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 |
|---|---|---|---|---|---|---|---|
1,455 | 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:
- Normal Volunteers:
- Older than 55 years of age
- No history of voice, swallowing, reflux, or progressive neurologic disease
affecting the swallowing mechanism.
- A normal self-administered dysphagia questionnaire (EAT-10 score of less than
three)
- Patients with Dysphagia
- Older than 55 years of age
- Patients with the following condition: Dysphagia, globus, gastroesophageal
reflux, or any other condition requiring referral for a dynamic swallowing study.
- Patients willing to provide written informed consent for their participation in
the study.
Exclusion Criteria:
1. Patients unable to complete the administration of the full taste and viscosity
protocol.
2. Patients with profound dysphagia unable to safely consume the test solutions.
3. Patients with known sensitivities or allergies to any of the test solutions.
4. Patients who are prisoners.
5. Patients have a history of diabetes.
6. Patients who are unable to follow the simple instructions to swallow the test
solutions on instruction and answer the questionnaire.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency | NCT01270204 | Entailment |
1,919 | 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. Signed and dated informed consent;
2. Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal
junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
3. Advanced stomach cancer patients who have failed to the second line or higher line
chemotherapy treatment
4. >=18 years old；ECOG PS：0~1；Estimated life expectancy >3 months
5. Main organs function is normal;
Exclusion Criteria:
1. Patients who have been treated with anlotinib previously;
2. Patients who have been treated with other VEGFR-TKI small-molecule drugs previously,
such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
3. Patients suffering from other malignancies currently or within 5 years, except for
cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder
cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma
invasion into lamina propria) ]
4. Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this
study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or
received mitomycin C within 6 weeks before this study). Extended field
radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field
radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
5. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous
treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by
oxaliplatin;
6. Patients with a clear tendency of gastrointestinal bleeding;
7. Patients with factors that could affect oral medication (such as dysphagia，chronic
diarrhea etc.)
8. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2
or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount
of activities, affecting Instrumental activities of daily life])
9. Patients with any severe and/or unable to control diseases;
10. Patients underwent major surgical treatment，open biopsy or significant traumatic
injury within 28 days prior to assignment;
11. Patients with any physical signs of bleeding diathesis or medical history, no matter
how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events
occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers
or fractures;
12. Patients with arterial or venous thromboembolic events occurred within 6 months, such
as cerebrovascular accident (including transient ischemic attack), deep vein
thrombosis and pulmonary embolism;
13. Patients with drug abuse history and unable to get rid of or Patients with mental
disorders
14. Brain metastases patients with symptoms or symptoms controlled < 2 months;
15. Patients participated in other anticancer drug clinical trials within 4 weeks or
Patients participating in other clinical trials now;
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.
| Study of Anlotinib in Patients With Gastric Cancer(ALTER0503) | NCT02461407 | Entailment |
3,370 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using
intra-tympanic injection of steroids to the middle ear
Exclusion Criteria:
- Patients with abnormal sense of taste
- Middle or inner ear anomaly
- Eustachian tube dysfunction
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 Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear | NCT04449848 | Contradiction |
4,777 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion criteria:
Adult (18 years and older) ED patients with all of the following (all determined
pre-randomization):
VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as
defined by consensus expert definitions in the International Classification of Vestibular
Disorders).
RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by
bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia
examination.
RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month
* Exam signs are required for randomization, but not for the observational arm
Exclusion Criteria
1. Excluded from Pre-Randomization Screening
Level 1 trauma or critical illness Altered mental status (e.g., delirium, dementia)
that would preclude active study participation (this includes patients with abnormal
mental state due to alcohol intoxication or illicit substance, which are known,
easily-recognized causes of dizziness or vertigo presentations to the ED) Non-English
speaking (enrollment of non-English speakers is not feasible given the logistics of
identifying a translator and the need for rapid recruitment and randomization in the
AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have
different meanings in other languages) Known pregnancy (all women of childbearing age
who are enrolled will undergo a urine or serum beta-HCG pregnancy test prior to MRI to
confirm no pregnancy, per local institutional guidelines)
Unable or unsafe to participate in screening, including VOG tests (as deemed by
specific pre-enrollment risk assessment questions or ED provider and/or Study
Coordinator judgment) including, but not limited to:
visual impairment sufficient to prevent visual fixation during the VOG testing
clinically-perceived risk to patient of participating in study (ED provider or staff
concerns) clinically-perceived risk to research staff (e.g., violence, blood/body
fluid/respiratory precautions) unstable cardiac status (given a single reported case
of bradycardia with impulse testing) acute cranio-cervical trauma or other condition
(e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that
would be a contraindication to neck rotation during VOG testing Obvious general
medical cause (as judged by treating ED provider) including, but not limited to, acute
myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug
intoxication, etc.
2. Excluded from Randomization (Eligible for Observational Arm Follow-up)
Patient previously randomized in the AVERT Trial (previously screened but not randomized
are eligible)
Unable to participate fully with study follow-up (particularly MRI) including, but not
limited to:
unable to return for follow-up testing within 30 days unable to undergo MRI because of
contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons
(severe claustrophobia, too large or too heavy for MRI scanner)
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.
| Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT) | NCT02483429 | Entailment |
267 | 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:
- Age 18-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (±3 days)
- Missed menses of 1 to 10 days as verified by report of last menstrual period
- Sexual activity in the past month
- Willing and able to sign consent forms
- Willing to return for a follow-up visit
- Willing to provide a urine sample at enrollment and at follow-up
Exclusion Criteria:
- Known allergies or contraindications to mifepristone
- Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or
spotting within the past week; unilateral pelvic pain or significant bilateral pelvic
pain within the past week; prior ectopic pregnancy; prior permanent contraception or
other tubal surgery
- Current use of an IUD, contraceptive implant or injectable
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills" | NCT04676776 | Contradiction |
2,252 | 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:
- People with gouty arthritis in the knee or ankle or metatarsophalangeal or
metacarpophalangeal or olecranon bursa or wrist
- Participants were Indonesian nationals aged ≥18 years
- They had visited a clinic of the Public CHS of Tomohon City
- They had agreed to participate in the study.
Exclusion Criteria:
- Participants who self-reported the presence of other types of inflammatory arthritis,
including RA or spondyloarthritis
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 Relationship Between Cold Water Immersion and the Progression in Gout Arthritis | NCT04587544 | Entailment |
2,601 | 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:
- Adult patients
- Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
- Groin hernia repair via robotic assisted laparoscopy or open surgery
- History of abdominal prostatectomy before the groin hernia repair
Exclusion Criteria:
- Age below 18
- Groin hernia repair via conventional laparoscopy
- Groin hernia repair via open surgery other than Liechtenstein method
- Groin hernia repair without mesh placement
Male
Subject must be at least 18 Years old.
| Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP | NCT04718597 | Contradiction |
3,500 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Age ≥18 years
- Documented chronic adrenal insufficiency
- Established corticosteroid replacement therapy
- Written informed consent
Exclusion Criteria:
- Age <18 years
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Management of Adrenal Emergency in Germany | NCT03426332 | Contradiction |
2,382 | 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. | - ELIGIBILITY CRITERIA:
This study will include healthy males and females who are over four years of age. The study
will involve healthy volunteers having normal lower extremity strength profiles and healthy
volunteers with impaired ankle joint plantarflexion strength. For this project, the term
healthy is defined as a lack of systemic disease that alters ability of subjects to
participate in activities of their choice. In addition, healthy means no current pathology
where there is any possibility of damage to muscle, ligament, or cartilage in the lower
extremity. An attempt will be made to obtain an equal distribution between males and
females. In addition, participation of minorities will be strongly encouraged through the
use of existing outreach programs.
INCLUSION CRITERIA:
Subjects must be capable of repeatedly walking 15m independently and unsupervised. They
must be co-operative and able to follow commands and have adequate natural step and stride
lengths to step on three force plates in series. Subjects must have a combined lower limb
size (shank and foot) that results in a PD-AFO size within the prototyping capacity (50 cm)
of the selective laser sintering machine. To participate in the impaired study, subjects
must have a manual muscle strength score for plantarflexion strength that is less than or
equal to three out of a five point scale.
EXCLUSION CRITERIA:
Subjects with an unsafe or highly variable gait pattern upon visual observation will be
excluded. Subjects who are unable to repeatedly walk through the data collection volume
without the use of assistive devices will be excluded. In addition, subjects with pain
related to walking or impaired skin sensation (touch and pressure) will be excluded.
Subjects with lower extremity muscle spasticity of 3 or greater on the Ashworth Scale will
be excluded. Subjects with a history of injury, surgery, or disease affecting the function
of the lower extremity will be excluded from the normal study. Subjects will be excluded
from participation in the normal study if muscle strength and joint range of motion
measures are outside normal limits.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
| Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use | NCT00115401 | Entailment |
679 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Men and women aged 18 and older
- Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype
testing
- Documented stable phlebotomy for ≥ 6 months
- Screening hemoglobin >11.5 g/dL
- Documented evidence of prior serum ferritin ≥500 ng/mL
- Serum ferritin >50 ng/mL and <300 ng/mL at screening
Exclusion Criteria:
- Clinically meaningful laboratory abnormality
- Receiving iron chelation therapy
- Receiving erythrocytapheresis
- Pregnant or lactating females
- Infection requiring hospitalization or intravenous antimicrobial therapy, or
opportunistic infection within 3 months of dosing; any infections requiring
antimicrobial therapy within 4 weeks of dosing.
- Serious or unstable medical or psychiatric condition that would prevent subject
providing informed consent
- Organ damage from iron overload
- Primary or secondary immunodeficiency
- Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection
- Known history of autoimmune/inflammatory diseases
- Any surgical procedures requiring general anesthesia within 1 month prior to screening
or planned surgery during study
- History of invasive malignancies within last 2 years, except non-malignant skin cancer
and local cured prostrate cancer, cervical cancer, or ductal carcinoma in situ
- Receipt of an investigational agent within 30 days of screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| PTG-300 in Subjects With Hereditary Hemochromatosis | NCT04202965 | Entailment |
6,733 | 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%. | Key Inclusion Criteria:
- Have severe hemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII as determined by
one-stage clotting assay from the central laboratory at Screening.
- Previously treated subject, defined as having at least 150 documented prior exposure
days (EDs) to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate
products at Day 1. Fresh frozen plasma treatment must not be considered in the count
for documented exposure days.
- No history of a positive inhibitor test or clinical signs of decreased response to
FVIII administrations. Family history of inhibitors will not exclude the subject.
- No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (>=0.6
Bethesda Unit per milliliter [BU/mL] is considered positive) at Screening.
Key Exclusion Criteria:
- Current enrollment in any interventional clinical study in which an investigational
drug or approved therapy for investigational use is administered within 30 days prior
to the Baseline Visit OR prior participation in any of the following Biogen studies:
998HA101 (NCT01027377), 997HA301 (NCT01181128), 8HA02PED (NCT01458106), 997HA307
(NCT02083965), and 8HA01EXT (NCT01454739).
- Previous participation in this study.
- Any concurrent clinically significant major disease that, in the opinion of the
Investigator or Biogen, makes the subject unsuitable for participation in the study.
- Other coagulation disorder(s) in addition to hemophilia A.
- History of hypersensitivity or anaphylaxis associated with FVIII or intravenous (IV)
immunoglobulin administration.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale | NCT02502149 | Contradiction |
4,229 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
-Male patients diagnosed with azoospermia and severe oligozoospermia.
Exclusion Criteria:
1. Klinefelter Syndrome ;
2. Structural chromosome aberrations；
3. Obstructive anspermia;
4. Male infertility caused by endocrine factors;
5. Do not meet requirements for acquisition, processing and preservation of samples；
6. After sampling, it doesn't conform to the standard of quality control, or other
experimental conditions that don't meet the test requirement；
7. Unable to obtain patient history;
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Detection of Microdeletions in the Azoospermia Factor (AZF) Regions in Infertile Male Patients | NCT03497728 | Contradiction |
6,996 | 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. | Participants will be classified as either Alzheimer's disease(AD) group, mild cognitive
impairment(MCI) group, elderly normal controls or young normal controls. Specific inclusion
criteria for each group is described below.
[Inclusion criteria: AD]
- Age : 55 - 90
- Clinical Dementia Rating (CDR)=0.5 or 1
- Diagnostic and Statistical Manual-IV(DSM-IV) criteria for dementia
- National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD
dementia
- Study partner or caregiver to accompany patient to all scheduled visits
- Written informed consent
[Inclusion criteria: MCI (amnestic)]
- Age : 55 - 90
- Clinical Dementia Rating (CDR)=0.5
- Concern regarding a change in cognition (obtained from the subject, from an informant
who knows the subject, or from a skilled clinician observing the subject)
- Lower performance in episodic memory domains that is greater than would be expected
for the subject's age and educational background
- Preservation of independence in functional abilities
- Study partner or caregiver to accompany subject to all scheduled visits
- Written informed consent
[Inclusion criteria: Elderly normal controls]
- Age : 55 - 90
- Clinical Dementia Rating (CDR)=0
- Those with contactable Informant
- Written informed consent
[Inclusion criteria: Young normal controls]
- Age : 20 - 55
- Clinical Dementia Rating (CDR)=0
- Written informed consent
[Exclusion criteria: general]
- Past history or presence of major psychiatric illness (e.g. schizophrenia, bipolar
disorder, alcohol/substance abuse or dependence, delirium)
- Significant neurologic or medical condition that can influence the mental state
- Contraindications for MRI scan (e.g. pacemaker, claustrophobia)
- Illiteracy
- Significant visual or hearing difficulty
- Taking investigational drug
- In pregnancy or breast-feeding
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 90 Years | Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease | NCT02137460 | Entailment |
6,913 | 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:
- Alzheimers disease according to (National Institute of Neurological and Communicative
Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
- The cognitive impairment and decline must be documented by cognitive /
neuropsychological testing and from an informant.
Exclusion Criteria:
- Stroke,
- Cancer,
- Psychiatric disorders (major depression, psychosis) or diseases / injuries in the
central nervous system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease | NCT02518412 | Entailment |
3,114 | 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. | General inclusion criteria for all subjects will include:
- Ages 50 to 89 years
- Capacity to give informed consent.
