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1,096 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- (near) syncope
Exclusion Criteria:
- age < 18 years
- progressive impairment of consciousness
- use of mind-altering drugs
- non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic
disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of
consciousness caused by craniocerebral injury
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.
| Syncope Patient Evaluation in the Emergency Department | NCT01916070 | Entailment |
3,897 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR
were included in the study
Exclusion Criteria:
- Unwillingness to participate in the study
- Recent history (within the last 3 months) of physical therapy to the same joint
- Recent history (within the last 3 months) of intra-articular procedure (injection
and/or lavage) to the knee
- History of knee surgery/fracture
- Acute synovitis/arthritis including the infectious conditions
- Taking pain relief medications
- Any metal implantation near site of stimulation
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 | Stimulate Brain and Reduce Knee Pain Due to Degeneration | NCT04320875 | Entailment |
1,518 | 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:
Age of 65 or older, MD determined medical stability, referred by MD for swallowing
evaluation because of suspected dysphagia, confirmed dysphagia by x-ray evaluation,
geographic access to return for clinic appointments, telephone in home, ability to perform
exercises, capacity to provide informed consent, frailty defined by Winograd et al
Exclusion Criteria:
Admitted from a nursing home after a longer than 3 month stay, previously enrolled in this
study, not able or willing to return for outpatient visits, unable to complete telephone
interviews, cerebrovascular accident within 90 days, medically unstable as determined by
MD, claustrophobia, known contraindications to MR imaging (e.g., pacemaker, aneurysm clip),
more than 2 dental crowns, poorly controlled psychosis, refractory alcoholism, other severe
disabling diseases resistant to medical management (e.g., class IV congestive heart
failure, end stage renal disease), allergy to barium, terminally ill (predicted survival
less than 6 months)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Effects of Age and Age-Related Diseases on Swallowing | NCT00038350 | Entailment |
4,848 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Aged 18-70 yrs
2. Body mass index (BMI) <35 kg/m2
3. Urine free cortisol (UFC) ≥150ug/d
4. Pituitary tumor >6mm on MRI or an inferior petrosal sinus sampling with central to
peripheral plasma adrenocorticotropic hormone (ACTH) gradient
5. Normal renal and thyroid function
6. HbA1c ≤8.0.
Exclusion Criteria:
1. Smoking
2. Alcohol >2 drinks/day
3. Uncontrolled hypertension
4. HIV given potential for lipodystrophic confounding
5. Pregnancy and nursing
6. Use of beta-blockers, β-adrenergic or diabetes medications other than insulin
7. History of claustrophobia or difficulty lying flat
8. In-dwelling metal hardware.
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 | Cushing's Lipodystrophy | NCT03817840 | Contradiction |
5,579 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- ability to provide written informed consent
- Prepubertal males and females form 5- 11years old
- Bone age <11 years in males and <9 years in females
- Height SD score<-2.25SD in males and females
- IGF-1SD score <-1SD in both males and females
- Peak GH level after stimulation >10ng/ml
Exclusion Criteria:
- History of prior chemotherapy and or radiation
- Active neoplasm
- Pediatric patients with closed epiphyses
- Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
- Treatment with inhaled or systemic steroids
- BMI <5th percentile or >95th percentile
- Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 11 Years | The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature | NCT01970800 | Contradiction |
3,344 | 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. | Hearing-impaired patients
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Measurement and Prediction of Outcomes of Amplification | NCT00013416 | Contradiction |
5,675 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Children age : 3 - 5 years old (36-60 months)
- Live in the research area
- Apparently healthy children, after examination by a physician
- Involved in a research study (informed consent signed by parent or guardian)
Exclusion Criteria:
- Children age < 36 month and > 60 month
- Live outside research area
- Unhealthy, after examination by a physician
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 5 Years | Immune and Scfa Profile of Stunting Children | NCT04698759 | Contradiction |
1,807 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. 18-65 years old
2. Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1
weeks before enrollment, and the modified Lanza score ≥ 2
3. Have at least two symptoms in four major symptoms (epigastric pain, epigastric
burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional
Gastrointestinal Disorders)
Exclusion Criteria:
1. Suspected upper gastrointestinal malignancy by endoscopy
2. Peptic ulcer and bleeding by endoscopy
3. Severe cardiac, hepatic or renal insufficiency
4. Severe neurological or psychological disease
5. Pregnant or lactating women
6. Have taken drugs which may affect evaluating the efficacy of study drug within two
weeks before enrollment (includes but not limits to: Proton pump inhibitors such as
omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor
antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium
carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and
other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum
magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as
amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone,
metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin,
ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen)
7. History of allergic reaction to the medications used in this study
8. Patients that investigators consider ineligible for this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis | NCT01284647 | Contradiction |
3,274 | 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:
- Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG)
American College of Rheumatology (ACR), or American College of Rheumatology/European
League Against Rheumatism (ACR/EULAR) criteria
- Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value
(during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline
value
- Baseline Ocular Surface Disease Index® (OSDI) total score ≥13
- Age greater than or equal to 22 years old
- Able to complete questionnaires independently
- Willing to sign the informed consent and deemed capable of complying with the
requirements of the study protocol
Exclusion Criteria:
- Use of any topical ophthalmic medication, including artificial tears, within 4 hours
of either visit
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the
opinion of the investigator, may lead to clinically significant increased bleeding
- Use of systemic anticoagulants
- Nasal or sinus surgery including nasal cautery or significant trauma
- Severely deviated septum
- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- Have an active implanted metallic or active implanted electronic device in the head, a
cardiac demand pacemaker, or an implanted defibrillator
- Known hypersensitivity to any of the procedural agents or materials in the study
device that contact the nasal mucosa
- Corneal transplant in either or both eyes
- Participation in any clinical trial within 30 days of the Screening Visit
- A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 22 Years old.
| TrueTear in Sjogren's Disease Patients | NCT03719885 | Entailment |
636 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | - Inclusion criteria:
- homozygous C282Y ;
- in the maintenance phase for at least 6 months ;
- follow-up at Rennes University Hospital ;
- patient who has not expressed his opposition to participate in the study.
- Exclusion criteria:
- Permanent: any cause of modification of the CST unrelated to hemochromatosis
(chronic inflammatory disease, excessive consumption of alcohol ...) ;
- Temporary: infectious syndrome within 7 days before bleeding.
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.
| Transferrin Saturation and Asthenia in Hemochromatosis | NCT03356548 | Contradiction |
228 | 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
- Regular menstrual periods for the last 2 cycles
- Currently not using hormonal contraceptives, including oral contraceptives, patch,
ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior
to study entry
- Currently not using tetracycline-class antibiotics
- Normal Pap smear
Exclusion criteria
- Pregnancy or breastfeeding within 2 months of study entry
- Chronic migraine headaches
- Uncontrolled high blood pressure
- Untreated sexually transmitted diseases
- Alcoholism or drug abuse within 12 months of study entry
- Insulin dependent diabetes
- Liver, kidney, or gallbladder disease
- Participation in another clinical trial within 30 days of study entry
- History of cancer
- History of blood clots, strokes, or heart disease
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Norplant and Irregular Bleeding/Spotting | NCT00064766 | Contradiction |
3,751 | 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:
- Knee osteoarthritis diagnosed by American College of Rheumatology clinical criteria
- Knee pain must be the primary musculoskeletal complaint participant is seeking
treatment for
- Pain duration greater than 3 months
- Pain severity ≥ 5/10 on Numerical Rating Scale
- Willing to abstain from simple analgesics and NSAIDs for 24 hours prior to testing
- Willing and able to give full consent
Exclusion Criteria:
- Lumbar or cervical radiculopathy,
- Systematic inflammatory disease,
- Positive screen for diabetic neuropathy
- Past medical history
- Previous surgery or disease of the peripheral or central nervous system,
- Sensory loss secondary to chemotherapy or radiotherapy
- Fibromyalgia
- Chronic fatigue syndrome
- Cognitive or psychiatric disorder interfering with ability to cooperate with
assessment
- Injection or physiotherapy treatment for knee joint within previous 3 months
- Taking anti-depressant or anti-convulsant medication
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.
| Pain Sensitization and Outcome Following Physiotherapy in Patients With Knee Osteoarthritis | NCT02310945 | Contradiction |
695 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y
- Patients regularly enrolled in a health insurance plan
- Patients with at least 10 natural teeth
- Patients who have given informed written, dated and signed consent
Exclusion Criteria:
- Diabetic patients
- Simultaneous participation in another study
- Pregnant or lactating women
- The incapacitated persons and persons deprived of their liberty
- Patients who do not speak French, both written and spoken
- Patients previously included in this trial
- Patients with heart valves or endovascular equipment (risk of infective endocarditis
...)
- Patients with a history of maxillofacial surgery
- Patients whose oral status is considered incompatible with entry into the study, at
the discretion of the investigator
- Patients on drugs that can cause gingival hypertrophy, such as Hydantoins (phenytoin),
Dihydropyridines, Diltiazem or Ciclosporin
- Patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet
agents and aspirin).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 64 Years | Haemochromatosis and Periodontitis | NCT04006249 | Entailment |
660 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- hemodialysis for three months minimum
- stable epoetin dose for two months minimum
- serum ferritin concentration < 1000 ng/ml
- transferrin saturation < 50%
- parathormone concentration < 800 pg/ml
Exclusion Criteria:
- hemoglobin concentration > 13g/dl
- serum ferritin concentration < 20 ng/ml
- vitamin B12 and/or folic deficiency
- other hematologic disease than anemia
- cancer
- hypothyroidism
- infectious disease
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.
| Changes in Iron Markers Following Iron Loading in Hemodialysis Patients | NCT00308490 | Contradiction |
343 | 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:
- 20-40 years old women
- Spontaneously ovulating women
- Treated in our IVF unit for frozen-thawed embryo transfer
- At least one top quality embryo
Exclusion Criteria:
- PGD patients
- More than 4 previous embryo transfers
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study | NCT02825290 | Contradiction |
1,442 | 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:
Eligible healthy volunteers must:
1. be at least 21 years of age;
2. have no speech, swallowing, or respiratory problems;
3. be in good general health;
4. not be on medications that would adversely affect swallowing ability.
Eligible dysphagic patients must:
1. be at least 21 years of age;
2. have a neurologic disorder (e.g., CVA, PD, PSD, CBD, MS, Gaucher, leukodystrophy,
cerebral palsy), musculoskeletal disease (e.g., polymyositis), or head and neck cancer
that has caused impairments in tongue function and swallowing;
3. present with oral or oropharyngeal dysphagia without aspiration based on results of
the standard modified barium swallow study.
4. have sufficient auditory comprehension and cognitive skills to follow test
instructions and understand the nature of the study.
EXCLUSION CRITERIA:
For healthy volunteers:
1. History of swallowing problems or other conditions that adversely affect swallowing
function, tongue motility and control, hearing, language, and cognition.
2. On medication (e.g., anticholinergics, antidepressants) that adversely affects
swallowing function, tongue movement, comprehension, or cognition.
3. Oral dryness that interferes with swallowing.
4. Unsatisfactory performance status, as judged by the examining speech-language
pathologist, that indicates poor compliance for the planned tasks (e.g., undiagnosed
oral motor deficits).
For dysphagic patients:
1. Aspiration, as identified via the modified barium swallow study.
2. Pregnancy, as determined via a urine pregnancy test prior to the MBS test.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Study of Tongue Pressures | NCT00013832 | Contradiction |
4,697 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. An age over 35 and below 50 years.
2. Menstruating women.
3. No symptomatic uterine prolapse. .
4. Normal cervical smears.
5. Benign lesions.
6. Active sexual life.
7. Functioning ovaries.
Exclusion Criteria:
1. Known endometriosis.
2. Overt neurological or psychiatric disorder.
3. Candidate for vaginal hysterectomy.
4. Use of hormone replacement therapy.
5. Oophorectomy.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Urinary and Sexual Functions After Subtotal Versus Total Abdominal Hysterectomy | NCT03087565 | Entailment |
2,312 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Diagnosis of DMD confirmed by muscle biopsy or DNA analysis
2. Age 7-15y
3. Ambulatory
4. No clinical evidence of heart failure
Exclusion Criteria:
1. Hypertension, diabetes, or heart failure by standard clinical criteria
2. Elevated BNP level (>100 pg/ml)
3. LVEF < 50%
4. Wheelchair bound
5. Cardiac rhythm disorder, specifically: rhythm other than sinus, SVT, atrial
fibrillation, ventricular tachycardia
6. Continuous ventilatory support
7. Liver disease
8. Renal impairment
9. Contraindications to tadalafil or sildenafil (use of nitrates, alpha-blockers, CYP3A
inhibitors, amlodipine, or other PDE5A inhibitors)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 15 Years | Tadalafil and Sildenafil for Duchenne Muscular Dystrophy | NCT01359670 | Entailment |
169 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male between the ages of 18 and 35
- Weight of at least 110 pounds
- Generally healthy (defined as an absence of a disease or medical condition which could
potentially be negatively influenced by study participation or confound study results)
- Low levels of habitual creatine consumption, defined as consuming an average of <10
g/week of creatine from all supplemental sources within the three months prior to
study initiation
- Willingness to report to baseline and final assessments with a similar haircut (i.e.
willingness to replicate baseline haircut prior final assessment, to the best of his
ability) and one that allows for evaluation of hair growth patterns (e.g., not a
completely shaved head that disallows visualization of the hairline)
- Willingness to adhere to the supplementation protocol for the duration of the study
(i.e., 6 months of daily supplementation with 5 grams per day of creatine monohydrate
or placebo) and abstain from additional creatine supplement ingestion during this
time.
- Willingness to abstain from any treatments related to hair loss or hair growth for the
duration of the study
- Willingness to maintain normal practices regarding hair products (i.e. continue to use
regular shampoo, conditioner, and other products over the duration of the study and
abstain from switching products during the study if at all possible)
Exclusion Criteria:
- Failing to meet any of the aforementioned inclusion criteria
- Presence of pacemaker or any electrical device (due to electrical currents
administered by bioimpedance devices used to assess body composition)
- Individual currently participates in any type of hair loss treatment or procedure or
has undergone any such treatment or procedure within the last 12 months
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments | NCT04298840 | Entailment |
2,113 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- Men diagnosed with infertility who consent to participate in the study
Exclusion Criteria:
- Prior hormone replacement therapy
- Antibiotic use in past 6 months
- Inability to consent for self, due to age or mental capacity
- Infertility attributable to identifiable causes other than hypogonadism
Male
Subject must be at least 18 Years old.
| Microenvironment and Male Fertility | NCT04704141 | Contradiction |
4,620 | 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:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with
oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine
bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to
participate.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice | NCT02367703 | Entailment |
6,373 | 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. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or
a molecular test ≤5 days prior to randomization. The test should have been authorized
by the relevant regulatory authority.
2. Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 days prior
to randomization:
1. Fever
2. New onset or worsening cough
3. Sore throat
4. Malaise or fatigue
5. Headache
6. Muscle pain (myalgias)
7. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
8. New onset or worsening shortness of breath (dyspnea)
9. New loss of taste (ageusia) and/or smell (anosmia). Note: any of these symptoms
(ageusia, anosmia) alone or in combination cannot be used as the SOLE qualifying
symptoms for enrollment.
3. At higher risk for progression to more severe COVID-19
1. Age ≥ 60 years
2. Age 18-59 years with a clinically stable medical history of at least 1 or more of
the following conditions that could lead to severe COVID-19:
- Chronic respiratory conditions such as asthma, chronic obstructive pulmonary
disease (COPD), pulmonary fibrosis
- Obesity with BMI ≥ 30 kg/m2
- Cardiovascular disease
- Sickle cell disease or thalassemia
- Diabetes mellitus being managed with concomitant medications
- Hypertension being managed with concomitant medications
- Chronic kidney disease
4. Oxygen saturation by pulse oximeter > 93% on room air
5. Negative pregnancy test (if woman of childbearing potential)
6. Females of childbearing potential and males with female partners of childbearing
potential must agree to use acceptable contraceptive methods from screening to Day 28
7. The patient must give informed consent
Exclusion Criteria:
1. Hospitalized patients
2. Patients who have received or are receiving other approved/authorized treatments to
prevent progression of COVID-19 disease severity, including but not limited to:
1. Monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab
2. Antiviral agents e.g., remdesivir
3. Other COVID-19 therapies used as part of the standard of care, e.g., convalescent
plasma, dexamethasone, baricitinib
3. Patients enrolled in interventional clinical trials for other experimental therapies
4. Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions
5. Patients with unstable comorbid conditions (e.g., decompensated congestive heart
failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes
mellitus, uncontrolled hypertension, uncontrolled asthma)
6. Patients with severe pulmonary comorbid conditions, including systemic
steroid-dependent asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung
transplant, or cystic fibrosis
7. Patients who have received highly immunosuppressive therapy (to include systemic
corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to
first dose of study drug
8. Patients with known or suspected intolerance or hypersensitivity to sargramostim, or
any component of the product
9. Patients who have previously experienced severe and unexplained side effects during
aerosol delivery of any kind of medical product
10. Pregnant or breastfeeding females
11. Patients who, in the opinion of the Investigator, will not be able to comply with all
the study procedures and visits as outlined in the schedule of events, including
follow-up
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.
| Sargramostim Use in COVID-19 to Recover Patient Health | NCT04707664 | Entailment |
6,659 | 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:
- Missing anterior teeth
Exclusion Criteria:
- Pregnancy
- Cigarette smoking
- Diabetes Mellitus
- Other significant medical conditions or habits likely to compromise bone healing
- Chronic use of medications likely to compromise bone healing
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Longitudinal Efficacy of Dental Implants in Anterior Areas | NCT00641277 | Contradiction |
6,628 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity
<2%, with or without inhibitors (any titer) are eligible.
- Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
- Age ≥18 years.
- Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not)
within the 6 months prior to screening.
- For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
- For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing
ITI.
Exclusion Criteria:
- History of any other coagulation disorder (particularly disseminated intravascular
coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
- History of diseases related to venous thromboembolic events (e.g., pulmonary embolism,
deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
- Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension,
uncontrolled diabetes).
- History of cardiac, coronary and/or arterial peripheral atherosclerotic disease
- Platelet count <100,000/μL.
- Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4
(CD4+) lymphocyte count of <200/mm^3
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors | NCT03597022 | Contradiction |
6,132 | 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. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any
specimen.
2. Hospital admission with at least one of the following:
- fever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from
tympanic or rectal site.
- Respiratory rate ≥ 24 bpm
- cough
3. Spontaneous breathing with or without hypoxia of any degree. Gas exchange and
ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any
system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP)
≤ 10 cmH2O.
4. ≤ 8 days since onset of the symptoms
Exclusion Criteria:
1. Pregnancy, or positive pregnancy test in a predose examination
2. Open tracheostomy
3. Therapy with high flow nasal cannula
4. Clinical controindication, as deemed by the attending physician
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.
| Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection | NCT04290858 | Contradiction |
5,092 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Healthy males and females between 45 to 80 years of age
- Postmenopausal females
- Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0
and -2.5, inclusive, for the lumbar spine [L1-L4] or total evaluable vertebrae [if
fewer than L1-L4] or total hip)
- 25-hydroxyvitamin D ≥ 20 ng/mL
- Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
Exclusion Criteria:
- Osteoporosis defined by bone mineral density (BMD) T-scores < -2.5 for the lumbar
spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip
- Diagnosed with any condition that would affect bone metabolism
- Previous exposure to AMG 785
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785) | NCT01825785 | Contradiction |
2,177 | 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:
- Males and females, age 18 years or older;
- Renal biopsy-proven diagnosis of ALECT2;
- For patients with kidney disease that could be due to ALECT2, a renal biopsy may be
obtained to confirm ALECT2 diagnosis.
Exclusion Criteria:
- There are no exclusion criteria for this observational study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease | NCT03774784 | Contradiction |
2,592 | 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:
- Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to
have a sperm test both prior to and following surgery.
Exclusion Criteria:
- History of prostatic surgery, testicular surgery, azospermia on first spermatogram,
single testis, patients after chemotherapy, patients receiving hormonal therapy,
patients receiving alpha blockers for any indication, patients who are receiving or
received oral antifungal therapy six months prior to surgery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Evaluating Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Fertile Males | NCT00282074 | Contradiction |
4,366 | 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:
- Age 60 years and older OR 20-30 years
- Higher functioning older adults: Score ≥ 11 on the Short Physical Performance Battery
(SPPB)
- Lower functioning older adults: Score ≤ 8 on the SPPB
- Body mass index: 20-35 kg/m2 to ensure homogeneity and strength of signal for EMG and
MRI analyses
- Willingness to participate in all study procedures
Exclusion Criteria:
- Failure to provide informed consent;
- Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator,
heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system,
cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal
slivers in the orbital area/eye socket
- active treatment for cancer or history of cancer in the past year
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure,
clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a
cardiac defibrillator, or uncontrolled angina;
- previous stroke with upper and/or lower extremities involvement within the last 6
months
- history of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or
severe neurological disorders likely to interfere with physical function
- renal disease requiring dialysis
- lung disease requiring steroids
- lower extremity amputation
- severe osteoarthritis or rheumatoid arthritis that interferes with physical function
- complicated diabetes requiring insulin
- A known diagnosis of dementia
- Unable to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or
intervention;
- Simultaneous participation in another intervention trial
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 100 Years | Development of Clinical Methods to Evaluate Neural Function in Aging | NCT02073201 | Entailment |
321 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women with a previous cesarean section
- who presented with postmenstrual spotting,
- sonohysterography had shown a isthmocele
Exclusion Criteria:
- Pregnancy,
- (suspected) malignancies,
- use of any hormonal contraceptives,
- fibroid,
- infection in the genital tract
Female
No healthy subjects accepted to join the trial.
| Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele | NCT04579965 | Contradiction |
4,963 | 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:
- Participant has a diagnosis of ET, defined as isolated tremor syndrome consisting of
bilateral upper limb action tremor for at least 3 years prior to screening, with or
without tremor in other locations and absence of other neurological signs, such as
dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and
position-specific tremors, sudden tremor onset or evidence of step-wise deterioration
of tremor.
- Participant scores at least 1.5 for each of the six items that comprise the combined
total upper limb TETRAS (total performance subscale part 4) with the total score for
the dominant upper limb (the sum of the three items for either the right or left upper
limb, whichever is dominant) being at least 5.5, at both Screening and predose on Day
1.
- Participant is willing to discontinue medications taken for the treatment of ET within
14 days or 5 half-lives prior to receiving IP. Medications taken for the treatment of
ET that were discontinued prior to receiving IP may be resumed following Day 29.
- Participant has no clinically significant findings, as determined by the investigator,
on Screening and pre-dose Day 1 physical examination including mental state
examination (MSE) and neurologic examination, 12-lead electrocardiogram (ECG), or
screening clinical laboratory tests.
Exclusion Criteria:
- Participant has a presence of known causes of enhanced physiological tremor.
- Participant has had recent exposure (14 days prior to Day 1) to tremorgenic drugs.
- Participant has had direct or indirect injury or trauma to the nervous system within 3
months before the onset of tremor.
- Participant has had a previous procedure for the treatment of ET, deep brain
stimulation, brain lesioning, or magnetic resonance (MR)-guided procedure, eg,
MR-guided focused ultrasound.
- Participant has historical or clinical evidence of tremor with psychogenic origin
(including but not limited to eating disorders, major depression, etc.).
- Participant has history of suicidal behavior within 2 years or answers "YES" to
questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at
Screening or at Day 1 or is currently at risk for suicide in the opinion of the
investigator.
- Participant has used any known moderate or strong cytochrome P450 3A4 and/or inducers
within 14 days or 5 half-lives (whichever is longer) prior to Day 1 or consumed
grapefruit juice, grapefruit, Seville oranges, pomegranates, tangelos, or St. John's
Wort or products containing these within 30 days prior to Day 1. Use of mild
cytochrome inhibitors and/or inducers may be permitted.
- Participant has concurrent or recent exposure (14 days or 5 half-lives, whichever is
longer, prior to the Day 1 visit) to sedative/hypnotic drugs, stimulants,
highly-caffeinated beverages or dietary supplements containing high doses of caffeine,
or recent increase above regular daily consumption of caffeine.
- Participant currently uses or has used within 14 days or 5 half-lives (whichever is
longer) prior to Day 1, any prescription or over-the-counter medication that is a
substrate of the OATP1B1 transporter.
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 Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor | NCT04305275 | Entailment |
5,362 | 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:
- Female subject from (and including) age 30 to 50 years
- Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months
- Predictable cyclic menstrual cycles over past 6 months
- Excessive uterine bleeding
- Premenopausal at enrollment
- Normal PAP
- Normal endometrial biopsy
- Willing to use reliable contraception
- Not currently taking hormonal medication
- Agree to use sponsor provided catamenial product (sanitary pads/tampons)
Exclusion Criteria:
- Pregnant
- Desires future childbearing
- Presence of an IUD
- Previous endometrial ablation procedure
- Evidence of STI
- Evidence of PID
- Active infection of genitals, vagina, cervix, uterus or urinary tract
- Active endometritis
- Active bacteremia, sepsis or other active systemic infection
- Gynecologic malignancy
- Endometrial hyperplasia
- Known clotting defects or bleeding disorders
- On anticoagulant therapy
- Hemoglobin <8gm/dl
- Prior uterine surgery
- Currently on medication that could thin myometrial muscle
- Severe dysmenorrhea, secondary to adenomyosis
- Abnormal uterine cavity
- Hydrosalpinx
- Uterine length <6cm or >12cm
- Currently in other clinical trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding | NCT01979861 | Contradiction |
6,169 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- All consecutive patients at participating centres referred for high-care unit or
intensive care unit admission who have suspected or known COVID-19
Exclusion Criteria:
- None
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.
| African Covid-19 Critical Care Outcomes Study | NCT04367207 | Contradiction |
5,250 | 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:
- be female
- at least 5 years post menopausal but <85 years
- be sufficiently mobile to undergo DXA and QCT scanning
- be able and willing to participate in the study and provide written informed consent
Exclusion Criteria:
- bi-lateral hip replacement
- have hip replacement on the non-fractured side
- have any history of cancer within the past 5 years excluding skin cancer non melanomas
- have a history of ongoing conditions or diseases known to cause abnormalities of
calcium metabolism or skeletal health (secondary osteoporosis)
- have a history of chronic renal disease (as defined by a creatinine clearance of ≤
30ml/min)
- Acute or chronic hepatic disease
- Malabsorption syndromes
- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- patients who are currently on glucocorticoid therapy
- have a history of any known condition that would interfere with the assessment of DXA
or CT of hip
- have markedly abnormal clinical laboratory parameters that are assessed as clinically
significant by the investigator
- have participated in another clinical trial involving active therapy 3 months prior to
randomisation
- have a known confusional state or dementia as documented in hospital notes, or be
unsuitable for approach in the opinion of the physician with duty of care
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years | 3D Imaging of the Hip Using DXA | NCT00666640 | Entailment |
5,653 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- healthy, female, aged 9-12 years
Exclusion Criteria:
- diagnosis of diabetes
- taking medications that alter body composition and bone mineral accrual
- physical disability that limits physical activity
- learning disability that would limit completion of questionnaires
Female
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 12 Years | Soft Tissue and Bone Development in Young Girls | NCT02654262 | Contradiction |
1,923 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | DISEASE CHARACTERISTICS:
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Locally advanced unresectable or metastatic disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10mm by spiral CT scan
- Bone metastases, ascites, or pleural effusions are not considered measurable
disease
- Evaluable disease must be present outside previously irradiated field
- No CNS or brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 mg/dL
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ ULN
- INR < 1.5
Renal
- Creatinine < 2.0 mg/dL
- Urine protein:creatinine ratio < 1.0
Cardiovascular
- No history of deep venous thrombosis requiring anticoagulation
- No active angina
- No myocardial infarction within the past year
- No cerebrovascular accident within the past year
- No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or
diastolic BP > 100 mm Hg) despite medical management
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
- No peripheral neuropathy > grade 1
- No history of allergy to any of the study drugs or drugs formulated with polysorbate
80
- No known HIV infection
- No active peptic ulcer disease
- No serious non-healing wound, ulcer, or bone fracture
- No unresolved bacterial infection requiring antibiotics
- No other active malignancy within the past 3 years except for cancers that have been
treated with a curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after
completion of non-taxane adjuvant chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since radiotherapy
Surgery
- At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter
placement)
- No concurrent surgery
Other
- At least 4 weeks since prior and no concurrent participation in another experimental
drug trial
- No concurrent full-dose anticoagulation
- No concurrent experimental drugs
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 120 Years | Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer | NCT00217581 | Entailment |
112 | 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:
Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass
lesions, Presence of gonadotropin response to GnRH, -
Exclusion Criteria:
diabetes mellitus, arterial hypertension other hormone deficiencies
-
Male
Accepts Healthy Volunteers
Subject must be at least 22 Years old.
