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4,464 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
Subjectswill be included with
- Aged between 18 and 65 years
- Elbow fracture in the six months before the study
- Elbow limitation in flexion or extension
- Being volunteer to participate
- Fractures should be managed with conservatively or surgically
Exclusion Criteria:
- Malunion or Nonunion Fracture
- Occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic
ossification, myositis ossification or post-traumatic ankylosing
- Non-healing wound or infection
- Previously received physiotherapy for elbow limitation
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases or
psychiatric diseases
- Could not adjust to treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Efficacy of Different Types of Stretching on Range of Motion, Pain and Function in Elbow Limitation | NCT03161782 | Contradiction |
3,661 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Subjects will be between the ages of 18 and 90.
- Male and female subjects will be recruited into the study.
- All patients will clinically demonstrate unilateral lower extremity pain in greater
proportion to low back pain symptoms if present. Imaging (CT) will document single
level lumbar herniated nucleus pulposis.
- Subjects participating will be required to speak and read English.
Exclusion Criteria:
- Cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity
symptoms, low back pain more than leg pain, the existence of significant co-morbidity
(e.g. cardiac condition, disease, etc.) of any form, and any other physical
limitations (musculoskeletal 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.
Subject must be at most 90 Years | Evaluation of Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For Lumbar Herniated Disc | NCT00927056 | Contradiction |
6,043 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Gender：male or female.
2. Age：from 20 years old (inclusive) to 75 years old (inclusive).
3. Diagnosis of gastroesophageal reflux disease.
4. there is a heartburn or acid regurgitation phenomenon.
5. After detailed description of the entire research purpose or process, voluntarily
participate in the study and sign the consent form.
Exclusion Criteria:
1. Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and
major diseases such as: cancer, congestive hear failured NYHA class>II, COPD attack.
2. Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal
tract.
3. History of esophagus and gastroduodenal surgery.
4. Tarry stool suspected gastrointestinal bleeding.
5. History of alcohol or drug abuse.
6. Patients with a history of allergies to the test drug.
7. Can not cooperate with mental illness.
8. Pregnant women or women who are breastfeeding.
9. Liver function SGOT and SGPT are more than twice the normal value.
10. renal function test BUN, Creatinine is greater than the normal value.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder | NCT04118647 | Entailment |
3,829 | 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 ≥40 and ≤80 years of age
- Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren &
Lawrence radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm Pain VAS ≤ 80mm at screening
- Score of 100mm Pain VAS ≥ 40mm at baseline
- Written consent form voluntarily
Exclusion Criteria:
- Disease of spine or other Lower limb joints that could affect fo evaluate the efficacy
- History of surgery or arthroscopy of the study joint within 6 months
- Trauma of study joint within 12 months
- Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
- Diagnosed with psychical disorder, and taking medication
- Medication of intra-articular injection within 3 months
- Uncontrollable Hypertension patients at screening test
- History of upper gastrointestinal ulceration within 6 months, History of upper
gastrointestinal bleeding within 12 months
- History of lower gastrointestinal bleeding within 12 months
- History of coronary artery bypass, systemic lupus erythematosus or mixed connective
tissue disease
- Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test
- History of hypersensitivity of LAYLA, CENATONE or NSAIDs
- Participation in another clinical trials within 4 weeks
- Medication of constantly (more than 1 week) narcotic analgesics within 3 months
- Not consent about using effectual contraception method during trial
- Pregnant or lactating woman
- History of malignant tumor within 5 years
- Investigator's judgment
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 | To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee | NCT02049606 | Entailment |
5,062 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- women age ≥65 years including those using assistive devices to maximize
generalizability if they:
1. Reside in long-term care (LTC);
2. Have:
- osteoporosis by axial bone density (spine, hip or forearm bone mineral
density (BMD) T-score ≤ -2.5 SD); or
- a previous adult fragility fracture of the spine or hip; or,
- would be treated based on FRAX National Osteoporosis Foundation (NOF)
treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic
fracture or ≥ 3% for hip fracture using femoral neck BMD.
Exclusion Criteria:
- Men because osteoporosis is less common in men and our initial ZEST 1 study only
included women.
- Institutionalized women with subacute illnesses surviving or discharged in < 3 years.
- Women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been
on a bisphosphonate for greater than 1 year during the previous 2 years because
bisphosphonates are long acting.
- Patients with a calculated creatinine clearance < 35 ml/min or who have a
contraindication for bisphosphonates (allergy, hypocalcemia).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II) | NCT02589600 | Contradiction |
4,584 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- women at childbearing age
- age 18-40 years
- BMI 18.5-24.9 kg/m²
- taking oral contraceptives
- not having any contraceptives
Exclusion Criteria:
- chronic and acute infectious diseases
- history of taking antibiotics or probiotics in the last 3 months
- gastrointestinal disorders in the last 3 months
- Polycystic Ovary Syndrome
- disorders of the menstrual cycle (e.g. oligomenorrhea, anovulation)
- other than mediterranean diet
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | The Relationship of the Intestinal Microbiome and the Menstrual Cycle | NCT03581201 | Contradiction |
2,384 | 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. | The samples used in this study will be derived from individuals at risk for, or suffering
from, neuromuscular disease, generally resulting in clinical weakness of one or more muscle
groups and their family members.
Inclusion criteria:
1. having a clinical and/or pathological diagnosis of a muscular dystrophy
2. being the first degree relative of someone with such a diagnosis
3. having had a muscle biopsy if diagnosed with a neuromuscular disease
4. willingness to provide a skin biopsy for research only
Exclusion Criteria:
1. not having such a diagnosis and not being related to such an individual
2. not wishing to participate
3. being incapable of giving consent and not having a legal guardian willing or able to
do so
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Molecular Analysis of Patients With Neuromuscular Disease | NCT00390104 | Entailment |
883 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Informed consent obtained.
2. Ambulatory (able to walk unassisted)
3. At least 18 years of age
4. Capable of understanding the study
5. Capable of writing and reading in local language
6. Predominantly tibiofemoral knee osteoarthritis and satisfy the clinical classification
criteria of the American College of Rheumatology (ACR): Knee pain and three of the
following criteria: over 50 years age, less than 30 minutes of morning stiffness,
crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth.
7. Highest probability to progress based on the algorithm based on the following
parameters:
- Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
- BMI (in recording height and weight)
- Pain NRS of the index knee at the moment of the screening visit
- Pain NRS of the index knee during the last week before the screening visit
- Age
- Gender
- KIDA parameters of the index knee, based on standardized weight-bearing (KIDA)
radiograph, measured < 3 months (patients with a Joint Space Width (JSW) < 2 mm
of the index knee will not be included)
Exclusion Criteria:
8. Not being able to comply to the protocol
9. Participating in a trial with local therapeutic intervention for index knee OA
(pharmaceutical or surgical) or systemic Disease Modifying OsteoArthritic Drugs
(DMOADs) or potential DMOADs treatments for OA at the same time or within the past 6
months or anticipated in the forthcoming; participation in non-interventional
registries or epidemiological studies is allowed.
10. Surgery of the index knee in the past 6 months (to avoid interferences with imaging)
11. Scheduled or expected surgery of the index knee in the next 2 years (to avoid
interferences with imaging)
12. Pregnancy (child bearing woman) because of imaging (radiation and MRI, risks)
13. Predominantly patellar femoral knee OA (clinical judgment)
14. The following secondary osteoarthritis of the knee: clinically significant deformities
of the lower limbs (varus >10°, valgus >10°), septic arthritis, inflammatory joint
disease, gout, major chondrocalcinosis (pseudogout), Paget's disease of the bone,
ochronosis, acromegaly, haemochromatosis, Wilson's disease, rheumatic symptoms due to
malignancies, primary osteochondromatosis, osteonecrosis, osteochondritis dissecans,
haemophilia
15. Generalized pain syndrome, for example fibromyalgia
16. Patients with contra indication to MRI or CT
17. Hip replacement or expected hip replacement within 6 months
18. Osteosynthesis material near the knee joint
19. Self-reported severe Intervertebral disc (IVD) degeneration or facet OA
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 2-year, European Multicentre Study to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis | NCT03883568 | Entailment |
2,065 | 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:
- Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness
of breath)
- Referred for CXR and/or CT scan
Exclusion Criteria:
- Life threatening medical condition requiring immediate treatment
- Unable to sit up for a chest ultrasound
- Unable to consent
- Pregnant
- Unable to speak, read and write in English
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.
| Chest Ultrasound of ER Patients With Cough or SOB | NCT02269761 | Entailment |
2,319 | 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:
Subject with Duchenne muscular dystrophy eligible for enrolment in the study must meet all
of the following criteria:
1. Has an out of frame deletion(s) that could be corrected by skipping exon 53 as
confirmed by any of methodology at the time of visit 1. If not confirmed by any of
methodology that evaluates the relative copy number of all exons (i.e. MLPA, CGH etc),
must be confirmed through these techniques by the time of visit 4.
2. DNA sequencing of exon 53 confirms that no DNA polymorphisms occur that could
compromise duplex formation between NS-065/NCNP-01 and pre-mRNA.
3. There is confirmation of detection of dystrophin mRNA with skipping of exon 53 and
dystrophin production after in vitro exposure of NS-065/NCNP-01 to subject-derived
cells.
4. Male and >= 5 years and < 18 years of age at the time of obtaining informed consent
and/or assent.
5. Able to give informed consent in writing signed by parent(s) or legal guardian who is
able to understand all of the study procedure requirements. If applicable, able to
give informed assent in writing signed by the subject.
6. Life expectancy of at least 1 year
7. Unable to ambulate. Ambulant subject can be enrolled according to the circumstances.
8. Have intact muscles, which have adequate quality for biopsy. (No lacks or severe
atrophy of tibialis anterior muscle)
9. QTc <450 msec (based on 12-lead ECGs), or <480 msec for subject with Bundle Branch
Block.
10. If taking glucocorticosteroids, no significant change in total daily dosage or dosing
regimen after the time of visit 1.
Exclusion Criteria:
Subject with Duchenne muscular dystrophy meeting any of the following criteria must not be
enrolled in the study:
1. Has participated in other pharmacological clinical trial that might recover dystrophin
protein by the readthrough or the exon-skipping therapy, and/or upregulate the
dystrophin-associated proteins such as utrophin.
2. A forced vital capacity (FVC) < 50% of predicted.
3. A left ventricular ejection fraction (EF) < 40% or fractional shortening (FS) < 25%
based on echocardiogram (ECHO).
4. Surgery within the last 3 months prior to the first anticipated administration of
study medication or planned for anytime during the duration of the study.
5. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or
human immunodeficiency virus (HIV) test at screening.
6. Current diagnosis of any immune deficiency or autoimmune disease.
7. Current diagnosis of any active or uncontrolled infection, cardiomyopathy, or liver or
renal disease.
8. Use of any other investigational agents and/or experimental agents within 3 months
prior to the first anticipated administration of study medication.
9. History of any severe drug allergy.
10. Unable to give informed consent about using adequate contraception from the first
administration until at least 6 months after the last dose of study medication, by
parent(s) or legal guardian.
11. Subject considered by the investigator (or sub-investigator), for any reason, to be an
unsuitable candidate for the study.
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | Exploratory Study of NS-065/NCNP-01 in DMD | NCT02081625 | Entailment |
3,137 | 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:
- Subject who is the age of older than 19 years at the screeing visit
- Subject who has symptom at least one or more as below for six months(Irritation,
foreign body sensation, burning, mucus discharge, blurring, itching, photophobia,
tired or heavy feeling and pain)
- Subject with dry eye syndrome who meet all of the following criteria among the left
and/or right eyes at the time of screening and baseline visit.
1. Over six grade as fluorescein corneal staining by National Eye Institute scale
2. Schirmer I test ≤ 10 mm/5 min.
3. TFBUT ≤ 6 seconds
- At the screening and baseline visit, the intraocular pressure(IOP) of both eyes is
more than 5 mmHg and below 22 mmHg
- At the screening and baseline visit, biocular best corrected visual acuity(BCVA) are
over 0.2(=+0.7 logMAR or Snellen 20/100)
- At the baseline visit, over 80% administration compliance during run-in period as
placebo in single blind
- Subject who signed and dated the informed consent form after understanding fully to
hear a detailed explanation in the clinical trial
Exclusion Criteria:
- Ophthalmic diseases that may confuse the interpretation of clinical trial results,
such as clinically significant corneal surface disease, abnormal corneal sensitivity,
and abnormal tearing
- Subject with wounds caused by refractive surgery such as LASIK surgery (However, if it
does not affect the clinical trial compliance and result evaluation according to the
investigator's judgment, participation is possible.)
- Subject with the following concomitant diseses at screening visit.
1. Eyelid disease (blepharopathy, blepharolysis, valgus, varus valgus, etc.),
conjunctival relaxation, cataracts, and eye diseases requiring treatment
2. Sjogren's syndrome and secondary Sjogren's syndrome (rheumatoid arthritis,
systemic lupus erythematosus, etc.)
3. Diabetes not controlled despite appropriate treatment (hemoglobin A1c (HbA1c)>
9%)
4. Subject with the following systemic diseases that are not controlled High blood
pressure that is not controlled despite administration of antihypertensive drugs
(systolic blood pressure (SBP)/diastolic blood pressure (DBP)>160/100 mmHg)
Clinically significant cardiopulmonary disease despite appropriate treatment
5. Acute active hepatitis A, active hepatitis B or C
- Subject with the following medical history (including surgical history) at screening
visit
1. Organ transplant or bone marrow transplant
2. History of known immunodeficiency disease or human immunodeficiency virus (HIV)
infection
3. Ophthalmic surgery within 1 year before screening (including LASIK/LASEK surgery)
4. Subject who has undergone punctal occlusion and have not passed 12 weeks from the
time point below.
After punctal cauterization using electrocautery. After inserting a permanent,
semi-permanent punctal plug. If a temporary punctal plug is inserted, remove the punctal
plug.
- Subject who has administered the following drugs before the clinical trial or who need
to be administered during the clinical trial.
1. Cyclosporine eye drops within 6 weeks before screening
2. Ophthalmic solutions or antibiotics due to blepharitis, meibomian gland disease,
herpes zoster, and eye infection within 6 weeks before screening
3. Drugs that cause dry eye within 6 weeks before screening (anticholinergics,
isotretinoin, etc.)
4. Oral aspirin or drugs containing aspirin within 6 weeks before screening
5. Contains corticosteroids, mast cell stabilizers, antihistamines,
anti-inflammatory drugs (NSAIDs, etc.), gamma linolenic acid, or omega-3 fatty
acids within 6 weeks before screening
6. Other ophthalmic solutions within 3 days before screening
- Subject who wears contact lenses within 1 week before screening or who needs to wear
them during the clinical trial
- Subject with alcoholism or drug abuse history within 1 year before screening
- Pregnant women, lactating women, and those who disagree with appropriate contraception
during the clinical trial (visit 1 to visit 6)
- Subject with hypersensitivity to investigator's drugs or their excipients
- Subject who participated in other clinical trials within 4 weeks before screening and
received/received investigator's drug or clinical trial medical devices
- Subject judged by other investigators to be inappropriate to participate in this
clinical trial
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.
| Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease | NCT04679883 | Contradiction |
261 | 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:
.After electrocision of intrauterine adhesions;
.Or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients
occurred urinary retention.
Exclusion Criteria:
- Pregnancy;
- Suspected acute inflammation of the genitourinary system;
- Postoperative persistent vaginal bleeding;
- Patients have vaginal stenosis;
- Patients have implantation of a pacemaker with a cardiac pacemaker;
- Patients have a malignant pelvic organ tumor; .Patients have nervous system disease
(dementia or unstable seizures),who cannot actively cooperate with the treatment.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery | NCT03524807 | Contradiction |
4,454 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Age 18 to 64 years
- onset of pain within the past 6 months
- willing to try a steroid injection in the elbow
Exclusion Criteria:
- systemic inflammatory diseases (e.g., rheumatoid arthritis)
- pregnancy
- prior steroid injection, iontophoresis treatments with corticosteroids, or surgery for
their pain
- history of adverse reaction to lidocaine
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.
| Corticosteroid Injection for Common Upper Extremity Problems | NCT00438672 | Contradiction |
2,847 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study. To be additionaly
signed by a delegate signer if the subject is unable to handwrite.
2. Patients aged ≥20 years and <80 years at the time of informed consent
3. Patients with positive already-reported SOD1 gene mutation and progressive muscle
weakness; sporadic ALS patients who are categorized as either "Definite ALS" or
"Probable ALS" or "Probable-laboratory supported ALS" in the Updated Awaji Criteria
for the diagnosis of ALS
4. Patients at Grade 1 or 2 in the Japan ALS Severity Scale of the grant-in-aid program
for chronic diseases from the Japanese Ministry of Health, Labour and Welfare;
patients with positive SOD1 mutation of Grade 1, 2 or 3
5. Patients with ALS that occurred within 2 years at the time of the first registration;
patients with positive SOD1 mutation within 5 years after disease onset
6. Patients who can visit hospital regularly as outpatients
7. Patients with change in total ALSFRS-R score during the observation period are -1 to
-3 points
8. Urine pregnancy test (for females of childbearing potential) negative at screening
Female patients of nonchildbearing potential must meet at least 1 of the following
criteria:
1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; status may be confirmed with a serum follicle stimulating
hormone (FSH) level confirming the postmenopausal state;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female patients (including
female patients with tubal ligations) are considered to be of childbearing
potential.
Male and female patients of childbearing potential must agree to use one highly
effective method of contraception as outlined in this protocol, throughout the study
and for at least 28 days after the last dose of investigational product.
9. Patients with appropriate renal function as defined as follows at the time of the
first and second registrations
a. Serum creatinine ≤1.5 × upper limit of normal (ULN) or estimated creatinine
clearance ≥60 mL/min as calculated using the method standard for the institution.