- Self-reported literacy (i.e. a "Yes" answer to the question "Have you learned how to
read?")
Additional inclusion criteria for the dry eye group will include both of the below:
- A previous diagnosis of dry eye syndrome by an eyecare specialist
- Ocular Surface Disease Index total scoring of 13 or above
Additional inclusion criteria for the Sjögren's syndrome group will include:
- A previous diagnosis of Sjögren's syndrome by an immunology specialist, per ACR criteria
22
Additional inclusion criteria for normal control subjects will include:
- No previous history of dry eye diagnosis
- Ocular Surface Disease Index total scoring of 12 or under
- Total corneal and conjunctival staining score of 0
Exclusion criteria will include:
- A binocular vision below 20/25 (with habitual correction)
- Any ocular surgery within the last 3 months.
- Mental issues, illiteracy, or language problems which might possibly interfere with
reading ability
- History of taking or current use of topical prescription anti-inflammatory eyedrops
(including, cyclosporine and steroids as well as any glaucoma eyedrops). Subjects who
are willing to discontinue their treatment for at least a period of 30 days can be
placed on a "wash out period" as per the discretion of the investigator and subject
safety, and be eligible at the end of this period, given all other criteria have been
met. Otherwise, subjects on these medications will be excluded.
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 89 Years | Effects of Sustained Reading on the Ocular Surface | NCT02031172 | Contradiction |
6,909 | 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. | Patient's inclusion criteria:
- Aged 65 and over
- AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological
assessment and a brain imaging
- Living at home
- Having a caregiver (more than 2 visits per week)
- Agreement for the study
Caregiver's inclusion criteria :
- More than 2 patient's visits per week
- Agreement for the study
Patient's exclusion criteria:
- Life expectancy less than 1 year
- Guardianship
- Already having a rehabilitation program's therapy
- Participation in a pharmacological study
Caregiver's exclusion criteria:
- Medical condition requiring regular care
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Alzheimer Disease : Rehabilitation's Intervention at Home | NCT01689948 | Entailment |
4,511 | 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:
- Women with regular menses
- Adenomyosis diagnosed via transvaginal ultrasound
- With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores >100)
- Duration of placement > 12 months
- Size of uterus by physical examination less than uterus of 12-week pregnancy
Exclusion Criteria:
- Desire for pregnancy or lactation
- With diagnosis of malignancies or precancerous lesions
- Acceptance of laparotomy
- Contraindication of placing levonorgestrel-releasing intrauterine system
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis | NCT03027648 | Contradiction |
1,168 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed
pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural
biopsy using Abram's needle.
3. Age>18 years old
Exclusion Criteria:
1. Transudative pleural effusion.
2. Exudative pleural effusion less than one third of hemithorax.
3. Presence of hemorrhagic diathesis (prothrombin concentration <50% and platelet count
<80,000/mm 3).
4. Poor performance state (ECOG performance status >4) as recommended in BTS (British
thoracic society) guidelines 2010.
5. Sever uncontrollable cough, hypercapnia and sever respiratory distress.
6. Fibrothorax, excessive pleural adhesion.
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Role of Cryobiopsy in Diagnosis of Pleural Effusion | NCT03828903 | Contradiction |
6,577 | 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:
- Complete physical and mental health, with no confounding history of systemic disease
and/or use of special local or systemic drugs
- No allergic reactions recorded in patient history
- Having primary molar teeth in one jaw, having deep caries and vital pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or
swelling of vestibule
- Normal gingival and periodontal condition, with no sensitivity to vestibular
palpation, and no pain on percussion test
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area
- No widening of PDL space or loss of lamina dura continuity
- No evidence of internal/external pathologic root resorption
Exclusion Criteria:
- Lack of informed consent by the child patient's parent
- Lack of informed consent by the child patient's parent
- Unable to attend follow-up visits.
- Refusal of participation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 4 Years old.
Subject must be at most 8 Years | Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA | NCT04710160 | Contradiction |
3,117 | 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:
- Nulliparous and primiparous
Exclusion Criteria:
- in G1 (nulliparous) were UI, neurological diseases, previous pelvic surgeries,
diabetes, smoking and cognitive difficulties. In G2 (primiparas), the same criteria
were used including women with gestational complications such as diabetes,
hypertension, vaginal and urinary infection.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 30 Years | Pelvic Floor Muscle Function in Nulliparous and Primiparous. | NCT01315769 | Contradiction |
739 | 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:
- Individuals diagnosed with knee osteoarthritis II-III level according to the results
of radiological evaluation by Kellgren and Lawrence
- Individuals aged between 40 and 65 years
- Individuals who have pain in his/her either of the knees in 3 month period and who
have a VAS score of 3 or more
- Individuals who can walk 10 meters independently (with or without ancillary device)
Exclusion Criteria:
- Individuals with Body Mass Index 35 and above
- Individuals with a history of surgery or injury involving the lower limb within the
last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
- Individuals who received hyaluronic acid or corticosteroid injections in the last year
- People with severe eyesight, hearing disabilities Individuals with neurological
deficit or disorder
- Individuals with regular exercise habits in the last 6 months
- Individuals with inflammatory rheumatic diseases.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | The Validity, Reliability and Responsiveness of the Fullerton Advanced Balance Scale in Osteoarthritis | NCT03728387 | Contradiction |
2,577 | 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:
- Groin pain (unilateral or bilateral) for at least 4 months. In this way, patients with
temporary symptoms will be excluded from undergoing unnecessary surgery.
- Tenderness over pubic tubercle or superficial inguinal ring.
Exclusion Criteria:
- Aged less than 18 years Aged more than 50 years - due to increased incidence of
sacro-iliac and hip pathology.
- Bulge, lump or cough impulse consistent with inguinal or femoral hernia on clinical
examination.
- Patients unwilling or unable to provide informed consent. Medically unfit for general
anaesthetic
- Pregnant women
- Diabetes - due to diabetic neuropathy
- Steroid use
- QST suggestive of nerve entrapment.
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 50 Years | A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain | NCT00934388 | Contradiction |
2,037 | 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:
- gastric cancer
Exclusion Criteria:
- for group III constituted gastric cancer associated with severe gastrointestinal
obstruction
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.
| Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients | NCT01704664 | Entailment |
476 | 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 of childbearing age from 20 to 50 years old
2. with or without menstrual changes:
1. menostaxis (longer than 7 days)
2. shortened menstrual cycles(less than 23 days)
3. menorrhagia(more than twice as much as usual)
4. abnormal vaginal bleeding(non-menstrual vaginal bleeding)
3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of
a menstrual cycle):
1. typical signs with a suspect of EP: (median/high) echo with a regular contour
within the uterine lumen;
2. atypical signs with a suspect of EP: punctate cystic areas within the endometrium
and the endometrial thickness >1cm;
Exclusion Criteria:
1. no menses within half a year;
2. surgery or drug treatment of endometrial lesions in the past half year;
3. with current intrauterine device;
4. combined with other acute gynecological inflammation;
5. with clinically suspected malignant tumors;
6. long-term use of oral contraceptives;
7. with abnormal liver and kidney function;
8. with benign or malignant breast tumors;
9. with any systemic malignant tumor or a history of tumors;
10. participants who are pregnant.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Dydrogesterone in the Treatment of Endometrial Polyps | NCT03790215 | Contradiction |
1,666 | 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:
1. Provided written informed consent to participating in the trial.
2. Caucasian, female or male, and aged 18 years to 55 years, inclusive.
3. Body mass index between 18.5 kg/m2 and 30 kg/m2, inclusive, with a lower body weight
limit of 50 kg.
4. In good health as determined by medical history, physical examination, 12-lead ECG,
vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure),
oxygen saturation, and laboratory monitoring (hematology, clinical chemistry,
clotting, and urinalysis).
5. Subjects must be able to feel thermal and mechanical sensation (cold, warm, sharp,
unpleasant sensation) on normal skin (at the forearm intended for menthol / capsaicin
administration) confirmed by routine neurological bed-side testing.
6. Female subjects must be postmenopausal (with at least 2 years since last
menstruation), surgically sterile (e.g., after hysterectomy or bilateral
oophorectomy), or practicing an effective method of birth control (e.g., oral
contraceptives, contraceptive injections, intrauterine device, double-barrier method,
contraceptive patch, male partner sterilization) at the Enrollment Visit and during
the trial.
7. Female subjects of childbearing potential must have a negative serum hCG test at the
Enrollment Visit.
Exclusion Criteria:
1. The subject has received any of the IMPs or used an investigational medical device
within 30 days or within a period less than 10 times the half life of an
investigational drug, whichever is longer, before the first dose of IMP is scheduled.
2. History or presence of opioid abuse, drug abuse, or alcohol abuse or presence of an
acute intoxication with alcohol, hypnotics, centrally acting analgesics, or
psychotropic drugs.
3. Positive or missing drugs of abuse screening (alcohol breath test, urine screening
test for drugs of abuse).
4. Diseases or conditions known to interfere with the absorption, distribution,
metabolism, or excretion of drugs.
5. History or presence of severe respiratory depression with hypoxia and/or hypocapnia,
severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma,
paralytic ileus.
6. History or presence of hypersensitivity to Tapentadol, menthol, capsaicin/chili
peppers or any of the other excipients of the Palexia® IR (Tapentadol), menthol, or
capsaicin formulations or to opioid antagonists (e.g., naloxone).
7. Subjects who have used any prescribed and non-prescribed systemic or topical
medication, except contraceptives, on a daily base within 14 days before the Enrolment
Visit, or anticipated use from the Enrolment Visit until the first administration of
the IMP.
8. History or presence of seizure disorder and/or epilepsy or any condition associated
with a significant risk for seizure disorder or epilepsy.
9. History of orthostatic hypotension.
10. Blood donation or acute loss of blood (more than 100 mL) during the 1 month before the
enrollment visit, or intention to donate blood or blood products during the trial or
within 1 month following the completion of the trial.
11. Pregnant or breastfeeding women.
12. Known or suspected of not being able to comply with procedures described in the trial
protocol.
13. Not able to communicate meaningfully with the investigator and staff.
14. Preplanned surgery or procedures that would interfere with the conduct of the trial.
15. Acute skin disease, lesions, acute sunburn, extensive tattoos or scars at the forearm
where the menthol / capsaicin application is planned.
16. Employee of the Investigator or trial site, with direct involvement in the proposed
trial or other trials under the direction of that Investigator or trial site, as well
as family members of the employees or the Investigator
17. Administration of a monoaminoxidase-inhibitor (MAO-Inhibitor) within 14 days prior to
recruitment visit.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models | NCT01615510 | Entailment |
5,147 | 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:
- Diagnosis of severe osteoporosis
- Non-response to anti-osteoporotic treatment for over 2 years
- Normal hematology function
- Ability to provide a written, dated, and signed informed consent prior to any study
related procedure, and to understand and comply with study requirements
Exclusion Criteria:
- Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
- Current or past medical disease that could interfere with the evaluation of the
efficacy, as judged by the investigator
- Severe renal or hepatic impairment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis | NCT02061995 | Contradiction |
2,439 | 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. | Inclusion Criteria:
1. Males or females, of any race, between 18 and 85 years of age, inclusive
2. Able to provide written informed consent
3. Clinician diagnosis of sarcoidosis
4. Treatment-naïve or receiving immunomodulatory therapy.
Exclusion Criteria:
1. Evidence of acute bacterial infection or other condition likely in the opinion of the
investigator to significantly impact results of blood assays.
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 | Exploring the Immunology of Sarcoidosis | NCT04637165 | Entailment |
22 | 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:
- Cancer survivors who have received chemotherapy and/or radiation therapy for their
cancer and are now in remission for at least one year
- Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
- Age: 18-50 years
- Serum testosterone, measured by mass spectrometry (gold standard method), of <348
ng/dl and/or free testosterone <70 pg/ml. The lower limits of the normal range for
total testosterone in healthy young men (age 19-40 years), is 348 ng/dL and the lower
limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample97.
Therefore, young symptomatic men with total testosterone <348 ng/dl could be
considered testosterone deficient. As sex hormone binding globulin levels may be
elevated in some men with cancer (resulting in elevation in total testosterone level),
some of these symptomatic men may still be hypogonadal despite having total
testosterone above this cut-off limit. However; their free testosterone levels may
still be below the lower limit of normal. Thus, we will also include men with free
testosterone <70 pg/mL.
- Self-reported fatigue. We have selected these symptoms because they are commonly
reported in male cancer survivors. Fatigue will be defined as a score on Functional
Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best
divides cancer patients from the general population with 84% accuracy96,185, and was
used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The
T-Trial).
- Ability and willingness to provide informed consent.
Exclusion Criteria:
- Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown
origin)
- Men with brain (potential cognitive impairment) and pancreatic cancers (short
life-expectancy)
- Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within
the past 6 months
- Appetite stimulating agents e.g. megestrol acetate within the past 6 months
- Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other
glucocorticoids for more than two weeks in the past 6 months
- Baseline hematocrit >48%
- PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans; nodule/induration on
digital rectal exam
- Men with 1st order relatives with a history of prostate cancer
- Uncontrolled congestive heart failure
- Severe untreated sleep apnea
- Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke
within 3 months
o Previous stroke with residual cognitive or functional deficits; Mini-Mental State
Examination score <24
- Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
- Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI)
>40 kg/m2
- Untreated unipolar depression (treated depression with medications or counseling will
be allowed
- Bipolar disorder or schizophrenia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer | NCT04049331 | Contradiction |
5,397 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Male or female patients;
- ≥ 16 to ≤ 75 years of age;
- Diagnosis of VWD-2B according to national expert guidelines for the USA [1] and Europe
[2] based on medical history and findings from a matrix of laboratory assays which may
include: platelet count, concentration of VWF antigen (VWF:Ag), VWF ristocetin
cofactor activity (VWF:RCo), Factor VIII (FVIII) activity, ristocetin-induced platelet
aggregation (RIPA), platelet function analyzer (PFA-100®) closure time, bleeding time
(BT), VWF multimer test, VWF: platelet-binding (VWF:PB) activity, etc.)
