/day for more
than 10 years.
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 65 Years | Inspiratory Muscular Training | NCT01593007 | Contradiction |
3,221 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Key Inclusion Criteria:
- Diagnosed with primary or secondary SjS according to the 2002 American European
Consensus Group (AECG) classification
- Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's
syndrome disease activity index (ESSDAI) ≥ 5
- Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or
anti-SSB)
Key Exclusion Criteria:
- Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD)
(prior bDMARD treatment allowed with appropriate washout as per study protocol)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 75 Years | Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome | NCT03100942 | Entailment |
2,873 | 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:
- Possible, probable (clinically or laboratory supported) or definite ALS according to
the revised version of the El Escorial criteria (Brooks et al. 2000)
- Disease duration < 36 months
- Vital capacity of more than 50% of normal (defined as slow vital capacity, best of
three measurements)
- Age ≥18 years
- Continuously treated with 100 mg riluzole daily for at least four weeks
- Capable of thoroughly understanding all information given and giving full informed
consent according to GCP
- Willing to complete a diet questionnaire throughout participation in the study
Exclusion Criteria:
- Simultaneous participation in another interventional clinical study
- Previous participation in a drug clinical trial where last intake of the trial drug
was within the last 12 weeks
- Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
- Tracheostomy
- Patients with gastrostomy
- Pregnancy or breastfeeding
- Any medical condition known to have an association with motor neuron dysfunction which
might confound or obscure the diagnosis of ALS
- Presence of any concomitant life-threatening disease or impairment likely to interfere
with functional assessment.
- Evidence of a major psychiatric disorder or clinically evident dementia precluding
evaluation of symptoms.
- Liable to be not cooperative or comply with study requirements as assessed by the
investigator, or unable to be reached in the case of emergency.
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.
| Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis | NCT02306590 | Entailment |
5,674 | 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:
- The patients are diagnosed as being clinically full term small for gestational age
infant.
- Girl are 3-6 years old, boys are 3-7 years old.
- Be in preadolescence (Tanner stage 1).
- The child did not achieve catch-up growth when he/she entered the group (the
definition of catch-up growth is that the height is higher the third percentile with
the same age and gender) (Appendix 2 and 3).
- The height of child is shorter than -2SDS of the median of normal children with the
same age and gender when he/she entered the group (the mean height and height standard
deviation of normal children with the same age and gender of normal children regard
the height data in the physical development investigation data of children aged 0-18
in 9 cities of China (2005) as standard [13], Appendix 4 and 5).
- Within a year before entering the group, after any growth hormone stimulation test,
the peak concentration of growth hormone in serum>10 µg/L.
- Bone age≤ the actual age+1.
- The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.
- Birth gestational age ≥ 37 weeks.
- The subjects and their guardians sign the informed consent (if the subjects is lack of
ability for signing the informed consent, his legal guardian can write the subjects
name instead).
Exclusion Criteria:
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
value, Cr> the upper limit of normal value).
- Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
(HBsAg) or hepatitis B e antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug or the excipient
of the study.
- People with diabetes, severe cardiopulmonary, hematological system and malignant
tumors diseases or general infection, immune deficiency and patients with mental
disease.
- Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth
hormone receptor deficiency.
- Potential tumor patients (family history).
- Patients who used growth hormone for treatment.
- Subjects took part in other clinical trial study within 3 months.
- Patients used other hormonal for treatment within 3 months (such as sex hormone,
glucocorticoid and etc., treat for more than a month) and received the drug treatment
which may interfere with the secretion of GH or GH function (oxandrolone, growth
hormone releasing hormone and etc.);
- Other conditions which in the opinion of the investigator preclude enrollment into the
study.