Subject must be at most 35 Years | Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism | NCT02728440 | Contradiction |
516 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Female subject age 35 to 50 years, inclusive
2. Suffering from heavy menstrual bleeding with no definable organic cause and are
candidates for global endometrial ablation or surgical treatment
3. Have a histological finding in a recent (max 4-month-old, with a window of 1 month)
endometrial biopsy (Pipelle® or other non-treatment-based biopsy) that demonstrates
benign endometrial histology: proliferative endometrium and/or disordered endometrium
and/or histological findings associated with dysfunctional endometrium (e.g. irregular
shading, un-ovulatory bleeding and such); no histological findings of hyperplasia are
allowed
4. Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L).
FSH level measurement will be repeated in case of a borderline result
5. Screening hemoglobin levels >9.0 g/dL
6. Uterine sound measurement of 6.5-11 cm (external os to internal fundus)
7. PBAC score of >150 for 3 months prior to study treatment or PBAC score >150 one month
prior to study treatment for women who had at least 3 prior months (documented) of
failed medical therapy
8. Predictable, cyclic menstrual cycles
9. Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
10. Sexually active women must agree to use an effective method of contraception
throughout the course of the study. For this study, effective methods of contraception
are considered to be those listed below:
- Barrier method, i.e., (a) condom (male or female) with spermicide or (b)
diaphragm with spermicide or
- Vasectomy (partner), or
- Abstinence, if in line with the preferred and usual lifestyle of the subject
[where abstinence is defined as refraining from heterosexual intercourse]
11. Subject able to understand and sign a written informed consent form
12. Subject willing and able to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures
13. Demonstrates an understanding of how to record menstrual blood loss using a menstrual
pictogram
Exclusion Criteria:
1. Pregnant women or those who desire to conceive at any time in the future
2. Congenital malformation of the uterine cavity (bicornuate, septate)
3. Inability to visualize the uterine cavity because of intracavitary pathology and/or
significant uterine asymmetry, including patients with submucous myomas and/or polyps
and synechiae that heavily distort the uterine cavity
4. Underwent prior uterine surgery that interrupts the integrity of the uterine wall
(e.g., transmural myomectomy, classical Cesarean section, endometrial ablation,
hysteroscopic resection) or a uterine biopsy accompanied by curettage in the last 12
months
5. Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia,
endometrial cancer)
6. Have a documented clinical history of metal allergy or hypersensitivity
7. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active
sexually transmitted disease (STD)
8. Suffers from active infection of the genitals, vagina, cervix, or uterus
9. Presence of bacteremia, sepsis, or other active systemic infection
10. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
11. Known clotting defects or bleeding disorders or subjects who went through blood
transfusion (for any reason) in the three months prior enrollment
12. Currently using anticoagulant treatment
13. Subjects with abnormal Papanicolaou (Pap) test or atypical squamous cells of
undetermined significance (ASCUS) with positive high-risk human papilloma virus (HPV)
test result within the appropriate screen timeframe, and prior to SEAD™ treatment.
Alternatively, a colposcopy performed prior to SEAD™ treatment, that showed evidence
of dysplasia requiring treatment. In case treatment was performed > 6 months prior to
enrollment and follow-up was done with no evidence of disease by clinical evaluation,
the subject is eligible.
14. Previously had endometrial ablation procedure of any kind
15. Suffers from clinically significant adenomyosis indicated by subject complaints,
imaging or clinician's judgment
16. Presence of an implantable contraceptive device
17. Post-partum ≤ 6-months
18. Currently participating in or considering participation in a research study of an
investigational drug or device that would begin during the course of this
investigational study
19. Any general health or mental, or other situation or condition which, in the opinion of
the Investigator, could present an increased risk for the subject or impact the
subject's ability to comply with protocol requirements.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Study to Assess the Safety and Efficacy of the IUB SEAD™ Device | NCT04381416 | Contradiction |
3,181 | 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:
- The patient must be a member or beneficiary of a health insurance plan
- Patients with primary Sjögren's syndrome according to the AECG criteria
Exclusion Criteria:
- The subject is participating in a category I interventional study, or is in a period
of exclusion determined by a previous study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Pregnant, parturient or breastfeeding patients
- Patients with secondary Sjögren's syndrome
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.
| Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity | NCT04462601 | Entailment |
6,969 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Persons with age-related MCI or AD according to clinical diagnosis, consistent with
NIA-AA diagnostic criteria
2. Individuals with DS according to clinical diagnosis, with cognitive ability sufficient
to follow directions, Age > 30 years
3. Non-DS community-dwelling controls, Age > 60 years
4. Non-pregnant mothers and fathers of DS individuals (controls)
5. Ability to complete baseline assessments
6. Has an informant (study partner) available to complete functional interviews/survey
measures annually
Exclusion Criteria:
- Presence of concomitant medical, neurological, or psychiatric illness or condition
that in the opinion of the investigators would confound interpretation of study
results. These include: Korsakoff encephalopathy; active substance abuse; hepatitis C;
opportunistic brain infection; brain tumor; active neoplastic disease (skin tumors
other than melanoma are not exclusionary; participants with stable prostate cancer may
be included at the discretion of the project director); multiple sclerosis; history of
clinically significant stroke; current evidence or history in the past 2 years of
focal brain lesion, head injury with loss of consciousness, or DSM-V criteria for any
major psychiatric disorder, including psychosis, major depression, bipolar disorder,
alcohol or substance abuse; blindness, deafness or any other disability which may
prevent the participant from participating or cooperating in the protocol.
- Presence of contraindication for MRI scan for Non-Down Syndrome participants
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Rocky Mountain Alzheimer's Disease Center Longitudinal Biomarker and Clinical Phenotyping Study | NCT02612376 | Entailment |
105 | 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:
- Patient or eligible for care at Phoenix VA Health Care System
- Male ages 30-70 years
- testosterone level below 250 ng/dl before treatment
- able to provide informed written consent
Exclusion Criteria:
- evidence of pituitary tumor >1mm by MRI or CAT scan
- chronic illness (renal, cardiac, liver failure)
- Prostate specific antigen (PSA) >4.0 ng/ml
- history of prostate, breast, or testicular cancer
- eye disease compromising vision (e.g. cataracts)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Clomid in Men With Low Testosterone With and Without Prior Treatment | NCT01904734 | Contradiction |
285 | 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:
Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding
involving at least last three consecutive menstrual cycles.
Exclusion Criteria:
1. Postmenopausal bleeding (over one year since the last menstrual period).
2. Irregular menses or intermenstrual bleeding.
3. Organic causes of heavy menstrual bleeding suspected or confirmed by experienced
abdominal and transvaginal ultrasound after thorough general and gynecological
examination.
4. Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g.
non-progestogen-releasing intrauterine contraceptive device, oral contraceptives,
other hormonal drug use or anticoagulant agent).
5. Iron deficiency anemia.
6. History of chronic diseases known to interfere with menstrual bleeding or prevent the
use of any of the listed drugs e.g previous or current thromboembolic disease.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 45 Years | Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause | NCT02943655 | Contradiction |
5,651 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | - INCLUSION CRITERIA:
Good general health. Individuals taking medications for obesity-related comorbid conditions
will not be excluded.
Obesity: body mass index for age and triceps skinfold above the 95th percentile (determined
by NHANES I age-, sex-, and race- specific data). All subjects will be required to be over
60 kg in body weight.
Evidence for a quantifiable obesity-related comorbidity. Examples include: systolic or
diastolic hypertension (determined by age-specific charts); frank Type 2 diabetes, impaired
glucose tolerance assessed by oral glucose tolerance testing; hyperinsulinemia (defined as
a fasting insulin greater than 15 mIU/mL); significant hyperlipidemia (total cholesterol
greater than 200 mg/dL, LDL cholesterol greater than 129 mg/dL or fasting triglycerides
greater than 200 mg/dL); hepatic steatosis (SGPT or SGOT above normal range with negative
hepatitis studies) or sleep apnea documented by a sleep study.
Age 12 to 17 years at the start of the study.
For girls with childbearing potential, a negative pregnancy test before taking and while
taking study medication. Sexually active females must be using an effective form of birth
control. These methods include total abstinence (no sex), oral contraceptives ("the pill"),
an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone
acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam
with a condom is recommended.
Race of all four grandparents self-identified as either all Caucasian or all African
American.
EXCLUSION CRITERIA:
Volunteers will be excluded (and referred to non-experimental treatment programs) for the
following reasons:
Presence of renal, hepatic (other than obesity-related steatosis), gastrointestinal, most
endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (other than either asthma
not requiring continuous medication or sleep apnea-related disorders);
Adolescent girls who are pregnant, who are currently nursing an infant, or who are having
unprotected intercourse;
Individuals who have, or whose parent or guardians have, current substance abuse or a
psychiatric disorder or other condition which, in the opinion of the investigators, would
impede competence or compliance or possibly hinder completion of the study;
Subjects who regularly use prescription medications unrelated to the complications of
obesity. Oral contraceptive use will be permitted, provided the contraceptive has been used
for at least two months before starting study medication. The use of over-the-counter and
prescription medications will be reviewed on a case-by-case basis; depending on the
medication, subjects who have continued to take prescription medication for at least 3
months prior to study entry may be eligible;
Recent use (within six months) of anorexiant medications for the purpose of weight
reduction;
Inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac
pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear
implants, non-detachable electronic or electromechanical devices such as infusion pumps,
nerve stimulators, bone growth stimulators, etc. that are contraindications).
For pilot study participants, hypersensitivity or allergy to methylene blue. Individuals
with documented G6PD deficiency will be excluded.
INCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:
Volunteers will qualify for inclusion if they meet the following criteria:
1. Good general health.
2. Age 12-17 years at study entry.
3. Body mass index (BMI) for age above the 5th percentile and below 85th percentile,
which is considered normal weight by CDC growth chart standards.
4. For females with childbearing potential, a negative pregnancy test at initial
evaluation.
5. Race of all four grandparents self-identified as either all Caucasian or all African
American.
EXCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:
Volunteers will be excluded for the following reasons:
1. Presence of past or present medical problems which would impair performance during the
exercise tests;
2. Females who are pregnant, or who are currently nursing an infant;
3. Individuals who have, or whose parent or guardian has, current substance abuse or a
psychiatric disorder or other condition that in the opinion of the investigators would
impede competence or possibly hinder completion of the study;
4. Recent weight change of more than 3% of body weight in the past two months;
5. Recent use (within six months) of anorexiant medications for the purpose of weight
reduction;
6. Physical impairments that would prevent completion of either the walk/run test or the
cycle test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 17 Years | Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases | NCT00001723 | Contradiction |
6,060 | 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:
Study patients will be included in the study if they satisfy the following criteria:
1. Male or female, between 18 and 75 years old.
2. History of frequent episodes of heartburn associated with GERD for at least 2 3 days
per week during 2-4 weeks before screening and have responded to standard PPI therapy
in the past 12 months.
3. Have not taken on-demand PPI therapy for > 3 consecutive days within 4 weeks before
the screening period.
4. The patient's written informed consent must be obtained prior to inclusion.
5. Willing and able to complete the entire procedure and to comply with study
instructions.
6. Females of childbearing potential must employ an adequate method of birth control.
Inclusion criteria applicable to Screening period:
1. Recorded at least 1 evaluable episode of heartburn on 2 separate days at level 4 or
higher on the 9-point Likert severity scale (point 3 on a 0-8 point scale) prior to
randomisation.
2. Competent in the use and completion of the e-diary.
Exclusion Criteria:
Study patients will be excluded if they meet any of the following criteria:
1. Age < 18 or > 75 years old.
2. Intake of any medication for the purpose of the eradication of Helicobacter pylori (H.
pylori) during the last 28 days before the start of the study.
3. Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs)
including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 days
before the start of the study; except regular intake of enteric coated aspirin dosages
up to 150 mg/d.
4. Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or
upper gastrointestinal tract (excluding: appendectomy, cholecystectomy and
polypectomy).
5. History of co-existing disease that affects the oesophagus (e.g. Barrett's oesophagus,
Zollinger-Ellison syndrome, oesophageal stricture), and have undergone an endoscopy
with results of incomplete healing of erosions following standard PPI therapy within
the last 3 months.
6. History of active gastric or duodenal ulcers within 3 months of the first dose of the
study drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
7. Documented presence of severe renal or hepatic insufficiency.
8. Known hypersensitivity to omeprazole.
9. Concurrent participation in a study with an investigational drug or participation
within 30 days of study entry.
10. Females who are pregnant, or planning a pregnancy. Females of child bearing potential
not using reliable methods of birth control.
11. Clinically significant laboratory abnormality or disease which, in the opinion of the
Investigator, will create a risk for the patient, obscure the effects of study
treatment or interfere with study results.
12. Received or require any of the following drugs within 2 weeks before the first dose of
study or continue to need these drugs for concurrent therapy: theophylline, bismuth
salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram,
benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin,
sucralfate, clopidogrel or protease inhibitors.
13. Taking concomitant medications that rely on the presence of gastric acid for optimal
bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
14. Onset of psychoactive medication (e.g. depressants, stimulants or hallucinogens) in
the previous 6 months and during the entire course of the study.
Exclusion criteria applicable to Screening period:
1. Recorded < 1 episode of heartburn on 2 separate days at level 4 on the 9 point Likert
severity scale (point 3 on a 0-8 point scale) during the 7 day screening period prior
to randomisation
2. Completing < 90% (< 9 out of 10) of the time points with evaluable data on the e
diary.
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 | Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease | NCT01493089 | Entailment |
3,248 | 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:
- Fulfilled revised American European Consensus Group criteria for pSS
- Seropositive at screening for anti-Ro/SSA antibodies
- Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular,
lymphoadenopathy, constitutional, biologic and hematologic.
Exclusion Criteria:
- Secondary Sjogren's syndrome
- Use of other investigational drugs
- Active viral, bacterial or other infections
- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS) | NCT02962895 | Entailment |
2,982 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion criteria:
Fragile X group
- DNA-based diagnosis of Fragile X syndrome
Autism group
- Documented diagnosis with ADOS; ADI-R; CARS and GARS
Both groups
- 18-50 years
- Measured IQ below 85
- Measured IQ >20
- Mental age >30 months
- Stable medication regimen for past 8 weeks
- Normal hearing
- Vision corrected to at least 20/50
- All females of childbearing age must have a negative pregnancy test at enrollment
Exclusion criteria:
- Recent history of seizure, epilepsy, or blackouts
- Unresolved medical issue impacting performance
- Behavioral dysfunction to the point that subject cannot cooperate for testing
- History of drug-induced neutropenia
- Uncontrolled hypertension
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Effects of CX516 on Functioning in Fragile X Syndrome and Autism | NCT00054730 | Contradiction |
6,033 | 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:
- Type I, II and III hiatal hernias, including complicated by GERD
- Able to undergo elective laparoscopic hiatal hernia repair
- Able to 24 months follow-up with office examinations
- Hiatal surface area (HSA) measuring 10 to 20 sq.cm (by granderath et al, 2007) which
correspond to the diameter of hernia defect measuring 5 to 8 cm (the distinct size is
determined intraoperatively, those with smaller or larger diameter will be excluded
from the study)
Exclusion Criteria:
- Unable to undergo laparoscopic hiatal hernia repair due to: severe comorbidities (ASA
III and more), previous major surgery with severe adhesions, etc.
