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5,256 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. women osteoporosis
2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral
density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or
a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture.
Menopause was defined as no natural menses for at least 1 year and a serum FSH level >
40 IU/L, with a reported hysterectomy
3. low levels of 25(OH)D > 9 ng/mL
4. patients who give written consent of agreement to voluntarily participate in the
clinical study
5. patients who can read and understand written instructions
Exclusion Criteria:
1. patients who had contraindications to oral bisphosphonates, such as esophageal
strictures
2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
3. low levels of 25(OH)D (less than 9 ng/mL).
4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period
was needed, depending on the duration of treatment. Two-year washout periods were
needed for bisphosphonate users and 3-6-month periods were required for vitamin D
users of > 200 IU.
5. drug administration after diagnosing as alcoholic or psychical disease
6. patients whom the investigators judge as improper to participate in this clinical
trial 7)13.patients who have experience to participate in other clinical trial within
30 days prior to study participation
Female
No healthy subjects accepted to join the trial.
| Post-menopausal Women Osteoporosis(Phase III) | NCT01806792 | Entailment |
608 | 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:
- tubal pregnancy
- tubal pregnancy except interstitial pregnancy
- a pretreatment β-hCG level <15000 mIU/mL
- a gestational sac with a largest diameter <4 cm
- hemodynamically stable status
- agreement to methotrexate treatment and follow up
Exclusion Criteria:
- heterotrophic pregnancy
- a presence of embryonic cardiac motion
- clinically or sonographically suspected tubal rupture
- laboratory tests showing possible deleterious effects of methotrexate treatment on
organ functions
Female
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 55 Years | Methotrexate Treatment for Ectopic Pregnancy | NCT01855568 | Entailment |
5,930 | 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:
- Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI > 3.5
SD)
- Are able to attend biweekly to monthly sessions with our support team and are capable
of adhering to the lifestyle changes advised
Exclusion Criteria
- Previous esophageal or gastric surgery or history of intestinal obstruction;
- History of moderate to severe inflammatory disease of the gastrointestinal tract such
as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or
stenosis; gastric or esophageal varices; congenital or acquired intestinal
telangiectasis
- Hiatus hernia >5 cm or <5cm with associated severe or intractable gastro-esophageal
reflux symptoms (assessed at balloon insertion);
- History of significant psychological disorder (permission sought from lead care
giver).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 19 Years | Effectiveness Gastric Balloon in Obese Adolescents | NCT04209842 | Contradiction |
4,513 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Healthy, women 18 through 40 years of age at the time of enrollment who have severe
menstrual related symptoms
- Willing and able to comply with the study protocol
- Has not used oral contraceptives, vaginal rings, or injectable contraceptives during
the last month and has had one regular menstrual period preceding enrollment OR is
within seven days post induced abortion
- Has been determined to be eligible for hormonal contraceptive use
- Willing and able to be contacted by research staff.
Exclusion Criteria:
- Does not speak or read English
- Is breastfeeding
- Has contraindications to use of estrogen-containing contraceptives including
thrombophlebitis or thromboembolic disorders including a past history of deep vein
thrombophlebitis or thromboembolic disorders
- Cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast, endometrium or suspected
estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Biliary tract disease
- Cholestatic jaundice of pregnancy or jaundice with prior contraceptive steroid use
- Hepatitis
- Cirrhosis
- Hepatic adenomas or carcinoma
- Hypertension (>140 systolic or >90 diastolic)
- Diabetes
- Migraine with focal neurologic symptoms
- Is pregnant or less than 3 months postpartum
- Concurrent use of medications that induce liver enzymes
- Has severe or chronic constipation
- Drug or alcohol abuse (current or within the last 12 months)
- Unable or unwilling to comply with protocol
- Is HIV-positive
- Has history or presence of cancer
- Treatment (other than hormonal contraception) has been recommended for menstrual
symptoms
- Taking prescription medication because of menstrual related symptoms
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Continuous Use of the Contraceptive Patch and the Personal Economic Impact. | NCT00357981 | Contradiction |
2,339 | 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. | Subject Inclusion Criteria
1. 5 to 10 years of age
2. ambulatory
3. diagnosis of DMD confirmed by at least one of the following:
- Positive x-linked family history of DMD in older male relatives (onset by 5
years, wheelchair bound by 12 years), or;
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical DMD, or;
- Gene deletion test positive (missing one or more exons) in the central rod domain
(exons 25-60) of dystrophin, where reading frame can be predicted as 'out of
frame', and clinical picture consistent with typical DMD.
4. glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort
within the past year)
5. Evidence of muscle weakness by MRC score or clinical functional evaluation
6. QMT biceps score variability no greater than 10% between screening visits
Subject Exclusion Criteria
1. Failure to achieve one or more of the inclusion criteria listed above
2. Inability to suitably cooperate with strength assessments
3. Symptomatic DMD carrier
4. Use of oxatomide (or other anti-histamine drugs) within the last 6 months for DMD or
any other disease
5. Use of creatine monohydrate or glutamine within the last 6 months
6. Use of carnitine, Coenzyme Q10, other amino acids or any herbal medications within the
last 3 months
7. History of symptomatic cardiomyopathy
8. History of impairment of hepatic function
9. History of significant concomitant illness or significant impairment of renal
function.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 10 Years | KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy | NCT00033813 | Entailment |
4,784 | 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:
1. Patients with age between 20 to 80-year-old who can cooperate to the whole treatment,
testing and questionnaire.
2. The chief complaint is dizziness which diagnosed by the doctor in charge of the
emergency department, in together to exclude the patients with severe unstable vital
signs, and then consult for help with Chinese medicine.
3. Sign the clinical trial agreement sheet.
Exclusion Criteria:
1. Inacceptable to the research content
2. Unable to complete the study process
3. Unwilling to cooperate with acupuncture and other treatments
4. Abnormal blood clotting profile
5. With wound or allergy over the treated acupoint
6. Unstable vital sign
7. Post major trauma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department | NCT04415307 | Entailment |
493 | 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:
- Patient's preparing for invitro fertilization and embryo transfer with endometrial
growth of less than 7 mm, unresponsive to standard treatment
Exclusion Criteria:
- Sickle Cell disease
- Renal insufficiency
- Upper respiratory infection or Pneumonia
- Chronic Neutropenia
- Known Past or present malignancy
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF | NCT01202643 | Contradiction |
4,428 | 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:
- Male or female
- 18-65 years of age, inclusive
- Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon,
or patellar tendon based on examination of medical history and confirmed by physical
examination including either manual movements of the injured limb, e.g., a positive
Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
- Body mass index (BMI) less than or equal to 30.0
- Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to
document all pain medication use during the study period.
Exclusion Criteria:
- History or current diagnosis of tendon tear in treated tendon
- Known neuropathy
- Type I or Type II diabetes mellitus
- Had surgery in target treatment area within 6 months
- Refuse to agree to not increase current use or initiate new use of pain medication
during the trial unless medically necessary to ensure patient safety
- Refuse to agree to not use any cream, gel, or topical solution during the
administration of treatment other than the approved ultrasound gel provided
- Refuse to discontinue all other interventional treatment modalities (e.g.,
transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.)
- Have had a local corticosteroid or platelet-rich plasma injection within the past 3
months
- Have participated in a clinical trial for an investigational drug and/or agent within
30 days prior to screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Long Duration Therapeutic Ultrasound for Tendon Healing | NCT02466308 | Contradiction |
1,109 | 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:
1. Control group: (1) Absence of known systemic diseases; (2)Normal examinations（normal
findings in both echocardiography and CMR）.
2. Hypertrophic cardiomyopathy: 1) genetic determination of a pathogenic mutation or 2)
left ventricular hypertrophy (LVH) (end-diastolic wall thickness >15 mm) with resting
left ventricular outflow tract obstruction or 3) hypertrophy in a recognizable
pattern, i.e., ventricular bulge in apical-variant HCM; Of note, patients with
documented HCM were divided into subgroups based on whether concomitant with
hypertension or left ventricular outflow tract (LVOT) obstruction.
3. Hypertensive Heart Disease: (1) Long durations of uncontrolled hypertension (systolic
blood pressure≥150 mm Hg or diastolic blood pressure ≥90 mm Hg); Echocardiography:
left ventricular wall thickness in diastolic >11mm; Absence of other cardiac or
systemic diseases; (2) left ventricular mass/body surface area >81 g/m2 (Male) or >61
g/m2 (Female).
Exclusion Criteria:
1. Documented coronary artery disease: previous history or CAG>50%;
2. NYHA Ⅳ level;
3. Severe aortic valve stenosis;
4. Standard metallic contraindications to CMR;
5. Systemic diseases or Infiltrative cardiomyopathy;
6. Septal ablation for drug-refractory hypertrophic obstructive cardiomyopathy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Differentiating Hypertrophic Cardiomyopathy From Hypertensive Heart Disease | NCT03271385 | Entailment |
3,635 | 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:
- ED patients >18 years old
- Seen in ED triage
Exclusion Criteria:
- patients <18 years old
- not seen in ED triage
- Adults unable to consent
- Prisoners
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.
| Emergency Department Safety Assessment and Follow-up Evaluation 2 | NCT02453243 | Entailment |
1,876 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction
(GEJ).
2. Age >18 years;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
4. Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior
chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a
radiosensitization is permitted, provided that the minimum time from completion of
such treatment to study entry is at least 12 months;
5. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of
bone marrow reserve provided that they have recovered from the acute, toxic effects of
radiotherapy prior to registration. A minimum of 14 days must have elapsed since the
end of radiotherapy.