- Thrombocytopenia (defined as a platelet count < 100 per nL on at least 2 occasions
within the month preceding enrollment;
- Female patients of reproductive age must be enrolled within 1 to 7 days of the
cessation of preceding menses;
- Female patients must be non-pregnant and willing to use effective, redundant methods
of contraception (i.e., for both self and male partner) throughout the study and for
at least 30 days after discontinuation of study drug treatment;
- Male patients must agree to use a medically acceptable contraceptive (abstinence or
use of a condom with spermicide) throughout the study and for at least 30 days after
discontinuation of study drug treatment;
- All patients must be capable of understanding and complying with the protocol and must
have signed the informed consent document.
Exclusion Criteria:
- Patients with a possible co-existing or alternative hematologic diagnosis which can
account for the laboratory findings of thrombocytopenia, etc.;
- Any significant medical co-morbidity which would pose an increased risk of bleeding
(e.g., recent trauma or surgery, a history of gastrointestinal ulcers, etc.) or
thrombosis (e.g., history of recurrent deep vein thrombosis (DVT).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 75 Years | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B | NCT00694785 | Entailment |
5,960 | 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:
- Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device
implantation date.
- Patient is a surgical candidate, i.e. is able to undergo general anesthesia and
laparoscopic surgery.
- Documented pathologic esophageal acid exposure by pH monitoring per institution's
standard of care (i.e. total distal ambulatory esophageal pH< 4 for ≥ 5.3% (BRAVO) or
≥4.5% (transnasal) or abnormal DeMeester Score (>14.72) within 12 months of proposed
implantation date (After Sleeve Gastrectomy).
NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO
TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE
VISIT.
- Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
- Age ≥ 21 years
- At least 30% loss of excess weight from date of original LSG surgery.
- Patient is willing and able to cooperate with follow-up examinations.
- Patient has been informed of the study procedures and the treatment and has signed an
informed consent form.
Exclusion Criteria:
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous
materials.
- Prior surgery in the area of the gastroesophageal junction (GEJ), including prior
hiatal hernia repair.
- Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
- Subject had any major complications related to the laparoscopic sleeve gastrectomy
that may interfere with, or increase the risks of the LINX procedure (such as, but not
limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy).
- Plans to surgically revise the gastric pouch (either known preoperatively or decided
intraoperatively).
- Currently being treated with another investigational drug or investigational device.
- Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal
surgery or endoscopic intervention for GERD (with the exception of sleeve
gastrectomy).
- Distal amplitude <35 mmHg or <70% peristaltic sequences.
- Presence of esophagitis - Grade C or D (LA Classification). BMI >35.
- Symptoms of dysphagia more than once per week within the last 3 months.
- Diagnosed with Scleroderma.
- Diagnosed with an esophageal motility disorder such as but not limited to achalasia,
nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.
- Patient has a history of or known esophageal stricture or gross esophageal anatomic
abnormalities (Schatzki's ring, obstructive lesions, etc.).
- Patient has esophageal or gastric varices.
- Patient has Barrett's esophagus.
- Patient cannot understand trial requirements or is unable to comply with follow-up
schedule.
- Pregnant or nursing, or plans to become pregnant during the course of the study.
- Any reason which the Investigator believes may cause the subject to be non-compliant
with or unable to meet the protocol requirements.
- Patient has an electrical implant or metallic, abdominal implants.
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.
| RELIEF Europe Study | NCT02762487 | Contradiction |
520 | 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:
- • Inclusion criteria of study group (1&2):
1. Women with primary or secondary infertility for more than 1 year due to
unexplained infertility (normal regular menstrual cycles and normal pelvic
examination, evidence of ovulation by TV/US and/or normal mid-luteal serum
progesterone, normal semen analysis of the husband according to WHO guidlines2010
(25), and evidence of tubal patency and normal uterine cavity by HSG and/or
laparoscopy).
2. Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26) • Inclusion
criteria for control group (2):
1. Women with no history of menstrual dysfunction or subfertility.
2. Normal regular cycles and normal pelvic examination.
3. Multipara with last delivery since ≥ 2 years with no history of abortions and not
on contraception (hormonal or IUD).
Exclusion Criteria:
- • Exclusion criteria of both groups:
1. History of pelvic surgery or pelvic inflammatory disease.
2. Current hormonal contraception.
3. On IUD.
4. History of or clinical features suggesting endometriosis or pelvic pathology like
uterine fibroid and ovarian cyst.
5. General medical disorders (e.g. D.M), smoking and lactation.
Female
| Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS. | NCT03397693 | Contradiction |
3,118 | 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
- Normal ophthalmic findings except dry eye disease
- Ametropy ≤ 6 diopters
- Chronic dry eye defined as longer than six months since diagnosis
- OSDI ≥ 22
- Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
- Current use of topical lubricants since at least 3 months
Exclusion criteria:
- Best far corrected visual acuity < 1/10
- Severe Dry Eye associated with:
- Eyelid malposition
- Sjogren Syndrome
- Steven Johnson Syndrome
- Corneal dystrophy
- Ocular neoplasia
- Filamentous keratitis
- Corneal neovascularisation
- Orbital radiotherapy
- History of any of the following within last 3 months:
- Systemic treatment of dry eye
- Systemic treatment of MGD
- Isotretinoide,
- Cyclosporine,
- Tacrolimus, Siromilus, Pimecrolimus
- Punctual plugs
- Anti-glaucoma treatment
- History of any of the following within previous six months:
- ocular trauma
- ocular infection, ocular allergy
- History of any of the following within last 12 months:
- inflammatory corneal ulcer
- Herpetic eye infection or uveitis
- Ocular surgery
- History of IOP increase caused by systemic or topical treatment with corticosteroids
- IOP > 22mmHg
- Glaucoma in the medical history
- Known hypersensitivity to any of the components of the IMP under investigation or
other study medication
- Allergic rhinitis; active or susceptible to reactivation during the study
- Pregnant or breast-feeding woman.
- Woman of childbearing potential (neither menopausal, nor hysterectomized, nor
sterilized) not using effective contraception (oral contraceptives, intrauterine
device, contraceptive implant or condoms)
- Inability of patient to understand the investigation procedures and thus inability to
give valid, informed consent.
- Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life
interfering with compliance)
- Participation in another clinical study or clinical investigation at the same time as
the present investigation
- Participation to the present clinical investigation during the exclusion period of
another clinical study
- Patient already included once in this clinical investigation
- Patient under guardianship
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.
| Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation | NCT03907865 | Contradiction |
6,774 | 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:
- congenital Hemophilia A and B patients more than 18 years old
Exclusion Criteria:
- All hemophilia patient less than 18 years old
- Patients with other bleeding disorders
- Patients with other comorbidities that can affect joint function as collagen disease
- Patients on steroids or non-steroidal analgesics
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.
| Quality of Life in Hemophilia by Clinical Scoring System (FISH)Score | NCT04102046 | Entailment |
100 | 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
- General good health and capable of undergoing strength testing
- Normal testosterone (300-1100 ng/dL), LH, and FSH levels
Exclusion Criteria
- Currently participating in competitive sports
- Mental state that would preclude complete understanding of the protocol and compliance
- Disorder known to cause or be associated with hypogonadism (e.g., pituitary tumors,
hyperprolactinemia, HIV infection, or Klinefelter's Syndrome)
- More than 20% over ideal body weight
- Disabilities that would prevent participation in strength testing (e.g., amputation of
limbs, blindness, severe arthritis, angina, or neurologic disorders such as
Parkinson's disease, stroke, or myopathy)
- Uncontrolled hypertension, diabetes, congestive heart failure, or chronic obstructive
lung disease
- Alcohol or drug dependence in the 6 months prior to study entry
- Disorders that might be exacerbated by androgen treatment (e.g., benign prostatic
hyperplasia or prostate cancer, erythrocytosis [hematocrit > 51% at baseline], or
sleep apnea assessed by Berlin's questionnaire)
- Serum PSA levels > 4 microg/L
- AST, ALT, or alkaline phosphatase elevation greater than three times the upper limit
of normal
- Creatinine greater than 2 mg/dL
- Medications that might affect muscle or bone metabolism (e.g., glucocorticoid, rhGH,
androgenic steroids, oral androgen precursors such as androstenedione or DHEA) or
androgen metabolism, action, or clearance (e.g., dilantin, phenobarbitol, aldactone,
flutamide, finasteride)
Male
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | The Effect of 5-Alpha Reductase on Testosterone in Men | NCT00070733 | Contradiction |
3,185 | 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. | Selection of subjects for the study will be restricted to the pool of NIDCR patients
already participating in protocol 84-D-0056, Evaluation and Treatment of Salivary
Dysfunction.
INCLUSION CRITERIA
A. Salivary Flow = 0.1ml/min pooled unstimulated; and
B. A diagnosis of SS (primary or secondary)
C. A diagnosis of non-SS auto-immune disease
D. The use of a medication with known xerostomic effect
E. Subjective xerostomia or xerophthalmia
F. The presence of permanent teeth.
EXCLUSION CRITERIA
A. Child and Adolescent:
Children and Adolescents will not be included in the study due to the presence of deciduous
teeth which are less suitable for bonding and which show an altered enamel morphology and
pattern of plaque accumulation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Oral Bacteria in Patients With Dry Mouth | NCT00048685 | Entailment |
2,345 | 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:
- Diagnosed with Duchenne Muscle Dystrophy
- No injuries and no neurological or orthopedic surgery in the last 6 months
- No other systemic or orthopedic / neurological disorders to prevent exercise
Exclusion Criteria:
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 16 Years | The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in DMD | NCT04669847 | Entailment |
5,090 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Postmenopausal women who meet at least one of the following bone mineral density (BMD) and
fracture criteria:
- BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral
fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
- BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to
randomization.
Exclusion Criteria:
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
- Hyper- or hypothyroidism
- Hyper- or hypoparathyroidism
- Possible signs of intolerance to alendronate
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis | NCT01631214 | Contradiction |
6,065 | 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:
- Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or
lower part of the chest up towards the neck) with or without regurgitation
- Patients must have had episodes of heartburn with or without regurgitation for 3
months or longer, and for >= 3 days in the 7 days prior to randomisation
- Able to understand and complete questionnaires, able to give written informed consent,
and have access to a telephone
Exclusion Criteria:
- Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal
symptoms that, in the opinion of the investigator, require further investigation prior
to or coincident with initiation of PPI therapy which would include, but are not
limited to, alarm symptoms such as unintentional weight loss, progressive difficulty
swallowing (dysphagia), iron deficiency anaemia and epigastric mass
- Significant gastrointestinal obstruction, major gastric or oesophageal surgery
(excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric
stenosis, extra-oesophageal manifestations of reflux disease
- Patients with Barrett's oesophagus (>3cm), Zollinger-Ellison Syndrome, scleroderma,
malignancy (other than non-melanoma skin cancers) present within the last 5 years,
hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant
condition that, in the opinion of the investigator, could interfere with the patients
participation or compliance in the study such as past or current history of alcohol or
drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have
participated in an investigational drug or investigational device study within 30 days
prior to the baseline visit or who are expected to do so during the 4 week study
period
- Female patients who are currently pregnant or breast feeding, or who, in the opinion
of the investigator, may become pregnant throughout the study
- Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation,
anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump
inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or
bismuth compounds within 14 days of randomisation
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 Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg | NCT00464308 | Entailment |
6,667 | 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:
- Adult or child with Clinical diagnosis of severe hemophilia A (FVIII activity < 1%)
with or without inhibitor
- Clinical indication to emicizumab therapy
Exclusion Criteria:
- Refusal to give informed consent
- acquired hemophilia A
- other inherited or acquired bleeding disorder
- bodyweight < 10 kgs
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| UPLC-MS/MS Monitoring of Emicizumab Therapy | NCT04472169 | Contradiction |
3,087 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the
center of language and learning disorders at Raymond Poincaré hospital;
- With severe learning disorders: deficiency in school work, need at least one medical
appointment and long-term rehabilitation in the center of language and learning
disorders at Raymond Poincaré hospital;
- Affiliated to a social protection schema;
- Written informed consent signed.
Exclusion Criteria:
- Absence of learning disorder;
- Intellectual deficiency;
- Epilepsia;
- Patients who will performed follow-up at Chartres city;
- Patients under guardianship or curatorship;
- Foreign patients under AME schema, a medical help from the state in France.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 30 Years | Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age | NCT04280367 | Entailment |
4,968 | 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:
1. Dopa responsiveness
2. Minimum disease duration of 5 years.
3. Diagnosis of idiopathic Parkinsons disease
4. Patients with intractable Essential Tremors.
5. Patients with intractable dystonia
Exclusion Criteria:
1. Significant medical health problems.
2. Significant cognitive impairment
3. Bleeding tendencies
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 90 Years | DBS in the Treatment of Intractable Movement Disorders | NCT03562403 | Entailment |
3,222 | 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:
- A diagnosis of primary Sjogren's syndrome according to the revised American-European
Consensus Group (AECG) criteria
- ESSDAI score greater than or equal to (>/=) 5
- ESSPRI score >/=5
- Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or
anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
- Negative pregnancy test at screening and baseline (for women only)
- Willing to comply with the study procedures and restrictions, including measures to
prevent pregnancy and restrictions on sperm donation
Exclusion Criteria:
- A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
- Severe complications of Sjogren's syndrome
- Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy
within 6 months prior to the screening visit
- Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
- A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal,
yeast or bacterial infection at screening
- A history suggesting reduced immune function or any other conditions predisposing
participants to serious infection
- A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance
(MGUS), or any other malignancies within the past 5 years
- A diagnosis of fibromyalgia or significant depression
- Having any concomitant disease or condition that could interfere with the conduct of
the study, or that would pose an unacceptable risk to the individual
- Participation in an investigational drug or device study within 3 months prior to
screening
- Inability to comply with the study protocol for any other reason
- Women who are lactating, breastfeeding or planning to nurse
- Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong
inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp];
sensitive substrates of CYP3A4 with a narrow therapeutic index)
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 | A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome | NCT02701985 | Entailment |
609 | 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:
- Confirmed diagnosis of missed miscarriage on pelvic ultrasound
- Gestational age ≤ 13 weeks
Exclusion Criteria:
- Patients who opted for surgical or expectant management.