- Cases of conversion to open surgery
- Age < 20 years and > 80 years
- BMI < 16 and > 39 kg/m2
- Pregnancy or plans for pregnancy within next 2 years (in females)
- Uncorrectable coagulopathy and immunosuppression
- Oesophageal motility disorders
- Oesophageal peptic strictures
- Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis,
connective tissue disorders (e.g. scleroderma)
- Oesophageal shortening (determined intraoperatively as inability to achieve
intra-abdominal length of oesophagus at least 3 cm in spite of intramediastinal
oesophageal mobilization)
- Barrett's oesophagus
- History of oesophageal/gastric/duodenal surgery including vagotomy
- Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed
gastric/duodenal emptying
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 80 Years | Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias | NCT01408108 | Entailment |
1,776 | 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:
- Older adults living independently;
- medical approval.
Exclusion Criteria:
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 79 Years | Study of the Long-term Effects of Exercise on Heath Indicators in Older People | NCT01874132 | Contradiction |
3,342 | 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:
1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or
postmenopausal or surgically sterile
4. BMI is > 18.5 kg/m2 and <35 kg/m2
5. If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering,
thyroid medication or hormone therapy, they have been on constant dosage for at least
two months prior to screening visit.
Exclusion Criteria:
1. Hemoglobin A1c value at screening of greater than or equal to 9%.
2. Uses exogenous insulin or exenatide for glucose control.
3. type 1 diabetes.
4. history of diabetic ketoacidosis.
5. current infection; has had inpatient surgery, or corticosteroid treatment in the last
3 months or antibiotics in the last 3 weeks prior to screening visit.
6. active malignancy
7. significant cardiovascular event ≤ six months prior to screening visit; or stated
history of congestive heart failure.
8. end-stage organ failure or is status post organ transplant.
9. history of renal disease.
10. current hepatic disease.
11. history of severe gastroparesis.
12. chronic, contagious, infectious disease
13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic
medications, that could profoundly affect blood glucose.
14. clotting or bleeding disorders
15. allergic or intolerant to any ingredient found in the study products.
16. habitual user of tobacco products (
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 | Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics | NCT01324921 | Contradiction |
6,363 | 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:
- SARS-CoV-2 infection as determined by PCR, performed by one of the certified
laboratories in Luxembourg
- Signed informed consent form
- Age ≥18 years old
- Hospitalized or at home
Exclusion Criteria:
- Patients not understanding French or German
- Patients already included in an interventional study on Covid-19 (Discovery or other)
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.
| Luxembourg Cohort of Positive Patients for COVID-19: a Stratification Study to Predict Patient Prognosis | NCT04380987 | Entailment |
2,806 | 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:
- Diagnosis of ALS and
- A confirmed COVID-19 infection determined by:
1. positive SARS-CoV-2 viral RNA PCR test and/or
2. positive serology antibody testing for SARS-CoV-2
Exclusion Criteria:
- No ALS diagnosis
- No confirmed COVID-19 infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry | NCT04559009 | Contradiction |
291 | 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:
- 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 v1.0 | NCT02524470 | Contradiction |
2,917 | 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:
- Patients with diagnosis of familial or sporadic ALS
- Onset of muscle weakness no more than 30 months before screening visit.
- Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and
height at Screening.
- If on riluzole, the dose must have been stable for at least 28 days prior to Baseline
visit.
- Age 18 - 80 years inclusive.
- Female subjects may participate if they are of non-child-bearing potential or if they
are of child-bearing potential they must agree to use the approved contraceptive
methods
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2x upper limit
of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN.
- QTc (both QTcB and QTcF) <450 milliseconds (msec) or <480 msec for subjects with
Bundle Branch Block at Screening and Baseline (average from triplicate ECGs).
Exclusion Criteria:
- Patients with other neuromuscular disorders (including a history of polio) which in
the opinion of the investigator could have contributed to the muscular atrophy or
weakness caused by ALS
- Patients with primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia
complex.
- Patients requiring non-invasive or mechanical ventilation (non-invasive ventilation
for sleep apnoea is allowed subject to discussion with Medical Monitor)
- Patients on diaphragmatic pacing.
- Presence of any of the following clinical conditions: Drug abuse or alcoholism,
uncontrolled hypertension, active major infectious disease, unstable psychiatric
illness within 90 days of the Screening visit
- Subjects, who in the investigator's judgement, pose a significant suicide risk. -
Current or chronic history of liver disease, known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones), positive
Hepatitis B surface antigen or Hepatitis C antibody test.
- Subjects who have participated in a clinical trial involving receipt of a
biopharmaceutical product within 6 months prior to the first dosing day.
- Exposure to non-biological experimental agents 1 month or 5 half-lives prior to
Baseline visit (whichever is longer).
- History of sensitivity to ozanezumab, or components thereof, or a history of other
allergies that, in the opinion of the investigator, contraindicates participation 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 80 Years | Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis | NCT01753076 | Entailment |
3,623 | 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:
- Presenting to Royal Preston Hospital Emergency Department
Exclusion Criteria:
- Trauma, purely psychiatric or obstetric presentation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Identification of the Sick Patient in the ED | NCT03209375 | Entailment |
4,305 | 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 ventilator associated-pneumonia to Pseudomonas aeruginosa
- patients hospitalized in intensive care units
- Pseudomonas aeruginosa susceptible to ceftolozane-tazobactam
- Simplified Acute Physiological Score II (SAPS II () > 20
- Expected duration of survival > 7 days
- Informed consent of the patient or, failing that, the patient's close or trustworthy
person
- Affiliated to a social security scheme or equivalent
Non inclusion criteria:
- history of allergy to one of the two molecules
- history of allergy to betalactamines
- Strain Isolated resistant to Ceftolozane-Tazobactam combination
- Renal insufficiency with a glomerular filtration rate evaluated by Chronic Kidney
Disease Epidemiology Collaboration (CKD-EPI) < 50 ml/min
- Patient on dialysis or under continuous hemodiafiltration
- pregnant or nursing women
- patient benefiting from a system of legal protection for adults
- patient with active immunodepression.
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.
| Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients With Ventilator Associated-pneumonia | NCT03581370 | Entailment |
2,743 | 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:
- All patients affected by primary inguinal hernia
Exclusion Criteria:
- Diabetes
- Corticosteroids treatment
- Immunosuppressive drugs
- Cirrhotic patients
- Chronic inflammatory disease
- Neoplastic patients
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty | NCT01090284 | Entailment |
2,097 | 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:
- Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis
according to global obstructive lung Global initiative for chronic Obstructive Lung
Disease criteria.
- Follow up at the Hospital Italiano de Buenos Aires.
Exclusion Criteria:
- Refusal to participate or to agree to the informed consent.
- Known non chronic obstructive pulmonary disease respiratory disease (ej: Lung Cancer,
Tuberculosis, Pulmonary Fibrosis, Neumoconiosis, Cystic Fibrosis, Sarcoidosis, etc)
- Severe alpha-1 antitripsin deficit (typr SZ or ZZ)
- Previously thoracic surgery (ej: lung volume reduction, lung transplantation).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Hospitalary Chronic Obstructive Pulmonary Disease Registry | NCT02659189 | Entailment |
5,771 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
1. Ages 18-79 years
2. Clinical diagnosis of papulopustular rosacea based on physician evaluation. Only
patients with 3-50 papules and/or pustules, and a CEA total score ≥ 5, (See Section
4.1.3) will be enrolled.
3. History of failing at least one conventional treatment for rosacea (metronidazole,
sodium sulfacetamide, tetracycline, azelaic acid) or not interested in continuous
treatment with these agents.
Exclusion Criteria:
1. < 18 or > 79 years of age
2. Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle
3. Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit
1
4. Use of systemic antibiotics within 1 month prior to Visit 1
5. Use of topical retinoids (on the face) within 1 month prior to Visit 1
6. Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1.
7. Use of laser or light based rosacea treatments (on the face) within 1 month prior to
Visit 1
8. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or
microdermabrasion of the face) within 2 months prior to Visit 1
9. Use of topical corticosteroids (on the face) 1 month prior to Visit 1
10. Use of systemic corticosteroids 3 months prior to Visit 1
11. Known or suspected history of drug or alcohol abuse within the past 6 months as
determined by the medical record or patient interview
12. History of adverse reaction to light exposure
13. History of disorder of porphyrin metabolism
14. Scarring or infection in the area being treated
15. Extensive facial hair that would either impair blue light exposure or interfere with
lesion evaluation
16. Inability to make study visits or anticipated poor compliance
17. Pregnant females or nursing mothers. Eligible women of reproductive age will be
required to have a negative urine pregnancy test at screening. They will also be
required to be on at least one reliable form of effective birth control [examples:
barrier method (condoms, diaphragm), oral, injectable, implant birth control or
abstinence] during the course of this study and 30 days following the last treatment
period.
18. Life threatening illness that would interfere with the patient's ability to complete
the study
19. Participation in another clinical experimental therapeutic study within 30 days of
screening visit
20. Any history or evidence of severe illness or any other condition that would make the
patient, in the opinion of the investigator, unsuitable for the study.
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 79 Years | Photodynamic Therapy for Papulopustular Rosacea | NCT02075671 | Contradiction |
2,051 | 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:
- Unexplained or refractory chronic cough for at least one year
- Chest radiograph or CT thorax within the last 60 months not demonstrating any
abnormality considered to be significantly contributing to the chronic cough
- Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
- Score of ≥ 40mm on the Cough Severity VAS at Screening
- Women of child-bearing potential must have a negative serum pregnancy test at
Screening
- Women of child-bearing potential must use a highly effective contraception method from
Screening through the Follow-Up Visit
- Male subjects and their partners of child-bearing potential must use 2 methods of
acceptable birth control
Exclusion Criteria:
- Current smoker or individuals who have given up smoking within the past 6 months, or
those with >20 pack-year smoking history
- Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
- Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or
requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior
to the Screening Visit
- FEV1/FVC < 60%
- History of upper respiratory tract infection or recent significant change in pulmonary
status within 4 weeks of the Baseline Visit
- History of concurrent malignancy or recurrence of malignancy within 2 years prior to
Screening
- History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
- Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at
Screening
- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of
trial results
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 Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough | NCT03979638 | Contradiction |
4,868 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Healthy male and female subjects aged 18-68 years, non-smokers or regular smokers of
greater than 6 cigarettes a day, BMI 16-29
- Male and female Cushing's syndrome aged 18-68 years with biochemically confirmed based
on cortisol and ACTH measurements, dexamethasone suppression test and 1 of the
following positive investigations (24 hour urine cortisol, salivary/serum cortisol
profile). Visible tumour in the pituitary and/or one of the following positive tests
pointing to pituitary source for ACTH overproduction (bilateral petrosal sinus
sampling, corticotropin releasing hormone test, high dose dexamethasone suppression
test) or adrenal tumour considered fit for surgery. No contraceptives for 6 weeks
prior to sampling (females only). Patients on medical therapy e.g. metyrapone for
Cushings to have a 2 week washout off treatment prior to sampling
- Male and female aged 18 -68 years with biochemically confirmed adrenal insufficiency
based on basal cortisol and ACTH measurements and/or Synacthen test +/- adrenal
antibodies, and on oral hydrocortisone or cortisone acetate glucocorticoid replacement
therapy
- Female aged 18-68 years with biochemically confirmed salt-wasting or simple virilising
CAH based on 17OHP, cortisol, androgen, renin and ACTH measurements; disease causing
mutation in CYP21A2 and/or synacthen testing.
- Male and female subjects aged 18 -68 years with biochemical confirmation of PHA based
on a valid pathological aldosterone/renin ratio and non-suppressible aldosterone
levels on one of the currently used confirmatory tests (saline/oral fludrocortisone
test). Unilateral only - diagnostic CT and/or adrenal vein sampling
- Male and female subjects aged 18-68 years with biochemically confirmed GHD (arginine
growth hormone releasing hormone test, insulin tolerance test, known pituitary disease
with confirmed pan hypopituitarism)
- Male and female aged 18-68 years with biochemically confirmed acromegaly (oral glucose
tolerance test or GH day curve and diagnostic insulin growth factor 1 levels) with
radiological evidence of a pituitary adenoma.
Exclusion Criteria:
- Healthy controls undergoing or planning pregnancy or lactating women. Presence of any
unstable pathological condition in past 3 months. On any regular prescribed
medications (except contraception). Prior or current history of an endocrine disorder.
Known allergy to Lignocaine, plasters. Current or past steroid therapies (oral,
inhaled, parenteral or topical) or other interfering medication in last 3 months.
Regular alcohol intake great then 26units of alcohol per week.Taking of any
investigational drug within the past two months. Abuse of illicit drugs. Occasional
smokers of cigarettes not able to abstain for sampling period or smoking less than 6
cigarettes a day. Needle phobia. Interfering diet/over the counter herbal remedies in
last 14 days.
- Cushing syndrome: Undergoing or planning pregnancy (females only). Known allergy to
Lignocaine. Adrenal cancer (post-operative histology diagnosis),cyclic Cushings,
squamous cell lung carcinoma, bronchial carcinoid and occult ectopic Cushings.
Concurrent use of steroid therapy for any other medical condition (oral, inhaled,
parenteral or topical)
- Adrenal insufficiency: Undergoing or planning pregnancy, known allergy to Lignocaine,
use of other steroid medications other than their standard glucocorticoid and
fludrocortisone replacement, other interfering medication or diet within 2 weeks of
sampling.
