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 |
|---|---|---|---|---|---|---|---|
5,915 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patient with GERD resistant to medical treatment, or requiring daily long-term medical
treatment
Exclusion Criteria:
- Contraindications to the realization of a upper GI endoscopy
- Achalasia or other esophageal motor disorders
- Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders
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.
| Endoscopic Resection in Gastro-Esophageal Reflux Disease | NCT03357809 | Contradiction |
4,922 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
Patients diagnosed with ET and/or ET-plus by the Consensus Statement on the Classification
of Tremors, from the Task Force on Tremor of the International Parkinson and Movement
Disorder Society.
Exclusion Criteria:
Lack of capacity to consent to participate in the project
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| National Survey of Essential Tremor Plus in China | NCT04837079 | Entailment |
2,602 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years
Exclusion Criteria:
1. - Immune compromised patients,
2. - Morbid obesity (BMI > 35 kg/m2)
3. - Chronic liver or renal disease
4. - Coagulopathy
5. - High-risk patients unfit for major surgery (ASA III or IV)
6. - Recurrent hernias
7. - Complicated hernias
8. - Massive scrotal hernias
9. - Previous infra-umbilical surgery
10. Persistent groin pain due to other causes
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 60 Years | Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia | NCT04357665 | Contradiction |
6,632 | 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 male and female subjects, 18-50 years of age, in good health as determined by
past medical history, physical examination, vital signs, electrocardiogram, and
laboratory tests at screening.
- Vital signs within the following parameters:
oral body temperature between 35.0-37.5 °C systolic blood pressure, 85-140 mm Hg diastolic
blood pressure, 50-90 mm Hg pulse rate, 40 - 100 beats per minute (bpm)
- Female subjects must have been surgically sterilized at least 6 months prior to
screening, with supportive clinical documentation OR Postmenopausal women must have no
regular menstrual bleeding for at least 1 year prior to inclusion.
- Body mass index (BMI) must be within the range of 18 to 30 kg/m2. Subjects must weigh
at least 50 kg to participate in this study.
Exclusion Criteria:
- Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as
any subject who reports tobacco use or has a urine cotinine greater than 300 ng/ml
- Participation in any clinical investigation involving medical intervention within 4
weeks before study start
- Donation or loss of 400 ml or more of blood within 8 weeks prior to before study start
- Significant illness within 2 weeks before study start
- A past personal or close family medical history of clinically significant ECG
abnormalities or of a prolonged QT-interval syndrome.
- History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
- History of acute or chronic bronchospastic disease (including asthma and chronic
obstructive pulmonary disease, treated or not treated),
- History of clinically significant drug allergy or history of atopic allergy (asthma,
urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs
similar to the study drug particularly benzodiazepines.
- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of drugs or which may jeopardize the subject in
case of participation in the study, including bowel, gastrointestinal, renal,
pancreatic, hepatic, hematological, immunological, or neurological disorders.
Other protocol-defined inclusion/exclusion criteria may apply
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 | Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects. | NCT00416442 | Contradiction |
1,596 | 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:
- Between 20 and 75 years old.
- No significant upper extremity joint pain or nerve palsy.(patients with tennis elbow
typical of lateral elbow pain)
- Never received surgical treatment of upper limb joints
- No significant history of cardiovascular disease
Exclusion Criteria:
- Significant disturbance of consciousness
- Unable to communicate with hearing and speech mode
- Lack of mental ability
- Emotional instability
- Significant systemic disease
- With upper limb joints or muscles, tendons obvious lesions
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 75 Years | An Intelligent Evaluation of Wrist Strength for the Elderly People and Its Clinical Application | NCT02190812 | Contradiction |
940 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Knee osteoarthritis
- Moderate radiographic evidence by Kellgren and Lawrence grade 2-4
- Knee pain > 20 on VAS pain scale
Exclusion Criteria:
- Bilateral knee replacements
- Unwillingness to take acetaminophen for pain relief
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 | Toward Better Outcomes in Osteoarthritis | NCT00000425 | Entailment |
2,911 | 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:
- Clinical diagnosis of ALS classified as definite, or probable with or without
additional laboratory evidence, according to the revised World Federation of Neurology
(WFN) El Escorial criteria.
- If patients are being treated with riluzole, they must have been on a stable dose for
at least the past 30 days prior to screening.
- The patient is, in the opinion of the investigator, medically fit to undergo the
surgery required for stereotactic implantation of the catheter and infusion pump.
Exclusion Criteria:
1. Impaired respiratory function judged to pose a risk to the patient during anaesthesia
for the device implantation.
2. Hypertension defined as blood pressure >160 mmHg systolic or >90 mmHg diastolic.
3. Values for coagulation parameters including platelet count, normalised prothrombin
complex (PK-INR), activated partial thromboplastin time (APTT) outside normal ranges.
4. Ophthalmological examination (fundus photography, visual acuity and perimetry) with
any clinically significant findings that imply safety concerns for this study.
5. Diagnosis of diabetes mellitus.
6. History of structural brain disease other than ALS, including tumours and hyperplasia.
7. An MRI of the brain and cervical spine, and an Magnetic Resonance Angiography (MRA) of
the brain with findings of tumours or potential sources of pathological bleedings, or
abnormality that may interfere with the assessments of safety or efficacy or that
would, in the judgment of the investigator, represent a surgical risk to the patient.
If an MRI and/or MRA has been performed within 1 month prior to screening, the results
from that examination can be used.
8. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or
inadequately treated infection), alters wound healing (e.g., including bleeding
disorders), or renders chronic i.c.v. delivery or device implants medically
unsuitable.
9. Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that
cannot be not managed optimally due to:
i. anatomical factors at or near the implant site (e.g., vascular abnormalities,
neoplasms, or other abnormalities), ii. underlying disorders of the coagulation
cascade, platelet function, or platelet count (e.g., haemophilia, Von Willebrand's
disease, liver disease, or other medical conditions) iii. administration of any
antiplatelet or anticoagulant medication in the preoperative period
10. A personal history of thromboembolic disease. A family history of thromboembolic
disease will prompt a laboratory assessment to exclude hereditary liability before the
patient is declared eligible.
11. Presence of additional risk factors for thromboembolism such as obesity (BMI > 35) or
use of oestrogens including combined contraceptive pills.
12. Presence of an implanted shunt for the drainage of CSF or an implanted Central Nervous
System (CNS) catheter.
13. Clinically significant abnormalities in haematology or clinical chemistry parameters
as assessed by the investigator.
14. Serological evidence of Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human
immunodeficiency virus (HIV)
15. Ongoing medical condition that according to the investigator would interfere with the
conduct and assessments in the study. Examples are medical disability (e.g., severe
degenerative arthritis, compromised nutritional state, peripheral neuropathy) that
would interfere with the assessment of safety and efficacy of investigational product
or device performance, or would compromise the ability of the patient to undergo study
procedures (e.g., MRI), or to give informed consent.
16. Participation in another clinical trial with an investigational drug or device within
3 months prior to screening visit.
17. For women only: pregnant, breast feeding and/or for fecund women unwillingness to use
adequate contraception during the trial such as:
- Established use of oral, injected or implanted hormonal methods of contraception
that do NOT contain oestrogens.
- Placement of an intrauterine device.
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
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 Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALS | NCT01999803 | Entailment |
1,042 | 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:
- ACR criteria for knee will be over age 50 less than 30 minutes of morning stiffness,
crepitus on active motion, Tenderness Enlargment No palpable warmth of synovium.
Osteoarthritis grade 1 and 2 by Kelly-green and Lawrence method.
Exclusion Criteria:
- (a) Any surgical procedure done in past 6 months and metal implants in lower extremity.
(b) Any infection and neoplastic disorder. (c) Post traumatic knee stiffnes. (d) Secondary
knee OA peripheral vascular disease
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.
| Mulligan Mobilization With Movement Versus Macquarie Injury Management Group in Function and Pain of Knee Osteoarthritis | NCT04818307 | Entailment |
110 | 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. History of TBI as defined as "damage to brain tissue caused by an external mechanical
force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to
brain trauma or by objective neurological findings that can be reasonably attributed
to TBI on physical examination or mental status examination;"82
2. Moderate to severe TBI as indicated by a Glasgow Coma Scale (GCS) score of less than
or equal to 12 at emergency department admission, or post traumatic amnesia (PTA) of
greater than or equal to seven days post-injury, or radiographic evidence of
intracranial injury;
3. Continuously hospitalized from time of injury until admission for rehabilitation;
4. Enrolled in study within 6 months of TBI;
5. Receiving inpatient rehabilitation for TBI at Craig Hospital;
6. Males between the ages of 16 to 65 (inclusive);
7. Approval by attending physician;
8. Testosterone level below the assay normal range;
9. Consent to study participation
Exclusion Criteria:
10. History of any conditions that would prohibit testing contained in the NIH toolbox;
11. Non-English or non-Spanish speaking (to the extent that would limit the ability to
complete study measures);
12. History of prior psychiatric illness requiring hospitalization;
13. Prior testosterone therapy;
14. History of or current or suspected hormonally dependent cancer , including carcinoma
of the breast or prostate cancer;
15. Known hypersensitivity to any T gel ingredients including alcohol and soy products;
16. Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or
transaminase elevation >4x upper limit of the normal range.
17. Abnormal finding on digital rectal examination such as nodule, asymmetry, or
induration (Does not include enlarged prostate or abnormal rectal tone)
18. PSA>4.0
19. BMI <16 or >40kg/m2
20. History of untreated prolactinoma
21. History of severe heart failure or uncontrolled medical problem that would interfere
with the participant's safety in the study as determined by the investigator.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 65 Years | Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy | NCT01201863 | Contradiction |
3,853 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Female
2. Age 40-85 years
3. One or more of the following:
1. Knee symptoms (pain, aching, or stiffness) on most of the last 30 days;
categorically defined, so all severity of symptoms ok, but must have knee
symptoms on most days
2. History of knee injury or surgery
3. Body Mass Index (BMI) greater than or equal to 25 kg/m2
4. BMI less than 45 kg/m2
Exclusion Criteria:
1. Knee injection within 6 weeks prior to the study
2. Resistance training at any time in the last 3 months prior to the study
3. Bilateral knee replacement
4. Lower limb amputation
5. Lower limb surgery in the last 6 months that affects walking ability or ability to
exercise
6. Back, hip or knee problems that affect walking ability or ability to exercise
7. Unable to walk without a cane or walker
8. Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or
polymyalgia rheumatica
9. Multiple sclerosis or other neurodegenerative disorder
10. Known neuropathy
11. Self-report of Diabetes
12. Currently being treated for cancer or having untreated cancer
13. Terminal illness (cannot be cured or adequately treated and there is a reasonable
expectation of death in the near future)
14. Peripheral Vascular Disease
15. History of myocardial infarction or stroke in the last year
16. Chest pain during exercise or at rest
17. Use of supplemental oxygen
18. Inability to follow protocol (e.g. lack of ability to attend visits or understand
instructions)
19. Staff concern for participant health (such as history of dizziness/faintness or
current restrictions on activity)
20. Unable to attend 12 or more sessions during the study
21. Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or
other implanted electrical device.
22. Dermatitis or skin sensitivity.
23. Pregnancy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Combined Application of Electrical Stimulation and Volitional Contractions for Muscle Strengthening and Knee Pain Inhibition (Seated Study) | NCT02802878 | Entailment |
290 | 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 patients associated with multiple implantation failures.
- Signatures consent and non-opposition letter.
- Patients with a standard infertility assessment.
- Patients with a monitored cycle (ultrasound, hormonal markers) during the mock frozen
embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
- Patients with complete treatment information during the mock frozen embryo transfer
cycle to perform the Win-test and during the embryo transfer cycle.
- Patients with accurate transfer day information.
- Patients for whom we have the outcome (pregnancy, live birth).
Exclusion criteria:
More than 24 weeks of amenorrhea
Female
No healthy subjects accepted to join the trial.
Subject must be at least 27 Years old.
Subject must be at most 48 Years | Prospective Study of an Human Endometrial Receptivity Test | NCT04192396 | Contradiction |
1,386 | 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:
- Patients eligible for enrollment will include all pediatric patients suffering from HD
at an age of 12 months or younger. All patients will require consent by either parent
or adult guardian
Exclusion Criteria:
- Patients will be excluded if children that are deemed hemodynamically unstable and
require immediate operative intervention, age more than one year of age, as this may
mean very delay in diagnosis and may affect the study results, or infants having major
congenital anomalies with short life expectancy. Additional exclusion criteria are
those patients' parents or adult guardian who refuse to undergo randomization.
Finally, those children who are transferred to another non-participating hospital 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 1 Month old.
Subject must be at most 12 Months | Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC) | NCT00630838 | Entailment |
5,121 | 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:
- Men and women aged > 18 years who/se:
- Present at the ER with a possible hip fracture and
- Have a negative x-ray for a hip fracture
- Physician has a high clinical suspicion of a hip fracture
- Provide provision of informed consent
Exclusion Criteria:
- Hip prosthesis on the same side of the suspected hip fracture
- Other serious medical illness that is likely to interfere with study participation
- Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which
could impair the ability to provide informed consent and to adhere to the trial
procedures
- Pregnant or suspected pregnancy
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Tomosynthesis Use in Detecting Subtle Occult Hip Fractures | NCT02133794 | Contradiction |
6,045 | 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:
- Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at
least 3 months, while treating with gastric acid modulating therapy (antacids, H2
receptor antagonists (H2RAs) and/or PPIs).
- Heartburn symptoms that average 3 times per week or greater including at least 2
episodes of nighttime heartburn symptoms per week over the past 30 days.
- When heartburn medications were used, subject had heartburn symptoms that were
responsive to antacids, non prescription H2RAs, or short term non prescription or
prescription PPIs at approved doses but complete resolution of heartburn was not
achieved.
Exclusion Criteria:
- A history (past or present) of erosive esophagitis verified by endoscopy.
- The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or
antacids for any indication through the study (eg, long term prescription therapy).
- Subjects requiring continuous intervention by a physician for the treatment of GERD
(ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 65 Years | Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment | NCT02708355 | Entailment |
298 | 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:
- Primary or secondary infertility designated for IUI treatment.
- Age of candidates: 20-40 years.
- Normal uterus x-ray.
- Women suffering from infertility on a background of non-ovulation.
- Infertility on a background of male problems (over 10 million of motile sperm cells
per sample).
- Infertility on background of unexplained problem
- Same sex patients / single patient
- Written informed consent
Exclusion Criteria:
- Woman under the age of 20 or over the age of 40 years.
- Female infertility on mechanical background (different blockages, irregular uterus).
- Infertility on male background of medium to very low level of spermatozoa - less than
10 million motile sperm cells per sample.
- Men and women who are opposed to the random spermatozoa insemination method.
- Participants who are not willing to sign the Consent Form.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination | NCT00745563 | Contradiction |
5,547 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA
A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR
criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4
or 5:
1. Age at disease onset ≥ 50 years.
2. New onset or new type of localized pain in the head.
3. ESR of > 40 mm in the first hour by the Westergren method or CRP measurement
above the laboratory normal limit.
4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation, unrelated to arteriosclerosis of cervical arteries).
5. Temporal artery or large vessel biopsy showing vasculitis characterized by a
predominance of mononuclear cell infiltration or granulomatous inflammation,
usually with multinucleated giant cell or an abnormal temporal artery ultrasound
showing features consistent with active giant cell arteritis ("halo sign") or
characteristic changes of large vessel stenosis or aneurysm by arteriography.
2. GCA with evidence of active disease (defined below) present within the past 8 weeks.
3. They must be willing and able to comply with treatment and follow-up procedures.
4. Both women and men who are of child-bearing potential must be willing to use an
effective means of birth control while receiving treatment through this study.