- Patients with co-morbidity
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage | NCT04604366 | Entailment |
1,740 | 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:
- Patients in different age groups with superficial soft tissue lesions
Exclusion Criteria:
- If the patient undergo previous operations at the same mass that could change the
criteria of that mass or if the mass is recurrent at the same site.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses | NCT03171857 | Entailment |
2,660 | 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:
- Adult (>18 years)
- Male
- Primary unilateral groin hernia
- Ability to use pain scales
Exclusion Criteria:
- Neurological disease
- Diabetes with late stage complications
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Predisposing Factors for Chronic Postherniotomy Pain | NCT00649142 | Entailment |
5,299 | 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: healthy women ages 55 and older who were at least four years
postmenopausal living independently in a nine-county rural area of Nebraska
-
Exclusion Criteria:
1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer
except for superficial basal or squamous cell carcinoma of the skin and
-
Female
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| Calcium and Vitamin D Malnutrition in Elderly Women | NCT00352170 | Entailment |
6,684 | 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:
- Patient of the Hemophilia Treatment Center at OHSU
- Male
- Aged 4 years, 0 months to 21 years, 11 months
- Diagnosis of bleeding disorder
Exclusion Criteria:
- Acute bleed or injury in the last two weeks that prevents activity
- Diagnosed developmental delay
Male
Accepts Healthy Volunteers
Subject must be at least 4 Years old.
Subject must be at most 21 Years | Motor Proficiency of People With Bleeding Disorders Using the BOT-2 (TM) | NCT02279199 | Contradiction |
3,096 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Patients with FXS as confirmed by genetic testing
Exclusion Criteria:
- none
- 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.
| EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes | NCT01711606 | Entailment |
347 | 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 female age 20-35 years
- Previous Failed one ICSI trial
- normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively,
--normal endometrial cavity
- patent tubes
- normal Husband semen analysis
Exclusion Criteria:
- Ovarian factor of infertility
- Tubal factor of infertility
- Endometrial factor of infertility
- Male factor of infertility
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Physical Endometrial Manipulation and Its Effect on ICSI | NCT03345251 | Contradiction |
3,040 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- fragile X full mutation
- normal or corrected vision
- English or Spanish speaking
- ability to pass three-span items following completion of a Cogmed training session at
baseline
- parental agreement to maintain adherence to the training schedule and to not alter
other treatments during the study unless medically necessary
Exclusion Criteria:
- previous Cogmed training
- significant medical problems that would interfere with the study or significant brain
trauma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 18 Years | Cognitive Training for Fragile X Syndrome | NCT02747394 | Entailment |
5,255 | 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:
- Informed consent: Subject is willing and able to provide written informed consent.
- Menopausal status: Ambulatory female aged < 80 years at screening and >5 years
postmenopausal.
- T-Score: A subject with either no or only one prevalent vertebral fracture is eligible
for inclusion if she satisfies one of the following T-score requirements:
If no prevalent vertebral fracture subject must have an absolute BMD value consistent with
a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck,
total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must
have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and
greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
- Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for
BMD measurement by DXA.
- Protocol compliance: Subject who, in the opinion of the investigator, is willing and
able to comply with the requirements of the protocol.
Exclusion:
- T-Score: Has an absolute BMD value consistent with a T-score less than or equal to
-4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.
- Vertebral fractures: Has >1 prevalent vertebral fracture at the screening visit.
- Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility
fracture after age 40.
- Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments.
- BMI: BMI ≥33kg/m2.
- Bone metabolic diseases: Other than osteoporosis, history or concurrent diseases
affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism).
- GI disease: History of major upper gastrointestinal disease
- Malabsorption: Active or history of malabsorption (e.g., history of celiac disease,
irritable bowel syndrome or inflammatory bowel disease).
- Liver disease: Past or current history of liver disease or known hepatic or biliary
abnormalities, (with the exception of previously documented diagnosis of Gilbert's
syndrome).
- Rheumatoid arthritis: Active disease or history of rheumatoid arthritis.
- Nephrolithiasis: History of or active nephrolithiasis (kidney stones).
- Osteosarcoma risk: Subjects at increased risk of osteosarcoma such as those with
Paget's disease of bone or any prior external beam or implant radiation therapy
involving the skeleton.
- Malignancy: Malignant disease diagnosed within the previous 5 years (except resected
basal cell cancer).
- Biological abnormalities: Any clinically relevant biological abnormality found and/or
volunteered at screening (other than those related to the disease under investigation)
which, in the opinion of the investigator, is clinically significant and would
preclude safe participation in this study.
- Surgical and medical conditions: Presence of the following conditions within six
months prior to screening: myocardial infarction, coronary bypass surgery, coronary
artery angioplasty, unstable angina, cardiac arrhythmia, clinically evident congestive
heart failure, or cerebrovascular accident.
- Glomerular filtration rate: Glomerular filtration rate (GFR) <35 mL/min as calculated
by the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR
(mL/min/1.73 m2) = 186 x (Serum creatinine mg/dL)-1.154 x (Age)-0.203 x (0.742 if
female) x (1.210 if African American) (conventional units).
- QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc
interval ≥450 msec on the Screening ECG).
- Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart
failure, hypokalemia, family history of Long QT Syndrome).
- Liver chemistries: Liver chemistries [aspartate aminotransferase (AST), alanine
aminotransferase (ALT) or total bilirubin] exceeding 2-fold the upper limit of the
laboratory-specified reference range, at screening.
- Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central
laboratory reference range at the screening visit.
- Abnormal PTH: PTH (intact or whole) outside the normal range.
- Abnormal creatine phosphokinase: Creatine phosphokinase (CPK) outside the normal
range.
- Abnormal alkaline phosphatase: Alkaline phosphatase outside of the normal range.
- Thyroid hormone replacement: Subjects receiving thyroid hormone replacement therapy
must have a TSH level checked. Subjects will be excluded if TSH levels are <0.1 or
>10.0mIU/L. However, subjects will not be excluded if TSH is in the range 0.1-4.5
mIU/L. If TSH is >4.5 and ≤10.0mIU/mL, measure T4 and exclude the subject only if the
T4 is outside the normal range.
- Vitamin D deficiency: Vitamin D deficiency (serum 25-hydroxy vitamin D < 20ng/mL,
equivalent to 50nmol/L) at screening. Subjects can undergo vitamin D repletion as per
local practice and be re-screened once only for vitamin D levels within the 6-week
screening period. They will remain excluded if the re-screened value is < 20ng/mL.
- Previous strontium or IV bisphosphonate: Any previous treatment with strontium
ranelate or intravenous bisphosphonate.
- Oral bisphosphonates: Any previous treatment with an oral bisphosphonate as follows:
any treatment within the last six months
- one month cumulative treatment within the last 12 months
- three months cumulative treatment within the past two years, or
- two years cumulative treatment within the past five years.
- Fluoride: Treatment with fluoride (dose greater than 10mg/day) within the
previous 5 years for osteoporosis.
- Digoxin: Current therapy with digoxin.
- Bone metabolism drugs: Treatment with other drugs affecting bone metabolism
within the last six months prior to screening:
Chronic systemic corticosteroid [e.g., glucocorticoid, mineralocorticoid] treatment of no
more than 2 intra-articular injections within the past year or use of oral, parenteral, or
long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid
will not exclude the subject from participating.
Hormones [e.g., estrogens/"natural estrogen preparations"(except for nonsystemic vaginal
treatment), 19-norprogestins, SERMs such as raloxifene, anabolic steroids/androgens such as
dehydroepiandrosterone (DHEA) or its sulfated form (DHEAS), nandrolone, tibolone, active
vitamin D analogs/metabolites such as 1,25-dihydroxy vitamin D (calcitriol) or
1alpha-hydroxyvitamin D3 (1-alpha hydroxycholecalciferol), calcitonin].
Calcineurin inhibitors [e.g., cyclosporine, tacrolimus] or methotrexate.
- Previous anabolic agents: Treatment with PTH, PTH analogues or similar anabolic agent
for osteoporosis within the last two years.
- Contraindications: Contraindications to therapy with calcium or vitamin D.
- Pregnancy: Women who are pregnant are not allowed in this study.
- Interfering medications: Vitamin A in excess of 10,000 IU per day, heparin, or
lithium, or anticonvulsant medications except benzodiazepines.
- Investigational drug exposure: Administration of any investigational drug within 90
days preceding the first dose of the study drug.
- Substance abuse: History or current evidence of drug or alcohol abuse within the
previous 12 months.
- Problems swallowing: Inability to swallow a tablet whole.
The following exclusion criteria do not apply to subjects allocated to the open-label
teriparatide group:
- Calcium channel blockers: Current therapy with calcium channel blockers diltiazem and
verapamil.
- Oral Azole Antifungals: Current therapy with any oral azole antifungal.
- Immunosuppressants: Current therapy with cyclosporine or oral tacrolimus.
- Ritonavir: Current therapy with ritonavir.
- Quinidine: Current therapy with quinidine.
- Macrolide Antibiotics: Subjects anticipated to require chronic use of macrolide
antibiotics.
- Alendronate Contraindications: Contraindications to therapy with alendronate.
Additional Exclusion Criteria for Subjects Recruited at QCT Sites
- Hip surgery: History of hip surgery resulting in a metal implant on either the left or
right side that would cause an artefact on a QCT scan.
Additional Exclusion Criteria for Teriparatide Subjects
- Teriparatide contraindications: Contraindications to therapy with teriparatide
according to locally approved datasheet.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 79 Years | A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis. | NCT00471237 | Entailment |
4,205 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male or female aged 18 to 75 years.
- Confirmed diagnosis of a persistent cough.
- Leicester Cough Questionnaire score of ≤ 17 at baseline.
- FEV ≥ 70% of predicted normal, at screening. See protocol Appendix 4 for formula for
calculating predicted values.
- Willing to use effective contraception for the duration of the study. Female subjects
who are neither surgically sterilized nor post-menopausal (defined as no menses for
one year or an FSH value > 40 mIU/L) will be required to use two methods throughout
the study and for 30 days after. Besides abstinence the following contraceptive
methods are acceptable: hormonal (e.g. oral, injection, transdermal patch, implant,
cervical ring), barrier (e.g. condom or diaphragm with spermicidal agent) or
intrauterine device. If hormonal contraceptives are used they must be used from 6
weeks before the first administration of test product. Male subjects must agree to use
condoms for the duration of the study and for 30 days after.
- Willing and able to give informed consent and of complying with the trial assessments
and any other trial procedures.
Exclusion Criteria:
- Pregnant or lactating females.
- Major surgery within the 30 days preceding the screening visit.
- Any serious infections within the 30 days prior to the screening visit.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled diabetes, renal or hepatic disease or psychiatric
illness/social situations that would limit compliance with study requirements.
- Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis
seropositivity.
- A history of serious adverse allergic reaction to any medication.
- Treatment with another investigational medicinal product within the 30 days prior to
enrollment.
- Treatment with:
- Systemic oral steroids within 7 days prior to randomisation at Visit 2.
- Theophylline and theophylline-like agents within 7 days prior to randomisation.
- Opiates or opioids e.g. codeine, dextromethorphan, within 7 days prior to
randomisation.
- ACE inhibitors within one month prior to the screening visit.
- Depot injection of corticosteroids within 6 weeks of the screening visit.
- History suggestive of febrile illness within the last 7 days prior to the screening
visit.
- Subjects with significant sputum production (defined as more than 5 ml (~one
teaspoon)/day on any three days in the screening period).
- Current smokers or past smokers who have a smoking history of > 20 pack years or
stopped smoking ≤ 12 months prior to screening.
- Any pulmonary co-morbidity such as COPD, recurrent lower respiratory tract infections
(≥ 2 in the 12 months prior to screening) and bronchiectasis where cough suppression
may lead to sputum retention and infection.
- Any pulmonary abnormality on chest X-ray or CT scan performed in the twelve months
prior to enrolment indicative of COPD, bronchiectasis etc.
- Subjects diagnosed with asthma who have suffered an exacerbation requiring
hospitalisation within 4 weeks prior to screening.
- A history of cancer within the previous five years (excluding carcinoma in situ or
nonmelanoma skin cancer treated by surgical excision).
- Uncontrolled hypertension (resting systolic BP > 170mmHg or resting diastolic BP > 95
mm Hg).
- A corrected QT interval of > 470ms for female subjects or of > 450ms for male
subjects, calculated using the QTcF correction formula, or second degree or higher
heart block on an ECG recording, at screening.
- Subjects known to have a sensitivity to methylxanthines and related compounds, or
known to have exhibited an allergic response or sensitivity to cocoa-based products.
- History or presence of alcohol or substance abuse.
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 of the Safety and Effectiveness of BC1036 Capsules to Treat Frequent Long-Term Cough | NCT01656668 | Contradiction |
6,896 | 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:
Three groups of participants are sought to take part in the survey:
- 70 primary caregivers(current or former) of persons with AD, or related memory
disorders
- 70 adult children and siblings of people with AD or related memory disorders
- 70 adults age 40 and older without immediate family history of AD or related memory
disorders
Exclusion Criteria:
- Not fluent in English
- Cognitive impairment that would preclude responding to a 30-minute telephone survey
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Alzheimer's Disease Treatment and Illness Perceptions Survey (TIPS) II | NCT00059410 | Entailment |
1,394 | 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:
1. Children aged 0-2 years.
2. Clinical diagnosis with Hirschsprung's disease who requires surgery;
Exclusion Criteria:
1. Complicated with severe complications such as enterocolitis associated with
Hirschsprung disease;
2. History of diseases associated with various organ systems that may be
life-threatening;
3. Other severe digestive tract malformations or other diseases that may interfere with
the treatment or compliance of the child;
4. Patients who have participated in other clinical trials within the last 1 month;
5. Any other conditions in which the investigator considers it inappropriate to
participate in the trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 2 Years | Nutrition Support for Hirschsprung Disease | NCT04598841 | Entailment |
42 | 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:
- Male Veterans with low total testosterone (<300 ng/dl) as defined by the Endocrine
Society, who are between 40-75 years of age.
- These patients must be ambulatory; and be willing and able to provide written informed
consent.