- CAH: Males, females undergoing or planning pregnancy, known allergy to Lignocaine, use
of other steroid medications other than their standard glucocorticoid and
fludrocortisone replacement or other interfering medication or diet within 2 weeks of
sampling
- Primary hyperaldosteronism: Undergoing or planning pregnancy (females only), known
allergy to Lidocaine, known adrenal failure and/or on steroid therapy (oral, inhaled,
parenteral or topical), concurrent use of interfering medication ( i.e. specific
interfering antihypertensive medication) or diet within 2-4 weeks of ultradian
sampling
- GHD: Undergoing or planning pregnancy (females only) or known allergy to Lignocaine
- Acromegaly: Undergoing or planning pregnancy (females only), known allergy to
Lignocaine treatment with somatostatin analogues and other interfering medication
(e.g. oestrogens)
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 68 Years | Dynamic Hormone Diagnostics in Endocrine Disease | NCT02934399 | Entailment |
6,200 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- All patients who followed up in emergency department ICU with the diagnosis of
COVID-19
- Accepted to participate with an informed consent
Exclusion Criteria:
- Patients under the age of 18 or more than 50 years
- declined to participate
- deaths caused by other than COVID-19
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 | Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic | NCT04480060 | Contradiction |
4,005 | 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:
- Symptomatic knee OA meeting American College of Rheumatology (ACR) criteria
- Radiographic criteria for knee OA with Kellgren-Lawrence (KL) stage of ≥ 2 in at least
one knee
- Response positive to the question "do you have pain, aching or stiffness of the knee
on most days of the past month
- Score of ≥ 40 out of 100 on a visual analogue scale (VAS) for pain
- Age ≥ 21 years or above
- Male and female subjects and all ethnicities included
- Patients to agree to avoid consuming grapefruit and grapefruit juice while using
colchicine
- Ability to provide informed consent
Exclusion Criteria:
- Exposure to a corticosteroid (either parenteral or oral) within 3 months prior to the
study enrolment
- Knee arthroscopic surgery within 6 months prior to the study enrolment
- Known history of avascular necrosis, inflammatory arthritis (e.g. Rheumatoid
Arthritis), Paget's disease, joint infection, periarticular fracture, neuropathic
arthropathy, Reiter's syndrome, or gout involving the knee
- Contraindication to arthrocentesis (warfarin use, bleeding disorder, skin rash or skin
infection of signal knee)
- Knee joint replacement;
- History of podagra, active gout or treatment for gout
- Pregnancy or lactation - women of childbearing potential will have serum pregnancy
testing (ßHCG) at time of entry prior to any imaging studies (X-ray or MRI); female
subjects of childbearing potential must agree to use some form of contraception during
the 16 week trial and for 1 week after the end of the trial (over 6 half-life
equivalents)
- Renal failure with serum creatinine > 150mmol/L (1.7 mg/dL);
- Hepatic impairment defined by serum alanine transaminase (ALT) above the upper limit
of normal for the clinical laboratory performing the screening test
- Muscle impairment defined by elevated serum creatine phosphokinase (CPK) above the
upper limit of normal for the clinical laboratory performing the screening test
- Personnel directly affiliated with this study or their immediate family members
(defined as a spouse, parent, child or sibling, whether biological or legally adopted)
- Current enrolment in or discontinued within the last 30 days from a clinical trial
involving an off-label use of an investigational drug or device, or are concurrently
enrolled in any other type of medical research judged to be scientifically or
medically incompatible with this study
- Inability to understand and cooperate with the investigators or to give valid consent;
- Contraindication for magnetic resonance imaging (MRI) - this is exclusion only for the
subset of individuals selected for this imaging procedure;
- Anticipation of need for joint replacement within 4 months of the start of the
intervention;
- Current treatment with drugs known to inhibit Cytochrome 450(3A4) isoforms and/or
P-glycoprotein (P-gp) that increase the risk of colchicine-induced toxic effects (see:
http://www.fda.gov/Drugs/Drug-safety/PostmarketDrugSafetyInformationforPatientsandProv
iders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm).
Inclusion can be considered after 14 day wash out of agents listed in the drug information
sheet, but only if treatment in the near future with one of these agents is not
anticipated. The clinical necessity for such treatments during the study will require
immediate discontinuation of the study drug and conversion of the patient to standard care.
However, the patient will remain on study and scheduled measurements taken. Analyses will
be performed on an intention-to-treat basis.
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.
| Colchicine for Symptom and Inflammation in Knee Osteoarthritis | NCT02176460 | Entailment |
6,711 | 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. Must be ≥ 18 years;
2. Understand and voluntarily sign an ICD prior to any study related
assessments/procedures are conducted;
3. Diagnosis of acquired hemophilia A；
4. acute bleeding episodes(≥once).
Exclusion Criteria:
1. Uncontrolled systemic infection;
2. Allergy to rituximab;
3. Positive for Lupus anticoagulant;
4. Life expectancy < 3 months;
5. Pregnant and breastfeeding women;
6. Neuropathy>Grade 1;
7. Positive for Hepatitis B surface antigen or hepatitis C antibody or human
immunodeficiency virus（HIV）antibody;
8. Patients with poor compliance；
9. Patient who is considered by the investigator not suitable for clinical study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A | NCT03700229 | Contradiction |
5,422 | 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:
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 21-40 years of age
- BMI > 18, < 30
- Serum P4 > 9 ng/ml on single sample collected between days 18-25 of self-reported
menstrual cycle
- Flexible schedule allowing morning blood draws on less than 48 hour notice
- In good general health
- Commit to remain on stable diet during study period (no changes to normal dietary
habits)
- Commit to using non-hormonal contraceptive methods during study period except those
prescribed in the experimental protocol
- No objections to taking study drugs
Exclusion Criteria:
- Oral contraceptive use or other hormone supplement within the preceding 2 months
- Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera®)
- Contraindications to study drugs
- Current or past pregnancy within the previous 6 months or currently trying to conceive
- Desiring to conceive in the next 8 months
- Breastfeeding in the past 2 months
- Diagnosed Diabetes or Metabolic Syndrome
- Current or previous use of cholesterol lowering drugs within the preceding 12 months
- Diagnosed Polycystic Ovary Syndrome
- History of, or self-reported, substance abuse
- Smoker
- Previous infertility treatment excluding male factor issues
- Use of an investigational drug within the past 2 months
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Relationship Between the Menstrual Cycle and Heart Disease in Women | NCT01546454 | Entailment |
6,121 | 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:
- pregnant
- 18 and over
- monofetal pregnancy between 22+0 and 41+0 weeks of gestation
- presenting a positive COVID-19 RT-PCR test result after nasopharyngeal swab for one or
more minor symptoms: cough, body temperature >37,3 °C, shortness of breath, diarrhea,
asthenia, anosmia, taste loss, myalgia
- presenting no contraindication to hydroxychloroquine and azithromycin
- informed consent signature
- affiliated to social security scheme
Exclusion Criteria:
- allergic to hydroxychloroquine or chloroquine, or azithromycin
- contraindication to hydroxychloroquine: retinopathy, G6PD deficiency, long QT
syndrome, any other heart rhythm abnormality on pre-recruitment electrocardiogram,
hypokalemia, porphyria, psoriasis.
- contraindication to azithromycin: long QT syndrome, liver failure, myasthenia
- receiving simultaneous treatments contraindicated in case of hydroxychloroquine
uptake: Citalopram (Seropram), escitalopram (Seroplex), hydroxyzin (Atarax),
domperidone (Motilium), piperaquine (Eurartesim), disopyramide (Isorythm, Rythmodan),
hydroquinidine chlorydrate (Serecor), amiodarone (Cordarone), dronedaron (Multaq),
tricyclic antidepressant, anti-infectious drugs (macrolids, fluoroquinolones,
trimethoprime-sulfamethoxazole (Bactrim).
- receiving simultaneous treatments contraindicated in case of azithromycin uptake:
Cisapride, Colchicine, Dihydroergotamine, bromocriptine, cabergoline, lisurid,
pergolide, atorvastatin, ciclosporin, digoxin, simvastatin, anti-vitamine K,
macrolids, ketolide
- hypoxemic respiratory failure due to severe pneumonia (needing supplemental oxygen)
- maternal disorders: Type I or II diabetes, congenital cardiopathy, liver or kidney
disease, liver failure, renal failure
- obstetrical disorders: insulin-dependent gestational diabetes, preterm delivery
threat, preterm rupture of membranes, bleeding, pre-eclampsia, gestational
hypertension, gestational cholestasis
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial | NCT04365231 | Contradiction |
1,767 | 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:
- Pathologically proven gastric or gastroesophageal junction adenocarcinoma
- Metastatic or recurrent unresectable disease
- Measurable lesions (according to Response Evaluation Criteria in Solid Tumors
[RECIST])
- Age: 65-85 years old
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet
count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
- Adequate renal function (serum creatinine≤ 1.5)
- Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate
aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
- No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to
study treatment is allowed with the exception of capecitabine or S-1) Written informed
consent was signed by the patient
Exclusion Criteria:
- Previous palliative chemotherapy
- Known allergy to study drugs
- CNS metastasis
- Significant medical comorbidities
- Active ongoing infection which antibiotic treatment is needed.
- Previous ( within 5 years) history of other malignancy except cured non-malignant skin
cancer and uterine cervical cancer in situ.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 85 Years | Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial | NCT00278863 | Contradiction |
3,345 | 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:
- Hearing loss Presbycusis Exostosis
Exclusion Criteria:
- Genetic hearing loss
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 60 Years | Development Cellular Models of the Ear and Nose to Study the Mechanisms of Hearing | NCT04823195 | Contradiction |
2,740 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- age> 18 years;
- ASA score I - II - III;
- patients undergoing elective inguinal hernia repair;
- signed informed consent;
Exclusion Criteria:
- chronic therapy with opioids/ antidepressants;
- urgent/emergent surgery;
- postoperative transfer to the intensive care unit;
- known allergy to any drug medication;
- local skin infection;
- epilepsy;
- alcohol or drug abuse;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia | NCT03128216 | Entailment |
6,915 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Meet the diagnosis criteria of AD formulated by the National Institute of Neurological
and Communicative Disorders and Stroke and the Alzheimer's Disease and Related
Disorders Association (NINCDS-ADRDA);
- MMSE score 0-10 points;
- Age 40-80 years;
- Provision of signed informed consent.
Exclusion Criteria:
- Abnormal brain structure prior to surgery (tumor, cerebral infarction, intracranial
hematoma)
- Complicated by other neurological system disorders, such as multiple sclerosis and
epilepsy;
- Psychiatric disorders, such as anxiety, depression or drug-induced psychosis;
- Severe internal diseases, are taking respiratory system drugs, cardiovascular drugs,
anticonvulsants or psychotropic drugs;
- Inability to tolerance clinical complications;
- Severe auditory and visual disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease | NCT03115814 | Entailment |
1,424 | 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:
- Having a child with swallowing disorders aged between 6 months-18 years
Exclusion Criteria:
- Having a child without swallowing disorders
- Having a child with swallowing disorders aged below 6 months
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 65 Years | The Turkish Feeding/Swallowing Impact Survey | NCT03005093 | Contradiction |
4,994 | 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. | Patients with essential tremor affecting the upper limbs who are 21 years of age or older.
Patients who are not taking medications for essential tremor or any other medical condition
for at least 2 weeks.
Patients who have not consumed alcohol or cold medications containing alcohol for at least
24 hours prior to the day of the study.
Women must not be pregnant or lactating. Women of childbearing age must use birth control
while participating in this study.
Patients must not have any neurological disease other than tremor (e.g., Parkinson's
disease).
Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| 1-Octanol to Treat Essential Tremor | NCT00001986 | Entailment |
3,696 | 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:
- To be included in the study, patients must be between the 18 and 70 years of age
- Completed a pre-surgery psychological evaluation, and have had intermittent knee pain
for at least a year.
- The bariatric surgery requirement involves a bypass of the stomach.
- Standard of care guidelines for this surgery require that these patients' previous
dieting attempts were without success
- Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation,
and joint pain.
- Patients will have a WOMAC pain scale score > 3, according to the study by Miller, et
al.
- Patients will have a standing AP, lateral and Merchant radiographic scan taken to
confirm that they have OA.
Exclusion Criteria:
- Patients will be ineligible for the study if any of these criteria are not met.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee | NCT00752765 | Contradiction |
741 | 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:
- Male or female of any race, between the ages of 18 and 75 years inclusive
- Female subjects must be of non-childbearing potential and have a negative pregnancy
test at Screening.
- Osteoarthritis of the knee of at least 6 months duration and meeting the American
College of Rheumatology Criteria. For radiographic criteria the Xray must have been
taken within the last 5 years. If none is available, one should be taken and the
diagnostic criteria confirmed prior to randomization.
- Willing and able to discontinue all current analgesic therapy, including OTC pain
medications and topical analgesics for OA pain, for period beginning with washout
phase (lasting 2 days or 5 half-lives of patient's current analgesic medication prior
to Day -6) and continuing for the entire duration of study. As an exception,
acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the
discretion of a qualified member of the study team.
- If a subject has evidence or a history of clinically significant endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological
disease, the investigator must confirm that the disease is stable (at least 4 weeks)
and under control.
- QTc interval ≤450 msec and a PR interval ≤210 msec on Screening ECG.
Exclusion Criteria:
- Pregnant or lactating females, and females of childbearing potential.
- Arthroscopy performed on index knee within 1 year of screening.
- Active depression as defined by or meeting The Hospital Anxiety and Depression Scale
(HADS) of >10.
- Unwillingness to refrain from consumption of grapefruit or grapefruit juice from 7
days prior to the first dose of study medication until completion of the study.
- First degree or higher AV block, defined as PR interval >210 msecs, bundle branch
block, fascicular block or intraventricular conduction delay or clinically relevant
abnormality on screening ECG.
- Active malignancy of any type or history of a malignancy within 10 years (with the
exception of subjects with a history of treated basal cell carcinoma).
- Symptomatic OA of the hip ipsilateral to index knee which the patient considers more
painful than the knee.
- Use of prohibited medications as listed below, in the absence of appropriate washout
period. The following analgesic agents must be discontinued within 48 hours or 5 half
lives of the analgesic being washed out prior to the baseline period (Day -6 to Day
0);
- NSAIDs and selective COX-2 inhibitors;
- Acetaminophen ( as an exception acetaminophen may be used for non-joint related
pain at doses ≤1g/day);
- Opioids.
- Oral or I/M corticosteroids within 4 weeks prior to screening. I/A steroids
within 12 weeks prior to baseline in study joint or any other joints within 4
weeks prior to baseline, or I/A hyaluronic acid within 24 weeks prior to
baseline;
- Use of concomitant medications that are CYP3A inhibitors or CYP3A inducers, or
that are P-glycoprotein substrates within 48 hours or 5 half lives prior to
baseline.