6. Previous Surgery: Previous surgery is permitted provided that wound healing has
occurred prior to registration. Minimum of 14 days must have elapsed between a major
surgery and start of chemotherapy.
7. At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions
are in a previously irradiated field, only a clear disease progression of the
irradiated lesion or a new lesion in the previously irradiated field will be accepted
8. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Neutrophils >1.5 * 10*9/L and platelets >100 * 10*9/L; Bilirubin <1.5 * upper limit of
the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine
aminotransferase (ALT or SGPT) <2.5 * ULN; Serum creatinine <1.5 * ULN;
9. Patients must give written informed consent to participate in the study.
10. Patients - both males and females - with reproductive potential (ie, menopausal for
less than 1 year and not surgically sterilized) must practice effective contraceptive
measures throughout the study. Women of child-bearing potential must have a negative
pregnancy test (serum or urine) within 14 days prior to registration.
Exclusion Criteria:
1. Concurrent anticancer therapy
2. Pregnant or lactating women
3. History of other prior malignancy except for adequately treated basal cell or squamous
cell skin cancer; in situ cervical cancer or malignancy from which the patient has
been disease-free for 5 years;
4. Brain metastases
5. Patients with active or uncontrolled infections or with serious illnesses or medical
conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV
and/or cirrhosis
6. History of any psychiatric condition that might impair the patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent.
7. Known hypersensitivity to any of the drugs.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients | NCT00526110 | Entailment |
293 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Female subjects undergoing stimulation with Pergoveris for the ovarian stimulation
with VZO or with IUI or in preparation for a technology of the assisted conception
such as IVF or ICSI
Exclusion Criteria:
- Subjects receiving combination cycles with clomifen, follitropin beta, urinary FSH,
urinary human menopausal gonadotropin (hMG)
Female
No healthy subjects accepted to join the trial.
| A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice | NCT01112618 | Contradiction |
4,873 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Patient with clinical and laboratory suspicions of hypersecretion of adrenal cortical
hormones
Exclusion Criteria:
- n/a
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) | NCT00591643 | Entailment |
5,591 | 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 and women with TS diagnosed by karyotype or other genetic evidence of X-chromosome
defects and ovarian failure (diagnosed by failure to enter puberty spontaneously by age 18
or 2nd degree amenorrhea greater than 6 months and FSH greater than 40 mIU/ml)
Subjects with TS who have been previously exposed to estrogen and progestin effect, either
endogenous or exogenous by medical treatment, sufficient to establish secondary sexual
development and menses
Subjects with TS - ages 14 to 50, who have completed near final height, as demonstrated by
a bone age of greater than or equal to 14 years
EXCLUSION CRITERIA:
Chronological or bone age of less than 14 years
Chronological age greater than 50 years
Chromosomal disorders in addition to TS
Absence of 2nd degree sexual development
Growth hormone or androgen treatment within 6 months of starting study.
Testosterone level greater than normal range for age.
Contraindications to the use of estrogen, progestin or androgens: Neoplasia;
Hypercoagulation disorder; Pregnancy; Gall bladder, biliary or liver parenchymal disease
(evidenced by jaundice, gastrointestinal symptomatology, other clinical evidence of
cholelithiasis or hepatitis); Hypertriglyceridemia (TGs greater than 300); Active coronary
disease (evidenced by documented MI or coronary angiography.
Mental or physical disability, which in the estimation of study investigators, prevents a
candidate from participation in study.
Female
No healthy subjects accepted to join the trial.
| Hormone Replacement Therapy to Treat Turner Syndrome | NCT00013546 | Contradiction |
3,125 | 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. | For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal
medical history, physical examination, ECGs and clinical laboratory determinations
- Men and women who are not of childbearing potential (ie, who are postmenopausal or
Surgically sterile WOCBP) ages 21 to 55 years
- Women must not be breastfeeding
- Men who are sexually active with women of child bearing potential (WOCBP) must use any
contraceptive method with a failure rate of less than 1% per year
Exclusion Criteria:
- Any significant acute or chronic medical illness Any major surgery within 6 weeks of
study drug administration
- Any condition that will clearly require medical or surgical treatment during the
period of study participation
- Any bone trauma or bone surgery within 3 months of study drug administration
- Known or suspected autoimmune disorder
- Donation of blood or plasma to a blood bank or in a clinical study (except at
screening visit) within 6 weeks of 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 55 Years | Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects | NCT02145234 | Contradiction |
390 | 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:
- first cycle of IVF with transfer of fresh embryo
Exclusion Criteria:
- use of non-autologous oocytes; prior diagnosis of premature ovarian failure or
diminished ovarian reserve; BMI>= 40; cryopreservation cycles; smokers; use of
PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and
oocyte- or embryo-banking cycles
Female
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 43 Years | AMH and Dosing Regimens for Initial IVF Stimulation Protocols | NCT03098199 | Contradiction |
6,715 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Male subjects ≥12 years to ≤65 years with a diagnosis of congenital moderate or severe
hemophilia A (FVIII:C ≤5%).