10. Patients with appropriate hepatic function as defined as follows at the time of the
first and second registrations b. Total serum bilirubin ≤1.5 × ULN unless the patient
has documented Gilbert syndrome; c. AST and ALT ≤2.5 × ULN
11. Able to take oral tablets
12. Patients whose acute effect of previous treatment has recovered to the baseline or
CTCAE v.4.03 ≤ Grade 1 at the time of the first and second registrations
13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures
Exclusion criteria:
1. Patients with tracheostomy
2. Patients who have used non-invasive ventilation due to ALS symptoms
3. Patients whose %FVCs are less than 70% at the time of first and second registrations
4. Patients who have nerve conduction study findings of demyelination such as conduction
block
5. Patients who are taking edaravone; patients who started riluzole or edaravone after
start of the observation period; patients who changed the dosage of riluzole after
start of the observation period
6. Patients with bulbar type ALS with dysphagia and dysarthria
7. Patients with cognitive impairment
8. Pregnant female patients; breastfeeding female patients; fertile male and female
patients of childbearing potential who are unwilling or unable to use 1 highly
effective methods of contraception as outlined in this protocol for the duration of
the study and for at least 28 days after the last dose of investigational product
9. History of clinically significant or uncontrolled cardiac disease including:
- History of, or active, congestive heart failure;
- Uncontrolled angina or hypertension within 3 months prior to registration;
- Myocardial infarction within 12 months prior to registration;
- Clinically significant ventricular arrhythmia (such as ventricular tachycardia,
ventricular fibrillation, or Torsades de pointes);
- Diagnosed or suspected congenital or acquired prolonged QT interval history or
prolonged QTc (QTcF should not exceed 500 msec);
- Unexplained syncope
10. Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the
QT interval
11. Patient who is taking the following medicines during study drugs administration.
a Combination of warfarin or other anticoagulation. Combination of therapeutic
anticoagulant therapy with low molecular weight heparin is acceptable b Src or c-Abl
inhibitors c Other treatments for cancer d Drugs known to prolong the QT interval or
predispose to Torsades de Pointe e Current or anticipated use of a strong or moderate
CYP3A inhibitor and inducer f Drugs affecting gastric pH such as Proton pump
inhibitors (e.g., lansoprazole)
12. History of malignancy within 5 years prior to registration with the exception of basal
cell carcinoma or cervical carcinoma in situ or Stage 1 or 2 cancer that is considered
adequately treated and currently in complete remission for at least 12 months
13. Patients who were enrolled in other clinical study within 12 weeks before the first
registration, or are expected to be enrolled in other clinical study using a study
drug during this study
14. Known prior or suspected severe hypersensitivity to study drugs or any component in
their formulations
15. Patients with active, uncontrolled bacterial, fungal, or viral infection, including
hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS) related illness
16. Recent or ongoing clinically significant GI disorder (eg, Crohn's disease, ulcerative
colitis, or prior total or partial gastrectomy).
17. Patients with chronic obstructive pulmonary disease
18. Major surgery or radiotherapy within 14 days prior to registration at the time of the
first registration
19. Patient who fulfills the conditions:
1. Neutrophil count (ANC) <1,500/mm3 or white blood cell <3,000/mm3 at the time of
the first and second registration
2. Hemoglobin <9.0 g/dL at the time of the first and second registrations
3. Platelet count <100,000/L at the time of the first and second registrations
20. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study
21. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 Years | iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study | NCT04744532 | Entailment |
5,041 | 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:
- Bilateral postural tremor with or without kinetic tremor involving hands or forearms,
which is visible and persistent, and long-standing in duration (>5 years). Tremor
involving body parts other than upper limbs may be present, the tremor may be
asymmetrical, amplitude may fluctuate, and the tremor may or may not produce
disability.
Exclusion Criteria:
- Neurological signs, except for Froment's sign
- Causes of enhanced physiologic tremor
- Concurrent or recent exposure to tremorgenic drugs
- Direct or indirect trauma to the central and peripheral nervous system
- Historical or clinical evidence of psychogenic origins of tremor
- Convincing evidence of sudden onset or evidence of stepwise deterioration
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Motor-related Cortical Potential in Patients With Essential Tremor | NCT01250067 | Entailment |
4,978 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Patients diagnosed with functional movement disorder by a fellowship trained movement
disorders neurologist, presenting predominantly with unilateral or asymmetrical
bilateral involuntary movement in the upper extremity
2. In patients with bilateral involuntary movements, the symptoms in one arm must be
minimal
Exclusion Criteria:
1. Patients with moderate to severe involuntary movement in both arms
2. Significant cognitive impairment that prevents proper informed consent
3. Severe involuntary movement that interferes with the use of the apparatus
4. Patients with hemiparesis or the loss of one arm due to various reasons (e.g.
amputations, birth defects, etc.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Mirror Box Therapy as a Treatment Option for Functional Movement Disorders | NCT03660098 | Entailment |
3,969 | 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 with osteoarthritis (OA) of the hip or the knee (as defined by the American
College of Rheumatology) and radiological evidence of OA from the target joint
- patients must be in need of and waiting for hip or knee replacement
- patients with chronic pain for longer than 3 months for >=20 days/month
- patients with moderate to severe OA pain of the target joint (VAS score >=50 on a
scale of 0-100), whose pain was not adequately controlled with weak opioids, with or
without non-opioid pain medication
- women must be postmenopausal or using adequate contraception, have a negative
pregnancy test at study initiation, and not be breastfeeding.
Exclusion Criteria:
- Patients who had previously failed fentanyl therapy or had discontinued treatment due
to adverse events
- known allergy or hypersensitivity to fentanyl or to the adhesives
- patients being treated for depression or epilepsy
- patients who received sedative hypnotics, anaesthetics and/or muscle relaxants in the
week preceding the Run-In Period
- patients experiencing another type of continuous pain that stands out in comparison
with OA pain
- patients with major trauma to the target joints, infection in these joints, or
irreversible damage to these joints during the 6 months before 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 41 Years old.
| A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, Compared With Placebo in Patients With Osteoarthritis | NCT00236366 | Entailment |
4,214 | 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 with primary infertility defined as a state of Azoospermia.
- Men with pathological sperm tests indices as defined by the WHO.
Exclusion Criteria:
- Men with genetic syndromes, and states of Azoospermia secondary to chemotherapy, bone
marrow transplantation or radiation.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 45 Years | The Effect of Low Electrical Current on Testicular Spermatocyte Count | NCT02617173 | Contradiction |
5,270 | 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:
- Age >=50 and one of the below
- New hip fracture in orthopedic ward
- Newly identified radiographic vertebral fractures from plan films in geriatric ward or
clinical vertebral fractures in outpatient clinics
- Newly prescribed with AOMs
- Recent change of AOMs
- Poor adherence to AOMs
- Participating physicians feel that the service will benefit the patient in overall
osteoporosis and medication managements.
Exclusion Criteria:
- Life expectancy less than 2 years or can't be assessed for communication problems
- Atypical fractures
- Patient in other medication clinical trials
- Unwilling to accept the assessment and treatment
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.
| Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study | NCT02635022 | Entailment |
399 | 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:
- Between 18 and 35 years
- BMI ≥ 18 kg/m2
- If ≥ 21 years old, must have had healthy pelvic exam w/in past 2 years
Either:
- Regular menstrual cycles (21-35 days);
- Irregular menstrual cycles (>36 days) with or without a previous diagnosis of PCOS
from a primary care provider
Exclusion Criteria:
- Current use of medication(s) known or suspected to interfere with reproductive
function (eg. oral contraceptives) or insulin sensitivity
- Pregnant or breastfeeding
- Not otherwise healthy
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea | NCT01927432 | Contradiction |
2,429 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion criteria
- Patient t referred for specimens by EBUS -TBNA with clinical and radiological
suspicion of sarcoidosis or lymphoma , with pathological lymph node on imaging (small
diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal
stations, sub-carinal and / or hilar (stations 2, 4, 7, 10, 11 and 12), right and / or
left.
- Lymph nodes with a small diameter of at least 0.5 cm in CT-scan or PET / CT scan
performed in the previous 4-6 weeks.
- Patient investigated in the setting of either an initial diagnosis or a suspicion of
lymphoma recurrence (post-treatment).
- Patient able to consent to the procedure and to authorize us by written proxy,
included in the consent form for the study, to obtain a copy of the subsequent results
or radiological (PET, CT-scan, chest X-ray) or histopathological (linked with age
sampled of intrathoracic lymph nodes).
- Patient deemed fit to tolerate the procedure.
Exclusion criteria
- Patient unable to give consent.
- Female patient during pregnancy
- Patient aged under 18.
- Patient with significant coagulopathy ( INR > 1.5 ; platelet count<50 000 / mm 3 ).
- Patient anticoagulated (oral or parenteral) and whose anticoagulation can not be
suspended for the procedure.
- Obvious involvement of organ (s) with the possibility of confirming granulomas or
suspicious cells of lymphoma by means of a procedure considered less invasive (.. e g,
lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
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.
| Effect of Needle Size in Diagnostic Yield of EBUS-TBNA in Sarcoidosis and Lymphoma | NCT03573362 | Contradiction |
737 | 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. | Main Inclusion Criteria:
- Male or female patients aged at least 40 years.
- Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and
Lawrence classification system.
- Radiographic evidence consistent with osteoarthritis carried out within 6 months
before screening.
- pain is currently not adequately controlled with a simple analgesic or an NSAID OR
would necessitate treatment, but is not yet treated.
Main Exclusion Criteria:
- Concomitant presence of another type of continuous pain that is more severe in
intensity in comparison with the osteoarthritis target joint pain
- Osteoarthritis causing significant pain in any joint other than the identified knee,
or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any
other painful joint concerned.
- Female patients who are pregnant or breast-feeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Osteoarthritis Topical Treatment | NCT01496326 | Contradiction |
770 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to
the Eaton Classification Stage
- Pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily
living (ADLs) at the time of the therapy initial evaluation.
- The ability to read and understand the patient information sheets and exercises
Exclusion Criteria:
- Neurological disorder affecting the upper limb.
- Had received specific treatment for hand or thumb pain in the same limb in the last 6
months including an intra-articular joint injection to wrist, fingers, or thumb; -
Fractures or a significant hand injury or previous surgery to the wrist or hand;
- Tenosynovitis and/or Dupuytren disease
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis | NCT04738201 | Contradiction |
3,131 | 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:
- Japanese descent male and female adults who do not have the potential to bear children
>= 50 years of age.
- Determined to be eligible for the study based on medical history, physical
examination, and clinical judgment. Subjects with preexisting stable disease, defined
as disease not requiring significant change in therapy or hospitalization for
worsening disease 12 weeks before receipt of study vaccine, are eligible.
- Sexually active men must agree and commit to use a medically accepted form of
contraception during the study and for at least 3 months after vaccination.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine.
- Receipt of any vaccine within 30 days before study vaccination, except influenza
vaccine.
- Documented S pneumoniae infection within the past 5 years before study vaccination.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years | NCT00562354 | Contradiction |
2,837 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease,
predominantly upper motor neuron disease, or bulbar
2. With or without cognitive involvement
3. Willing to participate
4. On no experimental treatment
5. Ages 18 - 85
6. No prior exposure to Edaravone (Radicava)
7. On a stable dose of Riluzole for 30 days or off Riluzole
8. Male or female
9. Females of childbearing age must use contraception
Exclusion Criteria:
1. Unstable medical illness
2. Abnormal liver function (>2x ULN)
3. Unlikely to survive for 26 weeks
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone | NCT04097158 | Entailment |
1,093 | 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:
- No history of cardiopathy / pneumopathy.
- No history of hypertension or mellitus diabetes.
Exclusion Criteria:
- Pregnancy.
- Athletes.
- Body mass index < 16 or => 30 kg/m2.
- Previous treatment with cardiotoxic chemotherapy.
- Dilated left ventricle (telediastolic diameter index > 30 mm/m2).
- Interventricular septal thickness => 12 mm.
- Dilated left atria (volume => 31 ml/m2).
- Systolic pulmonary pressure => 35 mmHg.
- Moderate or severe valvulopathy.
- Incomplete or suboptimal left atrial visualization.
- Frame rate < 50 fps.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Normal Values for Myocardial Left Atrial Strain | NCT03874624 | Contradiction |
677 | 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:
- Age 18 years of age or older
- Male or female patients homozygous for the C282Y mutation.
- Iron overload as documented by serum ferritin and transferrin saturation
- No known allergy or contraindication to the administration of deferasirox
- Ability to comply with all study-related procedures, medications, and evaluations
- Effective use of birth control measures.
Exclusion Criteria:
- Iron overload not due to hereditary hemochromatosis
- Males with hemoglobin <13 mg/dL, females with hemoglobin <12 mg/dL
- Desferal treatment within 1 month of the screening visit
- Patients currently or previously treated with deferiprone or deferasirox
- Significant medical condition interfering with the ability to partake in this study
- Presence of a surgical or medical condition that might significantly alter the
absorption, distribution, metabolism or excretion of any study drug
- Clinical evidence of Active Hepatitis B or C
- Positive HIV serology
- Pregnant or breast feeding patients
- Patients treated with systemic investigational drug within 4 weeks prior or with
topical investigational drug within 7 days prior to the screening visit
Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis | NCT00395629 | Entailment |
617 | 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:
- Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte
retrieval, at first ultrasound routine control (A "pregnancy of unknown location"
(PUL) is a term used to classify a women with a positive pregnancy test and an empty
uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal
ultrasound scan.)
- Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An
intrauterine gestational sac containing a fetal pole with visible cardiac activity
- Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity
with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac
seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac
and/or fetal pole with or without cardiac activity
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology | NCT01589016 | Entailment |
4,895 | 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:
- Age ≥ 18 years and < 50 years
- Important essential tremor (bilateral postural and/or action tremor since more than
one year)
- Normal physical and neurological examination, except for essential tremor
- Insufficient efficiency of usual essential tremor's treatment
- No treatment altering the cortical excitability
- Agreement to use a medically acceptable method of contraception throughout the study
for female of childbearing potential
Exclusion Criteria:
- Cervical tremor
- Current neurological or psychiatric illness other than essential tremor
- Individual who is on medication which is known to lower seizure threshold
- Previous history of seizure(s), malaise or current active epilepsy
- Contraindication for MRI or TMS study
- Pregnancy, breast feeding women and women who are of childbearing age and not
practicing adequate birth control
- Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide
an informed consent
- Simultaneous participation in another clinical trial
- Patients who are not enrolled at social security
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 | Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation | NCT01579435 | Contradiction |
1,793 | 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:
- Aged 18 or above.
- Endoscopically removed colorectal lesion with the following pathological
characteristics:
- A moderately-to-well differentiated adenocarcinoma.
- If possible to judge: distance between adenocarcinoma and vertical or lateral
resection margin is less than 1 mm.
- In case of piecemeal resection: unjudgeable radicality (mostly due to loss of
orientation and multiple fragments).
- Absence of / unjudgeable lymphatic / vascular invasion.
- No or only grade I tumor budding.
- No suspicion of dissemination on the following investigations: serum carcino-embryonic
antigen, a computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of
a rectal tumor (less than 15 cm from the anal verge): an additional magnetic resonance
imaging of the rectum.
- Operation is advised in agreement with the Dutch Guideline on Colorectal cancer,
planned and agreed on by the patient.
- Written informed consent is obtained.
Exclusion Criteria:
- Pathology shows one or more of the following characteristics:
- A radical en-bloc resection with a free vertical and lateral margin of ≧ 1 mm.
- A poorly differentiated or signet-cell containing adenocarcinoma.
- Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal
resection, no exclusion is done).
- Tumor budding grade II-III.
- Suspicion of dissemination on investigations as mentioned in the inclusion criteria.
- Patients already receiving anti-tumor treatment for another tumor or a synchronic
colorectal cancer.
- Patients in whom a second-look endoscopy would require major and unacceptable effort
and / or resources, for instance clinical admission for bowel preparation, long
travel, general anesthesia, extremely difficult to reach polypectomy site. Such at the
decision of the patient and / or treating physician.
- Patient is planned for trans-anal surgery.
- Patient is not planned for surgery.
- Patient is pregnant.
- Patient does not provide written informed consent or is unable to provide such.
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.
| SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality | NCT02328664 | Contradiction |
687 | 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 studied under this protocol will be at risk for or have evidence of significant
excess tissue iron.
Most patients will be on regular blood transfusion secondary to either congenital or
acquired anemia.
The majority of patients have homozygous beta thalassemia.
Patients with sickle cell anemia will be included only when there is an absolute indication
for regular blood transfusions (e.g., a history of stroke).
Twenty to thirty adults with acquired anemia and good long-term prognosis will be accepted
for study if chelation can be initiated early in their transfusion history (less than 30-50
units).