Exclusion Criteria:
- history of prostate cancer, breast cancer
- history of testicular disease
- untreated sleep apnea
- any ongoing illness that, in the opinion of the investigator, could prevent the
subject from completing the study
- patients with a hematocrit of more than 50% (2010 Endocrine Society Guidelines)
- prostate-related findings of a palpable prostate nodule on exam, a serum PSA of 4.0
ng/ml or more, International Prostate Symptom Score >8(9), urinary postvoid residual
by ultrasound of >149 ml, or an abnormal transrectal ultrasound
- patients who are on androgen replacement therapy, selective androgen receptor
modulator, or finasteride
- patients currently on medications that affects bone metabolism such as:
- estrogen
- the selective estrogen receptor modulator (SERM) as raloxifene
- use of bisphosphonates (i.e. risedronate, alendronate, zoledronic acid and
pamidronate)
- within two years of study entry
- aromatase inhibitors
- GnRH analogs
- glucocorticoids of at least 5 mg daily for one month or more
- anabolic steroids
- dilantin
- warfarin
- patients with diseases known to interfere with bone metabolism as hyperparathyroidism,
untreated hyperthyroidism, osteomalacia, chronic liver disease, renal failure,
hypercortisolism, malabsorption and immobilization
- those with current alcohol use of more than 3 drinks per day (62).
- history of documented coronary artery disease at high risk for recurrence
- Subjects with osteoporosis or a BMD T-score of -2.5 in the lumbar spine, total femur
or femoral neck as well as those patients with a history of osteoporosis-related
fractures (spine, hip or wrist) or vertebral deformities on lateral spine radiographs
deemed as fragility fractures by the team principal investigator.
- history of documented coronary artery disease at high risk for recurrence, history of
deep vein thrombosis and cerebrovascular event.
Male
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 75 Years | CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy | NCT01378299 | Contradiction |
2,824 | 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:
Research patients will be studied under this protocol if they fulfill the following
criteria:
Have an identifiable neuromuscular disorder that may be suitable for a specific current or
future protocol;
Present a diagnostic puzzle in spite of the previously performed diagnostic work-up;
Have unusual manifestation of a more usual neuromuscular disease;
Have a disorder useful for teaching purposes.
Patients should be referred by a physician who will continue their care after our
evaluation. A report of the patients' visit and tests, along with suggestions or
recommendations will be sent to each referring physician. There is a wide spectrum of
neuromuscular diseases to be studied, among them are: peripheral neuropathies, myopathies,
dystrophies, myasthenia, stiff person syndrome, muscle cramps, myotonias, motor neuron
diseases, post-polio syndrome, and certain demyelinating disorders affecting both the
central and the peripheral nervous system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Diagnostic Evaluation of Patients With Neuromuscular Disease | NCT00015470 | Entailment |
6,924 | 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:
- Between 55 and 90 years of age
- Study partner to accompany patient to all clinic visits for the duration of the
protocol
- Memory complaint by patient and/or study partner
- Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
- Mini-Mental State Exam score between 24 and 30 (inclusive)
- Clinical Dementia Rating = 0.5; Memory Box score at least 0.5
- General cognition and functional performance sufficiently preserved such that a
diagnosis of Alzheimer's disease cannot be made by the site physician at the time of
the screening visit
- Stability of the following permitted medications for 4 weeks (unless stated
otherwise):
- Antidepressants lacking significant anticholinergic side effects
- Estrogen replacement therapy
- Gingko biloba is permissible, but discouraged
- Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics,
chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to
screening
- Cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening
- Geriatric Depression Scale less than 6
- Visual and auditory acuity adequate for neuropsychological testing
- Good general health with no diseases expected to interfere with the study
- Not pregnant, lactating, or of childbearing potential (i.e. women must be two years
post-menopausal or surgically sterile)
- Hachinski less than or equal to 4
- Six grade education or has a good work history (sufficient to exclude mental
retardation)
- Fluent in English or Spanish
- Agrees to at least one lumbar puncture for the collection of CSF
- Willing and able to complete all baseline assessments
- Willing to undergo repeated MRIs and at least two PET scans and willing to provide DNA
and plasma samples as specified
- Willing and able to participate in a longitudinal imaging study
Exclusion Criteria:
- Any significant neurologic disease other than suspected incipient Alzheimer's disease,
such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal
pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,
subdural hematoma, multiple sclerosis, or history of significant head trauma followed
by persistent neurologic defaults or known structural brain abnormalities
- Screening/baseline MRI scans with evidence of infection, infarction, or other focal
lesions; multiple lacunes or lacunes in a critical memory structure
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal
fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in DSM-IV within the past 1 year
- Psychotic features, agitation or behavioral problems within the last 3 months which
could lead to difficulty complying with the protocol
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past 2 years
- Any significant systemic illness or unstable medical condition which could lead to
difficulty complying with the protocol
- Clinically significant abnormalities in B12, or TFTs that might interfere with the
study
- Residence in skilled nursing facility
- Current use of specific psychoactive medications (e.g.,certain antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of
warfarin (exclusionary for lumbar puncture)
- Use of investigational agents one month prior to entry and for the duration of the
trial
- Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any
procedures involving radioactive agents such that the total radiation dose exposure to
the participant in any given year would exceed the limits of annual and total dose
commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section
361.1
- Exceptions to these guidelines may be considered on a case-by-case basis at the
discretion of the protocol director
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 90 Years | Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) | NCT02843529 | Entailment |
6,637 | 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:
- History of moderate or severe congenital hemophilia A or B with or without inhibitors
to Factor VIII (FVIII) or Factor IX (FIX)
- Male subjects 18-65 years of age inclusive
- Able to dismiss factor replacement therapy during the course of the study unless
required for the treatment of an acute bleeding episode
- Written informed consent
- Willing and able to comply with the requirements of the protocol
- Have adequate venous access
- Willing to use an effective method of contraception until Day 30 of their study
participation
Exclusion Criteria:
- Received factor replacement therapy or treatment with any other procoagulant
therapeutics, or any antifibrinolytic agents, including blood products, at anytime
within 5 days prior to administration of investigational medicinal product (IMP)
- Planned administration of factor replacement therapy or treatment with any other
procoagulant therapeutics or any antifibrinolytic agents, including blood products, at
anytime during the study period
- Acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior
to administration IMP
- Clinically relevant coagulation disorder other than congenital hemophilia A or B
- History of angina or receiving treatment for angina
- History of coronary atherosclerotic disease, disseminated intravascular coagulopathy,
or stage 2 hypertension defined as systolic blood pressure (SBP) >/= 160 mmHg or
diastolic blood pressure (DBP) >/= 90 mmHg
- History of transient ischemic attack, stroke, myocardial infarction, coronary artery
disease, congestive heart failure, or thromboembolic event
- Active infection on day of IMP administration or septicemia at any time within 30 days
prior to administration of IMP
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors | NCT01921855 | Contradiction |
4,576 | 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:
- The inclusion criteria for RIF group were: unexplained repeated implantation failure
(RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks
after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after
the transfer of ≥10 embryos in multiple transfers.
The inclusion criteria for control group were: (1) age <35 years; (2) regular menstrual
cycles of 24-35 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4)
endometrial thickness ≥8.0 mm on the day of hCG administration.
Exclusion Criteria:
- (1) uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus); (2)
intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated
hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm
and/or endometrial pressure) (3) history of adverse pregnancy (including spontaneous
abortion, stillbirth, and fetal malformation).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle | NCT03222830 | Contradiction |
3,670 | 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:
- Must have Informed Consent Signed
- Lumbar Disc Herniations under 5mm without Sequestered Fragments
- Lumbar Disc Bulging
- Lumbar Degenerative Disc Disease (mild and moderate severity)
- Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65
years of age
- Segmental Dysfunction Secondary to Dyskinesia
- Unresolved Nerve Entrapment Syndrome
- Patients must be able to comply with study protocol
- Joint Fixation Syndrome
- Premenopausal Female Patients, excluding patients who have undergone a hysterectomy,
oophorectomy, or tubal ligation, must have one of the following methods of
contraception and must have a negative serum or urine b-HCG pregnancy test performed
within 48 hours before initiating protocol specified treatment.
Exclusion Criteria:
- Contraindications to Spinal Manipulative Therapy
- Lumbar Canal Stenosis resulting in significant neurological comprimise
- Any Spinal Cord Compression resulting in significant neurological comprimise
- Cauda Equina Syndrome
- Infection
- Osteomyelitis
->65 years of age
- History of Back or Neck Surgery
- Acute Arthritis
- Signs or Symptoms of Arterial Aneurysm
- History of Active Cancer with Bone Metastasis
- Widespread Staphyloccal and/or Strepococcal Infection
- Acute Gout
- Serious unstable medical illness such as cardiovascular, renal, respiratory,
endocrine, gastrointestinal, or psychiatric.
- Unstable Spondylosis, Spondylolisthesis, or Spondylolysis
- Prior adverse experience with Spinal Manipulation Therapy
- Uncontrolled Diabetic Neuropathy
- Gonorreal Spinal Arthritis
- Tuberculosis to the Bone
- Maligancy with Metatasis to Bone
- Excessive Spinal Osteoporosis
- Osteomalacia
- Ankylosis
- Syphlitic Articular or Peri-Articular Lesions
- Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury
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 65 Years | A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain | NCT00732394 | Contradiction |
2,522 | 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. | Inclusion Criteria:
- AD diagnosis by dermatologist or allergist based on Hanifin and Rajka criteria
- 5% or more treatable body surface area involvement
- baseline Investigator's Static Assessment (ISGA) score of mild (2) or moderate (3)
- patient on stable regimens (consistent use 14 days before day 1 of enrollment) of
inhaled corticosteroids and antihistamines
- must have lesional skin in the antecubital fossa
Exclusion Criteria:
- use of topical corticosteroid, calcineurin inhibitor, or PDE4 inhibitor within 14 days
of enrollment
- significant active infection
- any previous use of biologic therapy
- no pruritus at baseline visit, or other pruritic condition
- washing/moisturizer use 24 hours prior to tape strip biomarker collection at site
- uncontrolled asthma, uncontrolled allergic rhinitis, or other sleep disturbing
condition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 17 Years | Response of Children With Atopic Dermatitis (Eczema) to Eucrisa | NCT04023084 | Entailment |
1,348 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Diagnosis: Suspicion of genetic disease. (Only one of the following criteria is
required.) [1.1] Family member(s) with similar phenotype OR [1.2] At least two
affected organ systems OR [1.3] One affected organ system that is known to be
associated with multiple disease causing genes (e.g. long QT syndrome) OR [1.4]
Multiple birth defects
2. Both parents must be available for blood draw in order to confirm phase (segregation
analysis) or in order to perform WGS of the trio at a later time point.
3. Age: from birth up until age 18 years
4. Gender: Both sexes will be included
Exclusion Criteria:
1. Suspicion that the phenotype is due to an acquired disease
2. Missing informed consent from both parents or from all legal guardians for genetic
testing in the setting of a clinical trial.
3. Clinical diagnosis of a disease with a known monogenic cause, e.g. Phenylketonuria or
Cystic fibrosis.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Mutation Exploration in Non-acquired, Genetic Disorders and Its Impact on Health Economy and Life Quality | NCT02380729 | Entailment |
4,242 | 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:
- Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy
positive for sperm (either fresh or cryopreserved) following testicular sperm
extraction (TESE) or aspiration (TESA).
Exclusion Criteria:
- Cases with female factor infertility or woman age above 35 years will be excluded.
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 35 Years | Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men | NCT04675164 | Entailment |
5,749 | 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:
Each participant must meet all of the following inclusion criteria to participate in this
study:
1. Must be 18 years or older at time of consent.
2. Patients must have clinically active OLP that is being considered for systemic
therapy; and an oral biopsy within the last 12 months of randomization showing a
lichenoid reaction correlating clinically with OLP.
3. Must have failed topical corticosteroids therapy. Topical corticosteroid failure is
defined as receiving a trial of at least 4 weeks of high potency topical
corticosteroids without achieving sufficient improvement by patients.
4. Must be in general good health (except for disease under study) as judged by the
Investigator, based on medical history, physical examination, clinical laboratories,
and urinalysis. (NOTE: The definition of good health means a subject does not have
uncontrolled significant co-morbid conditions). Laboratory work-up includes the
following: complete blood count (CBC), creatinine, albumin, aspartate aminotransferase
(AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin,
serum, Beta-HCG (if female), Hepatitis C antibodies and HgbA1C.
5. Male participants must use a recognized effective method of contraception with any
female partner (i.e. at a minimum, barrier plus an additional method of contraception)
while on investigational product and for at least 4 weeks after taking the last dose
of investigational product.
6. Female participants of childbearing potential (FCBP)† must have a negative pregnancy
test at Screening. While on investigational product and for at least 4 weeks after
taking the last dose of investigational product, FCBP who engage in activity in which
conception is possible must use one of the approved contraceptive§ options described
below:
1. Option 1: Any one of the following highly effective methods: hormonal
contraception (oral, injection, implant, transdermal patch, vaginal ring);
intrauterine device (IUD); tubal ligation; prior hysterectomy; prior bilateral
oophorectomy or salpingo-oophorectomy; or partner's vasectomy;
OR
2. Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of
natural [animal] membrane [for example, polyurethane]; plus one additional
barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide;
or (c) contraceptive sponge with spermicide.
- A female of childbearing potential is a sexually mature female who 1) has
not undergone a hysterectomy (the surgical removal of the uterus) or
bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not
been postmenopausal for at least 24 consecutive months (that is, has had
menses at any time during the preceding 24 consecutive months).
- The female subject's chosen form of contraception must be effective by the
time the female subject is randomized into the study (for example, hormonal
contraception should be initiated at least 28 days before randomization).
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be
excluded from participation in this study:
1. Inability to give written consent by the patient or alternative decision maker (will
be assessed at screening visit).
2. Unwillingness to use at least one effective method of contraception due to unknown
fetal risks
3. Use of systemic or topical therapy for OLP other than allowed concomitant care for
symptomatic relief in the past 4 weeks.
4. Hypersensitivity to Apremilast or use of Apremilast within 4 weeks prior to start of
study drug. The contraindications to Apremilast use include prior hypersensitivity
reactions, breast-feeding, and pregnancy (Uptodate.com® accessed August 1st, 2016). An
increased incidence of depression or depressed mood by 1.3% for Apremilast 30 mg BID
(twice a day) (OTEZLA® drug monograph accessed August 1st, 2016) was observed in phase
3 psoriasis studies. Celgene suggests that prescribers should carefully weigh the
risks and benefits in patients with a history of depression and/or suicidal thoughts
or behaviour. The research team will discuss these psychiatric adverse events in the
screening visit where patients/caregivers will be instructed to notify the treating
team for any mood changes.