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 | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee | NCT00689273 | Contradiction |
2,880 | 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:
- individuals diagnosed with ALS defined according to the revised classification of El
Escorial;
- individuals who regularly attended the Neuromuscular Disease Research Sector (SIDNM)
of the Federal University of São Paulo
Exclusion Criteria:
- individuals who had other diagnosis of neuromuscular disease such as: progressive
muscular atrophy (PMA), progressive bulbar paralysis (PBP), primary lateral sclerosis
(PLS);
- individuals associated with other neurodegenerative diseases;
- those presenting established functional disability that would prevent the completion
of the task.
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 75 Years | Virtual Task in Amyotrophic Lateral Sclerosis | NCT03113630 | Entailment |
4,869 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | PATIENTS WITH NORMAL ADRENAL GLANDS:
Patients with normal adrenal glands will be recruited from those studied under NCI
protocols.
They will not have taken suppressive doses of glucocorticoids for 12 months, and will not
have any known adrenal pathology, either of the cortex or medulla.
They will not have Von-Hippel Lindau syndrome.
PATIENTS WITH ACTH-INDEPENDENT CUSHING'S SYNDROME:
Will be aged 18 or older;
Will have plasma ACTH levels of 10 pg/mL or less;
Will have an outside physician who will follow them after surgery.
Must not weigh greater than 380 pounds. These patients are unable to undergo CT scans.
Must not have a CT scan showing normal or atrophic bilateral adrenal glands.
Must not have a CRH test showing a response as defined above. The diagnosis of these
patients will need further evaluation.
Must not have any condition that would preclude surgery, including advanced heart failure,
significant coronary artery disease, severe pulmonary disease.
Must not have a hematocrit less than 30 or research blood withdraw greater than 450 mL in
the previous six weeks.
Must not be pregnant.
Must not have a history of angina or known coronary artery disease, because these patients
are at risk for exacerbation during the vasopressin test.
The SF-36 questionnaire will only be given to individuals who speak and read English
fluently. Patients may participate in the remainder of the study, however, if they do not
meet this criterion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Cushing's Syndrome Not Related to ACTH Production | NCT00006278 | Entailment |
5,625 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Bone age < 13 years for a boy and < 11 years for a girl
- Naive child: Measured Height < -2.5 SD for CA
- Child currently treated by GH
Exclusion Criteria:
- Idiopathic short stature
- Syndrome known to be associated with an increased risk of cancer e.g. family history
of adenomatous polyposis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 11 Years old.
Subject must be at most 13 Years | Growth Retardation In Children With Special Pathological Conditions Or Disease | NCT00163215 | Contradiction |
2,937 | 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:
ALS4 inclusion criteria:
- Age 5 or above
- Genetic diagnosis of ALS4 (heterozygous mutation in SETX)
- Able to communicate well with the investigator, to understand and comply with the
requirements of the study
- Capacity to consent (adults) or assent (pediatric subjects) to the study
Disease control inclusion criteria:
- Age 5 or above
- Genetic diagnosis of RNA processing defect mutation (RNaseH1, RNaseH2, recessive
mutations in SETX)
- Able to communicate well with the investigator, to understand and comply with the
requirements of the study
- Capacity to consent (adults) or assent (pediatric subjects) to the study
Related, unaffected healthy control inclusion criteria:
- Age 5 or above
- Family history (first, second, or third degree relative) of RNA processing defect
mutation (RNaseH1, RNaseH2, heterozygous or recessive mutations in SETX)
- Able to communicate well with the investigator, to understand and comply with the
requirements of the study
- Capacity to consent (adults) or assent (pediatric subjects) to the study
Unrelated, healthy control inclusion criteria:
- Age 5 or above
- Able to communicate well with the investigator, to understand and comply with the
requirements of the study
- Capacity to consent (adults) or assent (pediatric subjects) to the study
EXCLUSION CRITERIA:
ALS4 exclusion criteria:
- Patients with known claustrophobia, presence of pacemaker, ferromagnetic material in
their body, or any other condition that would preclude MRI assessments
- Pregnancy
- Disease control exclusion criteria:
--Pregnancy
- Related, unaffected healthy control exclusion criteria:
- Diagnosis of neuromuscular disease or weakness on physical examination
- Pregnancy
- Unrelated, healthy control exclusion criteria:
- Diagnosis of neuromuscular disease or weakness on physical examination
- Patients with known claustrophobia, presence of pacemaker, ferromagnetic material
in their body, or any other condition that would preclude MRI assessments
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
| Clinical Manifestations and Biomarkers in Amyotrophic Lateral Sclerosis Type 4 and Other Inherited Neurological Disorders of RNA Processing | NCT04394871 | Entailment |
3,763 | 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. Males or females in the age 40 - 70 years (both inclusive)
2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and
Lawrence radiographic criteria.
3. History of primary idiopathic osteoarthritis of the knee characterized by pain which
requires intake of analgesics.
4. Self-reported difficulty in at least one of the following activities attributed to
knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a
chair, or going up and down stairs.
5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate
analgesics, for the past three months.
6. Female patients of childbearing age must be willing to use accepted methods of
contraception during the course of the study
7. Ability to provide written informed consent.
Exclusion Criteria:
1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition,
alcoholism, drug abuse), medical history, physical findings, ECG findings, or
laboratory abnormality that, in the investigator's opinion, could adversely affect the
safety of the subject, makes it unlikely that the course of treatment or follow-up
would be completed, or could impair the assessment of study results.
2. History of surgery, or major trauma to the study joint
3. Arthroscopy on the study joint in the previous 12 months
4. Signs of active study joint inflammation including redness, warmth, and/or, if
qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
knee joint with the loss of normal contour of the joint at the screening visit or at
the baseline examination
5. Patients who had received intraarticular steroids or hyaluronan within the last three
months.
6. Infections in or around the knee.
7. Patients awaiting a replacement knee or hip joint
8. Patients with other conditions that cause pain
9. Patients with deformity of the knee joint.
10. Significantly incapacitated or disabled and would be categorized as ACR Functional
Class IV (largely or wholly incapacitated), or unable to walk without assistive
devices
11. Patients with other known rheumatic or inflammatory disease such as rheumatoid
arthritis
12. Other pathologic lesions on x-rays of knee
13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human
immunodeficiency virus (HIV) antibody test, or RPR
14. History of Bleeding disorders
15. Known hypersensitivity to Hyaluronan products or animal sera
16. For women of child-bearing potential: positive pregnancy test or lactating [Females
who are planning pregnancy within next one year should 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 40 Years old.
Subject must be at most 70 Years | Allogeneic Mesenchymal Stem Cells in Osteoarthritis | NCT01453738 | Entailment |
450 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria: To be considered eligible for enrollment into this study subjects must
meet the following criteria:
1. signed the Informed Consent;
2. female, between 18 and 55 years of age;
3. agree to practice abstinence or use an effective form of birth control (e.g.
intrauterine device, oral contraceptives, contraceptive implants or injections,
diaphragm with spermicide, cervical cap, or constant use of condom) for at least the
past 4 months and willing to continue throughout the study or have had a tubal
ligation or your partner has had a vasectomy at least 4 months before being enrolled
in the study;
4. be in generally good health without clinically significant disease as determined by
investigator or designee based on medical history and vaginal exam;
5. for at least the last 4 months, have a consistent menstrual cycle lasting 21-35 days
with menstrual bleeding lasting at least 3 days' duration;
6. primarily use tampons for their feminine protection needs during their periods (may
use provided pads and/or pantiliners as back-up to tampon);
7. typically use Regular (6-9 grams) absorbency tampons for the majority of their period,
8. wears tampons during menstruation with no history of abnormal discomfort;
9. last pap smear was normal in the past 3 years or a normal pap with a negative HPV in
the past 5 years (age 18-21 does NOT need a PAP if they have never been sexually
active), per standard of care (per ACOG guidelines), (self-reported);
10. agree to refrain from vaginal intercourse within 48 hours of each vaginal exam
scheduled visit;
11. agree to refrain from showering within twelve (12) hours or bathing within twenty-four
(24) hours (1 day) of each visit (except Visit 2);
12. agree to refrain from using douching substances, feminine hygiene products, and to not
apply powders, perfumes, wipes, lotions, creams, or emollients to their genital area
48 hours prior to the screening visit and through the completion of the study, if
accepted to participate in the study;
13. agree to refrain from taking anti-inflammatory, antihistamine and/or, steroid systemic
and/or topical, (including new hormonal contraceptives) medications until they have
completed the study (e.g. Advil, Motrin, Benadryl, etc.);
14. agree to only use the tampons, pads and pantiliners supplied at each study visit for
her menstrual protection while participating in this study;
15. be willing and able to comply with the study requirements;
16. agree to complete all study questionnaires;
17. agree to refrain from participation in other concurrent clinical research studies;
18. agree to refrain from genital hair removal (e.g. waxing/shaving, etc.) while on the
study;
19. agree to refrain from using antibacterial body soap while on the study (e.g.
Safeguard)
Exclusion Criteria: Subjects will be excluded from the study if they meet any of the
following criteria:
1. have a menstrual abnormality with in the last 4 months (such as oligomenorrhea or
amenorrhea);
2. has had a vaginal delivery in the last 6 months;
3. had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the
last 6 months;
4. are pregnant (per urine pregnancy test at screening), or intend to become pregnant in
the next 5 months;
5. have a history of Toxic Shock Syndrome (TSS);
6. have a history of heart valve replacement;
7. have had an abnormal Pap in either of your last 2 Pap Smears;
8. have taken steroids (systemic and/or topical), corticosteroids, antihistamines, and/or
anti-inflammatories within the past seven days (excludes hormonal contraception);
9. have a history of immunosuppressive drug therapy, chemotherapy, or radiation therapy;
10. have uncontrolled and/or unstable diabetes (exception...stable dose of Diabetic
medication for at least 6 months prior to enrollment) in the opinion of the
Investigator;
11. have a vulvar piercing;
12. have a history of genital herpes;
13. within the last 6 months have had endometrial disease/uterine fibroids with symptoms
of heavy menstrual flow (super plus tampon absorbency use) and/or severe menstrual
cramping;
14. have you been diagnosed with a current medical condition which might compromise the
immune system functions; including cancer, anemia, leukopenia, leukocyte function
deficiency, malnutrition, or chemical dependence (e.g. opiates, marijuana etc.)
(self-reported);
15. have clinically diagnosed genital warts, lesions, and/or vaginal infections (such as
bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the screening visit;
16. have clinically diagnosed active or vaginal infections (Chlamydia trachomatis and/or
Neisseria gonorrhoeae) identified through lab results from the microbiological sample
obtained at the screening visit;
17. has urinary incontinence which causes subject to regularly use and saturate diapers or
absorbent panties or pads more than 3 times a week over the last 4 months, or
currently under treatment for a pelvic floor disorder (i.e., perineal floor
re-education with vaginal probe within last 6 months);
18. have history of or current diagnosis of AIDS/HIV, organ transplant, neoplasia, liver
disease, renal disease, deep vein thrombosis, pulmonary embolism, haemophilia,
neutropenia, autoimmune disease, major depression or any other medical condition,
which in the opinion of the Investigator would preclude study participation
(exception...stable dose of Thyroid medication for at least 6 months prior to
enrollment);
19. having a vaginal probiotic therapy (self-reported)
20. have participated in a clinical study with exposure to any investigational drug
product within 30 days prior to this study;
21. have a vaginal erythema grade of ≥2.0 and/or the presence of abrasions and/or
ulcerations as determined by investigator, at the screening visit;
22. have taken antibiotics or antifungals within last 4 weeks (Topical use of antibiotics
or antifungals outside the perineal/genitourinary area is allowed at the discretion of
the Investigator);
23. have started a new hormonal birth control in the previous 4 months or plan changing
hormonal birth control throughout the study period;
24. currently experiencing bladder, uterine or rectal prolapse (investigator to verify at
screening visit).
25. history of led or laser vaginal therapy within last 6 months (self-reported)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | In-use Study of Four Different Tampons | NCT03478371 | Contradiction |
4,313 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Age of 18 to 45 years
2. Access to a participating HVTN clinical research site and willingness to be followed
for the planned duration of the study
3. Ability and willingness to provide informed consent
4. Assessment of understanding: volunteer demonstrates understanding of this study and
other relevant study results and completes a questionnaire prior to first vaccination
with verbal demonstration of understanding of all questionnaire items answered
incorrectly
5. Willingness to receive HIV test results
6. Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling,
and committed to maintaining behavior consistent with low risk of HIV exposure through
the last required protocol clinic visit
7. Assessed by clinic staff as being at "low risk" for HIV infection on the basis of
sexual behavior within the 12 months prior to enrollment defined as follows:
- Sexually abstinent, or
- In a mutually monogamous relationship with a partner with a known HIV-uninfected
status, or
- Had one partner believed to be HIV-uninfected with whom he/she regularly used
condoms for vaginal and anal intercourse
8. Willing to be contacted annually after completion of scheduled clinic visits for a
total of 3 years following initial study injection
9. Agrees not to enroll in another study of an investigational research agent prior to
completion of last required protocol clinic visit (excludes annual contacts for safety
surveillance)
10. Good general health as shown by medical history, physical exam, and screening
laboratory tests
11. Hemoglobin = 11.0 g/dL for volunteers who were born female, = 13.0 g/dL for volunteers
who were born male
12. White blood cell (WBC) count = 3,300 to 12,000 cells/mm3
13. Total lymphocyte count = 800 cells/mm3
14. Platelets = 125,000 to 550,000/mm3
15. Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
alkaline phosphatase < 1.25 times the institutional upper limit of normal
16. Cardiac Troponin T (cTnT) does not exceed the institutional upper limit of normal
17. Negative HIV-1 and -2 blood test: Sites may use locally available assays that have
been approved by HVTN Laboratory Operations.
18. Negative Hepatitis B surface antigen (HBsAg)
19. Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive
20. Normal urine:
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
microscopic urinalysis within institutional normal range).
21. Volunteers who were born female: negative serum or urine beta human chorionic
gonadotropin (ß-HCG) pregnancy test performed prior to vaccination on the day of
initial vaccination
22. Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception, from at least 21 days prior to
enrollment through 90 days after the participant's last vaccination, for sexual
activity that could lead to pregnancy. Effective contraception for participants
in South Africa is defined as using 2 methods, including 1 of the following:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
PLUS 1 of the following methods:
- Intrauterine device (IUD),
- Hormonal contraception, or
- Successful vasectomy in the male partner (considered successful if a volunteer
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity postvasectomy);
- Or not be of reproductive potential, such as having reached menopause (no menses
for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal
ligation;
- Or be sexually abstinent.