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 7 Years | Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature | NCT02375620 | Contradiction |
1,963 | 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:
1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
2. No prior chemotherapy
3. Patients of full age, independent of gender ECOG ≤ 2
4. No dissemination of the tumor confirmed by CT of the lung and the abdomen.
5. Signed Consent form of the Patient agreeing to investigations
6. Leucocytes > 3.000/µl
7. Thrombocytes > 100.000/µl
8. Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
9. informed consent of the patient
10. normal ejection-fraction of the heart
Exclusion Criteria:
1. Dissemination of the tumor or non-resectable primary tumor
2. Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the
cervix and appropriately treated basal cell carcinoma of the skin)
3. Patient not of full age
4. Inflammatory chronic bowel disease
5. Inclusion of the patient in a different study
6. Pregnancy or 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.
| Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer | NCT01683864 | Entailment |
5,753 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Participants must be over the age of 18 years old with healthy skin;
- Participant must be willing and comply with the requirements of the protocol;
- Participant must have the ability to understand and communicate with the investigator;
- Participant must provide informed consent.
Exclusion Criteria:
- Subjects who are unable to provide informed consent;
- Subject with significant medical history or current skin diseases that the
investigator feels is not safe for study participation;
- Subjects who self-report that they are pregnant or nursing;
- Subjects who do not speak English or have difficulty hearing or are otherwise impaired
for providing informed consent and communicating with the investigator;
- Subjects with known bleeding disorders or diathesis;
- Subjects with a history of keloids or excessive scarring;
- Subjects with known allergy to lidocaine, epinephrine, or any of the tested products;
- Subjects who foresee intensive UV exposure during the study (e.g. sunbathing, tanning
beds).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Effects of Over-the-Counter Products on the Skin | NCT03641430 | Contradiction |
4,542 | 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:
- Have dysmenorrheal syndrome
- Have menstrual cycle without pain
Exclusion Criteria:
- Have another health problem (systemic, neurologic, orthopedic or psychiatric)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Postural Sway at Menstrual Cyclus | NCT03586804 | Contradiction |
3,675 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Adults undergoing lumbar spinal surgery
Exclusion Criteria:
- Lack of informed patient consent
- Acute or chronic renal failure
- Known allergy or intolerance to pethidine or tramadol
- Chronic respiratory insufficiency
- Epidural contraindicated (coagulopathy, systemic infection)
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.
| Neuraxial Pethidine After Lumbar Surgery Trial | NCT00163553 | Entailment |
5,247 | 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:Subjects should be postmenopausal >age 45, and of any racial origin.
They must not be on any osteoporosis medication. They should be willing to participate for
the duration of the study and have no physical or psychological illness that would prohibit
them from participating. Pregnant women, protected individuals (institutionalized), and
those unable to give informed consent will not be recruited. Exclusion criteria are
detailed below.
Subjects who meet initial pre-screening criteria will present for an on site screening
visit and have a full medical history, brief physical exam, BMD and lab evaluation to
confirm eligibility. Osteoporosis will be defined by DXA BMD T-Score < -2.5 at lumbar spine
(at least 2 evaluable vertebrae between L1 and L4), or total hip or femoral neck. In
addition, women with confirmed vertebral deformity on radiograph or lateral DXA image, or
prior osteoporosis-related fracture at age >45 along with a DXA BMD T-Score < -1.5 at one
or more skeletal sites will be eligible to participate.
Exclusion Criteria:
- The use of drugs known to affect skeletal or calcium homeostasis.
- Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2
evaluable lumbar vertebrae
- Current use of anti-resorptive medicines
- Use of Hormone/Estrogen Therapy, raloxifene or calcitonin within the past 3
months
- Use of oral bisphosphonate for more than 4 months within the past 2 years or more
than 5 years total cumulative bisphosphonate use in the past 10 years
- Use of intravenous ibandronate within the past 18 months
- Use of intravenous zoledronic acid within the past 4 years
- A history of a symptomatic renal stone within the past 3 years or history of
multiple symptomatic renal stones
- Skeletal Disorders other than osteoporosis including: Hypercalcemia,
hyperparathyroidism, Paget's Disease or osteomalacia
- Untreated or uncontrolled thyroid disease
- Elevated Bone Specific Alkaline Phosphatase level
- History of external or internal radiation therapy
- Renal insufficiency with estimated GFR below 30 ml/min
- Liver function tests (ALT/AST) more than 1.5 times the upper limit of normal
- Clinically significant hyperuricemia or active gout
- Any contraindications to receipt of Teriparatide or Denosumab (including
hypocalcemia)
- History of an atypical fracture of the femoral shaft
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
| The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab | NCT02130973 | Entailment |
4,615 | 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:
- 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 |
5,997 | 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:
Each patient must meet all of the following criteria to be eligible for enrollment in this
study:
- Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18
years old at the Screening Visit.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
regurgitation) while taking standard proton pump inhibitor (PPI) therapy.