5. History of palpitations/tachyarrhythmia, severe renal impairment (eGFR less than or
equal to 29), or lactose intolerance within the past 5 years. Apremilast pills contain
lactose; however, the use of concurrent lactase enzyme in lactose intolerant
participants will not be considered and lactose intolerant patients will still be
excluded even if they take lactase enzyme supplementation. This is explained by the
potential exacerbation of gastrointestinal symptoms with Apremilast as an Adverse
Event (AE).
6. CYP3A4 inducers have been shown to diminish Apremilast levels (Lexi-Comp Online™
Interaction Monograph accessed August 1st, 2015); hence, patients will be excluded if
they are on concomitant Carbamazepine, Enzalutamide, Fosphenytoin, Lumacaftor,
Mitotane, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, and Rifapentine.
7. As per Celgene, the presence of any of the following will exclude a subject from
enrollment:
1. Other than disease under study, any clinically significant (as determined by the
Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric,
hepatic, renal, hematologic, immunologic disease, or other major disease that is
currently uncontrolled.
2. Any condition, including the presence of laboratory abnormalities, which would
place the subject at unacceptable risk if he/she were to participate in the
study.
3. Prior history of suicide attempt at any time in the subject's life time prior to
screening or randomization, or major psychiatric illness requiring
hospitalization within the last 3 years.
4. Pregnant or breast feeding.
5. Active substance abuse or a history of substance abuse within 6 months prior to
Screening.
6. Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in
situ of cervix with no evidence of recurrence within the previous 5 years.
7. Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
8. Prior treatment with apremilast
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.
| Apremilast - Oral Lichen Planus Trial | NCT03836885 | Contradiction |
1,399 | 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:
- Documented resistant hypertension (RH). In the absence of a specific RH diagnosis,
individuals being treated for two or more weeks with 3 antihypertensive medications of
different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or
DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more
antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP
≥ 80 mm Hg will also be eligible.
- Adherent to prescribed medications
- Overweight (BMI ≥ 25 kg/m2)
- Sedentary
- Willing to be randomized to one of the 2 treatment groups and able to fully
participate in intervention
- Informed consent
Exclusion Criteria:
- Secondary HTN, non-adherence to anti-HTN medications
- Severe CKD (eGFR <40 ml/min/1.73m2)
- Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85%
heart rate reserve on treadmill testing)
- Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe
valvular heart disease
- Severe asthma or chronic obstructive lung disease
- Diabetes requiring insulin
- Musculoskeletal or neurologic problems that would preclude participation in aerobic
exercise training
- Major psychiatric disorder, a history of drug abuse, alcohol consumption >14
drinks/week
- Life-limiting comorbid medical condition such as cancer
- Prior gastric bypass surgery
- Currently pregnant
- Cognitively impaired
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.
| Lifestyle Interventions in Treatment-Resistant Hypertension | NCT02342808 | Contradiction |
2,112 | 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:
- Chest radiograph or computed tomography scan of the thorax (within 5 years of
Screening/Visit 1 and after the onset of chronic cough) not demonstrating any
abnormality considered to be significantly contributing to the chronic cough or any
other clinically significant lung disease in the opinion of the principal investigator
or the sub-investigator
- Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough
or unexplained chronic cough
- Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or
agrees to follow contraceptive guidance
- Provides written informed consent and is willing and able to comply with the study
protocol (including use of the digital cough recording device and completion of study
questionnaires)
Exclusion Criteria:
- Is a current smoker or has given up smoking within 12 months of Screening, or is a
former smoker with greater than 20 pack-years
- Has a history of respiratory tract infection or recent clinically significant change
in pulmonary status
- Has a history of chronic bronchitis
- Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an
ACEI within 3 months of Screening
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR
an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal
function
- Has a history of malignancy <=5 years
- Is a user of recreational or illicit drugs or has had a recent history of drug or
alcohol abuse or dependence
- Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without
systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
- Has a known allergy/sensitivity or contraindication to gefapixant
- Has donated or lost >=1 unit of blood within 8 weeks prior to the first dose of
gefapixant
- Has previously received gefapixant or is currently participating in or has
participated in an interventional clinical 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.
| A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030) | NCT03449147 | Entailment |
1,029 | 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:
- OA in at least one hand as defined by ACR Criteria (nodal enlargement in two or more
of 10 defined joints, CMC-1, MCP=1, PIPs and DIPs).
- Hand pain duration greater than one year.
- History of NSAID use for hand pain on at least one occasion during the last year.
- Age 40 to 79 years.
- Ability to understand the English language and to comprehend written material at the
5th grade level.
Exclusion Criteria:
- History of psoriasis
- Other painful rheumatic disease, measured by a blood draw that will test for RF factor
and ESR.
- Rheumatoid arthritis, as measured by hand x-rays.
- Any diagnosis of fibromyalgia or neurovascular disease.
- Presence of Raynaud's disease.
- -Presence of Raynaud's disease.
- Presence of any peripheral neuropathy.
- Presence of cervical radiculopathy.
- Pregnancy in females (pregnancy test will be administered at intake to females of
reproductive capability and their method of birth control recorded.)
- Persons under age 40. Insufficient data are available in adults to judge potential
risk in children.
- Those who are not capable of providing informed consent.
- Known allergy to analgesic drugs and the drugs used in this study.
- Those who do not comprehend English. As this is a short-term Pilot study, the
potential benefits to the participants is currently unknown. Based upon this
knowledge, we believe we are exempt from the requirement to translate the informed
consent form into Spanish.
- Those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of
2 and GFS level 4.
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 79 Years | The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands | NCT02485145 | Entailment |
4,775 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Patients with subjective, chronic tinnitus
Exclusion Criteria:
- Enrollment in other tinnitus treatments simultaneously at the time of the intervention
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Internet-delivered Group Counseling for Chronic Tinnitus | NCT04382807 | Entailment |
3,497 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- 18-50 years old
- at least one intact and effusion-free middle ear
Exclusion Criteria:
- bilateral otitis media
- unable to remain relaxed and quiet for up to 2 hours
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c | NCT00422851 | Entailment |
1,322 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Diagnosis of ACH, confirmed by genetic testing
- Age 0 to < 60 months at study entry (Day 1)
- At least 6-month period of pretreatment growth assessment in Study 111-901 immediately
before study entry (cohort 1 & 2) or at least 3 months of observation prior to
treatment (cohort 3)
Exclusion Criteria:
1. Have hypochondroplasia or short-stature condition other than achondroplasia (e.g.,
trisomy 21, pseudoachondroplasia, etc.)
2. Have any of the following:
- Hypothyroidism or hyperthyroidism
- Insulin-requiring diabetes mellitus
- Autoimmune inflammatory disease (including celiac disease, systemic lupus
erythematosus, juvenile dermatomyositis, scleroderma, etc.)
- Inflammatory bowel disease
- Autonomic neuropathy
3. Have a clinically significant finding or arrhythmia that indicates abnormal cardiac
function or conduction or QTc-F > 450 msec on screening ECG
4. Have evidence of cervicomedullary compression (CMC) likely to require surgical
intervention within 60 days of Screening as determined by the Investigator and
informed by the following assessments:
- Physical exam (eg, neurologic findings of clonus, opisthotonus, exaggerated
reflexes, dilated facial veins)
- Polysomnography (eg, severe central sleep apnea)
- MRI indicating presence of severe CMC or spinal cord damage
5. Subject weight < 5.0 kg (cohort 1 & 2) or < 4.0 kg (cohort 3)
6. Treatment with growth hormone within 6-months prior to screening or prolonged
treatment (> 3 months) at any time
7. Any history of spine or long-bone surgery or any bone-related surgery with chronic
complications
8. Any history of limb-lengthening surgery or planned limb-lengthening during the study
9. Fracture of the long bones within 6 months prior to screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 59 Months | A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia | NCT03583697 | Contradiction |
167 | 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. Male patients >= 18 years of age
2. Hypogonadism not previously treated with testosterone
3. Testosterone deficiency confirmed clinically and biochemically
4. Being prescribed AndroGel® 1% in accordance with the local summary of product
characteristics
Exclusion Criteria
1. According to the contra-indications,
2. Unwilling or unable to sign informed consent form
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| ESPRIT Study in Hypogonadal Men | NCT01143818 | Entailment |
5,958 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated
by standard questionnaire GerdQ.16
2. Aged from 18 to 70 years old.
3. Willing to receive H. pylori eradication therapy.
Exclusion Criteria:
1. Symptomatic reflux patients with high grade erosive esophagitis ( Los Angeles
classification Grade C and D) or Barrett's esophagus documented by endoscopy.
2. Symptomatic reflux patients with a history of using PPI in recent one month.
3. Subjects with known allergy to PPI.
4. Peptic ulcer disease
5. Cancers of the esophagus, stomach, and duodenum
6. Esophageal or gastric varices
7. Active upper gastrointestinal bleeding within 7 days prior to enrollment
8. Status after total or subtotal gastrectomy
9. Pregnancy
10. Use of anticoagulants or antiplatelets within one week prior to enrollment
11. Subjects with bleeding tendency
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Symptom Assessment for GERD Patients Receiving H. Pylori Eradication | NCT01249482 | Contradiction |
2,492 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Older adults living independently;
- medical approval.
Exclusion Criteria:
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 79 Years | Study of the Long-term Effects of Exercise on Heath Indicators in Older People | NCT01874132 | Entailment |
1,761 | 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. Males and females 18 to 55 years of age.
2. In good general health as confirmed by a medical history and physical exam, vital
signs*, and screening laboratories conducted no more than 30 days prior to study
injection administration.
*Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm,
systolic blood pressure ≤140 mmHg and >89 mmHg, diastolic blood pressure ≤90 mmHg and
≥60 mmHg.
NOTE: Athletically trained subjects with a pulse ≥40 may be enrolled at the discretion
of the principal investigator or designated licensed clinical investigator.
3. Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total
bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count,
hemoglobin, and platelet count.
4. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus
(HCV) antibody.
5. Urine dipstick for protein and glucose (negative to trace protein are acceptable).
6. Women of childbearing potential* in sexual relationships with men must agree to
practice acceptable contraception** for the 30-day period before Day 0 through 90 days
after the last study injection.
*Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful
Essure® placement (permanent, non-surgical, non-hormonal sterilization) with
documented radiological confirmation test at least 90 days after the procedure, and
still menstruating or < 1 year of the last menses if menopausal). Post-menopausal
defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40
mIU/ml.
**Includes, but is not limited to, sexual abstinence, monogamous relationship with
vasectomized partner who has been vasectomized for 6 months or more prior to the
subject receiving study product, barrier methods such as condoms or diaphragms with
spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal
methods such as implants, injectables or oral contraceptives ("the pill").
7. Able to understand and comply with planned study procedures and willing to be
available for all study-required procedures, visits and calls for the duration of the
study.
8. Provide written informed consent before initiation of any study procedures.
9. Willing to abstain from donating whole blood or blood derivatives until 90 days after
the final study injection.
Exclusion Criteria:
1. Previous exposure to ID93 vaccines or experimental products containing GLA-SE.
2. History of treatment for active or latent tuberculosis infection.
3. History or evidence of active or documented latent tuberculosis, or positive
QuantiFERON®-TB Gold test.
4. Shared a residence within the last year prior to randomization with an individual on
anti-tuberculosis treatment or with culture or smear positive tuberculosis.
5. Received a tuberculin skin test within 3 months (90 days) prior to randomization.
6. History of autoimmune disease or immunosuppression.
7. Used immunosuppressive medication (e.g., oral or injected steroids) within 3 months
prior to randomization (inhaled and topical corticosteroids are permitted).
8. Received any investigational drug therapy or investigational vaccine within past 6
months prior to randomization, or planned participation in any other investigational
study during the study period.
9. Received investigational TB vaccine at any time prior to randomization.
10. Received any vaccine within 30 days prior to the first study vaccination and no
planned immunizations between Day 0-84 or Day 210-224 due to the washout period prior
to immunology blood draws.
11. History or laboratory evidence of immunodeficiency state including but not limited to
laboratory indication of HIV-1 infection at screening.
12. History of allergic disease or reactions, likely to be exacerbated by any component of
the study vaccine.
13. History of allergic reaction to kanamycin-related antibiotics.
14. Subjects with a history of previous anaphylaxis or severe allergic reaction to
vaccines or unknown allergens.
15. Previous medical history that may compromise the safety of the subject in the study,
including but not limited to: severe impairment of pulmonary function from
tuberculosis infection or other pulmonary disease; chronic illness with signs of
cardiac or renal failure; suspected progressive neurological disease; or uncontrolled
epilepsy or infantile spasms.
16. Known or suspected alcohol or drug abuse within the past 5 years.
17. Smokes 1 pack or more of cigarettes per day.
18. History of keloid formation or excessive scarring.
19. History or evidence on physical examination of any systemic disease or any acute or
chronic illness that, in the opinion of the investigator, may interfere with the
evaluation of the safety or immunogenicity of the vaccine, including axillary
lymphadenopathy.
20. Received a blood transfusion or immunoglobulin within the past 3 months prior to
randomization.
21. Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month
prior to randomization.
22. Presence of any febrile illness, oral temperature of >100.4 °F/38.0 °C within 24 hours
of study injection administration. Such subjects may be re-evaluated for enrolment
after resolution of illness.
23. Positive serum (at screening visit only) or urine pregnancy test at screening or
within 24 hours prior to study injection for women of childbearing potential.
24. Breastfeeding at any time throughout the study.
25. Rash, tattoos, or any other dermatological condition on the upper anterolateral arm
that could adversely affect the vaccine injection site or interfere with its
evaluation.
26. BMI <18 or >35 kg/m2.
27. Any medical or neuropsychiatric condition which, in the Investigator's opinion, would
render the subject incompetent to provide informed consent or unable to provide valid
safety observations and reporting.
28. Cancer or treatment for cancer within 3 years of study injection administration.
Persons with a history of cancer who are disease-free without treatment for 3 years or
more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the
skin are eligible.