Effective contraception methods include abstinence, surgical sterilization of either
partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal
contraception.
5. They must be willing and able to provide written informed consent.
Exclusion Criteria:
1. Evidence of a recent acute infection defined as:
- Any acute infection within 60 days prior to randomization that required
hospitalization or treatment with parenteral antibiotics.
- Any acute infection within 30 days prior to randomization that required oral
antimicrobial or antiviral therapy.
2. Patients with history of chronic or recurrent bacterial infection (such as chronic
pyelonephritis, osteomyelitis, and bronchiectasis etc.).
3. Patients with a history of recurrent herpes zoster (more than 1 episode) or
disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or
ophthalmic zoster. Symptoms of herpes zoster or herpes simplex must have resolved more
than 60 days prior to screening.
4. Patients with a history of systemic fungal infections (such as histoplasmosis,
blastomycosis, or coccidiomycosis).
5. Patients with a history of primary immunodeficiency.
6. Patients at risk for tuberculosis (TB) defined as follows:
- Current clinical, radiographic or laboratory evidence of active TB, even if
currently being treated. Chest x-rays (posterior/anterior and lateral) obtained
within the 6 months prior to screening and TB testing (IFN-gamma release assay or
PPD) performed in the past month prior to screening will be accepted; however, a
copy of the reports must be placed in the participant binder.
- A history of active TB unless there is documentation that the patient had
received prior anti-TB treatment that was appropriate in duration and type
according to local health authority guidelines.
- Patients with a positive TB screening test indicative of latent TB will not be
eligible for the study unless they:
i. Have no evidence of current TB based on chest x-ray performed during the
screening period and by history and physical exam, and ii. They are currently
being treated for latent TB or the site has documentation of successful prior
treatment of latent TB. Treatment regimens should be dictated by local guidelines
as long as the treatment dose and duration meet or exceed local health authority
guidelines. If permitted by local guidelines regarding treatment with biologic
medications, patients with latent TB may be randomized prior to completion of
treatment as long as they have completed at least 4 weeks of treatment and they
have no evidence of current TB on chest x-ray at screening.
7. Patients who are pregnant or who are nursing infants.
8. Inability to comply with study guidelines.
9. Cytopenia: platelet count <80,000/mm3, total White Blood Count (WBC) < 3,000/mm3 (3 x
109/L) absolute neutrophil <1500/mm3, hematocrit < 20%.
10. Renal insufficiency defined by a creatinine clearance of less than or equal to 20
ml/min.
11. AST or ALT > 3 times above normal laboratory range.
12. Other severe, progressive, or uncontrolled disease that in the investigator's opinion
could prevent a patient from fulfilling the study requirements or that would increase
the risk of study participation.
13. Patients who have a present malignancy or previous malignancy within the last 5 years
prior to screening (except documented history of cured non-metastatic squamous or
basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening
procedure that is suspicious for malignancy, and in whom the possibility of malignancy
cannot be reasonably excluded following additional clinical, laboratory or other
diagnostic evaluations.
14. Receipt of an investigational agent or device within 30 days prior to enrollment.
15. A live vaccination within 3 months before randomization.
16. Patients on non-biologic immunosuppressants must discontinue these medications before
randomization (azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide,
hydroxychloroquine, cyclosporin, tacrolimus, or other conventional immunosuppressive
agent).
17. Patients who had received an alkylating agent such as cyclophosphamide must
discontinue these medications at least 8 weeks before randomization.
18. Patients who have been treated within 4 weeks of randomization with etanercept or
within 8 weeks with adalimumab, certolizumab, golimumab, or infliximab.
19. Patients who have been treated within 8 weeks of randomization with anti-IL-6 agents
(e.g., tocilizumab, sirukumab) or a janus kinase inhibitor.
20. Patients who have been treated within 4 weeks of randomization with anakinra.
21. Patients who have received prior treatment with rituximab within the past 6 months
prior to randomization.
22. Patients who have received prior treatment with abatacept or CTLA4-Ig.
23. Patients who will require oral or IV glucocorticoid treatment during the trial for
conditions other than GCA.
24. Hypersensitivity to abatacept and/or its excipients.
25. Presence of any of the following disease processes:
- Takayasu arteritis
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
- Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
- Polyarteritis nodosa
- Cogan's syndrome
- Behçet's disease
- Sarcoidosis
- Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics
vasculitis
- Cryoglobulinemic vasculitis
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Mixed connective tissue disease or any overlap autoimmune syndrome
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.
| Abatacept for the Treatment of Giant Cell Arteritis | NCT04474847 | Entailment |
6,600 | 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:
- Severe hemophilia A (FVIII:C </=1%)
- No history of FVIII inhibitor formation and no current evidence of inhibitor antibody
(Bethesda Assay < 0.6 BU)
- Elective major surgery requiring at least 6 days of rFVIII-FS therapy
- Subjects should have been previously treated with FVIII concentrates for at least 150
exposure days. Previous treatment could have been with any type of rFVIII or with
plasma-derived FVIII concentrate or cryoprecipitate
Exclusion Criteria:
- Abnormal renal function (serum creatinine >1.3 mg/dL)
- Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
- Anemia (hemoglobin <11 g/dL)
- Known AIDS (HIV seropositive patients may be enrolled)
- Active liver disease (transaminases > 5 times the upper limit of normal)
- History of severe reaction to FVIII concentrates
- Interferon treatment within the last 3 months
- Thrombocytopenia (< 100,000 platelets/mm3) or other known hematological/bleeding
problems other than hemophilia A
- Intake of other investigational drugs within 1 month prior to study entry
- Need for pre-medication for FVIII infusions (e.g. antihistamines)
- Diastolic blood pressure >100 mm/Hg, which could not be controlled with
antihypertensive medications
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | BAY14-2222 Continuous Infusion in Surgeries | NCT00606060 | Contradiction |
5,173 | 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:
- VCF on X-ray of the spine (minimal 15% loss of height)
- level of VCF Th5 or lower
- back pain ≥ 12 weeks at time of X-ray
- ≥ 50 years of age
- bone edema on MRI of the fractured vertebral body
- focal tenderness on VCF level
- decreased bone density T-scores ≤ -1
Exclusion Criteria:
- severe cardio-pulmonary condition
- untreatable coagulopathy
- systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- suspected alternative underlying disease (malignancy)
- radicular and/or cauda compression syndrome
- contra-indication for MRI
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 95 Years | A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V) | NCT01963039 | Entailment |
1,875 | 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:
- carcinoma located in the lower 1/3 of gastric body or antrum of stomach
- diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
- diameter of the tumor <3cm
- no pyloric obstruction
Exclusion Criteria:
- diameter of the tumor ≥3cm
- associated with obstruction, bleeding, emergency surgery or surgical intervention
- tumor with extensive metastasis
- patient had previously undergone gastrostomy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Comparison of Delta-Shaped and Billroth II After TLDG | NCT02372747 | Entailment |
1,477 | 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:
- Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
- If the patient is currently taking a lipid modifying medication other than Zocor &
he/she is willing to discontinue this medication
- LDL-C levels and/or non HDL-C levels above normal.
- Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4
weeks prior to screening and for the duration of the study.
Exclusion Criteria:
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their
derivatives.
- HbA1c ≥ 9% in diabetic patients
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.
| Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS) | NCT00080275 | Entailment |
6,517 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients scheduled for dental extraction and treated with edoxaban, apixaban,
rivaroxaban or dabigatran
- Not having taken the direct oral anticoagulant on the day of the extraction
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the
duration of the study
Exclusion Criteria:
- Subjects with any condition that as judged by the Investigator would place the subject
at increased risk of harm if he/she participated in the study.
- Pregnancy or lactation
- Known allergic reaction to tranexamic acid
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.
| Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction | NCT03413891 | Contradiction |
3,971 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the
target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray
examination in the last 3 months (mild to moderate narrowing of joint space and / or
marked osteophytes of tibiofemoral joint space)
2. Persist pain of the target knee after exercise, weight loss and physical therapy;
3. A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe
walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign
the Informed Consent Form (ICF) that has already been approved by the Independent
Ethics Committee (IEC) Note: the informed consent may also be given by the duly
authorized representative of the subject.
Exclusion Criteria:
1. A diagnosis of bilateral knee osteoarthritis;
2. Clinically significant (requiring surgery) valgus or varus deformity of the knee
joint, ligamentous laxity or unstable meniscus;
3. Complicated by inflammation or any other disease /condition (e.g., rheumatic
arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis,
etc.) that may affect the knee joint;
4. A history of septicemia, clinically considered sub-acute infection of the target knee
joint;
5. A history of surgery on the target knee (in the last 6 months);
6. A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal
anti-inflammatory drugs (NSAIDs);
7. Severe hepatic or renal disease or hepatic /renal failure;
8. Any unscheduled surgery on the lower limb;
9. Clinically significant lower venous or lymphatic obstruction;
10. Clinically significant obvious exudation or inflammation of the target knee;
11. Skin disorders or infection at the injection site;
12. Pregnant or lactating women;
13. Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic
acid-based injection / diclofenac sodium;
14. Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within
six months before this trial;
15. Intra-articular (IA) injection of steroids into the target knee within 3 months before
this trial;
16. Presence of any contraindication to IA injection, e.g., patients who are receiving
anti-coagulation therapy or clinically have potential coagulation disorders (e.g.,
hepatic disease);
17. Presence of any clinically significant disease (e.g., significant mental or nervous
disorders, alcohol/drug abuse), unstable/poorly controlled diseases, or other factors,
which may affect their evaluation or participation in this study in the investigator's
judgment
18. Perioperative pain associated with coronary artery bypass surgery (CABG);
19. A history of gastrointestinal bleeding or perforation following use of NSAIDs;
20. Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent
ulcer/bleeding; Chief complaint complicated by pain beyond the target knee,
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 Study of Artz in the Treatment of Knee Osteoarthritis | NCT02826031 | Entailment |
4,354 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Volunteer subject, , willing to follow the protocol and able to read, comprehend and
sign the informed consent form,
- Age between 17 and 23 years
Exclusion Criteria:
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere
with study assessments,
- Aphakic or pseudophakic (intraocular lens)
- Participants who are wearing ortho-K lenses, or undergone any kind of myopia control
treatments or undergone refractive surgery.
- Any current or evolving pathology manifested in the eye or the appendages which might
have an influence on vision, or interfere with study assessments (e.g. AMD,
glaucoma…),
- Any previous ocular surgery which might have an influence on vision or interfere with
study assessments (e.g. iridectomy, refractive surgery…),
- Any untreated and/or uncontrolled systemic condition which might have an influence on
vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled
high blood pressure…),
- Any medical treatment or medication which might have an influence on vision or
interfere with study assessments (e.g. antidepressants, drugs with atropinic
effects…),
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 17 Years old.
Subject must be at most 23 Years | The Incidence and Progression of Myopia: Cohort Study | NCT03244670 | Entailment |
3,506 | 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
- Diagnosis of cirrhosis
- Admission to hospital
Exclusion Criteria:
- Age < 18 years
- Prior enrollment in study (i.e. readmission)
- Prisoner
- Pregnancy
- Prednisone or Hydrocortisone use in last 24 hours
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 110 Years | Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients? | NCT03368066 | Contradiction |
5,141 | 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:
- Women who are 60 to 90 years of age may be eligible to participate
- Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5
Exclusion Criteria:
- BMD T-Score at the hip or the spine of less than -4.0
- Patients with any severe or more than two moderate vertebral fractures on spinal x-ray
at entry
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis | NCT00089791 | Contradiction |
804 | 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:
- Hong Kong permanent residents aged on or above 50, both male and female;
- meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history,
physical examination and radiographic findings (recommended by the American College of
Rheumatology): history and physical examination: pain in the knee and one of the
following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3.
Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and
Lawrence Grades 2-4):
- with unilateral knee pain or bilateral knee pain;
- in chronic stage (pain of at least 6 month's duration);
- with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
- with X-ray or other radiographic reports are preferable (not necessary);
- who volunteer to participate and sign the consent form;
- able to write and read Chinese.
Exclusion Criteria:
- Patients who are unable to walk;
- with serious infection of knee;
- with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
- with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as
the cause of pain or functional problems (history of knee replacement will be
excluded);
- with history of local tumor/malignancy at knee;
- with physical or laboratory findings indicating infection, presence of autoimmune
disease or inflammatory arthritis;
- with knee pain caused by radiculopathy / herniation of intervertebral disc;
- with end-stage of diseases and other suspected severe conditions such as deep vein
thrombosis of the lower limb, edema related to cancer or cancer treatment, severe
blood coagulation disorders, uncontrolled systemic arterial hypertension and severe
diabetes;
- with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3
months;
- received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for
8 weeks prior to the trial;
- with more severe pain in other regions;
- have severe mental disorders;
- oversensitive to needles;
- insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;
- fail to be complaint with the treatment protocol.
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.
| Sinew Acupuncture for Knee Osteoarthritis | NCT03099317 | Entailment |
578 | 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:
- Pregnant patients with nonviable pregnancy document by ultrasound
- Gestation at or less than 13 weeks by ultrasound measurements
- Clinically stable as determined by provider
- Afebrile
- Hematocrit > 30
- Over 18 years of age
Exclusion Criteria:
- History of allergy to, or intolerance of, misoprostol
- Refusal to abstain from intercourse for 72 hours
- Significant vaginal bleeding (> 2 pad/hr)
- History of inflammatory bowel disease
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Misoprostol for Non-Viable Pregnancies | NCT00426491 | Entailment |
3,919 | 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
- Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for >6 months based
on clinical and radiographic criteria;
- Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or
III;
- The knee designated as the "study joint" must be the participant's primary source of
pain/disability in the lower extremity. If both knees are affected, the most painful
joint will be selected for evaluation for inclusion and clinical response;
- Female participants of childbearing potential must demonstrate a serum beta human
chorionic gonadotropin (β-hCG) level consistent with a non-gravid state at the
screening visit and urine β-hCG at Day -1 prior to first dosing and agree to use
adequate oral or barrier contraception or abstain from sexual contact at least 7 days
prior to treatment and continuing through the treatment period or a discontinuation
visit;
- Willing to limit alcohol intake (beer 8 ounces, wine 4 ounces, liquor 1 ounce) to no
more than 14 drinks a week (no more than 2 in a day) and to avoid unaccustomed
strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical
therapy) for the duration of the study;
- Judged to be in general good health with the exception of osteoarthritis based on
medical history, physical examination, and routine laboratory tests.
- For Part 2, if the participant is a regular user of non-steroidal anti-inflammatory
drugs (NSAIDs) including coxibs he/she must report a history of positive therapeutic
benefit in osteoarthritis of the knee with NSAID/coxibs in the past;
- For Part 2, participants must be taking a single NSAID on a regular basis and at a
prescription strength for at least 30 days prior to study screening ("regular basis"
is defined as at least 25 of the previous 30 days) for treatment of symptoms of
osteoarthritis.