- Patient has evidence of pathological acid reflux.
- Female patients must not be pregnant and must agree to avoid pregnancy for the
duration of the study.
- Patient must comply with study procedures.
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the
study:
- Patient has a history of complete lack of GERD symptom response to PPI therapy.
- Patient has a significant medical or surgical history including conditions that would
impact drug absorption or metabolism (such as bowel obstruction, poorly controlled
diabetes, gastroparesis, hiatal hernia).
- Patient reports pain or burning behind the breastbone or in the center of the upper
stomach as his or her predominant symptom at the Screening Visit.
- Patient has received an investigational drug during the 30 days before the Screening
Visit, or is planning to receive another investigational drug or use an
investigational device at any time during the study.
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
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.
| Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors | NCT03561883 | Entailment |
2,415 | 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:
For DMD patients:
- Male
- age 5-17 years
- genetically-proven diagnosis of DMD
- genetic mutation that abrogates expression of Dp427 alone (assigned in DMD Group 1:
Dp427-/Dp140+) or both Dp427 and Dp140 (assigned to DMD Group 2: Dp427-/Dp140-); or
all isoforms (assigned to DMD group 3)
For BMD patients:
- age 5-50 years
- genetically-proven diagnosis of BMD
- genetic mutation that decreases expression of Dp427 alone (assigned to BMD Group 1),
of both Dp427 and Dp140 (assigned to BMD Group 2), or of all the isoforms (assigned to
BMD group 3).
For MRI controls:
- Male
- age 5-50 years
Exclusion Criteria:
For DMD and BMD patients:
- Lack of a molecular diagnosis of DMD or BMD
- Mutation falls outside the regions of interest
- A severe co-morbidity or planned surgical intervention within 6 months from the study
which could interfere with the well-being of the participant
For MRI controls:
- any muscle disease
- a brain disorder (such as severe brain concussion in past history, congenital brain
anomalies, epilepsy)
General exclusion criteria for MRI:
- Claustrophobia
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- Intraorbital or intraocular metallic fragments
- Cochlear implants
- Ferromagnetic implants (e.g. thoracic implant for scoliosis)
- Inability to lie supine during less than 45 minutes
- not having a general practitioner
- severe learning disability which will require a general anaesthetic
Male
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 50 Years | Brain Involvement in Dystrophinopathies Part 2 | NCT04668716 | Entailment |
5,295 | 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:
-patients older than 50 years of age with vertebral fractures at the thoracic or lumbar
spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at
the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge,
fish, or flat)
Exclusion Criteria:
- patients younger than 50 years of age
- vertebral fractures at the cervical spine
- vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma
(motor-vehicle accident, sports-related accident, fall from a considerable height)
- patients suffering from a malignancy, making a pathological fracture presumably,
patients with vertebral fractures, whose dataset of follow-up monitoring was lacking,
to make an evaluation of osteoporotic involvement impossible
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.
| Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria | NCT02403726 | Entailment |
4,318 | 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:
- infertile males
Exclusion Criteria:
- suergery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 60 Years | Semen Analysis and Insight Into Male Infertility | NCT04178954 | Entailment |
435 | 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:
- - Woman older than 18 years
- Low-risk gestational trophoblastic neoplasia according to FIGO score (FIGO score ≤ 6)
with indication of methotrexate as first line treatment
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients with adequate bone marrow function measured within 28 days prior to
administration of study treatment as defined below
- Absolute granulocyte count ≥ 1.5 x 10 9 /L
- Platelet count ≥ 100 x 10 9 /L
- Haemoglobin ≥ 9.0 g/dL (may have been blood transfused)
- Patients with adequate renal function:
* Calculated creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula
(or local institutional standard method)
- Patients with adequate hepatic function
*Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤ 2.5 X UNL (≤ 5 X UNL for patients with
liver metastases)
- Patients must have a life expectancy ≥ 16 weeks
- Confirmation of non-childbearing status for women of childbearing potential.