29. Subjects unlikely to cooperate with the requirements of the study protocol.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults | NCT03722472 | Contradiction |
1,446 | 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:
- Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP
and LDL-C not at target according to governing guidelines
Exclusion Criteria:
- High liver enzymes
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 | Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia. | NCT00174304 | Contradiction |
6,658 | 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%. | Key Inclusion Criteria:
- Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII
- Male <12 years of age and weight ≥13 kg
- History of at least 50 documented prior exposure days to FVIII
- No current, or history of, inhibitor development to FVIII
Key Exclusion Criteria:
- Other coagulation disorders in addition to Hemophilia A
- History of anaphylaxis associated with any FVIII or IV immunoglobulin administration
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 11 Years | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A | NCT01458106 | Contradiction |
5,712 | 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:
- Ages 6-9 regardless of BMI status
Exclusion Criteria:
- non-English-speaking
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 9 Years | BMI Study for Children Ages 6-9 Years and Parents | NCT02421822 | Entailment |
4,487 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Comply with all study procedures, sign, initial and date back, of their own free will,
the IC;
2. Women aged between 18 and 35 years, regardless of race and class;
3. Make use of safe non-hormonal method of contraception such as tubal ligation,
non-hormonal IUDs or condoms, or be hysterectomised or be vasectomized sexual partner;
4. Examination of Beta-HCG negative;
5. with regular menstrual cycles every 24 to 32 days, at least the last three months;
6. present normal Pap test (current or during the past 02 years);
7. Present or vaginal examination found that the changes do not interfere in the study;
8. present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as
normal transvaginal sonographic reports.
Exclusion Criteria:
1. Provide a contraindication to the use of steroids;
2. Use regular or prediction of drugs that interfere with the metabolism of the
investigational products, such as antibiotics, anticonvulsants, anticoagulants and
hypoglycemic drugs;
3. smokers or have stopped smoking less than 12 months;
4. Diabetic;
5. Toxic-dependent;
6. BMI <18 and> 25;
7. have made use of topical or systemic sex hormone for at least two months before the
start of the study;
8. Background and personal or family history of thrombosis or bleeding disorders or
vascular disorders or cardiovascular disease;
9. Laboratory tests, gynecological ultrasound or changed, the medical criteria;
10. Individuals with allergies or rheumatic diseases for which is indicated the use of
cortico-steroid medication;
11. carry any endocrine changes, especially pituitary and gonadal and / or who are advised
to use hormones;
12. with lesions or abnormalities suspected or confirmed in the gonads.
13. personal or family history of breast cancer or other hormone-dependent breast
pathology;
14. with hypertension or diabetes mellitus (for drug interactions between the COC and
hypoglycemic agents and antihypertensives);
a) History of nausea with oral use of COCs; p) Any condition that may interfere with the
discretion of the investigator in the study data as well as being the measurement of the
study be deleterious to the patient.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®. | NCT01480778 | Contradiction |
3,512 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- healthy participants of both sexes
- aged 18-70 year
Exclusion Criteria:
- any clinical suspicion of hypoadrenalism, or any active medical condition or treatment
that might alter blood cortisol levels
- pregnant women and patients whose medical or mental condition precludes obtaining
informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test | NCT02413944 | Contradiction |
1,021 | 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:
- Osteoarthritis of the hip or knee for a minimum of six months duration requiring
treatment with either an analgesic or anti-inflammatory agent on a regular basis
(greater than or equal to three days/week) for at least three months
- History of osteoarthritis of the hip or knee characterized by pain of mild or moderate
intensity
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and
Lawrence radiographic entry criteria
- Physical ability must be either American College of Rheumatology (ACR) Functional
Class I or II
- Following the washout period, reports mild to moderately severe pain over the previous
24 hours and demonstrates a minimum increase of 20% in the WOMAC Osteoarthritis Index
pain subscale score, relative to the screening score.
Exclusion Criteria:
- History of surgery, including arthroscopy, or major trauma to the study joint in the
previous 12 months
- Radiographic evidence of severe osteoarthritis of the study joint based on the
Kellgren and Lawrence radiographic criteria of grade 4 osteoarthritis
- Signs of active study joint inflammation including redness, warmth, and/or, if
qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
knee joint with the loss of normal contour of the joint at the screening visit or at
the baseline examination after the washout period
- Morning stiffness of >30 minutes duration
- Significantly incapacitated or disabled and would be categorized as ACR Functional
Class III (able to perform only few or none of the duties of usual occupation or
self-care) or IV (largely or wholly incapacitated), or unable to walk without
assistive devices
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 75 Years | A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee | NCT00240773 | Entailment |
3,441 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²),
inclusive at screening
- For nondiabetic subjects: as determined by medical history, physical examination, and
safety assessments at screening
- For participants with a confirmed type 2 diabetes diagnosis: The condition must be
managed either by diet and exercise alone or on a stable dose of metformin for the
past 3 months
- Willing and agreeable to commit to the duration of the study and undergo study
procedures as instructed by the clinic staff
Key Exclusion Criteria
- Have undergone gastric bypass or bariatric surgery
- Have received prescription drugs or over the counter drugs that promote weight loss in
the past 6 months prior to screening
- For participants with a confirmed type 2 diabetes diagnosis: Have experienced more
than 1 episode of severe low blood sugar that require emergency treatment,
hospitalization or third parties to administer rescue treatment, in the past 6 months
- Have any lifetime history of a suicide attempt
- Have other medical conditions or medical history that make participation in the study
unsafe or which may interfere in the interpretation of the results of the study
- Unwilling to comply with smoking and alcohol restrictions during 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 18 Years old.
Subject must be at most 65 Years | A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide | NCT04407234 | Entailment |
4,137 | 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. | Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17
years) in two community handball clubs will be eligible for participation.
Inclusion Criteria:
- Players: ages 13-17 years and training ≥2 times/week in a team
- Coaches: leading ≥1 training session/week
- Caregivers: directly associated with the eligible players
- Club administrators: engagement in the issues of sports injury, coach education - or
policy development for youth players
Exclusion Criteria
- Employed/paid players
- Stakeholder other than the groups listed in inclusion criteria
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
| Implementation of the I-PROTECT Model | NCT04481958 | Contradiction |
4,790 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
Patients with significant tinnitus
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Treatment Methods for Clinically Significant Tinnitus | NCT00013390 | Entailment |
3,678 | 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:
Spinal cord injury with bowel & bladder problems
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Electrical Control of Bladder in Spinal Cord Injury Patients | NCT00011570 | Entailment |
6,539 | 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 subjects less than 12 years of age with a documented history of severe hemophilia
A (FVIII:C less than 1%).
- Subjects who are less than 6 years of age must have had at least 50 Exposure Days
(EDs) to prior FVIII products (including blood products).
- Subjects who are equal to or greater than 6 years of age must have had greater than
150 EDs to prior FVIII products (including blood products).
Exclusion Criteria:
- For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
titer greater than ULN for the testing laboratory at the time of screening.
- Any other bleeding disorder in addition to hemophilia A.
- Treatment with any investigational drug or device within 30 days before the time of
signing the parental informed consent/assent form.
- Major surgery planned to occur during the course of the study.
- Regular (e.g., daily; every other day) use of agents or medications known to influence
platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs
(NSAIDS).
- Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
immune tolerance induction (ITI) for inhibitor treatment.
- The subject is receiving treatment for HIV or hepatitis infection (unless the subject
is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
months before the parental informed consent/assent form is signed]).
- Platelet count less than 100,000/µL.
- Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized
ratio (INR) equal to or greater than 1.5.
- Known hypersensitivity to hamster protein.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 11 Years | Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients | NCT00914459 | Contradiction |
5,433 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Females of reproductive age who experience monthly menstrual bleedings
- Female Hemophilia A or B carrier (heterozygote, lyonized or Turner's Syndrome)
- FVIII or FIX activity ≤60% at time of the study
- Baseline Pictorial Bleeding Assessment Chart >150 mean at time of recruitment
- Negative pregnancy test at time of enrollment
- Both female and her male partner have agreed to use an acceptable barrier method of
birth control (e.g., diaphragm, cervical cap, male condom, female condom, and
spermicidal foam, sponges, and film) throughout the duration of this study (for
sexually active participants)
Exclusion Criteria:
- Has not reached menarche
- Menopause: natural or induced by surgical/medical treatment
- Pregnant or breasfeeding
- Female or her male partner refuses to use barrier method of birth control (for
sexually active)
- Current use of any of the following contraceptives (copper IUD, oral combined,
Progestin-only including but not limited to: Provera, Aygestin, Nexplanon, Implanon,
Depo Provera, Mirena IUD)
- VWF:Ag or VWF:RCo <40%
- Diagnosis of a qualitative platelet disorder
- Personal history of thrombosis or superficial thrombosis
- First degree relative with a history of thrombosis
- Personal history of concomitant bleeding or clotting disorder
- Cigarette smoker
- Willing to avoid taking an anti-fibrinolytic agent (amicar, transexamic acid, lysteda)
during the trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 55 Years | Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers | NCT03272568 | Entailment |
1,950 | 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... | 1. Required Tumor Parameters
1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or
gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the
gastroesophageal junction are not eligible.
1.2 Patients must have had en bloc resection of all known tumor. The surgical
resection must have been done with a curative intent.
1.3 Patients must have tumor extension beyond muscularis propria and/or nodal
involvement without evidence of M1 disease.
- Patients can have stages IB if there is evidence of either node-positive (N1)
disease or tumor extension beyond the muscularis propria (i.e., T1, N1, M0
patients are eligible but patients with T2, N0, M0 are allowed only if there is
extension beyond the muscularis propria).
- Patients can have stages II, IIIA, IIIB or stage IV with M0 (i.e., T4N2M0).
- Stages 0, IA, or any stage with M1 are not allowed. (see Appendix I for TNM
staging guide).
1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of
tumor at the distal or proximal line of stomach resection, noncontiguous resection of
tumor, or M1 (metastatic) disease are ineligible.
2. Prior Therapy
2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed
except for adequately treated basal cell or squamous cell skin cancer, noninvasive
carcinoma in situ which has been fully resected, or other cancer for which the patient
has been disease free for five years.
2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
3. Patient Characteristics
3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.
3.2 Patients are required to have an adequate total caloric intake to allow them to
maintain their post-surgical body weight. Patients must have documentation of stable
weight (or less than 2 pounds weight loss) for at least one week prior to
registration.
3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to
ensure that the patient is an appropriate candidate for radiation therapy.
3.4 Patients may not have unilateral renal function (only one functioning kidney) as
determined by CT scan with contrast, urogram, renal scan, or other study.
3.5 Pregnant or lactating women may not participate. Men and women of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method or practice abstinence while in this study.
- The effects of therapeutic radiotherapy are known to be teratogenic.
- The effects of Epirubicin, Cisplatin, and 5-FU on a developing human fetus at the
recommended therapeutic dose are less well known.
- For this reason and because DNA alkylating agents are known to be teratogenic,
women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation.
- Should a woman become pregnant or suspect she is pregnant while participating on
this study, she should inform her treating physician immediately. Because the
risk of toxicity in nursing infants secondary to Epirubicin, Cisplatin, and 5-FU
treatment of the mother is unknown but may be harmful, breastfeeding should be
discontinued.
3.6 Patients with any of the following cardiac conditions are ineligible:
- Uncontrolled high blood pressure
- Unstable angina
- Symptomatic congestive heart failure
- Myocardial infarction < 6 months prior to registration
- Serious uncontrolled cardiac arrhythmia
- New York Heart Association classification III or IV.
3.7 No uncontrolled serious medical or psychiatric illness which would prevent
compliance with treatment or adequate informed consent.
3.8 Patients with active infectious process are ineligible.
3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
4. Required Initial Laboratory Values:
- Granulocytes ≥ 1,500/μl
- Platelet count ≥ 100,000/μl
- Creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 2.0 mg/dl
- AST ≤ 3x upper limits of normal
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.
| Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer | NCT00052910 | Entailment |
4,657 | 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:
- Aged 18 years of age and over
- Regular menstrual cycles (23-35 days in length)-
Exclusion Criteria:
- Taking any hormonal medications
- Taking any medications that may affect heart rate
- Known heart condition or use of a pacemaker
- Skin condition where there is sensitivity to wearing a skin monitor
- Currently suffering with anxiety or panic attacks
- Pregnant or breastfeeding
- Undertaking any frequent travel or long-haul flights during the course of the study
- Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS
10.0 (or later)
Female
Subject must be at least 18 Years old.
| Heart Rate Variability During the Menstrual Cycle | NCT04382001 | Entailment |
3,980 | 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:
- 40 year-old and above
- Diagnosed with unilateral or bilateral knee OA
Exclusion Criteria:
- Patients with current or previous knee surgeries
- Inflammatory arthritis's (rheumatoid arthritis, gout, etc.)
- Alzheimer disease
- Parkinson disease
- Unable to walk unaided for 6 months
To maximize the efficiency of our experiments we excluded patients if they:
- Have participated in progressive resistance training or received pulsed
electromagnetic field treatment in the prior year
- Exercise regularly more than once a week.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis | NCT04106986 | Entailment |
972 | 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:
- Diagnosis of hand OA, according to the criteria of the American College of
Rheumatology (ACR) (Altman et al., 1990) with involvement of proximal and / or distal
IP joints
- More than 40 years old
- Visual analog scale of pain (VAS of 0-10 cm) in the joint of study between 3-8cm
- And agree and sign the Consent Term of the study.
Exclusion Criteria:
- Changed the use of oral corticosteroids and nonsteroidal anti-inflammatory drugs in
the last thirty days
- Changed the treatment of OA in the last two months (including drug and rehabilitation)
- Radiography of hands suggesting interphalangeal arthropathy of other etiology
(psoriatic arthritis, microcrystalline arthropathy).