Exclusion Criteria:
- Has a concurrent medical/arthritic disease;
- History of acute ligamentous or meniscal injury of the study joint within the previous
2 years or arthroscopy of the affected knee within 6 months prior to study entry;
- Is a candidate for imminent joint replacement;
- Has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary,
hepatic, endocrine, neurological (apart from migraine), or other systemic disease that
in the opinion of the investigator contraindicates the use of etoricoxib;
- Has congestive heart failure with symptoms that occur at rest or minimal activity;
- Has unstable angina that occurs at rest or with minimal activity;
- Has uncontrolled hypertension (sitting diastolic blood pressure >95 mm Hg, or sitting
systolic blood pressure >165 mm Hg);
- Has a history of stroke or transient ischemic attack (TIA) within the previous 6
months;
- Has a history of hepatitis/hepatic disease that has been active within the previous 2
years;
- Has a history of neoplastic disease;
- Is currently a user (including "recreational use") of any illicit drugs, or has a
history of drug or alcohol abuse within the past 5 years;
- Is allergic of has hypersensitivity to aspirin, ibuprofen, rofecoxib, celecoxib,
valdecoxib, other NSAIDs, acetaminophen, or sulfa drugs;
- Has used intravenous, intramuscular, or oral corticosteroids within 1 month of study
entry;
- Has used glucosamine and/or chondroitin sulfate for <6 months prior to study start;
- Has used intra-articular steroids, HYALGAN™ (sodium hyaluronate, Sanofi
Pharmaceuticals), or SYNVISC™ (hylan G-F 20, Wyeth-Ayerst Pharmaceuticals) to the
study joint within 3 months of entry into the study or intra-articular steroids,
HYALGAN™, or SYNVISC™ to any other joint within 1 month of study entry;
- Has used topical, oral or systemic analgesic medications within 2 weeks of study entry
and for the duration of the study;
- Requires treatment with warfarin, heparin, high-dose aspirin (>325 mg), or digoxin;
- Has used Arcoxia® within 2 weeks of study entry.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168) | NCT01980940 | Entailment |
92 | 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:
- 18 years or over male patients;
- Absent or incomplete puberty development;
- Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH
concentrations.
- at least two or more pituitary hormone deficiencies
- Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or
ectopic posterior pituitary.
Exclusion Criteria:
- cryptorchidism history
- other causes of hypopituitarism or severe systemic disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome | NCT02705014 | Contradiction |
3,066 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Intellectual disabilities (ID) group:
- children with mild to moderate intellectual disabilities.
- able to walk independently
- can follow simple commands
2. Typical developed children:
- age-matched TD children
Exclusion Criteria:
1. fracture or receive orthopedic surgery within six months.
2. Participate in regular soccer training.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 18 Years | Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population | NCT02486081 | Entailment |
4,154 | 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:
Healthy volunteers
- Able and willing to give written informed consent.
- Healthy male and female subjects, aged 18-80 years for the initial part and 40-80
years for the main part, inclusive. Women will be considered for inclusion if they
are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant,
including any female who is pre-menarchial or post-menopausal, with documented proof
of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has
been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing
potential and using a highly effective method of contraception during the entire study
(vasectomised partner, sexual abstinence - the lifestyle of the female should be such
that there is complete abstinence from intercourse from two weeks prior to the first
dose of study medication until at least 72 hours after treatment -, implants,
injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs) or
double-barrier methods, i.e. any double combination of IUD, condom with spermicidal
gel, diaphragm, sponge, and cervical cap).
- Normal lung function with Forced Expiratory Volume in 1 second (FEV1) predicted ≥ 80%
and FEV1/Forced Vital Capacity (FVC) > 70%.
- Body mass index between 18 and 32 kg/m2
- Ex-smokers since at least 12 months with a smoking history of at least 10 pack years.
- Able and willing to give written informed consent
COPD subjects
- Male and female subjects, aged 40-80 years, inclusive. Women will be considered for
inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart),
and not nursing. Of non-child bearing potential (i.e. physiologically incapable of
becoming pregnant, including any female who is pre-menarchial or post-menopausal, with
documented proof of hysterectomy or tubal ligation, or meets clinical criteria for
menopause and has been amenorrhoeic for more than 1 year prior to the screening
visit). Of childbearing potential and using a highly effective method of contraception
during the entire study (vasectomised partner, sexual abstinence - the lifestyle of
the female should be such that there is complete abstinence from intercourse from two
weeks prior to the first dose of study medication until at least 72 hours after
treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or
double-barrier methods, i.e. any double combination of IUD, condom with spermicidal
gel, diaphragm, sponge, and cervical cap).
- Clinical diagnosis of COPD stage II and III
- History of chronic cough and sputum production
- FEV1/FVC <70% post-bronchodilator at visit 1
- FEV1 30-80% of the predicted normal value post-bronchodilator at visit 1
- FEV1 >1.5 L
- Absence of lung emphysema assessed by pulmonary function measurement at visit 1: Total
Lung Capacity (TLC) <120% of predicted normal, Residual Volume (RV) <120% of predicted
normal, Diffusing Capacity for Carbon Monoxide (DLCO) >80%
- Ex-smokers since at least 12 months with a smoking history of at least 10 pack years.
- Body mass index between 18 and 32 kg/m2.
- Able and willing to give written informed consent.
Exclusion Criteria:
Healthy volunteers
- Past or present disease, which as judged by the investigator, may affect the outcome
of the study or put the subject at risk because of participation in the study. These
diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic
disease, renal disease, haematological disease, neurological disease, psychiatric
disease, endocrine disease, infectious disease, inflammatory disease or pulmonary
disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic
fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include
paracetamol for pain relief, oral contraceptive medication, hormonal replacement
therapy, dietary and vitamin supplements
- Clinically relevant history of allergy as judged by the investigator
- Intolerance against standard medication used during bronchoscopy, e.g. lidocaine,
midazolam.
- Infections of the lower respiratory tract within 6 weeks prior to screening
- Infections of the upper respiratory tract within 2 weeks prior to screening
- Any clinically relevant abnormal findings in physical examination, clinical chemistry,
haematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the
opinion of the investigator, may either put the subject at risk because of
participation in the study, or may influence the results of the study.
- HIV (Type I + Type II), hepatitis B or C, tuberculosis, or Sars-CoV-2 positive or not
performed at visit 1
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites,
amphetamines, barbiturates and benzodiazepines at visit 1
- History of drug or alcohol abuse
- Risk of non-compliance with study procedures
- Suspected inability to understand the protocol requirements, instructions and
study-related restrictions, the nature, scope, and possible consequences of the study
COPD subjects
- Past or present disease other than COPD, which as judged by the investigator, may
affect the outcome of the study or put the subject at risk because of participation in
the study. These diseases include, but are not limited to, cardiovascular disease,
malignancy, hepatic disease, renal disease, haematological disease, neurological
disease, psychiatric disease, endocrine disease, infectious disease, inflammatory
disease or pulmonary disease (including but not confined to asthma, tuberculosis,
bronchiectasis or cystic fibrosis).
- Regular intake of any prescribed or over the counter medication, which as judged by
the investigator, may affect the outcome of the study or put the subject at risk
because of participation in the study. Explicitly allowed is treatment with
short-acting beta-2-agonists (SABA)/long-acting beta-2-agonists (LABA)/long-acting
muscarinic-antagonists (LAMA), paracetamol for pain relief, oral contraceptive
medication, hormonal replacement therapy, dietary and vitamin supplements. Not allowed
are inhaled corticosteroids.
- Clinically relevant history of allergy as judged by the investigator.
- Intolerance against standard medication used during bronchoscopy, e.g. lidocaine,
midazolam.
- Infections of the lower respiratory tract within 6 weeks prior to screening.
- Infections of the upper respiratory tract within 2 weeks prior to screening
- Exacerbation of COPD (treatment with oral or parenteral antibiotics and/or oral or
parenteral glucocoterticosteroids (GCS) and/or hospitalization related to COPD) within
60 days of visit 1.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry,
hematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the
opinion of the investigator, may either put the subject at risk because of
participation in the study, or may influence the results of the study.
- HIV (Type I + Type II), hepatitis B or C, tuberculosis, or Sars-CoV2 positive or not
performed at visit 1.
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites,
amphetamines, barbiturates and benzodiazepines at visit 1.
- History of drug or alcohol abuse.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and
study-related restrictions, the nature, scope, and possible consequences of the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Activation of Apoptosis-related Receptors on Alveolar Macrophages | NCT04775394 | Contradiction |
1,584 | 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:
- right handed adults
- no known physical or neurological abnormalities
Exclusion Criteria:
- patients with:
- cardiac pacemaker
- surgical clips or values on the heart
- implants
- metal or metallic fragments in any part of the body
- pregnancy
- claustrophobia
- a personal or family history of epilepsy
- currently taking antipsychotic drugs
- currently taking antidepressant drugs
- currently taking antianxiety drugs.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Contribution of the Somatosensory System to Speech Perceptual Processing | NCT04818021 | Contradiction |
4,272 | 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:
- Age: 25-35 years.
- trained male caucasian cyclists
- Non-smokers
- Each subject completed an approved informed consent form and detailed health
questionnaire before testing.
Exclusion Criteria:
- Smokers.
- Presence of diseases during the test period. In particular, they had no current
symptoms of nasal disease, snoring, asthma or allergic rhinitis.
- Unwillingness to complete the study requirements.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 35 Years | Feel Breathe, Restriction Device Ventilatory Nasal | NCT01608529 | Entailment |
78 | 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:
- T2DM
- male sex
- HbA1c >=7,5% -11%
- Age >=18 -75 years
- BMI>=30kg/m²
- Hypogonadism assessed by laboratory testing (testosterone < 3,5ng/ml (=12nmol/l)
- Metformin, SGLT2 inhibitors, DPP4 inhibitors and long acting insulin (basal insulin) 8
weeks stable dose
- able and willing to not change diet and physical activity during enrollment in study
- consent and able to give informed consent.
Exclusion Criteria:
- Current testosterone treatment or testosterone replacement within the last 12 month
- Serum creatinine>1,5mg/dl
- Liver enzymes above 3 fold normal range
- PSA>4.0μg/l
- Hematocrit>50%
- Known intolerance to testosterone undecanoate or any of its ingredients
- Myocardial infarction within the last 12month
- Stroke within the last 12 month
- Untreated congestive heart disease
- malignancy within the last 5 years before randomization
- Prostate cancer or any suspicion thereof
- Breast cancer
- Liver tumor/cancer
- Epilepsy
- Migraine
- Presence of any absolute or relative contraindication for the conduct of an MRI
investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the
central nervous system, metallic splinters in the eye, ferromagnetic or electronically
operated active devices like automatic cardioverter defibrillators, cochlear implants,
insulin pumps and nerve stimulators, prosthetic heart valves etc.
- patients on antidiabetic medication like Sulfonylurea or Glitazones, GLP1A.
- Any other clinical condition that would jeopardize patients safety while participating
in this clinical trial
- Known autoimmune disease or chronic inflammatory condition
- Other liver disease including chronic viral hepatitis (B or C), alcohol abuse,
hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's
disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver
cirrhosis of any etiology
- Alcohol or drug abuse within the 3 months prior to informed consent that would
interfere with trial participation or any ongoing condition leading to a decreased
compliance to study procedures or study drug intake
- History of bariatric surgery
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to
informed consent or any other treatment at the time of screening (i.e. surgery,
aggressive diet regimen, etc.) leading to unstable body weight
- Subjects receiving antihypertensive medication and/or thyroid hormones, the dose(s) of
which have not been stable for at least 6 weeks prior to baseline
- Uncontrolled/ untreated hypertension
- Current treatment with systemic steroids at time of informed consent. (Treatment with
local and inhaled steroids is allowed)
- Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit
or during the duration of the study
- Participation in another trial with an investigational drug within 30 days prior to
informed consent.
- Pharmacist, study coordinator, other staff thereof, directly involved in the conduct
of the protocol.
- contraindication for intramuscular injection (e.g patient receiving anticoagulants on
a regular basis such as NOAKs or VKAs, or DAPT).
- COPD Gold IV or recurrent acute or allergic asthma (for MPI)
- Contraindications for cardiac stress test as acute myocardial infarction, instable
angina, severe hypertension, myocarditis, life threatening rhythmic disorders without
physical activity.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese Men With T2DM and Hypogonadism | NCT03851627 | Contradiction |
2,199 | 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:
- diagnosis of gout based on the ACR/EULAR 2015 criteria
- uricemia ≥6 mg/dL
- warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR
2016 criteria
- signature of the informed consent
- social insurance affiliation
Exclusion Criteria:
- pregnancy or breastfeeding
- patient under legal 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.
Subject must be at most 80 Years | Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit | NCT03162341 | Contradiction |
2,203 | 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:
- Subject is able to understand the study procedures, the risks involved and willing to
provide written informed consent before the first study related activity.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has been taking allopurinol as the sole urate-lowering therapy indicated for
the treatment of gout for at least 8 weeks prior to the Screening Visit at a stable,
medically appropriate dose, as determined by the investigator, of at least 300 mg per
day (at least 200 mg for subjects with moderate renal impairment).
- Subject must be able to take gout flare prophylaxis with colchicine or an NSAID
(including Cox-2 selective NSAID) ±PPI.
- Subject has an sUA level ≥ 6.5 mg/dL at the Screening Visit and ≥ 6.0 mg/dL at Day -7
Visit.
- Subject has reported at least 2 gout flares in the prior 12 months.
- Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
- Subject with known hypersensitivity or allergy to allopurinol.
- Subject who is taking any other approved urate-lowering medication that is indicated
for the treatment of gout other than allopurinol within 8 weeks of the Screening
Visit.
- Subject who is pregnant or breastfeeding.
- Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150
mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- Subject with a history or suspicion of drug abuse within the past 5 years.
- Subject that requires or may require systemic immunosuppressive or immunomodulatory
treatment.
- Subject with known or suspected human immunodeficiency virus (HIV) infection.
- Subject with a positive test for active hepatitis B or hepatitis C infection.
- Subject with a history of malignancy within the previous 5 years with the exception of
non-melanoma skin cancer that has been treated with no evidence of recurrence, treated
cervical dysplasia or treated in situ Grade 1 cervical cancer.
- Subject within the last 12 months with: unstable angina, New York Heart Association
class III or IV heart failure, myocardial infarction, stroke, or deep venous
thrombosis; or subjects currently receiving anticoagulants.
- Subject with uncontrolled hypertension.
- Subject with an estimated creatinine clearance < 30 mL/min.
- Subject with active peptic ulcer disease requiring treatment.
- Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
- Subject receiving chronic treatment with more than 325 mg of salicylates per day.
- Subject taking valpromide, progabide, or valproic acid.
- Subject who has received an investigational therapy within 8 weeks or 5 half-lives
(whichever is longer) prior to the Screening Visit.
- Subject with any other medical or psychological condition, which might create undue
risk to the subject or interfere with the subject's ability to comply with the
protocol requirements, or to complete 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 85 Years | Combining Lesinurad With Allopurinol in Inadequate Responders | NCT01493531 | Contradiction |
6,353 | 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. | Work Stream A (in-hospital; Group 1 and Group 2):
Group 1 Inclusion Criteria:
We will include participants (patients or staff):
1. That are 18 years or older
2. That will require testing for COVID-19 in the opinion of the treating clinician
3. That may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea,
anosmia) or chest x-ray changes or they may be asymptomatic but require testing for
other reasons
Group 2 Inclusion Criteria:
We will include participants:
1. That are 18 years or older
2. That have been admitted for another reason other than suspected SARS-CoV-2 infection,
but when routinely swabbed they have been identified as positive for SARS-CoV-2 PCR
Work Stream B (Group 3):
We will include participants:
1. That are 18 years or older
EITHER:
2. They have been identified as positive for SARS-CoV-2 PCR through testing at national
laboratory infrastructure OR
3. They have been identified as negative for SARS-CoV-2 PCR through testing at national
laboratory infrastructure
Work Stream C (Group 4):
We will include participants:
1. That are 18 years or older
2. Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic
for COVID-19
Exclusion Criteria for all Work Streams:
1. Patients where it is impossible/unsafe to obtain the required research samples
2. Prisoners
3. Patients where sampling is not feasible
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19) | NCT04408170 | Entailment |
729 | 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:
Subjects will include those for whom a discontinuation trial of NSAIDs is most appropriate:
1) Veterans with knee pain despite NSAID use and/or 2) Veterans at relatively higher risk
of NSAID toxicity 55-59 as ascertained by meeting 1 or more of the following 4 criteria:
- Answer affirmatively to the question: "Do you have some knee pain on most days over
the past 3 months?"