EXCLUSION CRITERIA
Such patients will be excluded from study if they have diabetes or cardiac disease due to
another cause (coronary artery or valvular heart disease).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Deferoxamine for the Treatment of Hemochromatosis | NCT00001203 | Entailment |
1,786 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, GEJ, or
GC based on biopsy material or adequate cytologic exam; tumors of the GC are defined
as originating within 5 cm of the GEJ
- Patients must be clinically staged according to the 7th edition (2010) of the American
Joint Committee on Cancer (AJCC) staging system and must have either clinical T3-4a,
or ≥ N1 disease; staging should include upper endoscopy with endoscopic ultrasound and
a fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT)
scan (with diagnostic CT abdomen/pelvis preferred)
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0-1
- Absolute neutrophil count ≥ 1,500/ul
- Platelet count ≥100,000/ul
- Serum creatinine (Scr) ≤ 1.5mg/dl; if the Scr > 1.5, patients may still be eligible if
the calculated glomerular filtration rate (GFR) (Cockroft-Gault) is ≥ 40ml/minute
- Serum total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3X the institutional ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3X the institutional
ULN
- Patients with Gilbert's syndrome are eligible provided the total bilirubin is ≤ 3 and
the remainder of the liver function tests (ALT, AST, alkaline phosphatase [ALK Phos])
are within the institutional normal range
- Patients must have a forced expiratory volume in one second (FEV-1) and diffusing
capacity of the lung for carbon monoxide (DLCO) > 50% predicted
- Patients or their legal representatives must be able to read, understand, provide and
sign informed consent to participate in the trial
- Patients of childbearing potential must agree to use an effective form of
contraception during this study and for 90 days following the last dose of
chemotherapy; an effective form of contraception is an oral contraceptive or a double
barrier method
Exclusion Criteria:
- Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma,
small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma, etc.) will be ineligible
- Patients with evidence of clinical T4b (unresectable) or M1 (distant metastasis)
according to the AJCC 2010 staging system will be ineligible
- No prior chemotherapy, radiation therapy, or surgery for this malignancy will be
allowed; prior endoscopic procedures for superficial disease (endoscopic mucosal
resection, cryotherapy, photodynamic therapy, etc.) will not exclude a patient; prior
dilatation is also allowed
- Patients with another active malignancy will not be eligible except for:
- Resected basal cell carcinoma and squamous cell carcinoma of the skin, cervical
or prostatic intraepithelial neoplasia, and ductal or lobular carcinoma in situ
of the breast
- Patients with localized prostate cancer who have received curative intent therapy
are also eligible provided:
- Surgically treated patients have an undetectable prostate specific antigen
(PSA)
- Patients treated with brachytherapy have a PSA within the institutional
normal range
- Patients who have received pelvic external beam radiotherapy are not
eligible
- Patients with a clinically apparent active infection will not be eligible (please
note, an isolated elevation in the white blood cell count, by itself, does not
constitute evidence of an infection)
- Patients with known hypersensitivity to any component of the chemotherapy regimen will
not be eligible
- Patients with a baseline peripheral neuropathy ≥ grade 2 will not be eligible
- Patients who are receiving any other concurrent investigational therapy, or who have
received investigational therapy within 30 days of the first scheduled day of protocol
treatment (investigational therapy as defined as treatment for which there is
currently no regulatory authority approved indication) will not be eligible
- Patients who are pregnant or lactating will not be eligible; pregnant patients are
ineligible
- Patients with angina, a cardiac ejection fraction < 50%, or ischemic heart disease are
not eligible
- Patients with any other medical condition, including mental illness or substance
abuse, deemed by the investigator to be likely to interfere with the patient's ability
to sign informed consent, cooperate and participate in the study, or interfere with
the interpretation of the results, will not be eligible
- Patients with any history of solid organ or bone marrow transplant will not be
eligible
- Patients with a known history of infection with hepatitis B or hepatitis C virus
(active, previously treated, or both) will not be eligible due to the increased risk
of hepatotoxicity and viral reactivation associated with systemic chemotherapy
- Patients with known infection with human immunodeficiency virus (HIV) will not be
eligible
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.
| FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma | NCT02037048 | Contradiction |
1,543 | 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:
- Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening
- Subject is a nonsmoker for at least 6 months prior to the study start
- Subject has a body mass index ≥ 18 and ≤ 30 kg/m2
- Subject has a clear increase in histamine-induced dermal blood flow; Subject has an
increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100%
as determined during the screening visit
- Subject is judged to be in good health on the basis of medical history, physical
examination and vital signs
- Subject understands the procedures and agrees to comply with them for the entire
length of the study by giving written informed consent.
Exclusion Criteria:
- Subject has excessive hair growth on the volar surface of the forearm
- Subject has a past or present history of diffuse dermatological conditions including
eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis
- Subject has any abnormality on the skin of the forearm, possibly interfering with the
study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts;
- Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed
which would cause a sunburn reaction) throughout the study and cannot cover the
forearms 24 hours before and after each study visit
- Subject currently uses lotions, oils, depilatory preparations, makeup or other topical
treatments on the arms and on a regular basis which cannot be discontinued for the
duration of the study; subject has used any topical treatments within 7 days of the
start of the study
- Subject has a past or present history of (symptomatic) asthma
- Subject has a history of severe allergic reactions to food or drugs or adverse
experiences of a serious nature related to the administration of either a marketed or
investigational drug, including histamine, cinnamaldehyde, capsaicin, desloratadine or
levocetirizine
- Subject currently uses any prescription or nonprescription drugs on a regular basis
which cannot be discontinued for the duration of the study; subject has used any
prescription or nonprescription medication within 14 days of the start of the study
- Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than
approximately 4 cups of tea, coffee or cola per day) at the time of the study.
Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior
to enrollment may participate; Subjects who cannot refrain from caffeinated beverages
24 hours before the study visit
- Subject is unable to refrain from drinking alcohol 24 hours prior to histamine
application, is currently a regular user (including "recreational use") of any illicit
drugs, or has a history of drug (including alcohol) abuse. A drug screen will include
amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines,
barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates
- Subject cannot refrain from being around second hand smoke 24 hours prior to histamine
application or uses nicotine-containing products. Ex-smokers should have ceased
smoking at least 6 months prior to screening
- Subject has any of the following vital sign measurements at screening: heart rate ≤ 40
or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood
Pressure ≤ 90 or ≥ 139 mmHg
- Subject has been involved in testing an investigational drug in another clinical study
within the last 4 weeks or 5 half-lives
- Subject has evidence of a clinically significant active infection, fever of 38°C or
above at the time of the study visits
- Subject has a history or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal or neurological disorders capable of significantly altering the
absorption, metabolism or elimination of drugs
- Subject is in a situation or has a condition, which, in the opinion of the
investigator, may interfere with safe and optimal participation in the study
- Subject has a history of any illness or disorder, which, in the opinion of the
investigator, might confound the results of the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. | NCT04399525 | Contradiction |
5,918 | 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:
- Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease
- Dietary fiber deficiency by dietary questionnaire
- pathological gastroesophageal reflux by 24-hours esophageal pH-impedance examination
- willingness to participate (signed informed consent)
Exclusion Criteria:
- presence of esophageal mucosal damages (esophagitis) by endoscopic evaluation
- gastrointestinal surgery in anamnesis
- current pregnancy or breast-feeding
- known hypersensitivity to Mucofalk or its components
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 | Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD | NCT01882088 | Contradiction |
1,336 | 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:
- Girls age 7-18 years
- Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)
- With or without signs of excess androgen
- Screening labs within age-appropriate normal range, with the exception of a mildly low
hematocrit (see below) and the hormonal abnormalities inherent in obesity which could
include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin,
DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH)
and/or sex hormone-binding globulin (SHBG)
Exclusion Criteria:
- Patients currently enrolled in another research protocol will be excluded, except for
those enrolled in IRB-HSR #12702/JCM022. This protocol is designed to allow subjects
enrolling in IRB-HSR #12702/JCM022 to simultaneously participate in this companion
protocol.
- Inability to comprehend what will be done during the study or why it will be done
- BMI-for-age < 5th percentile
- Weight < 27 kg if simultaneously participating in IRB-HSR #12702/JCM022 due to blood
volume limits
- Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome)
- Since the study involves looking at ovarian function, boys will be excluded.
- Positive pregnancy test or lactation. Subjects with a positive pregnancy test will be
informed of the result by the screening physician. Under Virginia law, parental
notification is not required for minors. However, the screening physician will
encourage them to tell their parent(s) and counsel them about the importance of
appropriate prenatal care and counseling. We will arrange follow-up for them at the
Teen Health Clinic at the University of Virginia or their primary care physician's
office in a timely manner.
- Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory
error.
- Morning cortisol < 3 microgram/dL or history of Cushing syndrome or adrenal
insufficiency
- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL, which
suggests the possibility of congenital adrenal hyperplasia (if postmenarchal, the
17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days
since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300 mg/dL is
confirmed on repeat testing, an adrenocorticotropic hormone-stimulated
17-hydroxyprogesterone <1000 ng/dL will be required for study participation.
- Total testosterone > 150 ng/dL
- Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5%
- Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated
hypothyroidism, reflected by normal TSH values, will not be excluded.
- Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations
<1.5 times the upper limit of normal will be accepted in this group.
- Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low
hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for up
to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous
gluconate daily (containing 36 mg elemental iron); subjects weighing >36 kg will take
two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron
each). They will return to the Clinical Research Unit (CRU) or alternate UVA clinical
unit after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked
and will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%,
respectively.
- Persistent liver test abnormalities, with the exception that mild bilirubin elevations
will be accepted in the setting of known Gilbert's syndrome. Mild elevations may be
seen in overweight girls, so elevations <1.5 times the upper limit of normal will be
accepted in this group.
Female
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 18 Years | Ovarian Contribution to Androgen Production in Adolescent Girls | NCT01421810 | Contradiction |
2,725 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- adult patients presenting with primary unilateral inguinal hernia
- patients planed for a laparoscopic repair
Exclusion Criteria:
- Age below 18 years
- recurrent or incarcerated hernias
- open hernia repair and bilateral hernias
- concomitant repair of another kind of abdominal hernia
- combined surgical procedures
- no informed consent
- pregnant women
- ASA score 4 or more
- contra-indications for MRI scans.
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 | Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation | NCT02781870 | Entailment |
4,336 | 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:
- Healthy Japanese men: According to the results of a complete medical history, the
physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG,
clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
- Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice and the local legislation
- Subjects must be able to inhale medication in a competent manner from the
Respimat®inhaler
Exclusion Criteria:
- Any finding of the medical examination (including ,blood pressure and pulse rate and
ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its
excipients)
- Intake of drugs with a long half-life (>24 hours) within at least one month or less
than 10 half-lives of the respective drug before drug administration or during the
trial
- Use of prescription or non-prescription drugs within 10 days before drug
administration or during the trial. However, over-the-counter drugs for external
application (such as lubricant eye drops for contact lens, insect bite reliever) shall
be allowed
- Participation in another trial with an investigational drug within four months before
drug administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous
(ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of
Japanese shochu, distilled alcoholic beverage)
- Drug abuse
- Blood donation (more than 100 mL within four weeks before drug administration or
during the trial)
- Excessive physical activities (within one week before administration or during the
trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
QTc interval >450 ms) or long QT syndroms
- A history of additional risk factors for torsades de pointes (TdP) (e.g., heart
failure, hypokalemia) or other cardiac arrhythmias
- hyperthyroidism
- Disagree with adequate contraception (the subject should use condoms and his partner
should use oral contraception or intrauterine device [IUD]) during the study
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers | NCT02172105 | Contradiction |
3,005 | 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:
- Diagnostic confirmation of full mutation FXS
- 50 ≥ Age ≥18 years. Males and Females included in study.
- General good health as determined by physical exam, medical history and laboratory
work up.
- FXS genetic reports at screening
- IQ less than or equal to 80. Note: IQ cutoff is used as a means to exclude cases of
females with FXS who have the full mutation, but may have neurotypical development
(ie: do not have the full FXS phenotype despite positive FXS genetic testing) due to
variability in X chromosome inactivation patterns.
- Male study participants who are sexually active with a female partner of childbearing
potential must be surgically sterilized, practicing abstinence, or agree to use highly
effective methods of birth control (defined in the list below), and not rely on
barrier methods and spermicide alone, from the time of screening until 1 week after
final dose of study drug. Male study participants must also not donate sperm from the
time of screening until 1 week after final dose of study drug. Given that AZD7325 is
not mutagenic, there is no mandatory requirement for condom use, either for avoidance
of procreation or in the case of treated males with a pregnant partner.
- Women of childbearing potential may be included in the study provided they are
established on, and continue to use, highly effective contraceptive methods from the
time of screening until 1 week after the final dose of study drug. Highly effective
methods of contraception associated with inhibition of ovulation (either oral,
intravaginal or transdermal), progestin-only hormonal contraception associated with
inhibition of ovulation (either oral [specifically Micronor, Nor-QD or their generic
equivalents], injectable or implantable).
- Aberrant Behavior Checklist total score of 20 or higher at screening
Exclusion Criteria:
- Concomitant use of modulators of GABA A neurotransmission. (examples)
- Use of more than three psychotropic drugs that do not directly impact GABA
transmission, and/or unstable dosing of any psychotropic medication in the 4 weeks
prior to baseline visit.
- Subjects are prohibited from use of strong and moderate modulators of CYP3A and
CYP2C19 during the screening (at least 2 weeks before initiation of the study) and
treatment periods of the study. Such prohibited drugs are outlined in
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/u
cm292362.pdf
- CNS-suppressing agents such as central analgesics, muscle relaxants, benzodiazepines,
other sedatives, and should also limit alcohol intake to ≤1 alcoholic beverage per
day.
- Unstable seizure disorder as defined by any seizure in the 6 months prior to baseline
visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study
entry.
- All patients with abnormal baseline safety lab assessments including, but not limited
to ALT or AST greater than 1.5 the upper limit of normal, total bilirubin or
creatinine greater than 1 time the upper limit of normal or other clinically relevant
lab abnormality or abnormality in ECG, HR or BP at screening as judged by the
investigator.
- Clinical relevant history or presence of any medical disorder judged by the
investigator at potentially interfering with this trial.
- History of or current abuse of drugs or alcohol including prescription medication.
- For female subjects of child bearing potential (women 50 & under is "amenorrhoeic for
12 months or more (following cessation of exogenous hormonal treatments - if these
have been previously taken) and with luteinizing hormone (LH) and follicle stimulating
hormone (FSH) levels in the post-menopausal range) a positive pregnancy test.
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 | An Initial Study of AZD7325 in Adults With Fragile X Syndrome | NCT03140813 | Contradiction |
5,853 | 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 must have had a minimum three-month history of symptomatic GERD, with
heartburn as the predominant symptom, and must report nocturnal heartburn symptoms
(i.e., heartburn symptoms experienced during the night-time period, between 2200 and
0600h)
- Patients must currently be taking a proton-pump inhibitor (PPI) or histamine-2
receptor antagonist (H2RA) at least four weeks prior to study admission
- Patients must be able to read, write and understand the language of the HRQOL and
productivity assessment instruments (PAGI-SYM, PAGI-QOL, WPAI-GH) i.e., English or
French
- Patients must have been at least 80% compliant with their current acid suppressive
therapy, and must have completed a minimum of 11 of 14 nocturnal heartburn ratings
during the run-in period (i.e. <=3 "missing" nocturnal heartburn ratings during the
14-day period)
- Patients must have a total nocturnal heartburn symptom score of >4 points during the
2-week run-in period
- 3 "missing" nocturnal heartburn ratings during the 14-day period) as recorded in the
diary
- Night-time heartburn control assessment of "very dissatisfied, dissatisfied, neither
dissatisfied nor satisfied" at the end of the 2-week run-in period.
Exclusion Criteria:
- Patients currently taking rabeprazole 20mg once daily (morning or evening
administration) or 10mg twice daily (morning and evening administration) on a
continuous basis
- Documented evidence of GERD refractory to acid suppressive therapy (i.e.
- no or poor clinical response to at least two treatment courses of 4-weeks duration
with a PPI)
- Esophagitis known to be the result of systemic events (e.g. scleroderma, ingested
irritants)
- Active GI bleeding, or presence of "alarm symptoms" (i.e., vomiting, blood in stool,
anemia, dysphagia)
- Documented history of significant pyloric stenosis or esophageal ring stricture
- Documented evidence of esophageal or gastric varices
- Patients with primary motility disorders, infectious or inflammatory conditions of the
small or large intestine, malabsorption syndromes, GI obstruction, history of
gastrointestinal malignancy, definitive acid-lowering surgery or other esophageal,
gastric or intestinal surgery (including vagotomy) except for simple closure of
perforation
- Patients who are unable or unwilling to discontinue the use of prostaglandins (e.g.
misoprostol), sucralfate, prokinetic agents (e.g. metoclopramide), anticholinergics,
cholinergic agents or spasmolytics. Use of opiates may be continued if started at
least 2 weeks before study admission and the dosage is consistent (± 25% for total
opioid daily dose) throughout the study
- Treatment with high-dose systemic corticosteroids (>10mg/day prednisone equivalent)
and NSAIDs, including COX-2 selective inhibitors, cannot be initiated at anytime
during the study. However, patients taking corticosteroids and NSAIDs (including ASA)
before study entry may continue these medications during the study, however, they must
have been taking a stable dose (e.g. for oral medication, a consistent daily dose ±
25%) for at least 2 weeks before study admission and the dosage must be kept constant
throughout the study. Occasional, intermittent use of NSAIDs for acute, self-limiting
conditions (e.g. headache relief) is acceptable during the study
- >3 daytime episodes during any 7 consecutive days of the run-in period
- >1 severe or very severe daytime episode (i.e., more than 1 daytime heartburn episode
rated >=3) during any 7 consecutive days of the run-in period
- Maximum total daytime heartburn score >5 during any 7 consecutive days of the run-in
period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms. | NCT00553449 | Contradiction |
1,503 | 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:
1. Patients aged 20 and older
2. Patients with Dyslipidemia
3. Patients with hypertension
4. Patients who voluntarily signed the consent form.
Exclusion Criteria:
1. Blood Pressure
- In case there is a sitting systolic blood pressure difference of 20mmHg and over
or sitting diastolic blood pressure is 10mmHg and over in selected arm.
- Patients with symptomatic orthostatic hypotension.
- Patients having the history of Secondary hypertension or suspected to be
Secondary hypertension, e.g., aortic coarctation, hyperaldosteronism, renal
artery stenosis, Cushing's disease, pheochromocytoma, polycystic renal disease,
etc.
2. Patients with severe heart diseases (NYHA class-III and IV), with ischemic heart
diseases (angina pectoris and myocardial infarction) and with peripheral vascular
diseases, and patients who underwent percutaneous transluminal coronary angioplasty
(PTCA) or treatments for coronary artery bypass graft within 6 months.
3. Patients with clinically significant ventricular tachycardia or atrial fibrillation or
atrial flutter, and patients with arrhythmia judged to be clinically significant by
investigators.
4. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive CAD, aortic
stenosis and hemodynamically significant aortostenosis or mitral stenosis.
5. Patients with severe cerebrovascular diseases.
6. Patients with severe or malignant retinosis.
7. Patients with consumption diseases or autoimmune diseases or connective tissue
diseases
8. Patients with endocrine or metabolic diseases that are known to affect serum lipid or
lipoprotein.