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.
| Hand Ultrasonography: Clinical and Functional Correlation in Symptomatic Osteoarthritis (OA) | NCT02324192 | Entailment |
513 | 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:
- Should be a female subject justifying an In Vitro Fertilization/Embryo transfer
(IVF)/ET treatment
- Should be between 36th and 42nd birthday (both included) at the time of the
randomization visit
- Have early follicular phase (day 2-4) serum level of basal FSH <= 12 IU/L measured in
the center's local laboratory during the screening period (i.e. within 2 months prior
to down regulation start)
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- Presence of both ovaries
- Normal uterine cavity, which in the investigator's opinion is compatible with
Pregnancy
- Have a negative cervical Papanicolaou (PAP or smear) test within the last 6 months
prior to randomization
- Have at least one wash-out cycle (defined as >=30 days since the last dose of
clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or
clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy
- Be willing and able to comply with the protocol for the duration of the trial
- Have given written informed consent, prior to any trial-related procedure not part of
normal medical care, with the understanding that consent may be withdrawn by the
subject at any time without prejudice to her future medical care
- Have a male partner with semen analysis within the past 6 months prior to
randomization considered adequate to proceed with regular insemination or
intra-cytoplasmic sperm injection (ICSI) according to the center's standard practice
Exclusion Criteria:
- Had 2 (or more) previous ART cycles with a poor response to gonadotrophin stimulation
defined as 6 (or less) mature follicles and/or 4 (or less) oocytes collected in any
previous IVF cycle or previous cycles with a hyper response defined as 25 (or more)
oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with
the absorption, distribution, metabolism or excretion of the drug. In case of doubt,
the subject in question should be discussed with Merck Serono's Medical responsible
- Had previous severe ovarian hyperstimulation syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the
occurrence of OHSS
- Presence of endometriosis requiring treatment
- Uterine myoma requiring treatment
- Any contraindication to being pregnant and/or carrying a pregnancy to term
- Extra-uterine pregnancy within the last 3 months prior to screening
- History of 3 or more miscarriages (early or late miscarriages) due to any cause
- Tumours of the hypothalamus and pituitary gland
- Ovarian enlargement or cyst of unknown etiology
- Ovarian, uterine or mammary cancer
- A clinically significant systemic disease
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the
trial subject or her male partner
- Abnormal gynecological bleeding of undetermined origin
- Known allergy or hypersensitivity to human gonadotrophin preparations
- Any active substance abuse or history of drug, medication or alcohol abuse in the past
5 years prior to the screening visit
- Entered previously into this trial or simultaneous participation in another clinical
trial
- Pregnancy and lactation period
- Participation in another clinical trial within the past 30 days
Female
No healthy subjects accepted to join the trial.
Subject must be at least 36 Years old.
Subject must be at most 42 Years | A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique | NCT01497197 | Contradiction |
6,274 | 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:
- Having been diagnosed with COVID-19,
- Having been diagnosed in the last 1 week,
- Being between the ages of 18-70,
- Patients who continue to be followed at home
Exclusion Criteria:
- Hospitalization patients
- Having a serious cognitive impairment
- Having serious hearing and vision problems
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Telerehabilitation for Patients Diagnosed With Coronavirus | NCT04346927 | Entailment |
6,177 | 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:
- Healthy workers asymptomatic for SARS-CoV-2
- Ability to consent with the study and its procedures
- Age above 18 years old
- Full time employee on site at least 3 full working days a week
- Working in a shared office/lab/manufacturing environment where at least 3 employees
are present and/or having frequent contact with others i.e reception area,
transportation and delivery areas.
Exclusion Criteria:
Workers presenting symptoms that could be signs of a SARS-CoV-2 infection such as:
- fever ≥38°C
- chills
- fatigue
- muscle ache (myalgia)
- sore throat
- cough
- runny nose (rhinorrhea)
- shortness of breath (dyspnea)
- wheezing
- chest pain
- other respiratory Symptoms
- headache
- nausea/vomiting
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers | NCT04405466 | Contradiction |
5,086 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Subject is willing and able to provide written informed consent.
- Of Chinese origin - defined as being born in China, having four ethnic Chinese
grandparents.
- Ambulatory woman between the age of 60 and 90 years, inclusive.
- The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at
either the lumbar spine or total hip.
- All subjects must have at least one of following additional the risk factors:
history of fracture parental history of hip fracture increased bone turnover rate at
screening (s-CTX >1.0 SD above the mean in healthy premenopausal women) low body weight
(BMI≤19kg/m2) elderly (age≥70y) current smoker
- Postmenopausal defined as >5 years postmenopausal, which can be >5 years of
spontaneous amenorrhea or >5 years post surgical bilateral oophorectomy. Use follicle
stimulating hormone (FSH) levels >40 mIU/mL to confirm surgical postmenopausal status,
where bilateral oophorectomy status is uncertain.
Exclusion Criteria:
- Bone/metabolic disease:
Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may
interfere with the interpretation of the findings.
Paget's disease Cushing's disease Hyperprolactinemia
- Current hyperparathyroidism or hypoparathyroidism by medical record
- Thyroid condition: Hyperthyroidism or hypothyroidism. Only subjects with
hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed
per the following criteria:
If TSH level is below normal range, subject is not eligible for the study. If TSH level is
elevated (>5.5 μIU/mL and ≤10.0 μIU/mL), serum T4 should be measured.
If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal
range, subject is not eligible for the study. If TSH level is > 10.0 μIU/mL, subject is not
eligible.
- Rheumatoid arthritis
- Malignancy:
Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical
or breast ductal carcinoma in situ) within the last 5years.
- Malabsorption syndrome: malabsorption syndrome or any gastrointestinal disorders
associated with malabsorption, for example Crohn's Disease and chronic pancreatitis.
- Renal disease - severe renal impairment
- Liver disease:
Cirrhosis of the liver Unstable liver disease (as defined by the presence of ascites,
encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent
jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if the subject
otherwise meets study entry criteria (e.g., presence of hepatitis B surface antigen or
positive Hepatitis C test result within 3 months of Screening).
- Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12
months which the investigator believes would interfere with understanding or
completing the study.
- Biological abnormalities:
Any disorder that compromises the ability of the subject to give written informed consent
or to comply with study procedures.
Any physical or psychiatric disorder which, in the opinion of the investigator, will
prevent the subject from completing the study or interfere with the interpretation of the
study results.
Known to have tested positive for human immunodeficiency virus (HIV).
- Vitamin D deficiency: Vitamin D deficiency (25-(OH) vitamin D level <20 ng/mL).
Vitamin D repletion will be permitted and after repletion subjects may be re-tested
once for 25-(OH) vitamin D levels.
- Oral/Dental Conditions Prior history or current evidence of osteomyelitis or
osteonecrosis of the jaw. Active dental or jaw condition which requires oral surgery.
Planned invasive dental procedure. Non-healed dental or oral surgery.
Concomitant Medications:
- Previous strontium or IV bisphosphonate: Administration of intravenous (IV)
bisphosphonate, fluoride, or strontium for osteoporosis within the last 5 years.
- Oral bisphosphonate: Oral bisphosphonate treatment for osteoporosis:
If used for ≥3 years cumulatively, subject is ineligible.
If used for >3-months but <3 years cumulatively:
If the last dose was <1 year before enrolment, subject is ineligible. If the last dose was
≥1 year before enrolment, subject is eligible. If used ≤3 months, cumulatively, subject is
eligible.
- Bone metabolism drugs: Administration of any of the following treatments within the
last 6 weeks:
Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. Anabolic steroids or
testosterone. Glucocorticosteroids (>5 mg prednisone equivalent per day for more than 10
days).
Systemic hormone replacement therapy. Selective estrogen receptor modulators (SERMs), e.g.,
raloxifene Tibolone. Calcitonin. Calcitriol or vitamin D derivatives. Other bone active
drugs including anti-convulsives (except benzodiazepines) and heparin.
Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease
inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
- Investigational drug exposure: Currently enrolled in an investigational device or drug
trial(s) or it has not been at least 30 days since the last study visit in an
investigational device or drug trial(s), or subject is receiving other investigational
agent(s).
- Sensitivity: Known sensitivity to mammalian cell-derived drug products.
- Clinically significant hypersensitivity to denosumab Abnormal laboratory values
- General: Any laboratory abnormality which, in the opinion of the investigator, will
prevent the subject from completing the study or interfere with the interpretation of
the study results.
- Abnormal serum calcium: current hypocalcemia or hypercalcemia. Albumin adjusted serum
calcium levels must be within normal limits of the central laboratory.
- Liver transaminases:
Serum aspartate aminotransferase (AST) ≥2.0 x upper limits of normal (ULN). Serum alanine
aminotransferase (ALT) ≥2.0 x ULN. Alkaline phosphatase and bilirubin ≥1.5 x ULN (isolated
bilirubin ≥1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
- DXA measurements:
Less than two lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth
which may preclude accurate DXA measurements.
- Subjects with a history of greater than 2 vertebral fractures.
- Subjects at very high risk of fracture who must be treated with active drugs in the
opinion of investigator.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | Denosumab China Phase III Study | NCT02014467 | Contradiction |
6,742 | 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:
- Healthy adult patients with one or more teeth to be extracted, from premolar to
premolar
Exclusion Criteria:
- Heavy smokers (more than 10 cig per day)
- Current Pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the past 5 years
- Long term steroidal or antibiotic 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 90 Years | Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT | NCT01800149 | Contradiction |
6,154 | 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:
- Participants must be at high-risk for Coronavirus disease 2019 (COVID-19) disease
progression by fulfilling at least one of the following criteria at screening:
- Presence of chronic pulmonary disease, chronic obstructive pulmonary disease
(COPD), pulmonary hypertension
- Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for
treatment
- Hypertension, requiring at least one oral medication for treatment
- Immunocompromised status due to disease (e.g., those living with human
immunodeficiency virus with a cluster of differentiation 4 [CD4] T-cell count of
<200 per cubic millimeter [mm^3])
- Immunocompromised status due to medication (e.g., taking 20 milligram [mg] or
more of prednisone equivalents a day, anti-inflammatory monoclonal antibody
therapies, cancer therapies)
- Any chronic disease that is associated with high risk for severe COVID in the
opinion of the site investigator
- Body mass index ≥35 Kilogram per square meter (kg/m^2) (based on self-reported
weight and height).
- Documented Severe Acute Respiratory Syndrome Coronavirus 2 positive diagnostic test of
≤7 days at the time of screening
- Symptomatic for COVID-19 for ≤72 hours at the time of screening (defined as having at
least 2 of the following symptoms of COVID-19 that is of new onset or has worsened
from baseline, and include fever, chills, myalgia, arthralgia, headache, fatigue,
cough, sore throat, nasal congestion, anosmia, ageusia, nausea, vomiting, or diarrhea.
If only two symptoms are present, they cannot both be anosmia and ageusia)
- Capable of giving informed consent, which includes compliance with the requirements
and restrictions listed in the inform consent form and in this protocol
- Agree to participate in all remote, in-person or home visits as required in the
protocol and provide updated contact information as necessary.
- Female of childbearing potential must agree to practice adequate contraception during
the study
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Currently hospitalized or under immediate consideration for hospitalization at
screening and Day 1
- Have new onset shortness of breath or increased shortness of breath from pre-COVID-19
(for people with known COPD) at screening and Day 1
- Hypoxemia (oxygen saturation <94% in ambient air or oxygen saturation below
pre-COVID-19 level for people with known COPD) at Day 1
- Require supplemental oxygen (new requirement or increase in requirement from
pre-COVID-19 condition) at screening and Day 1
- Have a history of (in the past 3 months) or current active pathological bleeding
- Have a history of hemorrhagic stroke or intracranial hemorrhage
- Have a recent severe head trauma within 30 days which includes concussion, skull
fracture or hospitalization for head injury
- Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or
aneurysm
- Have history of pregnancy-related hemorrhage
- Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the
past 3 months
- Currently are in a hemodynamically unstable state
- Currently require thrombolysis or pulmonary embolectomy
- Have history of severe hypersensitivity reaction to Xarelto®
- Currently have a prosthetic heart valve
- Have known diagnosis of triple positive antiphospholipid syndrome
- Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis)
- Have a history of thrombocytopenia or known platelet count <100,000 cells/mm^3
- Have history of bronchiectasis and pulmonary cavitation
- Have active cancer (e.g, receiving chemotherapy or treatment for complication of the
active cancer)
- Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks and plan
to undergo these procedures during the study
- Had surgery in the past 4 weeks or plan to undergo surgery during the study
- Currently is pregnant or plans to become pregnant
- Currently is breastfeeding
- Share household with an enrolled participant in this study
- Co-enrollment in any clinical trial that includes prohibited procedures (spinal
puncture or surgery) or that includes treatments within the same drug class as
rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited.
Note that any co-enrollment other than this requires approval by the Sponsor. For any
coenrolled study, the total volume of blood samples collected across the studies
should not exceed 275 milliliters (mL) in 4 weeks.
- Currently using and plan to use the following medications during the study
- Rivaroxaban or drugs in the same class
- Dual anti-platelets therapy
- Other anticoagulants
- Combined Permeability glycoprotein (P-gp) and cytochrome CYP3A inhibitors and
inducers
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 to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19) | NCT04504032 | Contradiction |
3,495 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Patient requires tympanic membrane closure.
Exclusion Criteria:
- Life expectancy < 12 months
- Known sensitivity to porcine material
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Biodesign® Otologic Repair Graft | NCT04635228 | Entailment |
6,661 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Subjects with moderate hemophilia A (baseline factor VIII activity 1-5%) or severe
hemophilia A (baseline factor VIII activity <1%) on prophylactic standard half-life
FVIII infusions OR subjects with moderate or severe hemophilia A who have not started
prophylactic treatment
- Less than 18 years of age
Exclusion Criteria:
- Subjects with documented FVIII inhibitor
- Subjects with a history of ≥ 2 target joints
- Subjects with a history of synovectomy
- Currently using medications known to impact bone and mineral metabolism (e.g.,
bisphosphonates, corticosteroids, estrogen, testosterone, calcitonin, thyroid hormone
therapy);
- Disease states known to affect bone integrity (e.g., primary hyperparathyroidism,
Paget's disease, clinically significant liver disease)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies | NCT04690322 | Contradiction |
3,457 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Only adult participants ≥ 18 years
- Informed consent form as documented by signature
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)
Exclusion Criteria:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to
the investigational product
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Benchmark Ear Impression Techniques | NCT03303183 | Entailment |
4,575 | 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:
- the ages of 18-30,
- being nulliparous,
- having a VAS score of 2 and higher,
- not having a systemic or chronic disease
- not using hormonal contraceptives.
Exclusion Criteria:
- using forms of analgesic and alternative treatments during the study
- experiencing menstrual irregularities
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Heat Application on Depression, Anxiety, Menstrual Attitude and Dysmenorrhea | NCT04572555 | Contradiction |
Subsets and Splits