- Have 1 or more risk factors for NSAID-induced nephrotoxicity (age greater than 60
years, atherosclerotic cardiovascular disease, current diuretic use, chronic renal
insufficiency, congestive heart failure (New York Heart Association class I-II. Note,
Class III and IV are excluded).
- Have 1 or more risk factors for NSAID-induced gastrointestinal toxicity (history of
peptic ulcer disease, age > 65 years, concurrent use of daily ASA or corticosteroids),
and are currently on a gastro-protective agent.
- Have 1 or more risk factors for NSAID-induced cardiovascular toxicity (prevalent
cardiovascular disease, hypertension, hypercholesterolemia, diabetes, smoking, family
history of early heart disease or age greater than 55 years for women).
In addition, subjects must:
- Be age 20 years or older. While the usual cut off for knee OA is approximately 40
years, the investigators chose to lower the age cutoff as younger Veterans have a
higher than expected risk of OA (see B.1).
- Have radiographic evidence of knee OA reported in the VistA electronic system.
- Be using an NSAID (other than daily ASA) for knee pain on most days of the month for
at least the past 3 months.
- Be able to understand and speak English and have a telephone.
- Be willing to engage in a CBT program, to discontinue (or replace) their NSAID, and to
restrict co-therapies to acetaminophen for 14 weeks.
Exclusion Criteria:
- Subjects desiring escalation of analgesics for their current level of knee pain as
determined by endorsement of the following statement: "Is your knee pain bad enough
that you want to talk to your doctor about taking stronger pain medications?"
- Current use of opioids and/or Celebrex.
- Current use of an NSAID (not including ASA) for a painful condition in addition to
knee OA.
- Contraindications to chronic NSAID use: current use of warfarin or antiplatelet agent
other than ASA, allergy to any NSAID, active upper gastrointestinal ulceration in the
previous 30 days, upper gastrointestinal bleeding in the past year, history of
gastroduodenal perforation or obstruction, cardiovascular event within the past 6
months (myocardial infarction, cerebrovascular event, coronary-artery bypass graft,
invasive coronary revascularisation, or new-onset angina), severe congestive heart
failure (New York Heart Association class III-IV), evidence of serious anemia,
hepatic, renal (including nephrotic syndrome), or blood coagulation disorders, and
pregnancy.
***Though the investigators are proposing a RWT - and thus will not be initiating NSAID
therapy - it would not be appropriate to continue NSAIDs (even when prescribed) in
high-risk patients. The investigators acknowledge that these exclusion criteria limit
generalizability, but the investigators feel justified to ensure subjects' safety.***
- Previous hyaluronic acid knee injections (within 6 months) or corticosteroid knee
injections (within 3 months).
- Scheduled knee hyaluronic acid or corticosteroid injections, arthroscopy, or knee
surgery.
- Co-morbid conditions that include the following: known other causes of arthritis
(infectious arthritis, rheumatoid arthritis, connective tissue disease, or psoriatic
arthritis), gout or pseudogout attack within the last 12 months, peripheral neuropathy
or cardiopulmonary disease that limits walking more than knee pain, bone metastases or
Paget's disease involving the lower extremities, and history of drug or alcohol abuse
within the past 2 years, bilateral knee replacements or knee pain in the replaced knee
only.
- Current involvement in litigation or receiving workmen's compensation.
- Hearing, cognitive impairment or mental illness, as determined by chart review that
would preclude participation in a CBT program.
- For Women of Childbearing Age: Must not currently be pregnant, agree to avoid getting
pregnant during the course of the study and should inform the study team if pregnancy
occurs at any time during study participation.
- Previous meloxicam use discontinued due to lack of effective symptom relief
- Contraindications to prolonged NSAID use, per PI discretion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Discontinuing NSAIDs in Veterans With Knee Osteoarthritis | NCT01799213 | Contradiction |
1,863 | 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... | Eligible criteria :
- Patient having endoscopic oesogastroduodenal endoscopy for suspicion of
oesogastro-duodenal adenocarcinoma.
- Benefiting from the social security system
Inclusion Criteria:
- Patient having endoscopy biopsies in front of a suspicious lesion suggestive of
gastroesophageal adenocarcinoma
Exclusion Criteria:
- Minor patient (<18 years old)
- known pregnancy
- Major patient under tutorship or curatorship
- Contraindication to gastric biopsies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of the Reliability of the Determination of MisMatch Repair Deficiency Status by Endoscopic Biopsies in Oesophagus and Gastric Adenocarcinoma. | NCT04774367 | Entailment |
4,814 | 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 referred to an otorhinolaryngological university clinic due to suspected
vestibular disorders (dizziness)
- Patients must be bothered with dizziness at the time of consultation
Exclusion Criteria:
- Patients uable to fill in questionnaires due language barriers
- Patients not able to undergo diagnostic and testing procedures
- Patients with vestibular Schwannoma
- Patients with diving-related inner ear injuries
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 67 Years | Musculoskeletal Pain in Long-term Dizziness | NCT04241822 | Entailment |
5,264 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Patients with established osteoporosis according to standard clinical criteria.
- Patients who give their written informed consent to participate in the study consent.
- Meet all the inclusion criteria
Exclusion Criteria:
- Patients with concomitant systemic disease in the opinion of the investigator.
- Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular
arthritis.
- Current patients with neoplasm or history of any malignancy in the last 10 years
except basal carcinoma or epidermoid skin.
- Patients with genetic disorders that are associated with secondary osteoporosis:
Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome,
Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
- Patients receiving immunosuppressive chemotherapy or that could interfere with the
process of cell proliferation.
- Transplant patients: bone marrow, kidney, liver, heart, lung.
- Patients with clinical criteria and anesthetics that contraindicate well sedation or
bone marrow extraction.
- Patients participating in a clinical trial in the last 6 months.
- Patients with positive serology for hepatitis B, hepatitis C or HIV.
- Patients with inability to understand informed consent.
- Patients who are pregnant or breast-feeding actively.
- Patients physically fertile, defined as all women physiologically capable of becoming
pregnant, UNLESS they are using reliable methods of contraception.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 70 Years | Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis | NCT02566655 | Entailment |
5,374 | 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:
- Have completed Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in
Paediatric Subjects with Von Willebrand Disease) or Study CSLCT-BIO-08-54 (Assessment
of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with Von Willebrand
Disease).
- The subject and/or his/her legal guardian understand(s) the nature of the study and
has/have given written informed consent to participate in the study and is/are willing
to comply with the protocol.
Exclusion Criteria:
- Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or
CSLCT-BIO-08-54.
- Mental condition rendering the subject (or the subject's legal guardian) unable to
understand the nature, scope and possible consequences of the study.
- Any condition that is likely to interfere with evaluation of the IMP or satisfactory
conduct of the study.
- Are not willing and/or not able to comply with the study requirements.
- Employee at the study site, or spouse/partner or relative of the Investigator or
Subinvestigators.
- Female subjects of childbearing potential either not using, or not willing to use, a
medically reliable method of contraception for the entire duration of the study, or
not sexually abstinent for the entire duration of the study, or not surgically
sterile.
- Intention to become pregnant during the course of the study.
- Pregnancy, or nursing mother.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Extension Study of Biostate in Subjects With Von Willebrand Disease | NCT01224808 | Entailment |
4,642 | 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:
- - Adult patient
- Patient benefiting from the routine management of a programmed hysterectomy by
vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis,
genital prolapse,...) within the CMCO
- Patient consenting to the use of cells from her uterus for incineration for research
purposes
- Patient giving her consent for the use of her medical data for the purposes of this
research.
- Patient agreeing to participate in the study
Exclusion criteria:
- - Patient refusing to participate in the study
- Patient under the protection of justice
- Patient under guardianship or curatorship
- Suspicion of gynaecological malignant pathology
- Pregnant or breastfeeding woman
- Impossibility to give the subject informed information (difficulties in understanding
the subject...)
Female
Subject must be at least 18 Years old.
| Study Of The Metabolic Parameters Of Uterine Muscle Cells | NCT03784157 | Entailment |
2,212 | 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:
- from 18yrs to 80yrs , man and women
- the patient who are taking allopurinol
- On screening, the patient shows that the level of protein/creatinine ratio is over 3.0
- On screening, the patient shows that MDRD GFR >= 30 ml/min and <= 60 ml/min
- the patient sign on the concent form
Exclusion Criteria:
- the patient have experience to take medication that have an effect on renal function
- the patient have experience to take cyclosporin within 3month
- At least, the average level of two separate blood pressure ( 2min interval ) shows
that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40
beats/min or > 90 beats/min
- uncontrolled hypertension
- pregnancy or anticipate pregnancy with 6 month
- hypersensitivity to allopurinol
- acute hepatitis or the level of AST or ALT is over 2times of normal range or the level
of bilirubin is over 2.0 mg/dL
- serum albumin < 3.5 mg/dL or > 5mg/dL
- urinary retension, prostatic hyperplasia
- the patient show gout attack on taking allopurinol
- the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic
pancreatitis, ulcer )or who have the surgical history of gastrointestine.
- the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan,
benzbromarone,fenofibrate,furosemide ,probenecid
- the patient who had taken part in the other study within 3months
- the patient who had gotten blood transfusion
- pregnant, breast feeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient | NCT01145274 | Contradiction |
5,133 | 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, aged ≥ 55 to ≤ 90.
- Received oral bisphosphonate therapy for at least 3 years immediately prior to
screening
- BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
- History of nonvertebral fracture after age 50, or vertebral fracture.
Exclusion Criteria:
- Use of other agents affecting bone metabolism including Strontium ranelate, fluoride
(for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV
bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH)
analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators
(SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic
glucocorticosteroids:
- History of metabolic or bone disease (except osteoporosis) that may interfere with the
interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid
arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
- Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined
by the central laboratory.
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 Years | An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women | NCT01796301 | Contradiction |
5,962 | 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:
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Exclusion Criteria:
- N/A
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH | NCT03735862 | Contradiction |
616 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women aged 18 years or older with an undesired pregnancy < 6 weeks gestation
- Women with a positive urine pregnancy test
- Proficiency in English
- Working phone and subject willing to be contacted by phone.
- Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction
with assigned follow-up method
Exclusion Criteria:
- Women with presence of a yolk sac or crown rump length visualized on ultrasound
- Women with a gestational sac greater than 13mm [11]
- High Suspicion for ectopic pregnancy
o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain
and/or vaginal spotting
- Hemodynamic instability
o Signs: heavy vaginal bleeding, hypotension, tachycardia
- Pelvic Infection
o Signs: pain or fever
- Medical conditions that contraindicate uterine evacuation according to PPLM clinic
policy
o These include but are not limited to: a bleeding disorder or anticoagulation,
significant cardiac disease, renal or liver failure, IUD in situ that cannot be
removed
- Unwilling or unable to comply with study follow-up procedures
- Being in a situation where receiving phone calls or additional contact with research
staff may endanger the privacy or safety of the subject (e.g. situations of domestic
violence or abuse)
- Inability to give informed consent
- Previous participation in this study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location | NCT01596972 | Entailment |
3,587 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Healthy male and female subjects, aged 18 to 45 years.
- A body mass index (BMI, or Quetlet index) in the range of 18.0 to 30.0 kg/m2, and
weighing between 50 and 100 kg at screening.
- Male subjects have to agree to contraception (condom with spermicide) in addition to
having their female partner (if of child-bearing potential) use another form of
contraception (e.g., an intrauterine device, diaphragm with spermicide, oral
contraceptive, injectable, or sub dermal hormonal implant) from the first dose until
16 weeks following the last dose administration. Also, the male subjects must not
donate sperm after the study for a period of four months.
- All women must have a negative serum pregnancy test at screening and a negative urine
pregnancy test at admission (Day -1). Women must be of non-childbearing potential
either: Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries
and/or uterus at least 6 months prior to dosing) or naturally postmenopausal
(spontaneous cessation of menses) for at least 24 consecutive months prior to dosing,
with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL.
- Sufficient intelligence to understand the nature of the trial and any hazards of
participating in it. Ability to communicate satisfactorily with the Investigator and
to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the ICF, and after
having the opportunity to discuss the trial with the Investigator or his delegate.
- Willingness to give written consent to have data entered into The Overvolunteering
Prevention Scheme.
- Willing to abstain from grapefruit/grapefruit juice and Seville oranges from 7 days
before the first dose and throughout the study.
- Willing to refrain from consuming food or beverages containing caffeine/xanthine
starting 24 hours prior to check-in on Day -1.
Exclusion Criteria:
- Clinically relevant abnormal history, including cardiovascular, haematologic,
pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled
endocrine/metabolic, oncologic (within the last 5 years), neurologic (including
previous transient ischemic attack or stroke), and psychiatric diseases, physical
findings, ECG, or laboratory values at the pre-trial screening assessment that could
interfere with the objectives of the trial or the safety of the volunteer.
- History of a serious reaction to any medicine.
- History of major bleeding, stomach ulcer, Raynaud's disease, major trauma, or major
surgical procedure of any type within 6 months of dosing.
- History of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood
on toilet paper), and gingival bleeding within 3 months before the study treatment.
- Familial or documented or suspected coagulopathy and haemoglobinopathy.
- Females with a history of dysfunctional uterine bleeding, including history of
menorrhagia, metrorrhagia, or polymenorrhea.
- History of an operation (e.g. stomach bypass), or a condition that could affect how
the body handles or absorbs medicines.
- History of gastro-oesophageal reflux disease.
- Females who are breastfeeding.
- Positive urine or faecal occult blood test at screening or admission (Day -1 or day
1).
- Bleeding time > 9.5 minutes at screening).
- aPTT, PT, INR, or platelet count outside the limit of normal of the clinical
laboratory's reference range at screening.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (based on Modification
of Diet in Renal Disease [MDRD] equation).
- Positive test for hepatitis B, hepatitis C, HIV1 & HIV2.
- QTcF interval duration > 430 msec for males and 450 msec for females, obtained as an
average from the 3 ECG measurements on the triplicate screening ECGs.
- Abnormal waveform morphology on any of the ECGs at screening at admission that would
preclude accurate measurement of the QT interval duration.
- Physical trauma, dental extraction, surgery, or a significant illness within 4 weeks
before the first dose.
- History or presence of keloid, hyperpigmentation, or other adverse reaction to skin
injury or surgery.
- Use of any prescribed or non-prescribed (over-the-counter [OTC]) systemic medications
(including anticoagulants or antiplatelet medications), topical medications, or herbal
supplements within 14 days before the first dose (excluding paracetamol ≤ 2 g/day).
St. John's Wort (hypericin) must not have been taken for at least 30 days before the
first dose.
- Donated or lost > 400 mL of blood or plasma during 3 months before the first dose on
Day 1.
- Donation of blood, plasma, platelets, or any other blood components during the 3
months before the trial, or unwilling to abstain from doing so during the study and
for 3 months after receipt of trial medication.
- Participated in a clinical study involving administration of an investigational drug,
or a marketed drug within 90 days before administration of the first dose.
- Male subjects who consume more than 21 units of alcohol per week or female subjects
who consume more than 14 units of alcohol per week (1 unit of alcohol equals 1/2 pint
of beer, a glass of wine, or 1 measure of spirits) or those subjects who have a
significant history of alcoholism or drug/chemical abuse within the last 2 years.
- Use of tobacco products or nicotine-containing products within 3 months before the
first dose.