- Patients with uncontrollable diabetes
- Patients with uncontrollable thyroid dysfunction
9. Patients who underwent treatments that may affect lipid before the clinical trial.
10. Patients having the history of myopathy or rhabdomyolysis.
11. Patients with severe renal disorders or hepatic disorders.
12. Patients with gastrointestinal diseases that may affect drug absorption, distribution,
metabolism and excretion or who underwent such operations, or patients with present
active gastritis or gastrointestinal hemorrhage or proctorrhagia or active and
inflammatory bowel syndrome that has occurred within 12 months.
13. All of patients with chronic inflammatory diseases whereto anti-inflammatory
treatments need to be applied.
14. Patients having the history of drug or alcohol abuse.
15. Pregnant women and/or women in the lactation period or the child-bearing period.
16. Patients who are hypersensitive to Pitavastatin and Valsartan.
17. Patients who have taken other investigational drugs within 3 months before undergoing
the screening test for this clinical trial.
18. Patients judged to be unsuitable for this clinical trial by investigators.
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.
| Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia | NCT01402843 | Entailment |
5,556 | 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:
- girls between 16 and 18 years
- being classified as being overweight or obese defined with the 85th percentile of body
mass index or above based on the 2007 growth chart for Korean children aged 2-18
years.
- After consultation with a physician, they were required to be considered physically
healthy enough to engage in regular exercise after school.
Exclusion Criteria:
- participation in any weight-management programme in the past 6 months
- engagement in other exercise programs except for regular physical education at school
- smoking
- amenorrhea for consecutive 2 months or more
- being treated for hereditary diseases, mental disorder, hypertension, diabetes
mellitus, or musculoskeletal impairments
- taking any medication or supplements for weight control
Female
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 18 Years | Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls | NCT04447391 | Contradiction |
5,531 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- diagnosis of a giant intracranial aneurysm
Exclusion Criteria:
- age younger than 18
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.
| Giant Intracranial Aneurysm Registry | NCT02066493 | Entailment |
6,036 | 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:
- meets the diagnostic criteria for GERD with a GERD history of frequent episodes of
GERD-related symptoms during the last 2 months prior to study screening. The patient
must also meet the following criteria:
1. The only or main symptom is heartburn (burning feeling back of breast bone)
and/or acid reflux. Symptoms persists or have occurred repeatedly for more than 2
months;
2. As assessed by the Investigator at screening by questioning of the patient, the
frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity
of heartburn in general is ≥ moderate within 3 weeks before screening
Exclusion Criteria:
- Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥
140g).
- Patients who have suffered cardiac chest pain within the last year.
- Patients who have suffered a recent, significant unexplained weight loss of more than
6 Kg in the last 6 months.
- Female patients of childbearing potential who, for the duration of the study, are
either unwilling or unable to take adequate contraceptive precautions or are unwilling
to be sexually abstinent.
- Pregnancy or lactating mother.
- Patients with a history and/or symptom profile suggestive of the following: any other
gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades
C-D), Barrett's esophagus, acute peptic ulcer and/or ulcer complications,
Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or
gastric surgery, intestinal obstruction, current pernicious anaemia, indication for
H-pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or
hematemesis) within the last 3 months, and severe diseases of other major body
systems.
- Patients who are observed at screening to have a hiatus hernia with a diameter which
exceeds 3cm.
- Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for
treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days
prior to screening or throughout the study.
- Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2
antagonists during the 5 days prior to screening or systemic glucocorticosteroids,
non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can
be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or
quadruple therapy for eradication of H-pylori during the last 28 days.
- Patients taking or requiring to take macrolide antibiotics, such as erythromycin,
azithromycin, from the day before screening.
- Patients with difficulty in swallowing.
- Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
- Patients with severe constipation, or history of intestinal obstruction.
- In the opinion of the Investigator, patients with damaged heart or kidney function and
patients who require a low sodium diet.
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 | Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients | NCT01872897 | Entailment |
4,638 | 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:
- American Society of Anesthesiology Classification (ASA) I-II
- 18-45 years
- Regular menstrual cycle
Exclusion Criteria:
- Irregular menstrual cycles
- Patients receiving hormones or drugs affecting the ovulatory cycle
- Amenorrhea
- Pregnancy
- Climacteric patients
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Menstrual Cycle on Injection Pain of Rocuronium | NCT02539706 | Entailment |
31 | 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 age 18-70
2. Baseline morning Testosterone 150-350 ng/dL x2
3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0
miU/mL, Prolactin 4-15 ng/mL
4. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when
an affirmative answer (''yes'') to either questions "Do you have a decreased sex
drive/libido?" or "Are your erections less strong?" or any three other questions.10
5. Body mass index (BMI) <40
6. Sexual health inventory for men (SHIM) score >7 and <21. Patients are allowed to be
taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline,
however we will ask them to do the SHIM survey as if they were not taking this
medication.
7. Men must attempt to have at least four sexual encounters over each of the eight-week
periods
8. Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
Exclusion Criteria:
1. Current or previous history of prostate cancer
2. Previous or current androgen deprivation therapy for prostate cancer,
3. Past surgical history of prostatectomy.
4. History of testicular cancer.
5. History of deep vein thrombosis (DVT) or blood dyscrasia
6. History of breast cancer
7. Men with past or current treatment for erectile dysfunction including MUSE
(alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or
men who are on phosphodiesterase inhibitors will be allowed to be in the study but
must stop their use at the screening visit.
8. Chronic opioid use
9. Use of steroids within the past 3 months, including prednisone and/or cortisone
injections, and inhaled steroids. Topical steroid cream is acceptable.
10. History of or current use of anabolic steroids, i.e. testosterone, (or any analog of
testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or
any growth promoters i.e. growth hormone itself or analogs of growth hormone
11. History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet,
estrogens
12. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
wine or cocktail daily)
13. Having started a new medication during the past three months which may interfere with
the outcome measures of the study
14. Polycythemia (HCT >52% )
15. History of prostate specific antigen (PSA)> 4.0 ng/dl
16. Hematocrit (HCT)< 36 %
17. Liver function tests greater than 2 times upper normal limits or history of abnormal
electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the
investigator.
18. Previous hypogonadal treatment within last 3 months. -
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales | NCT03933618 | Contradiction |
433 | 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:
- Patients undergoing IVF in an attempt to achieve pregnancy.
- Day 2-4 Follicle Stimulating Hormone (FSH) < 10 IU/ml, LH< 12 IU/ml, and estradiol <50
pg/ml on day 2-4 of menstrual cycle
- Antimullerian Hormone > 1.5
- Between 10 and 20 basal antral follicles on day 2-4 of the menstrual cycle
- Body weight >50 kg, with BMI > 18 and < 32 kg/m2
Exclusion Criteria:
- Smokers
- Polycystic ovarian disease
- Endometriosis greater than Stage I
- Testicular aspirated sperm
- Preimplantation Genetic Diagnosis (PGD) for single gene disorder
- Preimplantation Genetic Screening (PGS) banking cycles
- Donor Egg Cycles
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 38 Years | Mono-menotropins Versus rFSH Protocol on Embryo Quality | NCT02418533 | Contradiction |
1,162 | 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:
- Age ≥ 18 years.
- Unilateral pleural effusion of unknown course.
- Patients must be able to give informed consent.
Exclusion Criteria:
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
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.
| Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion | NCT04235998 | Contradiction |
2,443 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Patients with confirmed sarcoidosis
Exclusion Criteria:
- (ex-) smokers
- for healthy controls: controls with pulmonary disease excluded
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath | NCT02361281 | Entailment |
2,366 | 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. One of the following categories:
- Genetic confirmation of spinal muscular atrophy
- Genetic confirmation of Duchenne or Becker muscular dystrophy or evidence on
muscle biopsy with a clinical presentation consistent with DMD/BMD
- Healthy individuals.
2. Able to walk independently at least 25 meters
Exclusion Criteria:
1. Unable to walk 25 meters independently.
2. Use of investigational medications intended for the treatment of SMA or DMD/BMD within
30 days prior to study entry.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
| Wearable Technology to Assess Gait Function in SMA and DMD | NCT04193085 | Entailment |
4,220 | 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 18-45 years of either gender
2. Non-smoker (less than 10 cigarettes per month for at least the prior 3 years)
3. Negative pregnancy test (for females as applicable)
4. Oxygen saturation of > 94% and blood pressure with systolic value between 140-90 mm Hg
and diastolic between 80-55 mm Hg
5. Willingness to hold all nasal medications (including, but not limited to, nasal
steroids or nasal spray decongestants), oral antihistamines and leukotriene inhibitors
for at least 1 week prior to Day 0 and continuing throughout the remaining study
period.
6. Negative Allergy Skin Test (AST) at a separate screening visit performed prior to
study enrollment, University of North Carolina Institutional Review Board (UNC IRB)
approved study # 98-0799, Database and Screening Protocol for Research Studies of the
Center for Environmental Medicine and Lung Biology (CEMALB). (Results from AST
performed within the past 12 months as part of another study protocol or AST reports
from testing performed by the subject's Medical Doctor (MD) within the past 12 months
will also be accepted.)
7. Negative methacholine inhalation challenge as performed in the separate screening
protocol. (Less than a 20% decrease in Forced Exhaled Volume at 1 second (FEV1) at a
maximum methacholine concentration of 10 mg/ml).
8. Normal lung function, defined as (NHANES III predicted set):
- Forced Vital Capacity (FVC) of ≥ 80 % of that predicted for gender, ethnicity,
age and height
- FEV1 of ≥ 80 % of that predicted for gender, ethnicity, age and height
- Ratio of Forced Exhaled Volume at 1 second to Forced Vital Capacity (FEV1/FVC) ≥
.75
9. No nasal symptoms, based on respiratory questionnaire
Exclusion Criteria:
1. Presence of neutralizing antibodies to RG-HRV-16 at the screening visit to a titer of
≥ 1:2.
2. Inability or unwillingness of a participant to give written informed consent
3. History of rhinitis, chronic sinusitis, or other sinus disease, or any chronic
cardiorespiratory disease
4. Subjects with household contacts with chronic lung disease, who are children under the
age of 2 years, and who are adults over the age of 65 years
5. Subjects who live in communal settings (i.e. dormitories)
6. Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks
7. Received any live vaccine in the past 4 weeks or an inactivated vaccine within the
past 2 weeks
8. Active wheezing at the time of the Day 0 visit
9. Pregnancy or nursing or women who are currently trying to become pregnant; all female
subjects, except those who have had a hysterectomy with oophorectomy, will undergo
urine pregnancy testing on the morning of the screening visit and again on the on Day
0 at the time of arrival to the lab and prior to HRV administration. A positive
pregnancy test will exclude the subject
10. History of any immunosuppressive disease or a positive Human immunodeficiency virus
(HIV) test at the screening visit
11. Use of immunosuppressive drugs within the past 6 months
12. Chronic medications which, in the opinion of the study physician(s), may either
increase the risks of participation or may interfere with the findings of the study
13. Current use of beta-adrenergic blocking agents
14. Current use of antidepressants if classified as tricyclic or Monoamine oxidase
inhibitors (MAO) inhibitors;
15. Known hypersensitivity to methacholine or to other parasympathomimetic agents;
16. History of fainting or feeling severely dizzy with blood draws
17. History of Guillain-Barre syndrome
18. Subjects who will be unable to avoid contact with immunocompromised individuals for 3
weeks after receiving RG-HRV16
19. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study;
20. Unwillingness to use reliable contraception if sexually active (Intrauterine Device
(IUD), birth control pills/patch, condoms)
21. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements
22. Participation in any study using an investigational agent within 30 days of
enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection | NCT03508479 | Contradiction |
2,648 | 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 will be recruited in the general surgery clinic once the presence of an
operable, inguinal hernia has been identified.
- All patients with a unilateral, symptomatic, inguinal hernia, and
- Who are surgical candidates for a laparoscopic inguinal hernia repair.
Exclusion Criteria:
- Under 18 years,
- Emergent hernia repairs,
- Recurrent hernias,
- Bilateral hernias, and
- Incarcerated bowel.
Male
No healthy subjects accepted to join the trial.
| Characterizing Stray Energy Injuries During Robotic Surgery | NCT03477201 | Entailment |
5,856 | 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:
- Age is over 20 years old, under 75 years old, men or women
- Patients diagnosed with erosive esophagitis by gastroscopy
- Signed the informed consent forms
Exclusion Criteria:
- Patients who is impossible to receive gastroscopy
- Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic
ulcer or gastrointestinal bleeding
- Patients administered with prokinetics, H2 receptor antagonists, proton pump
inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to
study in 4 weeks
- Patients with surgery related to gastroesophageal
- Patients with Zollinger-Ellison syndrome
- Patients with any kind of malignant tumor
- Patients administered with anti-thrombotic drugs
- Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or
endocrine system primary disease
- Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- Patients taking other investigational drugs or participating in other clinical studies
in 4 weeks.
- Women either pregnant or breast feeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Efficacy of DA-5204 on Gastroesophageal Reflux Disease | NCT03998969 | Contradiction |
4,810 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
- Informed consent signed
- Medical examination performed prior to participation in research
- Patients with clinical criteria of Meniere's disease according to the classification
of the American Association of Otology (ie the combination of a sensorineural hearing
loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear
sensation)
- Recipient of a French social security scheme
Exclusion Criteria:
- Patients minors
- Patients on a legal protection regime type guardianship
- Respiratory pathologies, cardiovascular, renal, diabetes
- Claustrophobia
- Contraindications to exposure to a magnetic field
- Contraindications to injecting Dotarem ®
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.
| Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease | NCT02530931 | Entailment |
597 | 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:
- Patients with missed miscarriage up to 10 weeks from the last menstrual period
- Patients are able to provide written consent
- Patients with no underlying medical conditions
Exclusion Criteria:
- Inability to consent due to cognitive or language barrier
- Any underlying medical condition requiring medical treatment
- Documented failed hysteroscopy prior to the current referral
- Inability to consent due to cognitive or language barrier
- Uterine malformations or fibroids
- Previous cesarean section
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study | NCT04512820 | Entailment |
1,815 | 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 metastatic or recurrent adenocarcinoma of
the stomach or gastroesophageal junction Bidimensionally measurable or evaluable disease
Mediastinal or hilar lymph nodes assessed by CT or MRI scan must be at least 2 cm in
diameter to be considered measurable Must not be curable with a combination of chemotherapy
and radiotherapy No brain metastases No osseous metastasis as only site of disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper
limit of normal No known Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL
Calcium no greater than 12 mg/dL No symptomatic hypercalcemia under treatment Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No history of seizures No serious concurrent infections or nonmalignant
medical illnesses that are uncontrolled or whose control may be jeopardized by study
complications No psychiatric disorders that would preclude study compliance No other active
malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of
the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar less than 250 mg)
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease
No concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior chemotherapy
for metastatic disease No prior radiosensitizing chemotherapy in metastatic setting At
least 6 months since prior adjuvant therapy No other concurrent chemotherapy Endocrine
therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since
prior radiotherapy and recovered No prior radiotherapy to major bone marrow containing
areas (e.g., pelvis, lumbar spine) No prior radiotherapy to only evaluable lesion No
concurrent radiotherapy Surgery: At least 1 week since minor surgery and 3 weeks since
major surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other
antiepileptic prophylaxis No concurrent prochlorperazine on day of irinotecan
administration No other concurrent medications except for analgesics, chronic treatments
for concurrent medical conditions, or agents required for life threatening medical problems
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus | NCT00005607 | Entailment |
3,564 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- solitary erythema migrans
Exclusion Criteria:
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of lyme borreliosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Duration of Doxycycline Treatment in EM Patients | NCT03153267 | Entailment |
1,395 | 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:
- African American
- Hypertensive
- Owning a compatible smartphone
- Presenting to the Detroit Medical Center Detroit Receiving, Sinai-Grace Hospital, or
selected Community Health Screening Events with, but not necessarily for, uncontrolled
blood pressure (systolic blood pressure ≥ 135 mm Hg at triage and on repeat
measurement using the BpTRU device).
Exclusion Criteria:
- No self-reported prior history of hypertension
- No hypertension diagnosis documented in their medical record
- Non-English speaking
- Presenting with an acute illness necessitating immediate medical intervention
- Presenting with an admission to the hospital for critical reasons (as determined by
the attending physician)
- Pregnant (as determined by a dip test at screening), or self-report during trial.
- Having the following serious comorbidities or confounders due to the fact that they
may make blood pressure control difficult or necessitate frequent Emergency Department
use or hospitalization:
- Previous diagnosis of resistant hypertension (or current use of 3 or more
maximally dosed antihypertensive agents without achievement of blood pressure
control)
- Steroid dependent asthma or emphysema
- Cirrhosis or hepatic failure
- Chronic heart failure (any stage)
- Previous diagnosis of acute myocardial infarction, angina (stable or unstable),
or known coronary artery disease
- Previous diagnosis of cerebrovascular disease (including transient ischemic
attack or stroke)
- Known valvular heart disease
- Stage IV or V chronic kidney disease
- Cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
- Patients with other serious medical conditions that may affect their ability to
self-monitor blood pressure (such a dementia)
- Having a history of alcohol or drug abuse as determined by the CAGE-AID questionnaire
(excluded if 2 or more)
- Week 2 measurement of systolic blood pressure < 130 mm Hg using the BpTRU device
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 70 Years | MI-BP: mHealth to Improve Blood Pressure Control in Hypertensive African Americans | NCT02955537 | Contradiction |
4,035 | 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:
- Men/Women aged over 20
- Subjects who are diagnosed with one- or both-sided knee osteoarthritis according to
the standards of clinical diagnosis from American College of Rheumatology(ACR)have
knee osteoarthritis pain and meet over three of the following conditions.
1. Older than 50
2. Morning stiffness for less than 30 minutes
3. Crepitus on active motion
4. Bony tenderness
5. Bony enlargement
6. Not have heat-generating site
- Subjects who are diagnosed with degenerative osteoarthritis and have its pain at least
for over 3 months before the screening visit.
- Subjects who are uncontrolled with pain after administration of Celecoxib at least for
over 2 weeks before the randomization and have more than 40mm out of 100mm VAS at
randomization.
- Subjects who voluntarily agree to participate in this clinical trial in writing.
Exclusion Criteria:
- Subjects with rheumatoid arthritis or inflammatory, infectiousand metabolic arthritis.