23. Volunteers who were born female must also agree not to seek pregnancy through
alternative methods, such as artificial insemination or in vitro fertilization until
after the last required protocol clinic visit
Exclusion Criteria:
1. Vaccinia (smallpox) vaccination determined by: (1) clinical evidence of vaccinia
scarification; (2) self-reported history of vaccinia vaccination; or (3) birth year
1977 or earlier. (Not excluded: a participant born in or before 1977 who self reports
he/she did not receive vaccinia [smallpox] vaccination and has no evidence of
scarification.)
2. Within the 12 months prior to enrollment: excessive daily alcohol use or frequent
binge drinking or chronic marijuana abuse or any other use of illicit drugs
3. Within the 12 months prior to enrollment: a history of newly acquired syphilis,
gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia,
pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis,
proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
4. Untreated or incompletely treated syphilis infection
5. HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who
have received control/placebo in an HIV vaccine trial, the HVTN 086 / SAAVI 103 PSRT
will determine eligibility on a case-by-case basis.
6. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine
trial. Exceptions may be made for vaccines that have subsequently undergone licensure
by the FDA or MCC. For potential participants who have received control/placebo in an
experimental vaccine trial, the HVTN 086 / SAAVI 103 PSRT will determine eligibility
on a case-by-case basis. For potential participants who have received an experimental
vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by
the PSRT on a case-by-case basis.
7. Immunosuppressive medications received within 168 days before first vaccination. (Not
excluded: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical
corticosteroids for mild, uncomplicated dermatitis; or [3] oral/parenteral
corticosteroids given for non-chronic conditions not expected to recur [length of
therapy 10 days or less with completion at least 30 days prior to enrollment].)
8. Blood products received within 120 days before first vaccination
9. Immunoglobulin received within 60 days before first vaccination
10. Live attenuated vaccines (not including influenza vaccine) received within 30 days
before first vaccination or scheduled within 14 days after injection (eg, measles,
mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
11. Influenza vaccine or any vaccines that are not live attenuated vaccines and were
received within 14 days prior to first vaccination (eg, tetanus, pneumococcal,
Hepatitis A or B)
12. Investigational research agents received within 30 days before first vaccination or
scheduled within 14 days after vaccination
13. Allergy treatment with antigen injections within 30 days before first vaccination or
that are scheduled within 14 days after first vaccination
14. Current anti-tuberculosis (TB) prophylaxis or therapy
15. Clinically significant medical condition, physical examination findings, clinically
significant abnormal laboratory results, or past medical history with clinically
significant implications for current health. A clinically significant condition or
process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert
grave danger to the participant's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with
reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
16. Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence, assessment of safety or reactogenicity, or a participant's ability to give
informed consent.
17. Serious adverse reactions to vaccines including anaphylaxis and related symptoms such
as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a
participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a
child.)
18. Hypersensitivity to eggs or egg products
19. ECG with clinically significant findings, or features that would interfere with the
assessment of myo/pericarditis, as determined by a contract ECG laboratory or
cardiologist, including any of the following: (1) conduction disturbance (complete
left or complete right bundle branch block or nonspecific intraventricular conduction
disturbance with QRS =120ms, AV block of any degree, or QTc prolongation (> 440ms);
(2) repolarization (ST segment or T wave) abnormality; (3) significant atrial or
ventricular arrhythmia; (4) frequent atrial or ventricular ectopy (eg, frequent
premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST
elevation consistent with ischemia; (6) evidence of past or evolving myocardial
infarction.
20. Cardiac risk factors, including 2 or more of the following: (1) participant report of
history of elevated blood cholesterol defined as fasting low density lipoprotein (LDL)
> 160 mg/dL; (2) first degree relative (eg, mother, father, brother, or sister) who
had coronary artery disease before the age of 50 years; (3) current smoker; or (4) BMI
= 35.
21. History of, or known active cardiac disease including: (1) previous myocardial
infarction (heart attack); (2) angina pectoris; (3) congestive heart failure; (4)
valvular heart disease including mitral valve prolapse; (5) cardiomyopathy; (6)
pericarditis; (7) stroke or transient ischemic attack; (8) chest pain or shortness of
breath with activity (such as walking up stairs); (9) dysrhythmia/episodic
palpitations (Not excluded: sinus arrhythmia); or (10) other heart conditions under
the care of a doctor.
22. Autoimmune disease
23. Immunodeficiency
24. Asthma other than mild, well-controlled asthma. Exclude a participant who:
- Generally uses a bronchodilator (beta2 agonist) daily, or
- In the past year, has (any of the following):
- Had > 1 exacerbation of symptoms treated with oral steroids (Note:
oral/parenteral steroid use for asthma is exclusionary within 168 days before
first vaccination.);
- Routinely used moderate to high dose inhaled corticosteroids (eg, more than the
equivalent of 250 µg fluticasone; 400 µg budesonide; 500 µg beclomethasone; or
1000 µg triamcinolone/flunisolide, as a daily dose) or theophylline for asthma;
or
- Needed emergency care, urgent care, hospitalization, or intubation for asthma.
25. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
26. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
27. Angioedema within the last 3 years if episodes are considered serious or have required
medication within the last 2 years
28. Hypertension:
- If a person has been diagnosed with hypertension during screening or previously,
exclude for hypertension that is not well controlled. Well-controlled
hypertension is defined as blood pressure consistently = 140 mm Hg systolic and =
90 mm Hg diastolic, with or without medication, with only isolated, brief
instances of higher readings, which must be = 150 mm Hg systolic and = 100 mm Hg
diastolic. For these participants, blood pressure must be = 140 mm Hg systolic
and = 90 mm Hg diastolic at enrollment.
- If a person has NOT been diagnosed with hypertension during screening or
previously, exclude for systolic blood pressure = 150 mm Hg at enrollment or
diastolic blood pressure = 100 mm Hg at enrollment.
29. Body mass index (BMI) = 40
30. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
31. Malignancy (Not excluded: a participant with a surgical excision and subsequent
observation period that in the investigator's estimation has a reasonable assurance of
sustained cure or is unlikely to recur during the period of the study.)
32. Seizure disorder (Not excluded: a participant with a history of seizures who has not
required medications or had a seizure within the past 3 years.)
33. Asplenia: any condition resulting in the absence of a functional spleen
34. Psychiatric condition that precludes compliance with the protocol. Specifically
excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
or history of suicide attempt or gesture within the past 3 years.
35. Pregnant or breastfeeding
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 | Safety of and Immune Response to a DNA HIV Vaccine Boosted With a Modified Vaccinia HIV Vaccine and Protein HIV Vaccine in Healthy Adults | NCT01418235 | Entailment |
5,904 | 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:
- Patients with the diagnostic of GERD
Exclusion Criteria:
- hiatal hernia >2 cm
- previous operation at the LES
- actual erosive esophagitis
- Congenital or acquired immune disorders.
- Allergic status of any kind.
- Systemic diseases (rheumatic, infectious conditions, febrile state, vascular
alterations, endocrine including diabetes, metabolic and neoplastic).
- Leukemia.
- Severe psychiatric disorders.
- Neuromuscular or neurological injuries.
- Aneurysms.
- Abdominal or spine surgery.
- Vertebral fractures.
- Osteoporosis (advanced stage).
- Acute lesions of soft tissues or in an inflammatory state.
- Open wounds.
- Pregnancy.
- Intrauterine device.
- Patients with corticosteroid therapy.
- Hemophilia or treatment with anticoagulant therapy.
- Hypersensitivity of the skin or dermatological diseases in the trunk that
impossibilities the application of the techniques.
- Rejection of manual contact.
- Non-Spanish speaking patients.
- Patients who have previously received some treatment of myofascial release.
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 | Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease | NCT03299985 | Contradiction |
4,315 | 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:
- men who seek treatment for infertility (infertility is defined as the inability to
conceive after 1 year of unprotected intercourse)
- age ≥ 18 years
- in a heterosexual, stable relationship for at least 1 year
- able to read and speak Chinese
Exclusion Criteria:
- inability to read and understand the questionnaire because of language difficulties
- already evaluated during an earlier survey
- men on medication that could have affected their ejaculatory and erectile function
and/or psychological status
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men | NCT01893216 | Entailment |
5,136 | 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 60 years and older (i.e. those at a priori higher risk of fragility
fractures):
- Having an abdominal computed tomography (CT) (Axial or Sagittal slices / Slice
thickness of 4mm or better / Presence of the L1 to L4 vertebrae), performed between
2007 and 2013 and stored in the PACS (Picture Archiving and Communication System)
which is the database of all images of patients performed at AP-HP, whatever the
medical indication
Exclusion Criteria:
- Abdominal scan not legible (including patients with spine implants, screws and other
spinal devices).
- Impossibility to match the CT scan data with the French Hospital National Database
(Programme de Médicalisation des Systèmes d'Information : PMSI)*, which includes all
hospitalizations occurring in public and private acute care settings in France,
between 2007 and 2016. Probabilistic matching will give incident fracture data during
follow-up.
- Abdominal scan (i.e. any scan including L1 to L4 vertebrae) performed as outpatient
care (i.e. not related to an hospital stay)
- Foreign residents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Fracture Prediction by Opportunistic Screening for Osteoporosis | NCT03570177 | Contradiction |
1,600 | 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:
During the initial accrual period for this study, prior to the first interim analysis,
patients will be eligible for enrollment if they:
- are between 12 months and less than 18 years; AND
- are within the first 48 hours of the PICU admission; AND
- have an endotracheal tube, central venous catheter (new or old, tunneled or not
tunneled), or Foley catheter; AND
- are anticipated to have an indwelling arterial or central venous catheter for blood
sampling during the first three days of study enrollment.
After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after
enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning
enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves
enrollment of infants after the first interim analysis, then patients will be eligible for
enrollment if they:
- are between 40 weeks gestational age and less than 18 years; AND
- are within the first 48 hours of the PICU admission; AND
- have an endotracheal tube, central venous catheter (new or old, tunneled or not
tunneled), or Foley catheter; AND
- are anticipated to have an indwelling arterial or central venous catheter for blood
sampling during the first three days of study enrollment.
Exclusion Criteria:
During the initial accrual period for this study, prior to the first interim analysis,
patients will be ineligible for enrollment if ANY of the following is true or anticipated:
- are less than 1 year age; OR
- are greater than or equal to 18 years of age; OR
- have a known allergy to metoclopramide; OR
- planned removal of endotracheal tube, central venous catheter, AND Foley catheters,
within 72 hours of study enrollment, OR
- suspected intestinal obstruction, OR
- intestinal surgery or bowel disruption, OR
- chronic metoclopramide therapy prior to enrollment, OR
- failure to enroll within 48 hours of PICU admission, OR
- readmission to PICU in the previous 28 days, OR
- previously enrolled in this study, OR
- lack of commitment to aggressive intensive care therapies.
After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after
enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning
enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves
enrollment of infants after the first interim analysis, then patients will be ineligible
for enrollment if ANY of the following is true or anticipated:
- are less than 40 weeks gestational age; OR
- are greater than or equal to 18 years of age; OR
- have a known allergy to metoclopramide; OR
- planned removal of endotracheal tube, central venous catheter, AND Foley catheters,
within 72 hours of study enrollment, OR
- suspected intestinal obstruction
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Months old.
Subject must be at most 17 Years | The CRISIS Prevention Study | NCT00395161 | Contradiction |
3,462 | 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:
1. Age 50 to 80 years old.
2. non-renal dialysis patients.
Exclusion Criteria:
1. Life can not take care of themselves or the bed of a patient.
2. dialysis patients.
3. Patients who can not understand the details of this study or are unable to cooperate
with the examination.
4. history of alcohol or drug abuse.
5. history of high environmental noise exposure.
6. The pure tone hearing threshold is greater than 10 decibel (dB), and the audiogram 4
kilohertz (kHz) air conduction threshold is greater than 8 kilohertz (kHz) air
threshold value of 20 decibel (dB).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis | NCT03575390 | Entailment |
3,361 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- >18 years old
- Normal middle-ear status
Exclusion Criteria:
- Chronic illness including asthma, pulmonary, or cardiac problems
- Pregnancy
- >10 dB hearing loss in any of the speech frequencies
- Past history of sensitivity or allergic reaction to lidocaine or related compounds
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Eustachian Tube Testing in a Pressure Chamber -- Validation Study | NCT00694486 | Contradiction |
4,230 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Non-smoking, age greater than or equal to (>=) 18 years and less than (<) 55 years old
adult male or female (Cohorts 1 - 6) or age >=65 years and less than or equal to (<=)
85 years old elderly male or female (Cohort 7) at the time of informed consent
2. Weight of at least 50 kilogram (kg) and body mass index >=18 and <30 kilogram per
square meter (kg/m^2) at Screening
Exclusion Criteria:
1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and
their female partners do not meet the criteria (that is, not of childbearing potential
or practicing highly effective contraception throughout the study period plus 90 days
after study drug discontinuation). No sperm donation is allowed during the study
period plus 90 days after discharge from the study.
2. Females who are breastfeeding or pregnant at Screening or Baseline
3. Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of
contraception,
- Do not agree to use a highly effective method of contraception (as described
above) throughout the entire study period and for 28 days after study drug
discontinuation.
4. Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical treatment within 4 weeks of
dosing
5. Evidence of disease that may influence the outcome of the study within 4 weeks before
dosing
6. Evidence of disease related to chronic headaches, migraines, joint pain or other
disorders or disease resulting in chronic or intermittent pain within 4 weeks before
dosing
7. Any personal or family history of seizures (including febrile seizures) or diagnosis
of epilepsy or episode of unexplained loss of consciousness
8. Any history of neurological or other medical conditions which in the opinion of the
investigator has the potential to reduce seizure threshold
9. Any epileptiform discharges in EEG at Screening
10. A prolonged QT/ QT interval corrected for heart rate (QTc) interval >450 millisecond
[ms]) A history of risk factors for torsade de pointes
11. History of prolonged QT/QTc interval
12. Left bundle branch block
13. History of myocardial infarction or active ischemic heart disease
14. History of clinically significant arrhythmia or uncontrolled arrhythmia
15. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior
as indicated by the C-SSRS
16. Any lifetime history of psychiatric disease
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 Study to Assess the Safety and Tolerability of E2511 in Healthy Participants | NCT04547361 | Contradiction |
1,245 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Any patient with malignant pleural effusion who will undergo palliative treatment with
insertion of intercostal tube.
Exclusion Criteria:
1. Patients <18 years old, unable to provide informed consent.
2. Had an allergy or other contraindication to intrapleural pleurodesis.
3. Had evidence of unexpandable lung believed by the responsible clinician to represent
insufficient.