- Positive results on tests for drugs of abuse, carbon monoxide, or alcohol at screening
or admission.
- Possibility that the volunteer will not cooperate with the requirements of the
protocol.
- Objection by General Practitioner (GP) to volunteer entering the trial.
- Known aspirin allergy or intolerance.
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 45 Years | DS1040b/Aspirin Drug/Drug Interaction Study | NCT02071004 | Contradiction |
5,109 | 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:
- females 60 - 75 years old
- caucasian race
Exclusion Criteria:
- CHD-diseases
- thrombosis, embolism
- fractures at lumbar spine or hip
- secondary osteoporosis
- hyperparathyroidism
- medication, diseases with impact on muscle or bone
- hip or knee implant
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 75 Years | Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women | NCT00667667 | Contradiction |
5,821 | 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. Age over 18 years.
2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at
least have a typical GERD symptom (heartburn or regurgitation).
3. Total acid exposure time> 6% in pH measurement study without PPI treatment.
4. Patients who do not want to take PPIs or with chronic consumption, defined as PPI
consumption of more than 6 months (consecutive or not) in the last 2 years.
5. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL
questionnaire 15 days after discontinuation of the PPI.
6. Written informed consent to participate in the study.
Exclusion Criteria:
1. Patients with sliding hiatal hernia> 2 cm.
2. Presence of only atypical GERD symptoms.
3. Age> 75 years.
4. Grade D peptic esophagitis.
5. Body mass index> 35 40 kg / m2.
6. Liver cirrhosis.
7. Pregnancy.
8. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).
9. Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.
10. Esophagogastric surgery or previous endoscopic antireflux technique.
11. Barrett's esophagus with dysplasia.
12. Oncological disease.
13. Esophageal strictures or ulcers.
14. Severe cardiopulmonary comorbidity (ASA functional class IV-V).
15. Previously known coagulopathy.
16. Severe psychiatric disorder
17. Refusal to participate in 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 75 Years | Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease | NCT04711655 | Contradiction |
3,814 | 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:
- those with medical diagnosis (providing written evidence from a physician, physician
assistant, or nurse practitioner) of knee OA unilaterally or bilaterally.
Exclusion Criteria:
- bilateral total knee arthroplasty, requirement of an assistive device or assistance
with ambulation, spinal diagnoses which contraindicate participation in spinal
stabilization activities, and those currently limited by another lower extremity
pathology at the time of participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Effect of TA Contraction on Gait in Patients With Knee OA | NCT03513094 | Entailment |
370 | 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:
Healthy volunteers will be in excellent health.
Only women with regular menstrual cycles (every 26-35 days) using mechanical (condoms,
diaphragm) or sterilization methods of contraception will be included.
Only women with a negative pregnancy test, normal physical examination and laboratory
results, and a luteal phase progesterone value of greater than 4 ng/mL will be entered into
this study.
Women with endometriosis will be recruited from those with histologically-proven
endometriosis. Except for this diagnosis they will meet criteria for healthy volunteers as
stated above.
Women may participate in the study on more than one occasion, but biopsies may not be
performed in a "baseline" cycle.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 43 Years | Hormonal Effects on the Uterus and Endometrium | NCT00001454 | Contradiction |
2,151 | 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:
- Adults aged over 18 years old
- Gout confirmed by identification of urate crystals by joint fluid or tophus analysis
or by ultrasound of the affected joint or
- Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the
following items:
Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1)
(2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease
(1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts)
- Chronic kidney disease stage 4/5 or renal transplantation
- Flare ≤ 5 days
- Pain assessed by visual analogical scale ≥ 5
Exclusion Criteria:
- Participating in another trial including the administration of a drug
- Active infection
- History of anakinra or prednisone allergy
- Contra-indication of anakinra or prednisone
- Neutrophil count < 1000/mm3 (not due to ethnic cause)
- Difficulty understanding French
- Illiteracy
- Pregnant women or breastfeeding mothers (see PHC article L.1121-5)
- Persons deprived of liberty by judicial or administrative decision, persons receiving
psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a
health or social institution for purposes other than research (see CSP Article
L.1121-6)
- Major persons subject to a measure of legal protection or unseeding to express consent
(see PHC Article L.1121-8)
- Persons not affiliated to a social security plan or beneficiaries of such a plan (see
PHC Article L.1121-8-1)
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.
| Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation | NCT04844814 | Contradiction |
1,757 | 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:
- No history of benign and malignant tumors (including carcinoma and adenoma) of upper
GI (including esophagus, stomach and duodenum)
- undergo gastroscopy with intravenous anesthesia (or conscious sedation)
Exclusion Criteria:
- Subjects with focal lesions detected by gastroscopy within 1 year
- Subjects that cannot stand the gastroscopy procedure or cannot cooperate with
endosccopists
- Emergency endoscopy and therapeutic endoscopy
- Subjects with history of esophageal or stomach surgery or endoscopic surgery
- Pregnant
- Subjects that taking antiplatelet or anticoagulant drugs which contradicts endoscopic
biopsy
- Subjects with other serious complications that affect the speed of gastroscopy
- Subjects that refuse to cooperate with data collection or sign the informed consent
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 70 Years | Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors | NCT04602299 | Contradiction |
6,383 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Any adult with the following:
- Symptoms compatible with COVID-19 disease (Fever >37.8oC on at least one occasion
AND either cough and/ or anosmia) within the first 5 days of symptom onset
- OR ANY symptoms compatible with COVID-19 disease (may include, but are not
limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza)
and tested positive for SARS-CoV-2 within the first 7 days of symptom onset
- OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours
(date/time of test must be within 48 hours of enrolment)
2. Male or female aged 18 years to 70 years old inclusive at screening
3. Willing and able to take daily saliva samples
4. Able to provide full informed consent and willing to comply with trial-related
procedures
Exclusion Criteria:
1. Known hypersensitivity to any of the active ingredients or excipients in favipiravir
and matched placebo, and in lopinavir/ritonavir and matched placebo
2. Chronic liver disease at screening (known cirrhosis of any aetiology, chronic
hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known
elevation of liver aminotransferases with AST or ALT > 3 X ULN)*
3. Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m2*
4. HIV infection, if untreated, detectable viral load or on protease inhibitor therapy
5. Any clinical condition which the investigator considers would make the participant
unsuitable for the trial
6. Concomitant medications known to interact with favipiravir and matched placebo, and
with lopinavir/ritonavir and matched placebo, and carry risk of toxicity for the
participant
7. Current severe illness requiring hospitalisation
8. Pregnancy and/ or breastfeeding
9. Eligible female participants of childbearing potential and male participants with a
partner of childbearing potential not willing to use highly effective contraceptive
measures during the trial and within the time point specified following last trial
treatment dose.
10. Participants enrolled in any other interventional drug or vaccine trial (co-enrolment
in observational studies is acceptable).
- Considering the importance of early treatment of COVID-19 to impact viral load,
the absence of chronic liver/ kidney disease will be confirmed verbally by the
participant during pre-screening and Screening/Baseline visit. Safety blood
samples will be collected at Screening/Baseline visit (Day 1) and test results
will be examined as soon as they become available within 24 hours.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals | NCT04499677 | Entailment |
6,256 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Primary bariatric surgery;
2. Compensated DMT2;
3. Controlled hypertension;
4. Patients with OSAS can only be admitted if therapy with home CPAP is effective
5. Laparoscopic standard bariatric procedure;
6. Procedure duration less than 120 minutes;
7. Official SICOB's surgical informed consent given, including Covid-19 addendum.
Exclusion Criteria:
- previous Covid-19 infection;
- patients who may need an extended stay or intensive care (BMI > 60).
- concomitant procedure;
- previous major abdominal surgery
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Obesity Surgery During 2020 Italian Pandemic | NCT04480034 | Contradiction |
403 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women undergoing IVF/ICSI treatment with expected poor ovarian response according to
the Bologna criteria
Exclusion Criteria:
- Women with BMI >35 Kg/m2
- Women with a single ovary
- Known allergy to DHEA
- Diabetic women on insulin as insulin lowers DHEA levels and might reduce the
effectiveness of DHEA supplements
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 43 Years | DHEA Versus Placebo in Women With Poor Ovarian Response | NCT02561793 | Contradiction |
3,413 | 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:
- chronic tympanic membrane perforation
- dry ear at least 4 weeks before the procedure
- no evidence of cholesteatoma
- hearing test in the last 3 months
- signing informed consent
Exclusion Criteria:
- age under 18 years
- pregnant
- breastfeeding
- a known sensitivity for any ingredient
- a perforation that is more than one third of the tympanic membrane area.
- new onset perforation (less than 3 months)
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.
| Repair of Tympanic Membrane Perforation Using Tachosil Under Local Anesthesia | NCT04428463 | Contradiction |
1,332 | 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. Height of at least 2.0 standard deviations below the mean height for chronological age
and sex according to the 2000 standards from the Centers for Disease Control and
Prevention (CDC).
2. Children that have one of the following short stature pathologies:
1. IGHD or MPHD
2. ISS
3. SGA
3. Proper function of thyroid gland, kidney and liver
4. Prior to initiating growth hormone treatment
Exclusion Criteria:
1. Chronic diseases
2. Diseases in the digestive system.
3. Neurological diseases.
4. Malignant diseases in the past or in the present. Treated with chemotherapy or
radiation.
5. Genetic syndromes
6. Bone diseases
7. Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone
signal transduction.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 18 Years | Effects of Growth Hormone (GH) Treatment on Eating Regulation | NCT00562705 | Contradiction |
3,403 | 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:
- Serous Otitis Media for More Then 3 months
- Conductive Hearing Loss of More Then 15 decibels.
- Tympanometry type B or C.
Exclusion Criteria:
- No History of Tympanostomy Tube Insertion or Adenoidectomy
- No Cranio or Facial Malformations
- No Acute Upper Respiratory Tract Infection or Acute Otitis Media
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Years old.
Subject must be at most 18 Years | The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children | NCT00393159 | Contradiction |
3,127 | 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:
- Women ages 18-35 years who live with their husbands or partners within the
pre-selected study clusters
- Consent from husband/partner as well as eligible woman
- Women in polygynous unions, if the wife co-resides with her husband
Exclusion Criteria:
- Either woman or partner does not give consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Promoting Female Empowerment at the Household Level Among Couples in Ibadan, Nigeria | NCT03888495 | Contradiction |
4,052 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee
- Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for
OA pain
- Discontinued all analgesic therapy at Screening
- For women of childbearing potential: a woman who is not pregnant and not nursing, and
who is practicing an acceptable method of birth control
- Ability to ambulate
Exclusion Criteria:
- History of allergic reaction or clinically significant intolerance to acetaminophen,
aspirin, or any NSAIDs, including meloxicam
- Requires regular (more than 2 doses per week) use of opioid or opioid combination
products to control OA pain of the knee or hip
- Clinically significant unstable cardiac, respiratory, neurological, immunological,
hematological, or renal disease
- Significant difficulties swallowing capsules/tablets or unable to tolerate oral
medication
- Previous participation in another clinical study of Meloxicam Capsules or received any
investigational drug or device or investigational therapy within 30 days before
Screening
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.
| Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain | NCT02405793 | Entailment |
4,701 | 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:
General inclusion criteria:
Female gender--to evaluate effects in the target population for clinical trials.
In good health. Chronic medication use is acceptable except for glucocorticoid use. Other
chronic medication use may be acceptable at discretion of the principal investigator.
Interval use of over-the-counter drugs is acceptable but must be recorded.
Hemoglobin greater than 10 g/dL.
Willing and able to comply with study requirements.
Age 18 to 50.
Additional inclusion criteria for pre-menopausal women:
Using mechanical (condoms, diaphragms), abstinence, oral contraceptive, IUD or
sterilization methods of contraception for the duration of the study. Because the effect of
CDB-2914 on IUD efficacy is not known, women using this form of birth control will be
advised to use barrier methods during the cycle(s) in which they participate.
Negative urine pregnancy test within one week of the first study. If the second study
occurs in a subsequent cycle, the pregnancy test will be repeated.
EXCLUSION CRITERIA:
Significant abnormalities in the history, physical or laboratory examination
Pregnancy
Lactation
Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year
Unexplained vaginal bleeding
History of malignancy within the past 5 years
Use of anti-epileptic agents
Female
Accepts Healthy Volunteers
| Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914 | NCT00041899 | Entailment |
6,702 | 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:
Control group and hepatically impaired groups:
- Male and/or female subjects between 18 and 65 years of age. Female subjects must be
surgically sterilized or postmenopausal (Postmenopausal women must have no regular
menstrual bleeding for at least 2 years prior to inclusion. Menopause will be
confirmed by a plasma FSH level of >40 IU/L. Female subjects must have been surgically
sterilized at least 6 months prior to screening. Surgical sterilization procedures
must be supported with clinical documentation made available to sponsor and noted in
the Relevant Medical History / Current Medical Conditions section of the CRF)
- Able to communicate well with the investigator, to understand and comply with the
requirements of the study. The subjects must be able to provide written informed
consent prior to study participation, thus excluding subjects with encephalopathy
grade 3 or 4.
- Body mass index (BMI) must be within the range of 18 to 32. For instructions and
tables see Appendix 5.
Hepatically impaired group:
- Subjects must have liver cirrhosis (hepatic fibrosis with evidence of either micro- or
macro-nodular regeneration) confirmed by imaging techniques, ultrasound, MRI or CT.
- Subjects must have physical signs consistent with a clinical diagnosis of liver
cirrhosis (e.g., liver firmness to palpation, splenic enlargement, spider angiomata,
palmar erythema, parotid hypertrophy, testicular atrophy, gynecomastia).
- Subjects must have a Child-Pugh Clinical Assessment Score between 7 and 9 at both
screening and baseline.
- Vital signs (after 3 minutes resting in a supine position) which are within the
following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure,
100-180 mm Hg diastolic blood pressure, 60-115 mm Hg pulse rate, 60 - 100 bpm
- Subjects with creatinine clearance greater than 50 mL/min (based on Cockcroft and
Gault formula)
Control group:
- Subjects must be in good health as determined by past medical history, physical
examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Subjects should be matched to the hepatically impaired group in gender, age (±10%),
smoking status, BMI (±10%).
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and
pulse rate) will be assessed after the subject has rested for at least three (3)
minutes, and again when required after three (3) minutes in the standing position.
Vital signs should be within the following ranges: oral body temperature between
35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm
Hg pulse rate, 40 - 90 bpm When blood pressure and pulse will be taken again after 3
minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg
drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with
clinical manifestation of postural hypotension. All blood pressure measurements at
other time-points should be assessed with the subject supine, unless stated otherwise
in the protocol design, and utilizing the same arm for each determination.
Exclusion Criteria:
Control group and hepatically impaired group:
- Participation in any clinical investigation with experimental drug therapy within four
weeks prior to dosing or longer as required by local regulation.
- Donation or loss of 400 mL or more of blood within two months prior to dosing.
- Significant acute, new onset illness (ie, flu, gastroenteritis) within two weeks prior
to dosi4. A past medical history or clinically significant ECG abnormalities or a
family history (grandparents, parents and siblings) of a prolonged QT-interval
syndrome.
- History of hyponatremia or seizures.
- History of autonomic dysfunction.
- Subjects with a consistent, abnormally low total lymphocyte count (< 10% of total
white blood cell counts)
- A known hypersensitivity to the drug.
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test
result.
- Evidence of active alcohol or drug abuse as indicated by the laboratory assays
conducted during the screening or baseline evaluations.
- Smokers who report cigarette use of more than 20 cigarettes per day. Urine cotinine
levels will be measured during screening.