- Subjects with ochronosis, hemochromatosis, secondary knee osteoarthritis by systemic
disease.
- Subjects who have severe pain such as Sudek's atrophy, Paget's disease and spinal disc
herniation.
- Subjects with poly-articular affected by severe pain of knee osteoarthritis.
- Subjects who take psychtrophic medicine and narcotic analgesics for over 3 months that
might affect on pain sensory system.
- Subjects who had Tramadol but there was no improvement in pain.
- Subjects who got the follwing treatment and medicine before the screening;
1. Subjects who had surgery on knee ligaments within a year, cartilage transplant
and scarf osteotomy.
2. Subjects who had arthroscopy within 6 months.
3. Subjects with intra-articular knee joint steroid injection within 3 months.
4. Subjects with HA injection in knee joint within 2 months.
5. Subjects with systemic steroid injection within a month(but inhaled steroids)
6. Subjects with knee replacement surgery.
- Subjects who hot the following treatment and medicine before the randomization;
1. Subjects who had Celecoxib, acetaminophen or steroidal/non-steroidal
anti-inflammatory drugs except low dose aspirin(before 300mg/day) But,
acetaminophen and low dose aspirin (before 300mg/day) are prohibited within 24
hours)
2. Nutritional supplements, physical therapy and Korean herbal medicine for knee
osteoarthritis and it pain within 2 weeks.
- Subjects who have to take anticoagulant drugs such as warfarin and coumarin during
this clinical trial.
- Subjects who took MAO inhibitors within 14 days before the screening or needed to take
these drugs during this clinical trials.
- Subjects with drug and opioid hypersensitivity and who have history.
- Subjects with sulfanilamide allergy and who have history.
- Subjects with asthmma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic
reaction to aspirin or any oher NSAIDs(incluing COX-2 inhibitors)
- Subjects with significant investigations - Hyperkalemia(Exceeded 5.5mmol/L)
- Subjects with severe liver dysfunction (ALT or AST of more than 3.0 times the upper
limit of ULN and 1.5 tmines the upper limit of ULN)
- Subjects with severe renal impairment (Serum Creatine > 3x ULN).
- Subjects with active peptic ulcer and gastrointestinal bleeding.
- Severe blood disease (Agranulocytosis, aplastic anemia, hemolytic anemia,
Thrombocytopenia, etc.).
- Subjects with Crohn's disease or inflammatory bowel disease such as ulcerative clitis.
- Subjects with congestive heart failure(NYHA 2-4)
- Subjects with severe ischaemic heart disease, peripheral artery disease and/or
cerebrovascular disease.
- Subjects with genetic problesa such as galactose intolerance), lapp lactase deficiency
or glucose-galactose malabsorption).
- Subjects with acute alcohol intoxification.
- Subjects who are addicted with took central nervous system drugs such as painkillers,
sleeping pills, anti-anxiety medications, etc.
- Subjects with severe bronchopulmonary dysplasia.
- Subjects with head injury history of brain structure lesions which may be in danger of
mental confusion.
- Subjects with epilepsy who are treated properly.
- Subjects who use Tramadol to cure for narcotic withdrawal.
- Subjects who took other clinical drugs more than once within 30 days before the
clinical trial.
- Subjects suspected to be pregnant who don't agree with the clinical method which is
permitted medically during clinical trial(Method of hormone contraception,
IUD(Intrauterine device) or IUS(Intrauterine system)), tubal ligation, bilateral tubal
ligation(condom, Diaphragm, etc).
- Pregnant woman and breastfeeding woman.
- Subjects who can increase risk due to clinical test and administraion of drugs or have
severe grade / chronic medical, mental condition or abnormal laboratory result that
may interfere with the analysis of thest results.
- Any other ineligible condition at the direction of investigator that would be
ineligible to participate 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 20 Years old.
| Clinical Trial of YYC301 for Treatment of Osteoarthritis of the Knee | NCT03850587 | Entailment |
3,632 | 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 ED with epistaxis or nasal fractures ( over 18 years)
Exclusion Criteria:
- laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
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 Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures | NCT04279288 | Entailment |
6,107 | 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. Age ≥18 years of age, inclusive, at the time of signing the informed consent.
2. Willing and able to provide informed consent via an electronic process.
3. Healthcare worker employed at a participating institution that has been identified as
high-risk for SARS-CoV-2 exposure (may include doctors, nurses, nurse aids,
radiographers, physiotherapists, phlebotomists, technicians, porters, cleaners,
laboratory or other personnel identified as being at high risk of exposure) or a CHW
involved in the collection of samples for the identification of SARS-CoV-2 through
PCR.
4. Women of reproductive potential must be using a highly effective method of
contraception for at least 28 days prior to enrolment and must be able and willing to
continue its use throughout the duration of the study.
5. Body weight ≥45 kg.
6. Access to reliable video conference, telephone, direct/text messaging, or other device
permitting real-time, reliable information transfer.
Exclusion Criteria:
1. Pregnant or lactating women.
2. PCR and/or serology confirmed SARS-Cov-2 infection at screening.
3. Current symptoms of COVID-19 disease (including, but not limited to, fever or chills,
cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia,
or diarrhea).
4. Self-reported presence or history of any of the following conditions:
- Chronic kidney disease (Stage IV or receiving dialysis)
- Cirrhosis (Child-Pugh Class B or greater)
- Porphyria cutanea tarda.
5. Currently on treatment for epilepsy or other seizure disorder.
6. Currently on treatment with a protease inhibitor-based antiretroviral regimen, or
efavirenz, or on treatment with amiodarone, carbamazepine, phenobarbitone, phenytoin,
primidone, rifampicin, or St. John's wort.
7. Known hypersensitivity or specific contraindications to the use of any of the active
drugs in the treatment arms or similar compounds.
8. Current enrolment in another COVID-19 prevention trial.
9. Concurrent or recent (within 3 months) participation in other research with a compound
likely to interfere with any of the investigational products.
10. Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of
the volunteer or the objectives of the study. The Investigator should make this
determination in consideration of the volunteer's medical history.
11. Inability or unwillingness to be followed up for the study period.
12. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study
coordinator or anyone mentioned in the delegation log) directly involved in the
conduct of the study. (Personnel employed at a study site, but not directly involved
in the conduct of the study, who would like to participate in the study, may only do
so if they are enrolled in the study through a different site at which they are not
employed.)
13. Participant is judged by the Investigator to be at significant risk of failing to
comply with the provisions of the protocol as to cause harm to self or seriously
interfere with the validity of the study results.
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 99 Years | COVID-19 Prophylaxis South Africa (COVER HCW) | NCT04561063 | Contradiction |
170 | 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. | Eligibility
Ages Eligible for Study:
- Adolescents (16-17yrs)
- Adults (18 years and older)
- Genders Eligible for Study:
- Male and Female
- Accepts Healthy Volunteers:
- No
Criteria
Inclusion Criteria:
- adolescent boys (age 16-17 years) and adult male individuals (age 18 years and older)
with a single serum sample demonstrating low testosterone in association with low or
inappropriately normal gonadotropin levels
- adolescent girls (age 16-17 years) and adult female individuals (age 18 years and
older) with a single serum sample demonstrating low estradiol (estrogen) in
association with low or inappropriately normal gonadotropin levels
- suitable male and female hypogonadotropic hypogonadal subjects
Exclusion Criteria:
- no specific exclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Examination of Idiopathic Hypogonadotropic Hypogonadism (IHH)and Kallmann Syndrome (KS) | NCT00392756 | Entailment |
4,691 | 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:
- Subjects were male or female, aged between 18 and 65 years inclusive.
- Subjects had a BMI of between 19 and 30 kg/m2 inclusive.
- Prior to study commencement, subjects signed and dated a witnessed informed consent
form.
- Subjects had a satisfactory documented medical history during the 21 days prior to
study commencement.
- Normal blood biochemistry, haematology, urinalysis and ECG were confirmed during the
21 days prior to study commencement.
- Subjects had negative virology profile (hepatitis B surface-antigen and hepatitis C
virus antibody) confirmed during the 21 days prior to study commencement.
- Females of child-bearing potential had a documented negative urine pregnancy test and
were not lactating or trying to become pregnant during the course of the study. They
were using an adequate method of contraception. A female of non-childbearing potential
was defined as one who had been post-menopausal for at least 12 months, had been
surgically sterilised, or had a hysterectomy at least 3 months prior to study start.
Exclusion Criteria:
- Subjects with any evidence or history of clinically significant hepatic or renal
disorder, cardiovascular, respiratory, metabolic, immunological, neurological,
psychiatric or gastrointestinal disease.
- Subjects with a history of asthma or allergic skin rash or other relevant allergic
reaction.
- Subjects with known hypersensitivity or intolerance to drugs in general.
- Subjects with a history of alcohol abuse (more than 28 units per week for males and
more than 21 units for females).
- Subjects who tested positive for hepatitis B surface-antigen and hepatitis C virus
antibody.
- Subjects who had been on a course of prescribed drug treatment within 28 days of the
study start that had not been approved by the Principal Investigator.
- Subjects who had taken any over the counter (OTC) drugs, vitamins, herbal remedies or
used topically applied preparations within one week of study start unless the
Principal Investigator had given approval.
- Subjects who smoked more than five cigarettes daily.
- Subjects who participated in a clinical trial or donated more than 500 ml of blood in
the three months prior to study commencement.
- Female subjects who were pregnant, lactating or trying to become pregnant during the
course of 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 65 Years | Clinical Trial of Tahitian Noni Juice Safety | NCT01424748 | Entailment |
6,885 | 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:
The patients with amnestic MCI
The patients with single domain amnestic MCI have a Clinical Dementia Rating score of 0.5
with isolated memory impairment without deficits in other cognitive domains. A cutoff
scores below 1.5 Standard Deviation (SD) (or 7 percentile) of one of the tests in domains
of cognitions employed psychometric tests; They should meet the following criteria:
1. memory complaint
2. normal general cognition
3. normal activities of daily living
4. not demented
The patients with dysexecutive MCI
The patients of dMCI have relatively focal dysfunction in executive domain with the tests
of memory, language and visuospatial skills within normal limits. The patients with single
domain dysexecutive MCI should meet the following criteria:
1. relatively focal executive dysfunction
2. Within reference range on tests of memory, language and visuospatial skills
3. normal general cognition
4. normal activities of daily living
5. not demented
The healthy volunteers
The healthy volunteers should be normal neuropsychological assessments as well as CDR=0
without significant neuropsychiatric disorder, right-handed, gender balanced and meet the
following criteria:
1. Age and gender matched healthy subjects without significant neuropsychiatric disorder
2. Able to understand and provide signed informed consent
Exclusion Criteria:
The following exclusion criteria apply to all groups.
1. Cardiac pacemaker implantation.
2. Implantation of intracranial metal device.
3. Other major systemic disease, such as renal failure, heart failure, stroke,
AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
4. Alcohol or drug abuse
5. Meet the criteria for dementia ( DSM-IV )
6. History of neurological disorder
7. Current psychiatrical illness
8. Head trauma with loss of consciousness greater than 10 minutes
9. Severe sensory deficit
10. Taking medication that affect cognition
11. Vascular lesion on MRI with Longstreth grade >=4
12. Structural abnormalities that could produce dementia, such as cortical infarction,
tumor, or subdural hematoma
13. Treatments or concurrent illnesses other than Alzheimer disease that interfered with
cognitive function.
Conversion Criteria
Patient with AD is not an enrolling group. The criteria as the MCI patients converted to is
defined by NINCDS-ADRDA Criteria and CDR=0.5, 1 or 2. The diagnosis is based on the
following:
1. CDR = 0.5, 1.0 or 2.0. For those of CDR 0.5, the diagnosis of MCI or AD depends on the
judgment of the investigators on the level of clinical, ADL and neuropsychological
impairment.
2. Probable AD defined by NINCDS/ADRDA criteria.
3. Caregiver/informant to accompany patient to all scheduled visits.
4. HAM-D rating scale score of 12 on the 17-item scale(19) or Cornell Scale for
Depression in Dementia (CSDD) score<8(20).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 70 Years | Imaging the Neural Network Connectivity on Patients With Mild Cognitive Impairment | NCT01927653 | Contradiction |
1,969 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Subjects undergoing upper gastrointestinal endoscopy
Exclusion Criteria:
- Patients with a history of thoracotomy with resection of lung tissue
- Patients with a history of severe chronic obstructive pulmonary disease (defined as an
inability to climb a flight of stairs or FEV1/VC of less than 30% of predicted)
- BMI greater than 43.
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.
| An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy | NCT02310230 | Entailment |
2,359 | 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:
- Ambulatory and Non-ambulatory patients diagnosed with DMD that is proven both
clinically and genetically and are between 5-20 years old who need partial respiratory
support daily. Patients with less than or equal to stage 1 NIH, cardiac, liver, and
renal function. Patients must also not present any indication of cancer, allergic
disease, nor bleeding diathesis.
Exclusion Criteria:
- Patients who require full respiratory support. Patients have stage II NIH or greater,
cardiac, liver, and renal function. Patients present with signs of symptoms of cancer,
allergic disease, or bleeding diathesis.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 14 Years | Efficacy of Stem Cell Therapy in Ambulatory and Non-ambulatory Children With Duchenne Muscular Dystrophy - Phase 1-2 | NCT02484560 | Entailment |
139 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- men presenting ADAM according to their responses on the Aging Male Symptoms Scale and
testosterone levels <220 pmol/l
Exclusion Criteria:
- history of neurological or musculoskeletal diseases or who have prostate cancer will
be excluded, as also those who have been submitted toresistance and/or aerobic in the
three months prior to data collection
Male
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 59 Years | Physical Exercise for Men With Andropause | NCT03150225 | Contradiction |
6,738 | 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. Under going extraction of tooth including the surgical extraction.
2. Healthy individual with no known medical problems.
3. Not allergic to foreign body.
4. Extractions which are not due to periodontal causes.
Exclusion Criteria:
1. Bony disease.
2. Bleeding disorder.
3. Allergic to foreign body.
4. Mentally retarded persons.
5. Diabetic patient.
6. Drug addict.
7. Extraction due to periodontal disease.
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 70 Years | Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold | NCT00836797 | Contradiction |
1,528 | 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:
-
You are eligible to participate in this study because you meet all of our selection
criteria:
- You are between ages 18-50
- You are right-handed
- You are able to receive a MRI scan (you have no metal implants or other metal objects
or medical devices that would make a MRI scan unsafe for you)
- You are able to follow study instructions and can read and write English
Exclusion Criteria:
- You are not eligible to participate in this study if you:
- have any systemic musculoskeletal diseases such as rheumatoid arthritis, systemic
lupus, or scleroderma that would affect the function of your nervous system
- have any neurological conditions that might affect your hand, wrist, or arm
function
- respond to our questionnaires in a manner suggesting you may be suffering from
depression
- are pregnant or a nursing mother
- currently have any ongoing meditation practice, including MBSR.
- are unable to complete our 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 50 Years | MEG Study of Mindfulness Based Stress Reduction | NCT00571051 | Contradiction |
2,845 | 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 entering this study:
- Are between the ages of 18-80 years old.
- Legal residents of the United States or Canada.
- Have a history of a chronic onset of a progressive motor weakness of less than 24
months duration.
- Fulfill El Escorial criteria of probable or definite ALS.
- If female, are surgically sterile, two years postmenopausal, or if of child-bearing
potential, must be using a medically acceptable method of birth control and agree to
continue use of this method for the duration of the study. Acceptable methods include
a barrier method with spermicide, oral contraceptives (normal doses are acceptable;
low dose oral contraceptives or contraceptive implants must be used with a barrier
method), intrauterine device (IUD), or abstinence. Have a negative pregnancy test.
- Are able to comply with protocol requirements.
- Can provide written informed consent.
- Have a manual muscle testing score of less than 8.
- Have a forced vital capacity by pulmonary function testing *60% predicted.
Exclusion Criteria:
Patients entering this study will not:
- Have any of the following conditions:renal disease (Creatine > 2.0) or other active
systemic disease
- Have any clinically significant abnormalities on the prestudy laboratory evaluation,
physical examination, ECG, chest x-ray or ophthalmologic exam.
- Have any clinically significant medical condition (e.g., within six months of
baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure)
that, in the opinion of the investigator, would compromise the safety of patient.
- Have Type I or Type II diabetes.
- Have a history of cancer including melanoma with the exception of localized skin
cancers (with no evidence of metastasis, significant invasion, or re-occurrence within
three years of baseline) and carcinoma in-situ of the cervix (women only).
- Have used an investigational drug within 30 days of baseline visit.
- Have had a tracheostomy.
- Have a Beck's Depression Inventory score * 12.
- Have legal residency outside of the United States or Canada.
- Be pregnant or breast-feeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial | NCT00035815 | Entailment |
718 | 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 ≥21 years and ≤60 years old and with BMI ≤40
- Moderate to severe knee OA pain ≥3 and ≤8 on the NRS pain subscale in the affected
knee (signal knee)
- Mild or no pain ≤3 on the numeric rating scale (NRS) pain subscale in the
contralateral knee (unaffected knee)
- Persistent knee pain lasting at least 3 months prior to Screening
- Active life-style (play or train themselves at least 2 to 3 times per week)
- Diagnosis of knee OA confirmed by radiographic assessment (must be performed within 6
months prior to screening visit):
1. anterior-posterior view (weight bearing extension or semi-flexion) of
tibiofemoral joint, (posterior-anterior/Rosenberg view as an additional
alternate)
2. lateral view of both the tibiofemoral and patellofemoral joints
3. Merchant X-ray (or Sunrise) view for patellofemoral joint.
- Radiographic assessment must confirm K-L Grade 1 to 3 for TFOA and/or K-L Grade 1 to
for PFOA.
- Radiographic assessment confirms normal articulation of patella and trochlea in
Merchant (or Sunrise) view
Exclusion Criteria:
- Radiographic assessment confirms abnormal patellofemoral tracking or articulation in
lateral and/or Merchant view (or Sunrise View)
- Major injury to or disorder of the contralateral knee or other weight-bearing joint
that would interfere with the study assessments.