4. pleural apposition that would preclude pleurodesis, and/or had an expected survival
of<1 month.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 90 Years | Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion | NCT04074902 | Entailment |
2,729 | 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:
- inguinal hernia
- adult patient
Exclusion Criteria:
- patient not willing
- multiple recurrences
- inguinal pain without evidence of hernia
- femoral hernia
- large scrotal hernia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Glubran Mesh Fixation in Lichtenstein Hernioplasty | NCT00659542 | Entailment |
958 | 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:
- History of mild to moderate OA
- OA grade II
Exclusion Criteria:
- Intraarticular injections in the affected knee
- Oral application of glucosamine and chondroitin sulphate during the last 6 months
prior to the beginning of the study
- Clinically significant knee joint effusion
- Neoplasm
- Diabetes mellitus
- Osteonecrosis
- Rheumatoid arthritis or any other inflammatory arthritis diagnosed by American College
of Rheumatology 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.
Subject must be at most 95 Years | Intra-articular Hyaluronic Acid in Mild to Moderate Knee Osteoarthritis | NCT01239810 | Entailment |
2,685 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients, 18 years and above, presenting with primary reducible inguinal hernias
- Patients, 18 years and above, with irreducible inguinal hernias which is neither
obstructed nor strangulated.
Exclusion Criteria:
- Patients who do not consent to participate in the study.
- Patients presenting with recurrent, obstructed or strangulated hernias
- Patients with bilateral hernias
- Patients with immunosuppression (uncontrolled diabetes mellitus, malnutrition,
patients on long-term steroids, known AIDS patients)
- Patients with chronic debilitating illnesses (chronic renal or liver failure,
congestive cardiac failure) and urinary bladder outlet obstruction
- Concomitant repair of another abdominal hernia e.g. umbilical hernia
- Hernia repair combined with another surgical procedure
- Patients under the age of 18 years and over 80 years
- Pregnant women
- ASA score 4 or more
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair | NCT04149847 | Entailment |
5,338 | 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:
1. Women aged between 18-40 years.
2. Women with more than 12 month postpartum.
3. Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle
length variation of no more than 5 days, bleeding days from 2-7 days and number of
sanitary pads not more than 3 pads without blood clots or flooding of blood).
4. Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy
prevention for at least 1 year.
Exclusion Criteria:
1. Women on any anticoagulant therapy.
2. Women who had a history of uterine, cervical or ovarian pathology.
3. Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
4. Women received DMPA injection within the previous 9 months except they had three
spontaneous regular menstrual cycles.
5. Severely anemic women (hemoglobin < 8gm/dl).
6. Women with any contraindications for POCs following the WHO eligibility (Altshuler AL
et al., 2015).
7. Women refused to participate in the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Abnormal Uterine Bleeding and Progestin-only Contraceptives | NCT03398811 | Contradiction |
5,735 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- adults (age >18)
- any gender
- scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical
Center (SFVAMC)
- daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in
the last 7 days
- presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively
Exclusion Criteria:
- emergency surgery (booked <24 hours preoperatively)
- consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or
marijuana only
- already enrolled in a smoking cessation trial
- current smoking cessation pharmacotherapy
- daily user of e-cigarettes
- previous adverse reaction to e-cigarette or transdermal nicotine
- poor proficiency of English language¸as indicated by need for an interpreter
(including family members) at the preadmission visit
- lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by
consent for surgery and other medical procedures being obtained from a substitute
decision maker
- pregnant or breastfeeding
- unstable cardiac condition (unstable angina, unstable arrhythmia)
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 END Perioperative Smoking Pilot Study | NCT02482233 | Contradiction |
123 | 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. Men aged 18-40 years and 50-75 years
2. Chronically low testosterone group will have testosterone concentrations <300 ng/dl,
and young and older normal testosterone groups will have testosterone levels 400-1000
ng/dl
3. No use of sex hormones for at least 1 year
4. Body mass index <40 kg/m2
5. Nonsmokers
6. Resting blood pressure <160/90 mmHg
7. Fasting plasma glucose <126 mg/dL
8. Healthy, as determined by medical history, physical examination, standard blood
chemistries (chemistry panel, complete blood clot and circulating thyroid levels) and
a graded exercise stress test with monitoring of blood pressure and electrocardiogram
(ECG)
9. Sedentary or recreationally active (< 3 days/wk of vigorous aerobic exercise)
10. No use of medications that might influence cardiovascular function including
anti-hypertensive, lipid lowering medications, and corticosteroids
11. No use of vitamin supplements or anti-inflammatory medications, or willing to stop 1
month prior and throughout the study.
Exclusion Criteria:
1. Contraindications to:
1. Gonadotropin releasing hormone (GnRH) antagonist
2. Testosterone gel and aromatase inhibitor including hypersensitivity to Acyline,
Androgel®, Arimidex®
3. Extrinsic peptide hormones, mannitol, GnRH or any other GnRH analogs
2. History of or active prostate or breast cancer or other sex hormone-dependent
neoplasms
3. Pre-existing or active cardiac, renal or hepatic disease
4. History of stomach ulcer or bleeding
5. History of epilepsy or other seizure disorder
6. Diabetes
7. Active infection
8. Disease that affects the nervous system
9. Abnormal resting ECG
Additionally, men participating in the gonadal suppression intervention study will do so
with the understanding that they will be randomly assigned to study groups that involve
either GnRH antagonist plus testosterone gel plus placebo tablet (33% chance), GnRH
antagonist plus testosterone gel plus aromatase inhibitor tablet (33% chance) or GnRH
antagonist plus placebo gel plus placebo tablet (33% chance).
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Cardiovascular Outcomes of Low Testosterone | NCT02758431 | Contradiction |
1,953 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the esophagus, stomach,
pancreas, colon, or rectum More than 30% positively immunoreactive to monoclonal antibody
CC49 in the metastatic or primary lesion OR TAG-72 antigen serum level greater than 15
Measurable or evaluable unresectable or metastatic disease by CT scan
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than
150,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL ALT and
AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
PTT less than 37.0 seconds INR less than 2.0 Renal: Creatinine less than 2.0 mg/dL Other:
No known allergy to murine immunoglobulin No iodine allergy No concurrent illness that
would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception Must be ambulatory and able to comply with study schedule
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine immunoglobulin Chemotherapy:
Prior or concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy:
Prior radiotherapy allowed Surgery: See Disease Characteristics
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer | NCT00025532 | Entailment |
1,898 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Histologically and/or cytologically documented recurrent advanced/metastatic gastric
or gastroesophageal junction adenocarcinomas* previously treated with a platinum and
fluoropyrimidine-based regimen.
* The gastric or gastroesophageal junction adenocarcinomas that overexpress HER2
should have previously been treated with trastuzumab, except in the case of
contraindication.
- Patients older than 18 years
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Patients must have documented disease progression
- Patients who have measurable disease according to Response Evaluation Criteria in
Solid Tumors (RECIST) v1.1
- Accessible tumor lesion (primitive lesion or metastasis) for trial dedicated tumor
biopsy.
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (echo) or multigated
acquisition (MUGA) scan within 28 days before day 1 of treatment.
- Child-Pugh class A
- Patients must have normal organ and marrow function:
- Absolute neutrophil count ≥ 1,500/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 ULN except subject with documented Gilbert's syndrome,
AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, Serum alkaline phosphatase ≤ 2.5 x
ULN. Patients with bone metastases: alkaline phosphatase ≤ 5 x ULN.
- Albumin > 2.5 mg/dL.
- Glomerular filtration rate ≥ 60 mL/min as determined by the CKD-EPI equation (or
reference methodology such as Iohexol or isotopic technic).
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hour urine
must demonstrate < 1 g of protein in 24 hours.
- Normal blood pressure or adequately treated and controlled hypertension (systolic
BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
- Female patients of childbearing potential must have a negative serum pregnancy test
within 8 days of initiating protocol therapy.
- Female patients of childbearing potential must agree to use contraceptive methods with
a low failure rate (< 1% per year) during the treatment period and for 6 months after
the last dose of study drugs.
- Male patients of childbearing potential must agree to use contraceptive methods with a
low failure rate during the treatment period and for 6 months after the last dose of
study drugs.
- Patient is capable of understanding and complying with the protocol and has signed the
informed consent document.
- Patients affiliated to a social insurance regime.
Exclusion Criteria:
- Residual toxicity from previous treatment grade ≥1, except for alopecia or peripheral
neuropathy grade ≤ 2
- Radiotherapy within 28 days before inclusion, except for palliative radiotherapy if
patients recovered from all side effects
- Congenital risk of bleeding, or acquired coagulopathy, or curative anti-coagulant
therapies (except for low molecular weight heparin).
- Active digestive bleeding within 3 months before inclusion
- Patients pretreated with one of the experimental drugs, other immune checkpoint
inhibitor anti-cancer drugs (anti-PD1, anti-PDL1, anti-CTLA4, …), or with ramucirumab.
- Uncontrolled high cholesterol or triglyceride grade ≥ 2
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active
infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac
arrhythmia, congestive heart failure-New York Heart Association Class III or IV,
active ischemic heart disease, myocardial infarction within the previous six months,
uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the
previous 6 months, chronic liver or renal disease, or severe malnutrition.
- Current peripheral neuropathy of Grade ≥ 3 according to National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
- Active, second potentially life-threatening cancer
- Other malignancy within the last 5 years except: adequately treated non-melanoma skin
cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ
(DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may
be eligible provided he completed her adjuvant systemic therapy and remains free of
recurrent or metastatic disease.
- Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with
the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,
or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid
arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this
criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only
after consultation with the study physician
- Major surgery within 28 days before cycle 1, day 1
- Active infection requiring iv antibiotics at day 1 of cycle 1
- Medical condition that requires chronic systemic steroid therapy or on any other form
of immunosuppressive medication. For example, patients with autoimmune disease that
requires systemic steroids or immunosuppression agents should be excluded. Replacement
therapy (eg., thyroxine, or physiologic corticosteroid replacement therapy for adrenal
or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs,
resulting in dyspnea at rest
- Patient is positive for the human immunodeficiency virus (HIV), HepBsAg, or HCV RNA.
- Live vaccine within 28 days of planned start of study therapy
- History of abdominal fistula, gastrointestinal perforation and/or intra-abdominal
abscess within the previous 6 months
- History of Type I or Type II diabetes mellitus requiring insulin
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins or Chinese Hamster Ovary (CHO)
cell proteins or loperamide drug or excipient
- Known hypersensitivity to any of the components of atezolizumab, bevacizumab or
ipatasertib
- Participation in other interventional clinical research that may interfere with the
experimental drugs efficacy
- History of severe or life-threatening skin adverse reaction on prior treatment with
other immune-stimulatory anticancer agents
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.
| Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent GASTric Adenocarcinoma (IMMUNOGAST) | NCT04739202 | Entailment |
4,055 | 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:
- Knee-OA detected by x-ray (Kellgren & Lawrence grade 2 or greater)
- Considered a candidate for TKR by the orthopedic surgeon.
- The participant is > 18 years of age.
- The participant can provide relevant and adequate, informed consent.
Exclusion Criteria:
- Bilateral simultaneous TKR
- Revision of prior TKR, unicompartmental knee arthroplasty or high tibial osteotomy
- Rheumatoid arthritis
- Mean VAS > 60mm on a 0-100mm scale
- Investigator considers that the mental condition of the participant does not allow
participation.
- The participant must not be pregnant or plan pregnancy during the study.
- Inability to comply with the protocol;.
- Inadequacy in written and spoken Danish.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement | NCT01410409 | Entailment |
1,146 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Patients with an echocardiographically proven hypertrophic cardiomyopathy according to
the ESC guidelines or individuals with a HCM associated mutation without the clinical
characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients);
- Age ≥ 18 years;
- Able to comply with the protocol;
- Written informed consent.
Exclusion Criteria:
- Known significant epicardial coronary artery disease;
- Patients with LVH in the clinical setting of other disorders that explain the
myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.);
- Heart failure NYHA class III-IV;
- Patients with known hemodynamic instability or syncope during exercise due to left
ventricular outflow gradient or occurrence of ventricular arrhythmia;
- History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow
myectomy;
- Patients not able to complete a bicycle test;
- Any contraindication to MR imaging (MR imaging is not obligatory for assessment of the
primary objective, therefore relative exclusion criterion);
- Recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial
infarction, heart failure, cardiac arrhythmia, etc.);
- Severe renal insufficiency (eGFR < 30 ml/min);
- Any other condition which, in the opinion of the investigator, may pose a significant
hazard to the subject if he or she participates in the present study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy | NCT01559714 | Entailment |
1,344 | 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:
- Signed informed consent by study participant or parent(s) or legally authorized
representative (LAR) and signed informed assent by the study participant (when
applicable)
- Aged 2.5 to 10 years (inclusive) at study entry
- Diagnosis of ACH
- Ambulatory and able to stand without assistance
- Study participants and parent(s) or LAR(s) are willing and able to comply with study
visits and study procedures
Exclusion Criteria:
- Have hypochondroplasia or short stature condition other than ACH (e.g trisomy 21,
pseudoachondroplasia, psychosocial short stature)
- In females, having had their menarche
- Height < -2 or > +2 standard deviations for age and sex based on reference tables on
growth in children with ACH
- Annualized height growth velocity ≤1.5 cm/year over a period ≥6 months prior to
screening
- Have a concurrent disease or condition that in the view of the Investigator and/or
Sponsor, may impact growth or where the treatment is known to impact growth.
- Significant abnormality in screening laboratory results.
- Have been treated with growth hormone, insulin-like growth factor 1 (IGF 1), or
anabolic steroids in the previous 6 months or long-term treatment (>3 months) at any
time
- Have received a C-type natriuretic peptide (CNP) analog or treatment targeting
fibroblast growth factor receptor (FGFR) inhibition at any time
- Have had regular long-term treatment (>1 month) with oral corticosteroids (low-dose
ongoing inhaled steroid for asthma is acceptable)
- Have used any other investigational product or investigational medical device for the
treatment of ACH or short stature
- Have had previous limb-lengthening surgery
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Months old.
Subject must be at most 10 Years | Prospective Clinical Assessment Study in Children With Achondroplasia (ACH) | NCT04035811 | Entailment |
6,248 | 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:
- Stroke survivors with COVID19
- Non-stroke individuals with COVID19
Exclusion Criteria:
- Stroke survivors still in inpatient hospital care
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 120 Years | Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study | NCT04471831 | Contradiction |
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