Hepatically impaired group:
- Subjects with a history of unstable, severe, or clinically significant cardiovascular
disease
- Polymorphonuclears <1000/µL or platelets <100'000/µL at inclusion.
- Subjects with clinically significant abnormal findings, not consistent with underlying
disease, upon physical examination, ECG or laboratory evaluation.
- Subjects with frank symptoms of encephalopathy or ataxia.
- A recent history of acute or chronic bronchospastic disease, including asthma and
chronic obstructive pulmonary disease, treated or not treated.
- Any surgical or medical condition which might significantly alter the absorption,
distribution, or excretion of any drug.
- Current drug treatment with other mood stabilizers, psychotropic drugs and
antiepileptics.
Patients must be willing and able to forgo treatment with restricted medications throughout
the study. Approved prescription medications will be allowed during the course of the study
on a case by case basis only if the patient has been on a standard treatment regimen for at
least 3 months and will continue their regular regimen without change throughout the study
(unless required by protocol or to treat an adverse event) Treatments in table 5.1 are
allowed in the hepatically impaired group only.
Control group
- Use of any prescription medication within 1 month prior to dosing.
- Use of over-the-counter medications or vitamins during 14 days prior to dosing
(Paracetamol, aspirin or ibuprofen are acceptable, but must be documented in the CRF).
- History or presence of liver disease or liver injury as indicated by an abnormal liver
function profile such as SGOT, SGPT, GGT, alkaline phosphate, or serum bilirubin.
- Hepatitis B as indicated by positive HBs Ag or positive anti-HBc IgM result, or
Hepatitis C as indicated by positive anti-HCV result.
- History of acute or chronic bronchospastic disease, including asthma and chronic
obstructive pulmonary disease, treated or not treated.
- Any surgical or medical condition which might significantly alter the absorption,
distribution, or excretion of any drug. The investigator should be guided by evidence
of any of the following: History of inflammatory bowel syndrome, gastritis, ulcers,
gastrointestinal or rectal bleeding, chronic diarrhoea; History of major
gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel
resection; History of pancreatic injury or pancreatitis; indications of impaired
pancreatic function/injury as indicated by abnormal lipase or amylase; History or
presence of impaired renal function as indicated by abnormal creatinine or BUN values
or abnormal urinary constituents (e.g., albuminuria); History of urinary obstruction
or difficulty in voiding polymorphonuclears <1000/µL or platelets <100'000/µL at
inclusion.
- Known history of autoimmune disease such as SLE Other protocol-defined
inclusion/exclusion criteria may apply
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 | Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine | NCT00424671 | Contradiction |
4,353 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Age from 7 to 17 years old or from 18 to 45 years old;
2. Meet the diagnostic criteria for patients with simple low or moderate myopia, with
diopter < -6.0d and eye axis < 26.0mm;
3. Transparent refractive stroma, no other eye diseases except nearsightedness;
4. Agree to participate in the clinical study and sign the informed consent.
Exclusion Criteria:
1. Other ocular lesions, such as uveitis, retinal/choroidal vascular lesions, congenital
ocular lesions, glaucoma, high myopia (ocular axis > 26cm), degenerative retinal
disease, optic neuropathy, etc.;
2. Another eye with low vision
3. Corneal edema/epithelial detachment, corneal opacity;
4. Redness, pain, dry eye, photophobia, difficulty in opening eyes;
5. Had a history of eye surgery in recent 3 months;
6. Severe impairment of liver and kidney function and/or serious systemic diseases (such
as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc.);
7. Women who are already pregnant, preparing for pregnancy during the study period and
lactating;
8. A history of substance abuse or alcohol abuse;
9. Receiving prevention and control treatment for myopia other than glasses within the
first 30 days;
10. Any situation in which the study physician believes that the patient's condition will
interfere with the clinical study (e.g., the patient is prone to nervous tension,
uncontrollable emotions, depression, etc.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 45 Years | Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation | NCT04604405 | Entailment |
3,709 | 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:
Or at least two of criteria 2-6 established by the American College of Rheumatology (ACR):
1. Kellgren and Lawrence (K/L) grade ≥II
2. morning stiffness <30 min in duration
3. crepitus on movement of the knee joint
4. bony tenderness at the knee joint margins
5. palpable or visible bony enlargement
6. no palpable warmth.
Exclusion Criteria:
1. the presence of knee joint effusion determined by ultrasonography
2. a history of knee injury or surgery
3. a history of knee injection within 3 months
4. a history of inflammatory arthritis
5. taking anticoagulants
6. balance or gait disturbance
7. diabetes mellitus.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| The Effects of Joint Effusion on Proprioception | NCT01060215 | Contradiction |
3,315 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion:
- 2-6 years old
- complete ophthalmic examination including cycloplegic refraction conducted on the same
day or within 3 months
- strabismic, anisometropic, or normal (normal eye examination and refractive error
according to AAPOS guidelines)
- parent provides informed consent
Exclusion:
- other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid
hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA,
JRA, neurofibromatosis)
- developmental delay
- strabismus surgery in the past 6 months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 6 Years | Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner | NCT01726842 | Entailment |
4,685 | 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, diagnosed with benign gynecologic conditions, undergoing open abdominal surgery
Exclusion Criteria:
- Surgeries performed for cancer
- Intraoperative accidental injury to urinary or gastrointestinal organs
- Postoperative admission to intensive care unit (ICU)
- Postoperative intraperitoneal drain placement
- Unable to understand and follow oral/written instructions
- Severe neuromuscular or circulatory disorders
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions | NCT03820115 | Entailment |
3,858 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study | NCT02521922 | Entailment |
2,801 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients with Primary Ventral or Incisional Hernias
- Scheduled to undergo hernia repair through an open approach
- Hernia repair performed in an elective setting
- Hernia repair performed through a midline incision
- Hernia repair performed in a clean wound
- Hernia repair performed with mesh placed in the retromuscular position
Exclusion Criteria:
- patients with less than 18 years old of age
- patients scheduled to undergo a minimally invasive hernia repair
- patients where hernia repair is planned to be performed with mesh placement in a
different position than retromuscular
- patient undergoing hernia repair with a clean-contaminated, contaminated or infected
wound
- patients undergoing hernia repair in an non-elective fashion
- patients with allergy, hypersensitivity or contraindication to bupivacaine
- patients with history of chronic liver disease with moderate or severe impairment in
liver function defined as a Child-Pugh class B or C
- patients with chronic kidney disease on dialysis
- chronic opioid users, defined as daily or near daily use of opioids for at least 90
days in the past year
- patients unable to provide informed written consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair | NCT03541941 | Entailment |
1,809 | 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:
- Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal
discomfort, epigastric pain, epigastric burning) for at least 6 months before
obtaining informed consent
- Subjects showing two or more of the following symptoms: upper abdominal pain, upper
abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety,
nausea, vomiting and/or excessive belching for at least 3 months (one of them should
be post-prandial fullness or early satiation)
- Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or
early satiety at the time of obtaining informed consent
Exclusion Criteria:
- Subjects with structural disease that is likely to explain the symptom (e.g., GERD,
erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed
by upper endoscopy at the obtaining informed consent
- Subjects have heartburn in last 12 weeks before obtaining informed consent
- Subjects with irritable bowel disease (IBS)
- Subjects with diabetes mellitus requiring treatment
- Subjects with serious anxiety disorder
- Subjects with depression and/or sleep disorder
- Subjects with biliary tract disease and/or pancreatitis (including chronic
pancreatitis)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 64 Years | To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia | NCT00761358 | Contradiction |
4,786 | 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 males/females, 18-75 years of age at the time of enrollment.
- Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
- Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
- At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness)
of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study
enrollment.
Exclusion Criteria:
- Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
- History of otosclerosis or vestibular schwannoma.
- History of significant middle ear or inner ear surgery in the affected ear.
- Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal,
endocrine, immunologic, neurological, or psychiatric disease.
- Current use or within 30 days prior to study enrollment systemic steroids.
- Current use or within 7 days prior to study enrollment intratympanic steroids.
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 | SPI-1005 for the Treatment of Meniere's Disease | NCT04677972 | Entailment |
6,239 | 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:
- Have given informed consent by signing the informed consent form (ICF) before
initiation of any trial-specific procedures.
- They must be willing and able to comply with scheduled visits, treatment schedule,
laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to
follow good practices to reduce their chances of being infected or spreading
COVID-19), and other requirements of the trial.
- They must be able to understand and follow trial-related instructions.
- For younger adult cohorts, volunteers must be aged 18 to 55 years, have a body mass
index over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and
weigh at least 50 kg at Visit 0.
OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a body mass index
over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and weigh at
least 50 kg at Visit 0.
- They must be healthy, in the clinical judgment of the investigator, based on medical
history, physical examination, 12-lead electrocardiogram (ECG), vital signs
(systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate),
and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at
Visit 0.
- Women of childbearing potential (WOCBP) must have a negative beta-human chorionic
gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or
permanently sterilized will be considered as not having reproductive potential.
- WOCBP must agree to practice a highly effective form of contraception during the
trial, starting after Visit 0 and continuously until 60 days after receiving the last
immunization. WOCBP must agree to require their male partners to use condoms during
sexual contact (unless male partners are sterilized or infertile).
- WOCBP must confirm that they practiced at least one highly effective form of
contraception for the 14 days prior to Visit 0.
- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during trial, starting after Visit 0 and continuously until 60 days after
receiving the last immunization.
- Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
practice a highly effective form of contraception with their female partner of
childbearing potential during the trial, starting after Visit 0 and continuously until
60 days after receiving the last immunization.
- Men must be willing to refrain from sperm donation, starting after Visit 0 and
continuously until 60 days after receiving the last immunization.
- They must have confirmation of their health insurance coverage prior to Visit 0.
- They must agree to not be vaccinated during the trial, starting after Visit 0 and
continuously until 28 days after receiving the last immunization.
Exclusion Criteria:
- Have had any acute illness, as determined by the investigator, with or without fever,
within 72 hours prior to the first immunization. An acute illness which is nearly
resolved with only minor residual symptoms remaining is allowable if, in the opinion
of the investigator, the residual symptoms will not compromise their well-being if
they participate as trial subjects in the trial, or that could prevent, limit, or
confound the protocol-specified assessments.
- Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial,
starting after Visit 0 and continuously until at least 90 days after receiving the
last immunization.
- Have a known allergy, hypersensitivity, or intolerance to the planned investigational
medicinal product (IMP) including any excipients of the IMP.
- Had any medical condition or any major surgery (e.g., requiring general anesthesia)
within the past 5 years which, in the opinion of the investigator, could compromise
their well-being if they participate as trial subjects in the trial, or that could
prevent, limit, or confound the protocol-specified assessments.
- Have any surgery planned during the trial, starting after Visit 0 and continuously
until at least 90 days after receiving the last immunization.
- Had any chronic use (more than 21 continuous days) of any systemic medications,
including immunosuppressants or other immune-modifying drugs, within the 6 months
prior to Visit 0 unless in the opinion of the investigator, the medication would not
prevent, limit, or confound the protocol-specified assessments or could compromise
subject safety.
- Received any vaccination within the 28 days prior to Visit 0.
- Had administration of any immunoglobulins and/or any blood products within the 3
months prior to Visit 0.
- Had administration of another IMP including vaccines within 60 days or 5 half-lives
(whichever is longer), prior to Visit 0.
- Have a known history or a positive test of any of human immunodeficiency virus (HIV) 1
or 2, Hepatitis B, or Hepatitis C, within the 30 days prior to Visit 0.
- Have a positive polymerase chain reaction (PCR)-based test for severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) within the 30 days prior to Visit 1.
- Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates,
cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and
tricyclic antidepressants) result at Visit 0 or Visit 1.
- Have a positive breath alcohol test at Visit 0 or Visit 1.
- Previously participated in an investigational trial involving lipid nanoparticles.
- Are subject to exclusion periods from other investigational trials or simultaneous
participation in another clinical trial.
- Have any affiliation with the trial site (e.g., are close relative of the investigator
or dependent person, such as an employee or student of the trial site).
- Have a history (within the past 5 years) of substance abuse or known medical,
psychological, or social conditions which, in the opinion of the investigator, could
compromise their well-being if they participate as trial subjects in the trial, or
that could prevent, limit, or confound the protocol-specified assessments.
- Have a history of hypersensitivity or serious reactions to previous vaccinations.
- Have a history of Guillain-Barré Syndrome within 6 weeks following a previous
vaccination.
- Have a history of narcolepsy.
- Have history of alcohol abuse or drug addiction within 1 year before Visit 0.
- Have a history of or suspected immunosuppressive condition, acquired or congenital, as
determined by medical history and/or physical examination at Visit 0.
- Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the
investigator, would obstruct the ability to observe local reactions at the injection
site.
- Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or
injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial,
starting after Visit 0 and continuously until at least 7 days after receiving the last
immunization.
- Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath
and breathing difficulties.
- Have had contact with persons diagnosed with COVID-19 or who tested positive for
SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1.
- Are soldiers, subjects in detention, contract research organization (CRO) or sponsor
staff or their family members.
- Regular receipt of inhaled/nebulized corticosteroids.
- Have a condition known to put them at high risk for severe COVID-19, including those
with any of the following risk factors:
- Cancer
- COPD (chronic obstructive pulmonary disease)
- Immunocompromised state (weakened immune system) from solid organ transplant
- Obesity (BMI of 30 or higher)
- Serious heart conditions, such as heart failure, coronary artery disease, or
cardiomyopathies
- Sickle cell disease
- Diabetes mellitus
- Hypertension
- Asthma
- Chronic liver disease
- Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60
mL/min/1.73 m^2)
- Anticipating the need for immunosuppressive treatment within the next 6 months
- Resident in a long-term facility
- Current vaping or smoking (occasional smoking is acceptable)
- History of chronic smoking within the prior year
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults | NCT04537949 | Contradiction |
6,368 | 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:
- the patient has a recent mild or moderate COVID-19 with no or low-grade fever 99.5-
100.94 °F (37.5-38.3 °C). Mild COVID-19 included that the patient has symptoms of
acute upper respiratory tract infection (fever, cough, myalgia, runny nose, fatigue,
sore throat, sneezing) or gastrointestinal symptoms (nausea, vomiting, abdominal pain,
diarrhea). Moderate grade of COVID 19 included that the participant has pneumonia
(cough, frequent fever) with no obvious hypoxemia, the presence of lesions on chest CT
Exclusion Criteria:
- that patient was not hospitalized and has moderate or high-grade fever <100.94 °F
(<38.3 °C) or other chronic diseases such as heart problems, hypertension or diabetes.
Women how were using contraceptives were excluded due to contraceptives decrease
immune functions and might affect the subjectivity to autoimmune disorders with marked
increases in risk for various autoimmune disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Years old.
Subject must be at most 45 Years | The Effect of Aerobic Exercise on Immune Biomarkers and Symptoms Severity and Progression in Patients With COVID-19: A Pilot Randomized Control Trial | NCT04581291 | Entailment |
485 | 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:
- Female subjects of childbearing age, who are being screened for pregnancy and who have
signed the informed consent
Exclusion Criteria:
- Subject is post-menopausal.
- Subject within the past six weeks has experienced any of the following: delivered a
newborn; had an abortion or a natural termination (miscarriage); or, received hCG
supplements.
- Subject has had a hysterectomy.
- Unable to understand and consent to participation.
Female
No healthy subjects accepted to join the trial.
| Sofia hCG FIA Field Study | NCT01803113 | Contradiction |
1,705 | 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. Between the ages of 15-49 years;
2. Consent to participation;
3. Resident of at least 6 months in study community;
4. Enrollment into RCCS at baseline (2005-06);
5. Report of sexual activity or being in a partnership in the year prior to the baseline
interview;
6. Provision of follow-up information on variables of interest.
7. For HIV incidence, only participants with initial HIV-negative serostatus at their
baseline visit were included in the analyses.