- Secondary OA of the study joint due to a prior or concomitant condition (e.g., septic
arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia, or
congenital abnormality, hemochromatosis, etc.).
- Surgery to the study joint within the previous 12 months prior to Screening. Surgery
to the contralateral knee or other weight-bearing joint within the previous 12 months
that would interfere with the study assessments.
- Patients with either total joint replacement implants, unicondylar implants or
patellofemoral replacement implants in the affected joint.
- Ligament reconstruction of the affected knee within 3 years.
- Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic
arthritis.
- Episode of gout or calcium pyrophosphate (pseudogout) diseases within 6 months prior
to Screening.
- IA or local peri-articular corticosteroid injections to the study joint/knee within 8
weeks (2 months) prior to Screening or to any other joint (other than the study joint)
or soft tissue area within 1 month prior to Screening.
- Any oral corticosteroid within 1 month prior to Screening. Steroid inhalants are
permitted if the Subject has been on a stable regimen for the past 1 month prior to
Screening and remains on this regimen throughout the course of the trial.
- Intra-articular HA in the study joint within 6 months prior to Screening.
- History of allergic reaction to an intra-articular Hyaluronic acid injection.
- Known hypersensitivity (allergy) to gram positive bacterial proteins.
- Use of glucosamine or chondroitin sulfate containing products unless the subject is on
stable doses for at least 14 days prior to Screening and willing to remain on these
stable doses throughout the course of the study.
- Inability to perform the climbing stair test.
- X-ray findings of acute fractures, severe loss of bone density, avascular necrosis
and/or severe deformity.
- Axial deviation of the lower limbs greater than 20 degrees in valgus or varus on
standing X-ray.
- Symptomatic OA of either hip or spine with a pain score ≥2 on the NRS on or off pain
medication.
- Clinically significant medio-lateral and/or anterior-posterior instability.
- Osteonecrosis of either knee.
- Participation in a physical therapy regimen that has not been stable during the 1
month prior to Screening and the subject is unwilling or unable to maintain the same
regimen throughout the course of the trial or is unwilling to stop previously
prescribed or self-initiated physical therapy regimen and switch solely to and
initiate study defined PEP program.
- K-L Grade 4 TFOA of the knee (i.e., large osteophytes, marked narrowing, severe
sclerosis, and definite deformity).
- K-L Grade 4 PFOA of the knee (i.e., large osteophytes, marked narrowing, severe
sclerosis, definite deformity)
- Hemiparesis of the lower limbs.
- Significant surgery of lower limbs (hip, ankle, foot) that may interfere with knee
assessments.
- Chronic use of analgesia for pain (including pain in the other knee or any other
joint) that may interfere with the evaluations of the test knee (such as possible use
of rescue medication for these other conditions).
- Known allergies to acetaminophen and hyaluronan preparations.
- Know hypersensitivity (allergy) to anesthetics
- Recurrent medical history of severe allergic or immune-mediated reactions.
- Active infection or skin diseases in the area of the potential injection site or
joint.
- Any dermatological disease overlying the signal joint that would contraindicate
multiple injections or aspirations.
- Use of any agent reported to have symptom relief for arthritis or be a
disease/structure modifying drug (e.g. doxycycline, long-term tetracycline,
s-adenosylmethionine [SAM], methylsulfonylmethane [MSM] or dimethylsulfoxide [DMSO],
dietary supplements or any herbal remedy taken for arthritic and joint conditions
within the past month (exceptions as specified in Exclusion #14).
- Peripheral neuropathy that would be severe enough to interfere with the evaluation of
the subject.
- Psychological status (e.g., anxiety, depression, poor sleep quality, pain
catastrophizing, etc.) that may interfere with functional assessment of the target
knee.
- Vascular insufficiency of lower limbs that is severe enough to interfere with the
evaluation of the subject.
- Concomitant therapy with anticoagulants (low dose aspirin, not exceeding 325 mg per
day as an anti-thrombotic agent is permitted if stable for 1 month prior to Screening
and remains stable throughout the study).
- Any concomitant disease(s) or condition(s) that may interfere with the free use and
evaluation of the affected knee for the 6 months course of the trial (cancer, other
rheumatic diseases, gout, severe congenital defects, etc.).
- Any serious mobility problems (e.g. Parkinson's disease) or claustrophobia
- Any concomitant chronic disease(s) or condition(s) that may predispose them to a high
probability of interfering with the completion of the 6-month follow-up of the study
such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer,
pregnancy, alcoholism, drug abuse, mental state, or other clinically significant
condition.
- Excessive alcohol consumption or alcoholism that would be contraindicated with the use
of acetaminophen.
- Use of marijuana, whether prescribed or not
- Any clinically significant diagnostic test and/or abnormal laboratory test result(s)
that, in the opinion of the clinical investigator, may place the subject's health at
risk, impact the study, or impact the subject's ability to complete the study.
- Inability to legally comprehend the details and nature of the study for any reason,
including psychiatric illness.
- Likelihood of protocol violations or unlikely to compete the study for any reason, as
determined by the clinical investigator.
- Continued participation in an experimental drug/device study or any clinical trial
within the previous 8 weeks prior to Screening. Subjects must have fully completed
participation in an experimental drug/device study of any clinical trial at least 8
weeks prior to screening.
- Pregnancy, breastfeeding, planned conception, premenopausal women who have not had
tubal ligation, hysterectomy, or are unwilling or unable to utilize contraceptive
measures (or contraception)
- Prior history of any malignancy with the exception of basal cell carcinoma of the skin
treated more than 2 years prior to Screening.
- Significant bleeding diathesis.
- Participation in current litigation for injuries related to the study knee or other
injuries that might interfere with their completion of the study protocol.
- Non-English speaking subjects.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 60 Years | 2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA) | NCT03281837 | Contradiction |
1,237 | 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:
- Requiring Tunneled Catheter Placement for a Pleural Effusion
Exclusion Criteria:
- Patient with a nonexpandable lung
- Non-english speaker
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.
| Betadine Pleurodesis Via Tunneled Pleural Catheters | NCT02975921 | Entailment |
4,184 | 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. Male or female subjects, aged 18 to 65 years.
2. Physician diagnosis of mild intermittent allergic asthma (GINA I according to GINA
guidelines9).
3. Normal lung function parameters at baseline (FEV1 > 80 % of predicted)
4. Non smoker or smokers with a history of less than 10 pack years with no smoking in the
last 12 months.
5. Able and willing to give written informed consent
6. Women will be considered for inclusion if they are:
not pregnant, as confirmed by pregnancy test, and not nursing of non-child bearing
potential (i.e. physiologically incapable of becoming pregnant, including any female who is
pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation,
or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year
prior to the screening visit) of childbearing potential and using a highly effective method
of contraception during the entire study (vasectomized partner, sexual abstinence - the
lifestyle of the female should be such that there is complete abstinence from intercourse
from two weeks prior to the study until at least 72 hours after the end of the study -,
implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier
methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm,
sponge, and cervical cap)
• Available to complete all study measurements
Exclusion Criteria:
1. History of lower respiratory tract infection four weeks prior to the informed consent
visit.
2. Past or present disease, which as judged by the investigator, may affect the outcome
of this study. These diseases include, but are not limited to, cardiovascular disease,
malignancy, hepatic disease, renal disease, hematological disease, neurological
disease, endocrine disease or pulmonary disease (including but not confined to chronic
bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
3. Regular intake of any prescribed or over the counter medication. Exceptions include
paracetamol for pain relief, oral contraceptive medication, hormonal replacement
therapy, dietary and vitamin supplements, and short acting beta mimetics (SABA) on as
needed basis.
4. Use of anti-inflammatory medication including systemic or inhaled corticosteroid
within the last four weeks.
5. Any history of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic
seizures.
6. Conditions or factors, which would make the subject unlikely to be able to undergo
methacholine challenge.
7. Conditions which provide a contraindication for methacholine challenge testing such as
uncontrolled arterial hypertension, known aortic aneurysm, myocardial infarction or
stroke within three months prior to study, current use of cholinesterase inhibitor
medication.
8. Inability to perform acceptable-quality spirometry.
9. History of drug or alcohol abuse.
10. Participation in another clinical trial 30 days prior to enrolment.
11. Suspected inability to understand the protocol requirements, instructions and
study-related restrictions, the nature, scope, and possible consequences of the study.
12. Risk of non-compliance with study procedures.
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 | Characterization of Aerosol Generation and Transport in the Human Lung | NCT01095627 | Contradiction |
28 | 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:
- Volunteers patients with hypogonadism
Exclusion Criteria:
- Coronary heart disease
- Other pituitary/hypothalamic disorders or other non-hypogonadism diseases
- None was receiving vitamins, lipid-lowering drugs, or other medications known to
interfere with PON1 activity, lipid profile, or gonadal function
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 25 Years | Phase IV Study to Investigate the Effect of Testosterone Treatment on Paraoxonase Level in Male Patients With Hypogonadotrophic Hypogonadism | NCT01107067 | Contradiction |
5,578 | 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:
- at or above the age appropriate cut-offs for overweight (OW) or obese (OB) on WHO
growth charts: ≥85-97% for OW and >97% for OB for BMI
- between 10 and 18 years old
- menarcheal
- low dairy consumers (0-2 svgs/d and <700 mg Ca/d measured by baseline FFQ)
- otherwise healthy (i.e. no diagnosed disease or illness)
- lower levels of physical activity (0-2 times/week)
- no allergy to dairy foods or diagnosed lactose intolerance
- not on medications related to a chronic condition or that affect bone health
Participants will be excluded from participation in the study if they do not meet one or
more of the above inclusion criteria.
Female
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 18 Years | Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program? | NCT02581813 | Contradiction |
4,098 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Ages of 18 to 50 years (adult), inclusive.
- Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International
Classification of Sleep Disorders (3rd edition) criteria (new or previously
diagnosed).
- Have undergone an multiple sleep latency test (MSLT) within the previous 15 years
showing an MSLT of ≤ 8 minutes.
- An ESS score of ≥ 12; and mean MWT time of < 12 min.
- Body mass index ranging from 18 to < 45 kg/m2
- Negative urine drug screen.
- A woman must be either not of childbearing potential or of childbearing potential
practicing highly effective methods of birth control.
- Willingness to complete the study protocol with full compliance with procedures and
sign an informed consent form (ICF).
Exclusion Criteria:
- Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of <
6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
- Use of any investigational therapy (including pitolisant) within the 30-day period
prior to enrollment.
- Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline
assessments and during the course of the trial.
- Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens
at night to smoke).
- Use of concurrent medications prescribed to treat narcolepsy as specified including
stimulants, antidepressants and sodium oxybate.
- Current diagnosis of or past treatment for syndromes known to cause sleep disruption
or any other cause of daytime sleepiness.
- Clinically significant ECG abnormalities.
- An occupation requiring variable shift work, night shifts, or frequent overnight
travel which disrupts sleep patterns.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy | NCT04072380 | Entailment |
3,895 | 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. All patients ages 30-80 with chronic painful knee osteoarthritis who would undergo
treatment by genicular nerve radiofrequency ablation.
2. Knee pain for at least 6 months.
3. Kellgren-Lawrence knee osteoarthritis of 2 or greater.
4. Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants,
oral steroids, physical therapy, and intra-articular injection therapy.
5. No pain referral beyond the expected distribution for knee osteoarthritis.
Exclusion Criteria:
1. NRS pain score of 4 or more
2. Focal neurologic signs or symptoms.
3. Previous radiofrequency ablation treatment for similar symptoms.
4. Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
5. Concomitant radicular pain.
6. Previous knee surgery.
7. Patient refusal.
8. Lack of consent.
9. Active systemic or local infections at the site of proposed needle and electrode
placement.
10. Coagulopathy or other bleeding disorder, current use of anticoagulants or
anti-platelet medications.
11. Allergy to medications being used for injection procedures (contrast, local
anesthetic).
12. Inability to read English, communicate with staff, or participate in follow-up.
13. Pregnancy.
14. Pacemaker.
15. Cognitive deficit.
16. Unstable medical or psychiatric illness.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | Diagnostic Genicular Nerve Block Prior to Radiofrequency Ablation for Knee Osteoarthritis Pain | NCT02578108 | Entailment |
6,918 | 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:
- All participants:
- Normal Education> 7 years
- French mother tongue
- right-handed (Edinburgh Inventory)
- score on the scale of Beck <7 (depression scale)
- signing the informed consent of the protocol in agreement with the Committee to
Protect People
- Medical examinations, neurological, neuropsychological and neuroimaging depth in
accordance with the specific inclusion and exclusion criteria for each
population, that is to say:
- Young healthy subjects aged between 18 and 44 years
- Healthy subjects intermediate age: between 45 and 69 years
- score on the Mattis Dementia Scale higher than 137, in order to exclude any
potential dementia
- Performance "normal" to test RI RL-16 (that is to say, not differing by more than
1.65 standard deviation from the norm for age and cultural level [see normative
values published Van der Linden et al., 2004]), test conventionally used to
assess the verbal episodic memory.
- Healthy elderly subjects aged 70 and over, living at home
- score on the Mattis Dementia Scale higher than 137, in order to exclude any
potential dementia
- Performance "normal" to test RI RL-16 (that is to say, not differing by more than
1.65 standard deviation from the norm for age and cultural level [see normative
values published Van der Linden et al., 2004]), test conventionally used to
assess the verbal episodic memory.
- MCI patients: older than 50 years and recruited from memory clinics and meet the
current criteria and recognized including amnestic MCI
- memory complaint
- targets deficits of episodic memory (lower performance of at least 1 standard
deviation from the norm for age and cultural level to one or more (sub) episodic
memory scores of diagnostic battery - cf. . Tables 1 and infra)
- performance in the standards for age and cultural level in all tests of
diagnostic battery measuring other cognitive functions as memory, including the
evaluation of overall cognitive ability tests.
- Alzheimer's patients: older than 50 years were recruited from the clinics and memory
satisfying the standards NINCDS-ADRDA criteria for probable AD which include
- abnormal global cognitive functioning and deficits in two or more cognitive
domains identified by the diagnostic battery
- mild to moderate AD (MMSE ≥ 18).
Exclusion Criteria:
- Cognitive disorders of sudden onset (contrary to their slow and progressive onset in
AD), which could reflect a stroke; a modified Hachinski ischemic score ≤ 2 (Loeb &
Gandolfo, 1983); history of head trauma with loss of consciousness for more than 1
hour, or encephalitis;
- Chronic neurological disease, psychiatric, endocrine, hepatic, infectious;
- A history of major illness (chronic lung disease, heart disorder, metabolic,
hematologic, endocrine or immunological severe, cancer);
- A medication that may interfere with the mnemonic or metabolic measures
(psychotropics, hypnotics, anxiolytics, neuroleptics, anti-Parkinson, benzodiazepines,
anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle
relaxants central, as is usual The investigating doctor deems the annoying character
for the study of the regular intake of certain medications). Taking anticholinesterase
treatment will also be a criterion for non-inclusion.
- Chronic intake of alcohol or drugs;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Cerebral Substrates of Prospective Memory in Young and Its Disruption in Normal Aging and in Alzheimer's Disease: A Study in Anatomical MRI, Diffusion Tensor MRI and Functional MRI | NCT02522091 | Entailment |
5,371 | 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:
- Being in the age range of 18-35
- To be of reproductive age,
- Not giving birth before, Healthy women with regular menstrual periods (those who have
bleeding between menstrual cycles for 3-8 days for 21-35 days),
- To be an undergraduate student,
- AcOG PMS criteria (according to ACOG diagnostic criteria; women with at least one
premenstrual syndrome and symptoms in at least three consecutive cycles)
Exclusion Criteria:
- Having a regular yoga history for 3 months before and during the workout;
- Having a chronic disease (Endocrine, DM, Heart diseases, psychiatric illness) Oral
contraceptive use
- To have a physical problem that prevents him from doing yoga asanas
- Over cyst and PICOS
- Get a score lower than 110 from the total scale score according to the PMS scale score
- Over 10 in Beck Depression Inventory, Students with a history of gynecological surgery
were excluded from the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters? | NCT04821232 | Contradiction |
4,342 | 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:
An individual who is affected with a disorder under study. Our initial list of exemplar
disorders has been discontinued; these disorders were examples of those which meet the
general attributes for inclusion in this protocol. As stated above, individuals with
disorders we choose to investigate under this protocol will generally represent simplex
cases with rare phenotypes whose molecular etiology is unknown.
In rare instances, we may accept DNA from deceased individuals, including DNA or other
saved biological specimens from deceased fetuses/neonates in accordance with Policy 400.
These samples may provide us exceptional opportunities to study variants and manifestations
of severe genetic overgrowth disorders. In the rare circumstance where we plan to accept
samples from fetuses/neonates, we may engage with pregnant mothers to begin consent
discussions and coordinate specimen collection. We will only enroll pregnant women who
voluntarily donate fetal tissue from invasive prenatal testing, and for which trio analysis
is appropriate and necessary. While rare, there may be circumstances in which the
scientific objectives (to elucidate the molecular etiology of the proband s genetic
condition) would not be possible without analyzing the DNA of the fetus/proband and the
biological parents.
Family members of an affected individual where that family member (often a parent) is
potentially informative or useful for linkage or other bioinformatic analyses of genetic
variants may be enrolled. Probands who are minors or decisionally impaired adults are
eligible if they have a parent or legal guardian who has authority to sign a consent form
on their behalf.
EXCLUSION CRITERIA:
Probands who are adults and decisionally impaired are ineligible if they do not have a
legal guardian who has authority to sign a consent form on their behalf.
Subjects who have known, significant affective or psychiatric disorders that, in the
judgment of the team, may impair their ability to understand and appropriately use complex
medical and genetic information will be considered decisionally-impaired and will be
ineligible unless they have appointed (or, in the case of minor children, are in the
custody of) an appropriate surrogate decision-maker.
In addition, guardianship for cognitively impaired adult probands must be legally
established and proof of guardianship must be supplied prior to that family s enrollment.