An evolutive pregnancy can be ruled out in the following cases:
- in case of a previous hysterectomy
- if serum hCG level ≥ 2 000 IU/L and no intra or extra-uterine gestational sac is
detected on pelvic ultrasound
- if serum hCG level < 2 000 IU/L on a first measurement and serum hCG increases <100%
on a second measurement performed 3 days later.
- Highly effective contraception if the risk of conception exists. (Note: The
effects of the trial drug on the developing human fetus are unknown; thus, women
of childbearing potential must agree to use 2 highly effective contraceptions,
defined as methods with a failure rate of less than 1 % per year. Highly
effective contraception is required at least 28 days prior, throughout and for at
least 12 months after avelumab treatment.
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
- Patient is willing and able to comply with the protocol for the duration of the
treatment
Exclusion Criteria:
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA 4
antibody (including ipilimumab, tremelimumab or any other antibody or drug
specifically targeting T-cell costimulation or immune checkpoint pathways).
- Illness, incompatible with avelumab, such as congestive heart failure; respiratory
distress; liver failure; uncontrolled epilepsy; allergy.
- Patients with a known allergic hypersensitivity to methotrexate or any of the other
ingredients (sodium chloride, sodium hydroxide, and hydrochloric acid if excipient)
- Patients with second primary cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for ≥ 5 years.
- All subjects with brain metastases, except those meeting the following criteria:
- Brain metastases that have been treated locally and are clinically stable for at
least 2 weeks prior to enrolment, No ongoing neurological symptoms that are
related to the brain localization of the disease (sequelae that are a consequence
of the treatment of the brain metastases are acceptable).
- Subjects with brain metastases must be either off steroids except a stable or
decreasing dose of <10mg daily prednisone (or equivalent).
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative
reasons), within 2 weeks from the last dose prior to study treatment (or a longer
period depending on the defined characteristics of the agents used). The patient can
receive a stable dose of bisphosphonates for bone metastases, before and during the
study as long as these were started at least 4 weeks prior to treatment with study
drug.
- Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia and sensory
neuropathy, caused by previous cancer therapy.
- Treatment with other investigational agents.
- Bowel occlusive syndrome, inflammatory bowel disease, immune colitis, or other
gastro-intestinal disorder that does not allow oral medication such as malabsorption.
- Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease
- Clinically significant (i.e., active) and severe cardiovascular disease according to
investigator opinion such as myocardial infarction (< 6 months prior to enrollment)
- Patients with immune pneumonitis, pulmonary fibrosis
- Known severe hypersensitivity reactions to monoclonal antibodies, any history of
anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled
asthma Global Initiative for Asthma 2011).
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness.
- Active infection requiring systemic therapy.
- Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV
antibody tested positive)
- Administration of a live vaccine within 30 days prior to study entry.
- Current or prior use of immunosuppressive medication within 7 days prior to start of
study treatment.
The following are exceptions to this exclusion criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg,
intra-articular injection);
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or
equivalent;
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- Active autoimmune disease that might deteriorate when receiving an
immunostimulatory agents.
Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not
requiring immunosuppressive treatment are eligible.
- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method of birth control.
- Treatment with oral anticoagulant such Coumadin.
- Alcoholism (patient interview, investigator judgment)
- Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or
family history of long QT syndrome. Torsades de Pointes, arrhythmias (including
sustained ventricular tachyarrhythmia and ventricular fibrillation, bradycardia
defined as <50 bpm), right bundle branch block and left anterior hemiblock
(bifascicular block), unstable angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure (CHF New York Heart Association Class III or IV),
cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
- Prior organ transplantation, including allogeneic stem cell transplantation (excluding
autologous bone marrow transplant)
- Patients under guardianship.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment | NCT04396223 | Contradiction |
6,824 | 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 ≥13 years of age and ≤21 years of age with Mild Hemophilia A (MHA), with a
historical baseline FVIII:C level of ≥5% to ≤40% followed at either the Hospital for
Sick Children or St. Michael's Hospital (Toronto).