Exclusion criteria:
1. Younger than 15 years and older than 49 years;
2. Did not consent to participation;
3. Non-resident in study community;
4. Not enrolled in RCCS between 2005-06;
5. Not yet sexually active or not sexually active during year prior to baseline;
6. Incomplete follow up information on variables of interest;
7. HIV positive at baseline
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 49 Years | Assessing the Impact of an Intervention to Prevent Intimate Partner Violence and HIV in Uganda | NCT02050763 | Entailment |
2,574 | 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:
- Male and female children aged 2 - 8 years
- physical status classification system (ASA) score I or II
- Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)
Exclusion Criteria:
- Hypersensitivity to Levobupivacaine
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 8 Years | Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery | NCT00970086 | Contradiction |
4,596 | 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:
Healthy women who meet the following criteria:
- Aged 18-<40 years who wish to use a combined hormonal contraceptive.
- Women not intending to become pregnant for 13 months.
- Intact uterus and both ovaries.
- Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal
contraception; if postpartum or postabortal, history of regular menstrual cycles of
21-35 days in length and at least one cycle (2 menses) with a cycle length consistent
with her past cycles.
- Sexually active (currently) and willing to discontinue current contraceptive method to
participate in the study.
- In the opinion of the investigator, able to comply with the protocol, e.g. live within
the clinic catchment area or within a reasonable distance from the clinic.
- Do not meet any of the exclusion criteria.
- Signed informed consent prior to entry into the trial.
[For pharmacokinetics study only; 39 subjects already recruited]
- Willing to undergo frequent blooding sampling
Exclusion Criteria:
Contraindications for enrollment will be the same as those for use with combined hormonal
contraceptives in addition to contraindications specific to this clinical trial including:
- Known hypersensitivity to estrogens or progestins.
- Known hypersensitivity to silicone rubber.
- Known or suspected pregnancy.
- History of infertility of >1.0 year in woman or her male partner.
- History of vasectomy or sterility in male partner; tubal ligation (sterilization) in
women.
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed
at screening with a chlamydia or gonococcus infection may be included in the trial
following treatment; partner treatment is also recommended. Investigators should make
a determination if subjects are at high risk for reinfection, e.g. multiple sex
partners, untreated partner, and whether such subjects can be included.)
- History of pelvic inflammatory disease since last pregnancy episode.
- History of toxic shock syndrome.
- Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative
may participate provided there is follow up for this finding per standard of care).
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a
vaginal ring.
- Women planning to undergo major surgery.
- Smoking in women who are 35 years and over or will be 35 years during the course of
the trial; women < 35yrs who smoke 15 cigarettes or more must be evaluated by the PI
for inclusion based on risk factors that would increase their risk for CVD, e.g. lipid
levels, glucose level, BP, BMI, family history of CVD at a young age.
- Breastfeeding.
- Current or past thrombophlebitis or thromboembolic disorders.
- History of venous thrombosis or embolism in a first-degree relative, <55 years of age
suggesting a familial defect in the blood coagulation system, which in the opinion of
the PI, suggests use of a hormonal contraceptive could pose a significant risk.
- Cerebrovascular or cardiovascular disease.
- History of retinal vascular lesions, unexplained partial or complete loss of vision.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- Past history of any other carcinoma unless in remission for more than 5 years.
- Current or history of medically diagnosed severe depression, which, in the opinions of
the investigator, could be exacerbated by use of a hormonal contraceptive.
- Headaches with focal neurological symptoms.
- Severe constipation.
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
- Benign or malignant liver tumors; active liver disease.
- Diastolic blood pressure (BP) 85 mm Hg and/or systolic BP 135 mm Hg after 5-10 minutes
rest.
- Known or suspected alcoholism or drug abuse.
- Abnormal serum chemistry values according to the physician's judgment.
- Participation in another clinical trial within last 30 days.
- Weight >95 kg or >209 lbs.
- Use of liver enzyme inducers on a regular basis.
- Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months
before initiation of treatment. Use of Depo-Provera [depo-medroxyprogesterone (DMPA)]
unless suspended 6 months before treatment.
- Current use of implanted hormonal contraceptives, including Mirena® [progestin
containing intrauterine system (IUS)], Jadelle®, Norplant® or Implanon® (subjects
using any of these methods who request removal for reasons unrelated to the purpose of
enrollment in this study may be considered for participation).
- Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons
unrelated to the purpose of enrollment in this study may be considered for
participation.
- Known HIV infection.
- Women at high risk of contracting HIV, e.g. women with multiple sex partners who need
to use condoms consistently, injection drug users. If women enrolled in the study do
use condoms to protect against STIs, they should be instructed that this occasional
use should be with non-N-9 containing condoms and they should record condom use in
their diaries. Women found to have an STI at screening will be treated prior to
inclusion in the study (with the exception of those infected with HIV).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol | NCT00263341 | Contradiction |
1,341 | 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:
- a diagnosis of achondroplasia or hypochondroplasia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
| C-Type Natriuretic Peptide and Achondroplasia | NCT01541306 | Entailment |
5,855 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male and female patients over the age of 18 years.
- Women in the follicular phase of the menstrual cycle (visits will be arranged so that
in menstruating women, the study will be started in the follicular phase of the
menstrual cycle to standardise for possible confounding effects of the menstrual cycle
on symptom perception).
- Able to give informed consent
- Able to speak and understand English without the need for an interpreter
- No evidence of erosive esophagitis by OGD
- Presence of chest pain, heartburn, and/or regurgitation ≥ 3 days/week
- Normal acid exposure on MII-pH
- Positive symptom reflux association on MII-pH (symptom index ≥ 50% and symptom
association probability ≥ 95%)
- OGD is performed within 2 years before the enrolment
- MII-pH study is performed within 2 year before the enrolment
Exclusion Criteria:
- Current or previous GI or medical illnesses that may affect ANS / GI function
- Current or previous significant CNS illness
- Current medications affecting the CNS, GI or ANS systems
- Pregnancy and lactation
- Cardiac dysrhythmias
- Those who do not have access to the internet-based questionnaire
- The use of acid suppression therapies (e.g. proton pump inhibitor or H2 blocker)
or pain modulators (e.g. low-dose Tricyclic Antidepressants, TCAs or Selective
Serotonin Reuptake Inhibitors, SSRI) does not change the decision of
participation as long as above-mentioned symptoms remain.
Patients are asked to refrain from smoking for 12 hours and drinking alcohol as well as
using recreational drugs for 48 hours prior to study visit.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effect of Autonomic Modulation on Symptoms in Patients With Reflux Hypersensitivity | NCT04253444 | Contradiction |
2,548 | 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:
- Male and female children aged ≥6 months to ≤6 years
- Baseline PEST score of 3- 4
- Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the
NESS
- Diagnosis of current flare (increased dryness, itching, redness, swelling and general
irritability) at baseline visit according to Investigator's judgement
- Patients who have not visited the dermatologist before (dermatologist-naïve)
- Agree to participate and provide written consent by parent or guardian (and assent if
applicable)
Exclusion Criteria:
- History of severe episodes of atopic dermatitis (for example: oozing, crusts)
- Clinical signs of skin infection (viral, bacterial or fungal)
- Grading of >11 as defined by the Nottingham Eczema Severity Score (NESS) within 3
months prior to study inclusion
- Known reaction or allergy to test drug or excipients or steroids
- History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or
cutaneous bacterial disease requiring a topical or systemic therapy during the study
period
- Patients who are receiving any investigational drug or who have taken part in a
clinical study with an investigational drug within three months prior to the start of
study treatment
- The patient has been exposed to below therapy within the set timeframe:
i. Systemic administration of corticosteroid - four weeks; ii. Systemic administration
of immunosuppressive drugs - four weeks; iii. UV therapy four weeks
- Any serious medical condition which, in the opinion of the investigator, may interfere
with the evaluation of the results
- Parents/guardians may be unable to complete the patient diaries or questionnaires
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 6 Years | Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen | NCT02073591 | Entailment |
1,351 | 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. | Patients and their families with known or suspected genetic disorders within the following
categories will be recruited:
Hereditary connective tissue disorders;
Phacomatoses;
Chromosomal disorders;
Dysmorphic syndromes;
Neuromuscular or neurological disorders;
Inherited immunological and hematologic disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Clinical and Molecular Manifestations of Genetic Disorders | NCT00001466 | Entailment |
508 | 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:
- Willing and able to use OCs or DMPA
- General good health (by volunteer history and investigator assessment) without any
clinically significant systemic disease
- Currently having regular menstrual cycles of 25 to 35 days by volunteer report
- History of Pap smears and follow-up consistent with American Congress of Obstetricians
and Gynecologists (ACOG) practice bulletin #99 or #109 or willing to undergo a Pap
smear at Visit 1
- Willing to follow protocol requirements including abstinence, use of study condoms,
and prohibited use of intravaginal products
- Willing to follow post-biopsy restrictions for at least 5 days following genital
biopsies
- Meets one of the following criteria:
1. Sexually abstinent and planning to remain abstinent for the duration of the
study.
2. In a mutually monogamous relationship for at least the last 4 months with a male
partner who is at least 18 years of age, willing to use condoms, and has no known
HIV infection or risks for sexually transmitted infections (STIs)
3. In a mutually monogamous same-sex relationship for at least the last 4 months
with a partner who is at least 18 years of age and has no known HIV infection or
risks for STIs
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Negative urine pregnancy test
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures, as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within 2 calendar months from the last pregnancy outcome. (Note:
If recently pregnant must have had at least 2 spontaneous menses since pregnancy
outcome.)
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of DMPA in the last 6 months
- Protection from pregnancy by presence of a copper IUD
- Currently breastfeeding or having breastfed an infant in the last 2 months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study product, or topical
anesthetic, or allergy to both silver nitrate and Monsel's solution
- Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 6
months. (Note: Women with a history of genital herpes or condylomata who have been
asymptomatic for at least 6 months may be considered for eligibility.)
- Positive test for Trichomonas vaginalis, Neisseria gonorrhoeae or Chlamydia
trachomatis
- Symptomatic vulvovaginal candidiasis, Nugent score greater than or equal to 7 at
screening or bacterial vaginosis (BV) at Visit 2, or urinary tract infection (UTI)
- Deep epithelial genital findings such as abrasions, ulcerations, or lacerations, or
vesicles suspicious for STIs
- Positive test for HIV
- Positive test for Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Chronic or acute vulvar or vaginal symptoms (e.g., pain, irritation, or spotting)
- Contraindications to the chosen contraceptive method
- Known current drug or alcohol abuse which could impact study compliance
- Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS
Table for Grading the Severity of Adverse Events
- Participation in any other investigational trial (device, drug, or vaginal trial) in
the last 30 days or planned participation in any other investigational trial during
the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix in the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, antifungals, antivirals or antiretrovirals
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use | NCT01421368 | Contradiction |
1,108 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Identifying High Risk Patients With Syncope | NCT00005202 | Entailment |
2,890 | 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:
- Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
according to EI Escorial diagnostic criteria
- Age: 18-70 years
Exclusion Criteria:
- Refuse to cooperate or reject the informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China | NCT04328675 | Entailment |
1,678 | 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 with common hand conditions
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.
| Question Prompt List for Common Hand Conditions | NCT03868449 | Entailment |
2,527 | 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:
- Pediatric subjects aged ≥ 2 to 17 years, inclusive
- Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.
- Subjects with active inflammation associated with AD.
- Subjects with an Investigator's Global Assessment (IGA) score of at least 2 at
screening and baseline.
- Subjects with body surface area (BSA) of AD involvement of 8% to 20% at screening and
baseline.
- Subjects who agree to discontinue all agents used to treat AD from screening through
the final follow-up visit.
- Subjects of childbearing potential must agree to take appropriate precautions to avoid
pregnancy or fathering a child for the duration of study participation.
- Written informed consent of the parent(s) or legal guardian and a verbal or written
assent from the subject when possible.
Exclusion Criteria:
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined
by the investigator over the previous 4 weeks before baseline.
- Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream)
within 2 weeks of baseline.
- Concurrent conditions and history of other diseases:
- Presence of AD lesions only on the hands or feet without a history of involvement
of other classical areas of involvement such as the face or the flexural folds.
- Other types of eczema.
- Any other concomitant skin disorder (eg, generalized erythroderma such as
Netherton Syndrome, or psoriasis), pigmentation, or extensive scarring that in
the opinion of the investigator may interfere with the evaluation of AD lesions
or compromise subject safety.
- Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,
Wiskott-Aldrich syndrome) or have a history of malignant disease within 5 years
before the baseline visit.
- Chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before
the baseline visit.
- Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster,
chicken pox) skin infection within 1 week before the baseline visit.
- Chronic asthma requiring more than 880 μg of inhaled budesonide or equivalent
high dose of other inhaled corticosteroids.
- Subjects with cytopenias at screening per protocol-defined criteria.
- Use of the following medications:
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable
corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine)
within 4 weeks or 5 half-lives of baseline (whichever is longer).
- Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole
within 2 weeks or 5 half lives, whichever is longer, before the baseline visit
(topical agents with limited systemic availability are permitted).
- Subjects who have previously received JAK inhibitors, systemic or topical (eg,
ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
- Current treatment or treatment within 30 days or 5 half-lives (whichever is
longer) before the baseline visit with another investigational medication or
current enrollment in another investigational drug protocol.
- Use of any prohibited medications within 14 days or 5 half-lives (whichever is
longer) of the baseline visit.
- Parent or legal guardian who, in the opinion of the investigator, is unable or
unlikely to comply with the administration schedule and study evaluations or are
unable or unwilling to apply the study drug.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 17 Years | A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis | NCT03257644 | Entailment |
5,944 | 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:
- willingness to participate (based on the signed informed consent form);
- presence of gastroesophageal reflux disease, based on the following: a) typical
symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should
be present at least weekly, be actual for at least 3 months prior to the enrolment,
and the patient should report the history of symptoms which lasts for at least 6
months); b) previous response to the intake of proton pump inhibitors; c) data of
24-hours oesophageal pH-impedance monitoring with detected pathological
gastroesophageal reflux according to the Lyon consensus definitions;
Exclusion Criteria:
- pregnant or breast-feeding females;
- abdominal or chest surgery (except appendectomy or cholecystectomy in case they are
not followed by adhesive disease of the abdominal organs);
- constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of
NSAIDs will be allowed in case the course of treatment was discontinued at least 2
weeks prior to the enrolment, in case that constant use of NSAIDs happen to be
necessary after the enrolment, the patients may continue in the study but doses,
frequency and duration of treatment should be carefully documented;
- history or current evidence of cancer of any aetiology and location besides skin
cancer in situ successfully treated before the enrolment;
- severe patient's conditions which may lead to misinterpretation of data, or in case of
patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in
cases when on discretion of the investigator patient's condition would not allow him
to complete the course of the observation. These conditions include, but not limited
to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe
neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe
depression or other psychological disorders;
- the patient may stop his participation in the study at any time by informing the site
personal about his/her decision to withdraw the consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence | NCT04255693 | Contradiction |
2,374 | 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:
- Patients 8 - 16 years of age at time of enrolment
- Male
- Presence of cardiac involvement/dysfunction, defined by abnormal peak systolic strain
in left ventricle (LV) inferolateral wall
- Confirmed diagnosis of DMD (out of frame dystrophin gene deletion OR absent/<5%
dystrophin protein on muscle biopsy; clinical picture consistent of typical DMD)
- If on chronic glucocorticosteroids treatment (deflazacort, prednisone) for DMD (or any
other disease) (i.e. concomitant medication): dosage must be stable (unchanged) 6
months prior to inclusion
- If on chronic medication for DMD associated cardiomyopathy (β-blocker, diuretics):
dosage must be stable (unchanged) 3 months prior to inclusion
- Ability to provide reproducible repeat quantitative muscle testing (QMT) upper limb
score within 15% of first assessment score (at Visit1/Day 1 versus Screening Visit
Exclusion Criteria:
- Symptomatic cardiomyopathy or heart failure
- Asymptomatic but severe cardiac dysfunction on baseline (Screening) evaluation:
Fractional shortening (FS) < 20% and/or Ejection fraction (EF) < 40%
- Use of ACE-inhibitors
- Previous history of ventricular arrhythmias (other than isolated ventricular
extrasystole); ventricular arrhythmias presented at Screening
- Previous (6 months or less) participation in any other therapeutic trial for DMD
- Use of coenzymeQ10, idebenone, creatine, glutamine, oxatomide, or any herbal medicines
within the last 6 months
- History of significant concomitant illness or significant impairment of renal or
hepatic function
- Known individual hypersensitivity to idebenone
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 16 Years | Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy | NCT00654784 | Entailment |
2,907 | 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:
1. Subject has the ability to understand the purpose and risks of the study and provide a
signed and dated informed consent and authorization to collect and use protected
health information (PHI) in accordance with national and local subject privacy
regulations.