We request the ability to use this protocol for multiple genetic disorders, without
specifically delineating them a priori. We believe this approach to be appropriate because
for nearly all inherited disorders, the risks and benefits of GSMS do not substantively
differ. This concept was validated by our now-closed protocol 94-HG-0193, which was a
broad-based protocol for heritable congenital anomaly disorders, many of which do not fall
neatly into a specific diagnostic classification.
We may request permission to retain some information about prospective participants who, at
the time of their inquiry, may not be eligible for the study but who could become eligible
in the future. As these participants will not be signing a consent form, we propose to NOT
count these participants in our Inclusion Enrollment Reports but will provide the IRB with
a tally of retained records at each Continuing Review.
Consent documents for this protocol are available in English and Spanish. In rare
instances, we may enroll participants who speak other languages using the NIH Short Written
Consent Form Translation.
We will not enroll pregnant women, except as outlined in the section above.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Month old.
| Whole Genome Medical Sequencing for Genome Discovery | NCT01087320 | Entailment |
6,879 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | - Participants must meet National Institute of Neurological Disorders and Strokes, and
Alzheimer's Disease and Related Disorders Association (NINDS/ADRDA) criteria of
probable Alzheimer's disease of mild to moderate severity.
- Age at inclusion into study is between 62 and 85 years. Age at onset of symptoms of
Alzheimer's disease must be between 60 and 85 years of age.
- Participants must have no systemic or other brain diseases that could explain deficits
in memory or cognition.
- Imaging studies must be consistent with a diagnosis of Alzheimer's disease.
- Hachinski Ischemic Rating Scale score of 4 or less.
- Participants must have sufficient visual and auditory acuity and verbal communication
skills to read and hear the testing materials and respond to questions.
- Participants must be able to read and speak English.
- Participants must have a responsible caregiver/informant willing to participate in the
study.
- Use of anti-dementia drugs is permitted if participants have been on a stable dose for
at least 3 months prior to enrollment.
Exclusion Criteria:
- Family history of early onset Alzheimer's disease.
- History of recent acute myocardial infarction.
- Unstable angina.
- Participants receiving anticoagulants or anti-platelet agents.
- History of malignancy, active systemic infections, clinically significant respiratory
dysfunction and/or liver disease.
- History of bleeding disorders, uncontrolled diabetes mellitus and/or hypothyroidism.
- History of stroke.
- Diagnosis of Normal Pressure Hydrocephalus.
- Chronic renal insufficiency.
- History of severe head injury.
- History of alcohol and/or drug abuse.
- Positive FTA, low serum B12.
- Participants exhibiting Parkinsonian signs.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 62 Years old.
Subject must be at most 85 Years | COGNIShunt® System for Alzheimer's Disease | NCT00056628 | Contradiction |
5,106 | 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:
- Random population-based sample of women:
- Age 35-40 yr
- residing in the city of Oulu, Finland
- in March 2002
Exclusion Criteria:
- cardiovascular, musculoskeletal, respiratory, or other chronic diseases that might
limit training and testing
- diseases or medication affecting the bone
- pregnancy and breastfeeding
- regular current or previous participation in impact-type exercises and long-distance
running more than three times a week
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 40 Years | Bone Adaptation to Impact Loading | NCT00697957 | Contradiction |
6,609 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Severe hemophilia A (FVIII: C<2%),
2. Age 1-7y
3. Historical bleeding in any knee, elbow and ankle joint (s),
4. >50 EDs irrespective of FVIII product, including human coagulate factor and
recombinant factor VIII
5. No inhibitor present or history/family history,
6. On-demand or low-dose prophylaxis (the dose per kg.week less or as Step 1 prophylaxis
regimens factor consumption)
7. Regular clinical visit with accessible data,
8. Informed consent will be obtained from patient legal guardians before the enrollment.
Exclusion Criteria:
- 1. Other bleeding disorders or systemic disorders, or don't fit for enrollment
according to the investigator, 2. FVIII inhibitor development:>0.6 BU (confirmed by
two separate tests), 3. Unable to follow the protocol or refuse to continue the
participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 7 Years | A Clinical Phenotype Based Individualized Prophylaxis in Chinese Hemophilia A Children | NCT02999308 | Contradiction |
306 | 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. Good general overall health with no chronic medical conditions that result in periodic
exacerbations requiring significant medical care.
2. Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least
18 years of age to provide consent.)
3. Have a regular menstrual cycle 21-35 days in duration when not using hormonal
contraception
4. Have an intact uterus and at least one ovary.
5. Consistent use of effective contraception during the preceding cycle with no
unprotected intercourse since last use (NOTE: women who use oral, transdermal,
vaginal, or implantable hormonal contraceptives in the preceding cycle must have
discontinued hormone use at least 4 days prior to start of treatment and must not have
had unprotected intercourse since discontinuing the method. Copper IUD or
Levonorgestrel releasing IUD users must have discontinued IUD use at least 4 days
prior to start of treatment and have experienced a spontaneous menses following IUD
removal.)
6. No use of injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the
10 months prior to screening unless the subject has returned to normal menses (two
consecutive menses) since last injection.
7. Have a negative pregnancy test at the enrollment visit.
8. Have a diastolic blood pressure (BP) <90 mm Hg and systolic BP <140 mm Hg after 5
minutes rest in sitting position at the admission visit (below hypertension stage 2).
(Note: History of hypertension stage 2 or higher, even if controlled with treatment,
is exclusionary.)
9. Willing to abstain from use of non-water based (including silicone based) vaginal
lubricants during the study that could adversely affect the ring, causing it to
expand.
10. Understand and sign an IRB-approved informed consent form prior to screening
activities (including fasting blood draws).
11. BMI ≤ 35 kg/m2 and not having previously undergone bariatric surgery.
12. Planning to have at least one act of heterosexual intercourse without the use of
another contraceptive method each month during study participation until end of
treatment and at risk for pregnancy.
Exclusion Criteria:
1. Planning pregnancy during study participation through the end of treatment visit.
2. Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous
menses.
3. Post-abortal and has not had a spontaneous menses.
4. Abnormal genital bleeding.
5. Participating in another clinical trial involving an investigational product within
the last 30 days (prior to screening) or planning to participate in another clinical
trial during this study.
6. Not living in the catchment area of the study site.
7. Known hypersensitivity to progestins or estrogens.
8. Contraindications to combined estrogen-progestin contraceptive use including:
1. Thrombophlebitis or thromboembolic disorders.
2. Personal history of deep vein thrombophlebitis or thromboembolic disorders.
3. History of venous thrombosis or embolism in a first-degree relative <55 years of
age suggesting a familial defect in the blood coagulation system.
4. History of thrombosis or embolism OR any other personal or family history which
in the opinion of the investigator suggests increased risk.
5. History of stroke.
6. Known history of any of the following genetic mutations: Factor V Leiden
mutation, prothrombin mutation, antithrombin deficiency, or other clinically
significant thrombophilia.
7. Known or suspected carcinoma of the breast.
8. Carcinoma of the endometrium or other known or suspected estrogen-dependent
neoplasm.
9. History of cholestatic jaundice of pregnancy or jaundice with prior hormonal
contraceptive use.
10. History of hepatic adenomas or carcinomas.
11. Known or suspected pregnancy.
12. Smoking in women who are or will be 35 years during the course of the trial;
women <35 years who smoke 15 cigarettes or more per day must be evaluated by the
investigator for inclusion based on risk factors that would increase their risk
for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose
level, BP, BMI, family history of CVD at a young age. Individuals who use other
forms of tobacco should be evaluated similarly by the investigator for inclusion
based on the amount of tobacco use and their risk factors.
13. History of retinal vascular lesions, unexplained partial or complete loss of
vision.
14. History of headaches with focal neurological symptoms (e.g., migraines with
auras).
15. Impaired mobility (e.g. wheelchair bound, bed-ridden) that, in the opinion of the
investigator, places the woman at increased risk of thrombosis.
9. Unevaluated vaginal discharge or vaginal lesions. Subjects diagnosed at screening with
a chlamydia or gonococcal infection may be included in the trial following treatment
completion; partner treatment is also recommended. Subjects with yeast,
trichomoniasis, or bacterial vaginosis infection requiring treatment may be enrolled
after treatment completion. Investigators should determine if subjects are at an
elevated risk for reinfection, e.g. multiple sex partners, untreated partner, and
whether such subjects can be included. Women with a history of genital herpes can be
included if outbreaks are infrequent.
10. Have a known clinically significant Pap test abnormality, as managed by normal
standard of care guidelines, that would require repeat evaluation or treatment during
study participation based on the initial Pap findings.
11. Known benign or malignant liver tumors, renal disease or active liver disease.
12. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin
cancer).
13. Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive.
14. Known or suspected current alcohol dependence, chronic marijuana use, or any illicit
drug use that may affect metabolism/transformation of study product and/or study
treatment compliance. A chronic marijuana user is defined as someone who uses
marijuana 4 or more times per week for study purposes.
15. Elevated fasting clinical chemistry values or complete blood count (CBC) values
designated clinically significant by the investigator or medically qualified
sub-investigator.
16. Uncontrolled thyroid disease.
17. Known impaired hypothalamic-pituitary-adrenal axis.
18. Known hypersensitivity to silicone rubber.
19. History of toxic shock syndrome.
20. Vaginal anatomic abnormality such as cystocele or rectocele that would preclude
correct use of a vaginal ring.
21. Planning major surgery during study participation.
22. Severe current constipation.
23. Use of liver enzyme inducers or inhibitors on a regular basis.
24. Known HIV infection.
25. Use of any medications, including antibiotics that can significantly interfere with
the metabolism of hormonal contraceptives.
26. Have an anticipated need for regular condom use, defined as use of at least one condom
per month after enrollment.
27. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
28. Any site staff member with delegated study responsibilities or a family member of a
site staff member with delegated study responsibilities.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring | NCT03432416 | Contradiction |
5,120 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis
may be enrolled in the trial if the following inclusion/exclusion criteria apply.
All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
1. Has the subject given informed consent according to local requirements before any
trial related activities? (A trial related activity is any procedure that would not
have been performed during the routine management of the subject).
2. Is the subject above 50 years old?
3. Is the subject postmenopausal (more than 5 years) - in the judgement of the
investigator?
4. Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at
lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
5. Does the subject have a life expectancy of >3 years?
6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a
helper)?
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) | NCT00365456 | Contradiction |
3,776 | 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 20 - 70 years (both inclusive)
2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and
Lawrence radiographic entry 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 for the past three months.
6. Patients who have not received intra articular steroids or hyaluronan within the last
three months.
7. Female patients of childbearing age must be willing to use accepted methods of
contraception during the course of the study
8. 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, including arthroscopy, or major trauma to the study joint in the
previous 12 months
3. 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
4. Infections in or around the knee.
5. Patients awaiting a replacement knee or hip joint
6. Patients with other conditions that cause pain
7. Significantly incapacitated or disabled and would be categorized as ACR Functional
Class IV (largely or wholly incapacitated), or unable to walk without assistive
devices
8. Patients with other known rheumatic or inflammatory disease such as rheumatoid
arthritis
9. Other pathologic lesions on x-rays of knee
10. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human
immunodeficiency virus (HIV) antibody test, or VDRL
11. History of Bleeding disorders
12. Known hypersensitivity to Hyaluronan products or animal sera
13. For women of child-bearing potential: positive pregnancy test or lactating
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Allogeneic Mesenchymal Stem Cells for Osteoarthritis | NCT01448434 | Entailment |
1,132 | 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:
- LV wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by
loading conditions
- LVOT gradients ≥ 30 mmHg at rest and/or ≥ 50 mmHg at Valsalva's maneuver or exercise
- NYHA ≥ III
Exclusion Criteria:
- < 18 years
- Fertile women who do not use anti-contraceptives
- Pregnancy
- Patients are allowed to have a pacemaker (eg. an implantable cardioverter
defibrillator (ICD)) but cannot be pace-dependent
- Amiodarone treatment
- Persistent or permanent atrial fibrillation/flutter
- Previous SRT
- Alcohol or drug abuse
- Significant co-morbidity (judged by the investigator)
- Patients who cannot give valid consent (e.g. mental illness or dementia) or who do not
understand Danish.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effect of TASH in Patients With HOCM | NCT04066777 | Entailment |
6,133 | 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:
- Healthcare professionals from all disciplines
- Technicians from all disciplines (health related)
- Working in a face-to-face manner during the pandemic in the services of health
institutions
- Professional or technical personnel in charge of the quality and patient safety
processes in the institutions.
Exclusion Criteria:
- Professional or technical staff from the administrative areas
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Health Care Workers' Perception of Patient Safety During COVID-19 Pandemic | NCT04576299 | Contradiction |
2,411 | 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:
- Evidence of signed and dated informed consent/assent document(s) indicating that the
participant (and/or his parent/legal guardian) has been informed of all pertinent
aspects of the trial.
- Ambulatory (10 meters walk/run in less than [<] 30 seconds) and functional grade on
the Brooke Upper Extremity Scale of a 1 or a 2.
- Currently being treated with ataluren 10, 10, 20 mg/kg for >=9 months, with no gap in
treatment of greater than (>) 1 month, in an ongoing PTC-sponsored nmDMD clinical
trial prior to study entry.
- Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of
characteristic clinical symptoms or signs (for example, proximal muscle weakness,
waddling gait, and Gowers' maneuver) by 6 years of age and an elevated serum creatine
kinase (CK). Medical documentation of phenotypic evidence of DMD needs to be provided
upon request by the medical monitor.
- Willing to undergo muscle biopsy.
Exclusion Criteria:
- Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).
- Exposure to another investigational drug within 2 months prior to study enrollment or
ongoing participation in any non-ataluren interventional clinical trial.
- Requirement for daytime ventilator assistance or any use of invasive mechanical
ventilation via tracheostomy. Note: Evening non-invasive mechanical ventilation such
as use of bilevel positive airway pressure (Bi-PAP) therapy is allowed.
- Prior or ongoing medical condition (for example, concomitant illness, psychiatric
condition, behavioral disorder), medical history, physical findings or laboratory
abnormality that, in the investigator's opinion, could adversely affect the safety of
the participant, makes it unlikely that the course of treatment or follow-up would be
completed, or could impair the assessment of study results.
Male
No healthy subjects accepted to join the trial.
| A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have Been Treated With Ataluren | NCT03796637 | Entailment |
4,011 | 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:
- Meet the America College of Rheumatology (ACR) criteria for clinical knee OA assessed
by a rheumatologist
- Knee pain, visual analogue scale (VAS) pain at least 40mm
- Kellgren-Lawrence(K-L) grade of 2-4
- Physical examination showed signs of inflammation (at least 2 of the following 4
clinical signs of inflammation: warmth around the joint; tenderness around joint
margin; articular cavity effusion; swelling of soft tissue around the knee joint)
- MRI evaluated effusion synovitis grade of ≥ 2
- Capable of understanding the study requirements and willing to cooperate with study
instructions, and voluntarily sign informed consent
Exclusion Criteria:
- Inflammatory arthritis (such as gout, reactive arthritis, rheumatoid arthritis,
psoriatic arthritis, seronegative spondyloarthropathy), systemic lupus erythematosus
- Knee surgery or arthroscopic examinations were performed or planned within one year,
Severe valgus knee deformity (angle of genu valgum > 30°) or previous traumatic
history
- MRI contraindications
- Intra-articular injection, intramuscular injection or oral glucocorticoid were used
within the last 4 weeks
- Other anti-synovitis agents (such as hydroxychloroquine and sulfasalazine) were
applied in the past 3 months
- Clinical significant conditions, such as (but not limited to) active malignant tumor,
abnormal renal function (assessed by GFR), hepatic abnormalities [active hepatitis B,
hepatitis C, abnormal liver function (ALT is more than twice the upper limit)],
respiratory diseases (lung infection, pulmonary fibrosis), hematological changes (e.g
white blood cell (WBC) count < 4 x 10^9 /L, platelet < 100 x 10^9 /L or hemoglobin <
100 g/L), serious diseases of gastrointestinal, endocrine, heart, nerve or brain
assessed by clinical physicians
- Infectious history such as HIV infection
- Hypersensitivity to methotrexate
- Pregnant and Lactating women
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 | Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis | NCT03815448 | Entailment |
193 | 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:
- Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
- mean testosterone level less than 300 ng/dl
- stable weight for the previous 3 months (no weight change greater than or equal to 10
lbs)
- normal serum TSH
- normal serum prolactin levels
Exclusion Criteria:
- Type 2 diabetes mellitus
- history of diabetes in parents
- sleep apnea
- bleeding disorder
- seeking fertility
- 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias,
family history of cardiovascular disease before age 60.
- history of previous cardiovascular event: myocardial infarction, unstable angina,
cerebro-vascular accident.
- illicit drug use/alcohol use (>4 drinks per day)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH) | NCT03118479 | Entailment |
1,533 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. A male and a female subject aged: 18 - 60 years inclusive.
2. All subjects must be generally healthy and in a mutually monogamous heterosexual
relationship - current relationship ≥ 3 months.
3. All couples must be sexually active, and agree to have penile-vaginal intercourse with
a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over
4 weeks).
4. The female partner should use one other established highly effective form of
non-barrier contraception, unless post-menopausal.
5. Couples must agree not to use drugs or non-investigational devices that can affect
sexual performance e.g. medication/medical devices used to treat erectile dysfunction.
Exclusion Criteria:
1. Either partner is or becomes aware of an allergy or sensitivity to the ingredients of
the test products, including the test or control condoms or any lubrication products
provided.
2. Either partner has a pre-existing skin condition (severe eczema/psoriasis) or systemic
allergic reactions or as confirmed by the subject and physical examination.
3. Either partner that needs to use condoms for a specific sexually transmitted infection
(STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
4. Subjects that have previous or planned genital surgery, that in the opinion of the
Investigator would consider the subject unsuitable to participate in the clinical
investigation e.g. laser for abnormal smear.
5. Male partners that have known erectile or ejaculatory dysfunction.
6. Either partner that requires to use/is using medication or preparations that are
applied topically to the genitalia area or intravaginally other than that supplied for
the investigation.
7. A female partner that has been diagnosed with or treated for vaginal complaints
(including vaginal dryness) in the previous 3 months which, in the opinion of the
investigator, deems the partner unsuitable for the investigation.