- Patients ≥13 years of age and ≤21 years of age with genetically confirmed Mild
Hemophilia A (MHA), with FVIII:C level of ≥5% to ≤50% followed at either the Hospital
for Sick Children or St. Michael's Hospital (Toronto).
Exclusion Criteria:
- A currently circulating or history of a previous inhibitor ( ≥0.5 BU) within the past
5 years. As inhibitor development in MHA is rare, it is not expected that any patient
will be excluded for this reason.
- Any FVIII infusion or DDAVP use in the preceding week. This is to avoid an residual
FVIII still being present in a patient who has taken an extended half-life FVIII.
- Co-existence of a congenital bleeding disorder other than MHA (e.g. VWD).
- Prior history of coronary artery disease or pulmonary disease, severe arthropathy
interfering with ability to exercise.
- Patients on beta-blockers, anti-platelet agents or regular non-steroidal
anti-inflammatory medications (e.g. Celebrex).
- Patients with an active infectious or inflammatory condition. This includes HIV,
active hepatitis B or C as reflected in elevated AST, ALT, RNA positivity for
hepatitis B or C.
- Patients who are active (defined as smoking daily) smokers (cigarettes, marijuana).
This exclusion is put into place as we do not know if daily smoking will impact on the
hemostatic response to either exercise or DDAVP.
- Patients with limited exercise tolerance for any reason.
- Patients with a history of a recent bleed (in preceding 2 weeks) in any location, or a
joint/muscle bleed in the lower limbs in the preceding 4 weeks.
- Patients who for medical reasons should not receive DDAVP [those with renal or CNS
disease (e.g. brain tumor)] or have previously experienced adverse events with DDAVP
(e.g. hypotensive event; seizure).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 21 Years | DDAVP vs. Exercise in Patients With Mild Hemophilia A | NCT03136003 | Entailment |
4,151 | 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:
- sperm count less than 10 million per milliliter
- non-obstructive azoospermia
Exclusion Criteria:
- high FSH ( > 10 mIU/ ml )
- high prolactin ( > 36 mIU/ml )
- abnormal karyotype
- AZF
Male
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 55 Years | Insulin Resistance in Idiopathic Oligospermia and Azoospermia | NCT01509482 | Contradiction |
5,575 | 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:
If a subject meets any one of these criteria, he/she will potentially be eligible to
participate:
- Short stature (height less than - 2 SDS), either currently or previously - or
- Tall stature (height greater than + 2 SDS) or
- Bone age delay (greater than 3 years) or
- Bone age advancement (greater than 2.5 years or greater than 1.5 years with short
stature) or
- Predicted adult height < - 2SD
- Growth disorder that was treated promptly, thus maintaining the child s height within
the normal range, e.g. a subject with congenital growth hormone deficiency or multiple
pituitary hormone deficiency of unknown genetic etiology who received growth hormone
treatment beginning in early life or
- Family member of subjects who meet any of the above criteria
- Subjects have a current height at a low normal percentile but has short adult height
prediction based on bone age (> 5 inches shorter than mid-parent height)
In addition, subjects are only eligible, if, the pedigree suggests a monogenic inheritance,
and, in the judgement of the investigators, there is a reasonable likelihood of identifying
a novel gene responsible for the condition.
EXCLUSION CRITERIA:
- A non-genetic disorder or condition, either congenital or acquired, that explains the
growth abnormality, for example, pituitary injury, chronic thyroiditis, whole body
irradiation, or celiac disease.
- In the opinion of the investigators, there is an established diagnosis of a genetic
disorder or condition that explains the growth abnormality and for which the molecular
genetic etiology has already been identified, for example, SHOX deficiency,
hypochondroplasia, or Noonan syndrome.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Genetic Causes of Growth Disorders | NCT02311322 | Contradiction |
5,031 | 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:
- Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of
test item 4 (upper limb tremor) confirmed by an independent TETRAS expert by means of video
assessment.
Exclusion Criteria:
- History or presence of day-to-day fluctuations in ET which would jeopardize meaningful
tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on
another day.
- Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the
judgment of the investigator could interfere with the ET diagnosis and/or assessment
of ET in ULs.
- Tremor types other than ET
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 Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm | NCT04766723 | Entailment |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.