2. Subject lives within reasonable driving distance of study center (approximately 3
hours).
3. Subject has a caregiver willing/able to assist in the transportation and care required
by study participation.
4. Subject is 18 - 80 years of age (inclusive) on the first day of the Screening Period.
5. Subject is diagnosed with sporadic or familial ALS within the past 48 months.
6. Subject meets the laboratory-supported probable, clinically probable, or definite
criteria for diagnosing ALS according to the World Federation of Neurology El Escorial
criteria.
7. Subject has an upright FVC ≥65% of predicted value for age, height, and gender at
Screening.
8. Subject has not taken riluzole for at least 30 days prior to the first day of the
Screening Period, or has been on a stable dose of riluzole for at least 30 days prior
to the first day of the Screening Period (Riluzole-naïve subjects are permitted in the
study).
9. Subject is medically able to undergo the study procedures and physically able to
adhere to the visit schedule at the time of study entry.
10. Women of childbearing capacity must have a negative pregnancy test during the
Screening Period and at the Pre-Operative Visit.
11. Subject must agree to practice effective birth control during study participation.
Exclusion Criteria:
1. Subject in whom causes of neuromuscular weakness other than ALS have not been
practically excluded.
2. Subject with a diagnosis of significant cognitive impairment, clinical dementia, or
major psychiatric illness including psychosis, bipolar disease, major depression, as
determined by the DSM-V.
3. Subject with a diagnosis of other neurodegenerative disease (e.g., Parkinson's
disease, Alzheimer's disease).
4. Subject with a diagnosis of any medical condition that impairs nerve or muscle
function (e.g., notable peripheral neuropathy, metabolic muscle disease).
5. Subject with a clinically significant history of unstable cardiac, pulmonary, renal,
hepatic, endocrine, hematologic, or active malignancy or infectious disease or other
medically significant illness, which, in the opinion of the Investigator, would
preclude study participation.
6. Subject with a history of spine surgery or anatomic variation incompatible with route
of administration (as determined by neurosurgeon).
7. Subject with severe cervical or lumbar stenosis, cord compression, or cervical or
lumbar myelopathy.
8. Subject with abnormal flow voids on the surface of the spinal cord suggestive of
arteriovenous malformation (AVM).
9. Subject demonstrating any evidence of CNS malignancy or CNS lesions as defined by
imaging studies of the CNS (MRI of brain and spinal cord).
10. Subject having uncontrolled hypertension (Systolic BP>180mmHg and/or Diastolic BP
>110mmHg) or having a history of thrombotic events or poorly controlled medical
conditions that, in the opinion of the Investigator and/or surgeon, increase risk of
surgery.
11. Subject who cannot undergo MRI examination because of the presence of a pacemaker, an
implanted defibrillator or certain other implanted electronic or metallic devices, or
who have been or might have been exposed to metal fragments, or any reason the subject
cannot undergo an MRI routinely for the duration of the trial.
12. Subject with clinically significant abnormal clinical laboratory values, as determined
by the Investigator during the Screening Period.
13. Subject who is immune compromised or who has a condition contraindicated to treatment
with immunosuppression agents (e.g., tuberculosis, latent infection).
14. Subject with an aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
value >3.0 times the upper limit of normal or creatinine >1.5 times the upper limit of
normal and/or eGFR <50cc/min during the Screening Period.
15. Subject with a history of alcohol or drug abuse or dependence within 1 year of the
first day of the Screening Period, per DSM-V criteria.
16. Subject unlikely to comply with study requirements, as determined by Investigator.
17. Subject who has been exposed to any other experimental agent (off-label use or
investigational) within 30 days of the first day of the Screening Period. Biologic
agents may need additional time for washout and will be evaluated by the Sponsor on a
case-by-case basis.
18. Subject who has previously been administered stem cells.
19. Subject with pre-existing anti-human leukocyte antigen (HLA) class I or class II
antibodies directed against the Q-Cells®, as determined by panel reactive antibody
(PRA) assay during the Screening Period.
20. Subject with an allergy to Q-Cells® or any of its constituents (e.g., chicken eggs),
or an allergy to any of the co-administered immunosuppressants or any of their
excipients.
21. Subject with any medical condition or using concomitant medication that would
contraindicate the use of tacrolimus, mycophenolate mofetil, or prednisone as
determined by Investigator.
22. Subject with evidence of deep vein thrombosis (DVT) by venous ultrasound or any
previous evidence of DVT.
23. Subject who, in the opinion of the Investigator, has taken or is taking concomitant
medications, supplements, or other agents that may interfere with the safety
evaluation of Q-Cells® or may affect the course of the subject's ALS progression.
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 to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS) | NCT02478450 | Entailment |
1,381 | 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:
Hirschsprung Disease, surgery
Exclusion Criteria:
-
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 | Registry for Hirschsprung Disease of the BELAPS | NCT04622410 | Entailment |
4,740 | 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:
- all patient presented by thyroid nodules either discovered clinically or incidentally.
Exclusion Criteria:
- no
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Clinical Diagnostic Approach for Cases of Thyroid Nodules | NCT03884140 | Contradiction |
5,220 | 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:
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or
have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean
value and also have at least one prevalent vertebral body fracture
Exclusion Criteria:
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI >32 kg/m
- use of medications within 3 months of starting study drug that impact bone metabolism
such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
parathyroid hormone
- hypocalcemia or hypercalcemia of any cause
- markedly abnormal clinical laboratory measurements that are assessed as clinically
significant by the investigator
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis | NCT00541658 | Entailment |
4,744 | 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:
- 18 years of age or older with the ability to provide informed consent
- English as the primary language
- Medically and psychologically suitable
- Willing to receive/have received meningitis vaccinations
- Able to pay for all care received through the study, either through the subject's
insurance company or through self-pay
- Able to comply with study requirements, including travel to the investigational sites
- Severe to profound sensorineural hearing loss (≥70 dB HL (decibel hearing level)
thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20%
Consonant-Nucleus-Consonant (CNC) word scores
- Duration of single-sided deafness ≥ one year
- Tinnitus localized to the affected ear, both ears, or in the head localized to the
affected ear, both ears, or in the head
- Expected subjects include those with:
- Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis
or labyrinthitis
- Ménière's disease
- Sudden sensorineural hearing loss
- Vascular disease affecting the inner ear
- A combination of any number of the above conditions
Exclusion Criteria:
- Duration of single-sided deafness ≥ ten years
- Pure tone thresholds ≥ 35 dB HL at 500, 1000, 2000, and 4000 Hz in the better ear
- Consonant-Nucleus-Consonant (CNC) word scores ≤ 70% in the better ear
- Chronic otitis media in either ear
- Inner ear malformation in either ear
- Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear)
- Evidence of retrocochlear pathology, including vestibular schwannoma
- Unilateral tinnitus in the unaffected ear
- Cochlear ossification
- Demonstrated cognitive and/or developmental challenges
- Major depression or anxiety; post-traumatic stress disorder; substance abuse
- Medical or psychological conditions that serve as contraindication to surgery
- Additional handicaps that would prevent or limit participation in evaluations
- Unrealistic patient or family expectations regarding the benefits, risks, and
limitations inherent to the procedure and the prosthetic device
- Pregnant women: The investigators will specifically ask all women of childbearing age
if there is a possibility they are pregnant or trying to become pregnant at the
initial clinic visit; any women who are pregnant or actively trying to become pregnant
will be excluded. In cases that are questionable on the day of planned surgery, a
pregnancy test will be performed as per current Massachusetts Eye & Ear Infirmary
anesthesia pre-operative protocols.
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.
| Cochlear Implantation for Treatment of Single-sided Deafness | NCT02532972 | Contradiction |
3,590 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
1. When subject signs the informed contest, 18≤ age ≤ 40, Male or female;
2. Body weight: male ≥50 kg, female ≥45 kg. Body mass index (BMI) of 19.0 to 26.0 kg/m²,
inclusive;
3. Subject's with normal or or abnormity without clinical significance judged by the
investigator by physical examination, vital signs, electrocardiogram, blood routine,
blood biochemistry, coagulation tests, fecal occult blood, urine routine, serological
tests and other important indicators;
4. All subjects who adopt effective non-hormonal contraceptive measures (such as condoms,
intrauterine devices without drugs, etc.) from the signing of informed consent to
three months after the end of the study;
5. Subjects who voluntarily signed the informed consent and are able to cooperate to
complete the test according to the protocal.
Exclusion Criteria:
1. Allergic history to more than one drug or other serious allergic rhistory;
2. Serious diseases of the central nervous system, cardiovascular system, digestive
system, respiratory system, urinary system, blood system, metabolic disorders or other
diseases (such as history of psychosis, malignant tumors, etc.)In the past or now,
which were not suitable for clinical trials.
3. History of abnormal bleeding or coagulation disorders (e.g. prone to bruising, gum
bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, menorrhagia,
postpartum hemorrhage, vitamin K deficiency, haemorrhagic diseases caused by acquired
coagulation factor antibodies, trauma, wound or post-operative bleeding, etc.);
4. History of severe head trauma in 2 years;
5. Severe gastrointestinal diseases occurred within three months before signing informed
consent, which affected drug absorption;
6. Have a disease which Haemorrhage could cause serious consequences, such as peptic
ulcer;
7. Had undergone surgery within six months before signing the informed consent; planned
to undergo surgery (including cosmetic surgery, dental surgery and oral surgery)
within two weeks after the end of the trial; or planned to take part in vigorous
exercise (including physical contact exercise or collision exercise) during the trial;
8. Bleed or donated more than 400 mL within three months before signing informed consent,
or planned to donate blood during the study or within one month after the end of the
trial;
9. Have taken any prescription drugs, nonpreserip drugs, biological products, traditional
Chinese medicines, herbal medicines, vitamin dietary supplements and health products
within four weeks before signing the informed consent or use oral long-acting
contraceptives or implanted long-acting contraceptives;
10. Subjects participating in other clinical trials and taking trial products, or
participated in any other clinical trials of drugs within three months before signing
the informed consent;
11. History of drugs or drug abuse or alcoholics or drug abuse screening shows positive
response;
12. current or past alcoholics (drinking more than 14 standard units per week, 1 Standard
unit containing 14g alcohol, such as 360 mL beer or 40% spirits or 150 mL wines with
45 mL alcohol), or alcohol breath test positive;
13. Smokers: The average daily smoking volume was more than 5 cigarettes within six months
before signing the informed consent;
14. Habitually consume excessive caffeine-containing beverages or foods, or foods that may
affect drug metabolism within four weeks before signing informed consent. Such as:
coffee (no more than 1100 mL per day), tea (no more than 2200 mL per day), cola (no
more than 2200 mL per day), functional drinks (no more than 1100 mL per day),
chocolate (no more than 510 g per day);
15. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
16. QTc interval≥450 ms, electrocardiogram abnormality with clinical significance, or
prolonged history of QTc interval;
17. Abnormal results of chest X-ray (posterior and anterior) with clinical significance;
18. Female subjects: positive pregnancy tests or pregnant or breast-feeding or planning to
conceive, who plan to conceive within three months from the signing of informed
consent to the end of the study; male subjects: whose partners plan to conceive or
plan to donate sperm within three months from the signing of informed consent to the
end of the study;
19. Not suitable for this trial according to the investigator.
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 40 Years | Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers | NCT04036656 | Contradiction |
2,077 | 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:
prior asbestos exposure at least 20 years ago and/or documented pleural plaques (chest
x-ray evidence)
Resident of Ontario, Canada
Exclusion Criteria:
prior cancer (except non-melanotic skin cancer)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 85 Years | Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers | NCT00188890 | Entailment |
4,211 | 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:
- 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes.
- Treated with inhaled steroids and long acting beta agonists.
Exclusion Criteria:
- Active ischemic heart disease, heart failure, orthopedic problems that preclude
ergometric bicycle activity.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 70 Years | The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise | NCT00476736 | Contradiction |
4,239 | 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:
- Patients with non-obstructive Azoospermia
- Patients between 25 - 60 years old.
Exclusion Criteria:
- Patients with obstructive Azoospermia
- Men with previous surgery in testis
- Men with infectious genital diseases and anatomical abnormalities of the genital tract
- Those with major medical problems such as malignancy, hepatitis, etc.
- Chromosomal aberration (e.g. Y microdeleion, trisomy….)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 60 Years | Testicular Injection of Autologous Stem Cells for Treatment of Patients With Azoospermia | NCT02041910 | Contradiction |
6,537 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Male adults or children > 4 months of age.
2. Severe hemophilia A (FVIII < 0.01 U/ml).
3. Current or past high-responding inhibitor, anti-FVIII >= 5.0 B.U., ITI-refractory or
ITI-naive.
Exclusion Criteria:
1. Acquired hemophilia or any bleeding disorder other than hemophilia A.
2. Current use of Emicizumab, or if used, > 8 weeks since last treatment.
3. Use of an experimental drug(s).
4. Surgery anticipated in the next 48 weeks.
5. Life expectancy less than 5 years.
6. Patient/parent/caretaker unable or unwilling to keep a personal diary of bleeding
frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 8,
12, 24, 36, and 48.
7. Other illness, condition, or reason in the opinion of the investigator that would make
the patient unsuitable for the trial.
Male
No healthy subjects accepted to join the trial.
| The Hemophilia Inhibitor Eradication Trial | NCT04303572 | Contradiction |
58 | 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. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.
3. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from the time of signing
of informed consent throughout the duration of the study and for 12 weeks after the
last dose.
Exclusion Criteria:
1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality
that may impact the ability of the participant to participate or potentially confound
the study results. Participants will be excluded based on:
1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.
2. Is receiving dialysis treatment.
3. Has an American Urological Association (AUA)/ International Prostate Symptom
Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram
per milliliter (ng/mL) at Screening.
4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units
per liter (mIU/L) at Screening.
5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood
pressure >100 mm Hg (if out of range may be repeated once for eligibility
determination) at Screening.
6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.
7. Is receiving insulin therapy.
8. Has a hematocrit <30 percent (%) or >48% at Screening.
9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).
2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated
hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular
disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome,
systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or
prior pituitary surgery.
4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists,
antiandrogens, clomiphene, or other reproductive hormone-related agents within 6
months prior to Screening.
5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA],
androstendione, any other androgen, or recombinant human growth hormone) within 1 year
of Screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone | NCT02381288 | Contradiction |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.