8. Any participant who has clinical symptoms or signs of a sexually transmitted diseases
(STD) or HIV/AIDS or has a previous history of high risk behaviour as judged by the
investigator.
9. Female partner using medication which in the investigators opinion would affect
vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5
half-lives of the drug, whichever is longer) before first condom use.
10. A male partner with abnormal penile anatomy that would, in the opinion of the
investigator, affect the ability to keep the condom in place during intercourse.
11. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or
pain killers for the duration of the investigation.
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 | A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples | NCT03739190 | Contradiction |
5,080 | 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:
- Ambulatory postmenopausal women, who had their last menstrual period at least 2 years
before beginning the study
- Free of severe acute or chronically disabling conditions with a life expectancy of at
least 5 years
- Expected to remain ambulatory throughout the entire study and expected to return for
all study visits
- Expected to be compliant with study procedures, including procedures for WBV usage
- Women who have no language barrier, are cooperative, and who give informed consent
before entering the study
- Women must be on standard therapy with alendronate or raloxifene for at least 3 months
before the commencement of WBV, and their treatment must be expected to remain stable
throughout the study
Exclusion Criteria:
- Participation in another clinical study within the last 30 days and/or during the
study
- Subjects who are inmates of psychiatric wards, prisons, or any other state
institutions
- Investigators or any other team member involved directly or indirectly in the conduct
of the clinical study
- Thrombophlebitis, deep venous thrombosis, any thromboembolic disorders (including
pulmonary or retinal embolism) within the last year
- Any vascular disorders of the lower extremities with the exception of asymptomatic
varicosis
- Current bone disorders other than primary osteoporosis, such as hyperparathyroidism,
Paget's disease, renal osteodystrophy, osteomalacia, osteonecrosis, spondylolisthesis
- Vertebral fracture or fractures of the lower extremities within the last 6 months
before start of WBV
- Frequent occurrence of muscle spasms limiting the use of WBV
- Spastic disorders
- Morbus Sudeck (CRPS I)
- Malignancy within the past 2 years with the exception of in situ removal of basal cell
carcinoma
- Severe cardiovascular disorder, such as but not limited to: not controllable
hypertension, clinically relevant cardiac arrhythmia and cardiac valve disorder, heart
failure (NYHA III-IV)
- Cerebral vascular accident within the past 1 year
- Any neurologic/psychiatric disorder which might interfere with the conduct of the
trial or the study results such as, but not limited to, the following: Depression,
schizophrenia, dementia, Parkinson's disease, epilepsy
- Benign Paroxysmal Positional Vertigo
- Frequent occurrence of migraine attacks (more than once per month), limiting the use
of WBV
- Active renal lithiasis or gall stones as defined by any colic within 6 months prior to
start of WBV
- Acute inflammation, infection and/or fever
- Immune compromised conditions such as, but not limited to, rheumatoid arthritis, HIV
- severe diabetes, e.g. defined by the coexistence of an arterial occlusive disease
- Major surgical interventions within 3 months prior to WBV
- Metallic or plastic implants like joint implants, pace makers, cardiac valves, stents,
eye lenses that limit the use of WBV
- Any acute joint inflammation of the lower extremities or other parts of the body which
might interfere with the use of WBV within the last 6 months before start of WBV
- Start or change in regimen of physical therapy, or extreme sportive activity within 1
month prior to study and during the study
- Treatment with doses of any of the following medications more recently than 6 months
before beginning the study: Androgen, Calcitonin, Estrogen, Progestin, strontium
ranelate, parathormone, proton pump inhibitors
- Long term treatment (more than 6 months) with Heparin within the last 2 years
- Patients in the alendronate group must be naïve to other bisphosphonates and raloxifen
- Patients in the raloxifen group must be naïve to all bisphosphonates
- Treatment with WBV within the last 6 months
- Treatment with therapeutic doses of systemic corticosteroids for more than 1 month
during the 12 months before beginning the study
- Treatment with 50,000 IU or more of vitamin D once weekly more recently than 3 months
before beginning the study
Female
No healthy subjects accepted to join the trial.
| Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women | NCT01415050 | Contradiction |
6,678 | 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:
- Diagnosis of inherited, severe (FVIII:C < 1%) or moderately severe haemophilia A
(FVIII ≤ 2%)
- Any age
- Ability to comply with study methods and willingness to participate to the study
- Written informed consent.
FOR THE LOW RESPONDERS COHORT
- Documented low anamnestic response after FVIII exposure (FVIII inhibitors titre >0.6 and
< 5 BU/ml tested by Bethesda assay, Nijmegen modification). It will be included in this
study those patients who have never been submitted to ITI and also those patients who have
completed ITI with partial success (defined as inhibitors titre >0.6 and < 5 BU/ml and no
increase in the INH titer > 5 BU over treatment with FVIII)
INCLUSION CRITERIA FOR THE HIGH RESPONDERS COHORT
- Documented high response after FVIII exposure (FVIII inhibitors titre > 5 BU/ml tested
by Bethesda assay, Nijmegen modification). It will be included in this study those
patients who are potential candidates to a first or rescue ITI.
- Any historical peak ≥ 5 BU
Exclusion Criteria:
- Diagnosis of acquired haemophilia
- Diagnosis of inherited mild haemophilia A (FVIII > 2%)
- Life expectancy lower than 1 year
- Psychiatric illness and any other conditions may impair ability to comply with study
methods
Male
No healthy subjects accepted to join the trial.
| Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors | NCT01505946 | Contradiction |
4,166 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Healthy male or female subjects in good health as determined by past medical history
- physical examination, vital signs and safety lab at screening
- between 18 to 45 years of age
Exclusion Criteria:
- Significant illness
- pregnant or lactating women
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 and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat | NCT04644705 | Contradiction |
6,846 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- Idiopathic inflammatory myopathies
Exclusion Criteria:
- Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies,
overlapped myopathies, others myopathies
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.
| Optimizing Treatment on Idiopathic Inflammatory Myopathies | NCT03092180 | Entailment |
1,017 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Patients with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP
tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:
- Grade 0: no radiographic features of OA are present
- Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
- Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing
radiograph
- Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
- Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony
deformity
2. Patients who are between the ages of 18 - 85 years
3. Patient has signed informed consent
4. Patient has access to a smartphone or tablet (Android or iOS)
5. Subject must be ambulatory.
6. Subject must be willing to stop taking any pain medications 24 hours prior any
scheduled study visit.
7. Subjects must be proficient in English.
8. Subject must be willing and able to sign an informed consent document.
9. Subjects must be willing and able to comply with all study procedures for the duration
of the clinical study.
Exclusion Criteria:
1. Subjects who have a body mass index > 40 at the time of consent. Exclusion of a
patient with BMI>40 is up to the discretion of the PI.
2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint
infection, Lyme disease, SLE, etc.).
3. Subjects who have had an injury or an acute traumatic injury to the index knee within
6 months of screening will be excluded.
4. Subject must NOT have had arthroscopy within 8 weeks of randomization.
5. Subjects who have had treatment of the target knee with intra-articular injections of
steroids within 8 weeks of screening.
6. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of
screening.
7. Subjects who have had a scheduled surgery on the target knee within the study period.
(Note- Patients who are scheduled to go under surgery within the next 6 months will be
excluded. Patients that are contemplating the surgery can be included.)
8. Subjects who have used electrotherapy or acupuncture for OA of the target knee within
4 weeks of screening
9. Subjects with significant and clinically evident mal-alignment of the target knee (>
10 degrees varus or valgus in the target knee).
10. Subjects with surgical metallic hardware in the target knee.
11. Subjects who have contraindications to MRI and X-rays, for example, implanted
electrical devices (cardiac pacemakers, deep brain stimulators).
12. Subjects with a current malignancy or who have received treatment for malignancy with
the last 5 years, with the exception of resected basal cell carcinoma and squamous
cell carcinoma of the skin.
13. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of
chronic substance abuse (> 5 years).
14. Subjects with skin breakdown or infection in the area where the study device will be
placed.
15. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart
failure, etc.) that have not been well-controlled for at least 3 months prior to
screening.
16. Subjects who have any ongoing litigation for worker's compensation.
17. Subjects with any condition, in the opinion of the Investigator that might interfere
with the evaluation of the study objectives.
18. Subjects who are pregnant.
19. Subject must not have participated in a clinical study within the past 12 weeks that
required the use of an investigational device, drug or biologic
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 | Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients | NCT03980964 | Entailment |
4,932 | 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:
- having a diagnosis of essential tremor (ET) based on Movement Disorder Society
criteria, involving at least one hand.
- 18 years or above
- cognitively eligible to give informed consent of participation in the trial.
Exclusion Criteria:
- Cardiac pace-maker or other implanted magnetic device or having other
contraindications of performing a routine non-contrast MRI
- skin defect at the occipital area preventing placement of a coil
- Currently pregnant or plan for pregnancy in the next 6 months
- History of seizure
- Other comorbid medical conditions capable of producing or enhancing tremor
- advanced cardiac, renal, hepatic or other disabling conditions making patient physical
unable to participate in examination and receiving the intervention
- Use of new drugs with potential effect on tremor
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.
| Cerebellar rTMS for Essential Tremor | NCT02704793 | Entailment |
6,916 | 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:
General inclusion criteria
- Be older than18 years old.
- Consulting in one of the centers (patients only)
- Sufficient cognitive capacities for the realization of the clinical and
neuropsychological evaluations, left to the judgement by the investigator.
- Women old enough to procreate under effective contraception
- Signed consent
- Absence of general or systemic disorders that may interfere with cognition.
- If available before inclusion, absence of brain lesions as determined by MRI that may
account for even part of the clinical presentation.
Patients with Hippocampal sclerosis non AD (n=40)
Clinical criteria :
- CDR (Clinical Dementia Rating Scale) = 0.5 or 1
- Progressive amnestic syndrome of the hippocampal type, defined by a free recall score
≤ 17/48 and a total recall score ≤ 40/48 on the FCSRT.
Biological criteria : Absence of Profile suggestive of AD on the study of the biomarkers of
the CSF (IATI ratio > 0.8)
Patients with Alheimer's Disase (n=40)
Clinical criteria :
- CDR (Clinical Dementia Rating Scale) = 0.5 or 1
- Typical amnesic AD : Progressive amnestic syndrome of the hippocampal type, defined by
a free recall score ≤ 17/48 and a total recall score ≤ 40/48 on the FCSRT, associated
or not with others cognitive impairment
- Posterior Cortical Atrophy : initial presentation of progressive visual or
visuospatial impairment; absence of ophthalmologic impairment with evidence of complex
visual and/or visuospatial disorder on examination; a relatively preserved episodic
memory
- Logopenic progressive aphasia : word retrieval deficits in spontaneous speech and
confrontation naming, impaired repetition of sentences, errors in spontaneous speech
and naming (eg, phonological errors), and relative sparing of word and object
knowledge and motor speech.
Biological criteria : CSF biomarkers suggestive of AD defined on CSF.
Patients with DLFT (n=20) :
Clinical criteria :
- Modifications of the personality and the social conducts in the foreground
- Compatible brain imaging with the diagnosis : profile of atrophy and/or hypometabolism
in TEP-FDG (or hypoerfusion in Spect) compatible with the diagnosis of DFT and/or
absence of atypie Biological criteria : No AD profile on CSF biomarkers
Patients with CBD/PSP (n=20) (Armstrong et al., 2013)
1. Corticobasal syndrome :
- at least one of the following signs : limb rigidity or akinesia, limb dystonia,
limb myoclonusplus at least one of the following sign : orobuccal or limb
apraxia, e) cortical sensory deficit, alien limb phenomena (more than simple
levitation)
- Nonfluent/agrammatic variant of primary progressive aphasia: Effortful,
agrammatic speech plus at least one of: a) impaired grammar/sentence
comprehension with relatively preserved, single word comprehension, or b)
groping, distorted speech production (apraxia of speech)
2. Progressive supranuclear palsy syndrome :
- Three of the following items present: a) axial or symmetric limb rigidity or
akinesia, b) postural instability or falls, c) urinary incontinence, d)
behavioural changes, e) supranuclear vertical gaze palsy or decreased velocity of
vertical saccades
Normal controls (n=20):
Absence of known psychiatric disorder Score on the Folstein Mini Mental Status (MMSE > or =
27) Normal neuropsychological assessment for the age and the educational level
Exclusion Criteria:
- Subject with a psychiatric evolutionary and/or badly checked pathology (left to the
judgement of the investigator).
- Subject with a grave, severe or unstable pathology (left to the judgement of the
investigator) the nature of which can interfere with the variables of evaluation.
- Epileptics subjects, badly tolerant MRI (1.5T, 3T or 7T), Subject presenting
contraindications to the MRI (if necessary, a blood pregnancy test will be performed
before 7T MRI) (Pacemaker or stimulating neurosensory or implantable defibrillator,
cochlear implants, eye or cerebral ferromagnetic foreign bodies close to nervous
structures, metallic prostheses, agitation of the patient : not cooperative or
agitated patients, very young children, claustrophobics subjects, pregnant women,
neurosurgical ventriculoperitoneal shunt valves, brace)
- Known or supposed histories (< or = 5 years) of severe alcoholism or misuse of drugs
- Vascular, inflammatory or expansive, visible lesion in the MRI which can interfere on
the criteria of diagnosis.
- No health insurance
- Pregnant, breast-feeding woman or planning a pregnancy in two years of follow-up.
- For controls : anomaly detected on the MRI in the appreciation of the investigator
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Hippocampal Sclerosis and Amnesia Not Due to Alzheimer's Disease | NCT02576821 | Entailment |
2,350 | 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:
- Duchenne muscular dystrophy genetically confirmed;
- Males between 6 and 14 years old;
- Able to walk independently at least 75 meters;
- Patients on a stable dose of corticosteroids at least 6 months prior to baseline;
- Patients able to swallow capsules size 4 according to the parents and investigator
opinion;
- Willing and able to comply with all protocol requirements and procedures;
- Signed informed consents by the parent(s)/legal guardian(s);
- France only: Affiliated to or a beneficiary of a social security system
Exclusion Criteria:
- Patients with significant renal disease or impairment, with Glomerular Filtration Rate
estimated using plasma cystatin C level using the Filler formula less than
90ml/min/1.73m2
- Current or history of liver disease or impairment,
- History of any significant medical disorder which may confound the interpretation of
either efficacy or safety data e.g. inflammatory, coagulation disease, unstable
cardiac or respiratory disease
- Acute illness within 4 weeks of the first administration of study medication which may
interfere with study assessments;
- Significant change of dosage and/or dosing regimens for corticosteroids planned for
the duration of study medication;
- Use of beta blockers / and ACEI or ARB unless at stable dose for at least 3 months
prior to baseline;
- Use of Proton Pump Inhibitors unless at a stable dose for at least 3 months prior to
baseline
- Use of aldosterone antagonists (i.e. spironolactone, eplerenone) within 3 months prior
to first administration of study medication;
- Use of anticoagulants, antithrombotics or antiplatelet agents,
- Use of antibiotics with predominant renal secretion (e.g., cephalosporins),
immunosuppressive agents exception corticosteroids, continuous treatment with
non-steroidal, anti-inflammatory drugs (NSAIDs), or lithium;
- Previous treatment with idebenone or other forms of Coenzyme Q10 within 1 month of the
first administration of study medication;
- Previous treatment with investigational drugs within 4 weeks (or 7 half-life if longer
than 4 weeks) of the first administration of study medication including placebo;
- A baseline QTc>450msec,or history of risk factors for torsades de pointes (eg, heart
failure, hypokalaemia, family history of long QT syndrome);
- LVEF≤ 45% at screening or within the past 6 months and/or history of acute heart
failure;
- Ventilator dependent;
- Known individual hypersensitivity to any of the ingredients/excipients of the study
medication;
- Patients with specific contraindication to MRI (e.g.: metallic foreign body,
claustrophobia, etc.).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 14 Years | Rimeporide in Patients With Duchenne Muscular Dystrophy | NCT02710591 | Entailment |
4,720 | 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. Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the
informed consent form
2. body weight: ≥ 55kg(male), ≥ 50kg(female)
3. BMI: 18.5 kg/m2 ≦ BMI < 25.0 kg/m2 [BMI(body mass index) = Body weight (kg)/[height
(m)]2 ]
4. in female subjects, the result of serum β-hCG pregnancy test comes out negative at
screening, urine β-hCG test comes out negative before taking medication during the
period set by this protocol have to be included one of the below conditions.
- postmenopausal(no natural menstruation at least 2 years)
- surgically sterile(hysterectomy or bilateral ovariotomy, tubal ligation or
sterile condition by other ways)
- sterility of male partner before screening(proof the azoospermia after
vasectomy), and this is the only partner of the subject.
- agree with using a proper and continuous method of contraception start on 14
days(at least) before the1st IND administration and for 28 days(at least) after
the last IND administration
- proper contraception means physical barrier method including condom,
contraceptive diaphragm or cervix cap, do not use a hormones including
contraceptive or oral contraceptive during the study.
5. if the male have a sex life with childbearing aged female, maintain proper
contraception during the study and for 28 days after the last IND administration,
agree with "do not donate the sperm"(if the female partner is infertility, above
contraceptions are not necessary)
6. Written consent on voluntary decision of participation and compliance with precautions
after being fully informed of and completely understanding this trial
Exclusion Criteria:
1. Hypersensitivity to a drug containing an ingredient of the investigational
product(EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g.,
aspirin, antibiotics) or medical history of clinically significant hypersensitivity
2. Active infection such as chronic or local infection based on screening tests or
inquiry, verifiable medical records
3. Serious infection that required hospitalization or use of antibiotics within 30 days
prior to the first dose of the investigational product, based on an inquiry or
verifiable medical records
4. Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory,
musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric
disorder or its prior history
5. (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results
from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a
tuberculosis patient within the past 3 months or signs and symptoms of suspected
tuberculosis
6. Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery
(except for simple appendectomy or hernia surgery) that may affect drug absorption,
etc.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 45 Years | Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers | NCT02700360 | Entailment |
Subsets and Splits