2. Documented history of at least 50 exposure days (EDs) to FVIII-containing products.
3. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative, parent(s)/legal guardian) has
been informed of all pertinent aspects of the study. For minors under the age of legal
consent in India, assent of the participating child needs to be documented for the age
range 12 to 18 in addition to the parental informed consent.
Exclusion Criteria:
1. Prior history of inhibitor to FVIII or positive inhibitor testing (≥0.6 BU/mL) during
Screening. Clinical signs or symptoms of decreased response to FVIII.
2. Known hypersensitivity to the active substance or any of the excipients.
3. Known allergic reaction to hamster proteins.
4. Presence of any bleeding disorder in addition to hemophilia A.
5. Participation in other studies involving investigational drug(s) (Phases 1-4) within
30 days before the current study begins and/or during study participation.
6. Planned surgery within 6 months from the start of the study.
7. Unsuitable to participate in study for any other reason as assessed by the
investigator; including any disorder, except for conditions associated with hemophilia
A, which in the investigator's opinion might jeopardize subject's safety or compliance
with the protocol.
8. Subjects (or a legally acceptable representative) is not able to understand study
documents and study procedure.
9. Immunocompromised subjects due to human immunodeficiency virus (HIV) infection
(defined as viral load above or equal to 100,000 copies/mL; and for HIV+ subjects:
cluster of differentiation 4 positive (CD4+) lymphocyte count below or equal to
200/μL). HIV status and CD4+ lymphocyte count results may be obtained at screening or
from available medical records; results must be not older than 6 months prior to
screening.
10. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, subjects who have been previously enrolled into the study, or subjects
who are Pfizer employees directly involved in the conduct of the study.
11. Planned use of any non-study medication for treatment of hemophilia (eg, other factor
replacement agents, bypassing agents, or non-factor treatments [such as anti-tissue
factor pathway inhibitors]).
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients | NCT04396639 | Contradiction |
1,673 | 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:
- age > 18 years
- native Italian speakers
- wrist/hand pathology
- trauma (fractures, tendon injuries, etc.)
- chronic pathology, the pathology has been present for at least 1 month (tenosynovitis,
chronic arthrosis pain, rheumatic hand or wrist disorders)
- in case of hand/wrist surgery: at least 4 weeks have elapsed since surgery to avoid
that the patient could not perform certain actions evaluated by the scale, for example
lifting a pan or shopping bags, due to normal post-operative precautions.
- full possession of mental capacity
Exclusion Criteria:
- age < 18 years
- non-native Italian speakers of Italian, thus also excluding second generation Swiss
Italians ("secundo")
- mental incapacity
- upper limb in cast/locked by splint (criterion in Chung's article 98) at the time of
the evaluation
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.
| Italian Translation of the Michigan Hand Outcomes Questionnaire | NCT04527588 | Entailment |
1,376 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Diarrhea
- constipation
Exclusion Criteria:
- Shock
- Sepsis
- Past history with GI tract surgery
- Immunodeficiency
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Months old.
Subject must be at most 10 Years | Effect of Probiotics on Intestinal Bacterial Population and Immune Modulation | NCT00763399 | Contradiction |
585 | 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:
- Crown rump length (CRL) is appropriate to less than 12 weeks.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment | NCT00782860 | Entailment |
3,727 | 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:
- Adults over 50
- Patients undergoing outpatient treatment in orthopedic surgery for osteoarthritis of
the knee joint
- Patients diagnosed with Kellgren-Lawrence grade II or III osteoarthritis of the knee
by imaging examination
- Patients with a pain VAS scale of 4 or more out of 10 with a pain in the knee joint
during daily activities on flat ground
- Patients confirmed by the examiner for no abnormal results in blood tests, etc.
- Patients who are willing or able to follow doctor's instructions, including joint
exercises
- Patients not participating in other clinical trials
- Patients who have received sufficient explanation for this clinical trial and agreed
to participate
Exclusion Criteria:
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to Celebrex or Joins
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous
neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
- Patients who underwent total knee arthroplasty within 180 days of the knee joint
opposite the pain area
- If there is construction or deformation of the knee joint in the pain area
- Patients with serious heart-related diseases such as cardiac arrest, a history of
cerebral infarction, or ischemic heart disease
- Hemoglobin A1c level >8% of patients not managed by diabetes
- Patients with high blood pressure with poor blood pressure control (Systolic Blood
Pressure of> 150 mmHg or Diastolic Blood Pressure> 95 mmHg)
- Patients taking PPI drugs for recurrent upper gastrointestinal ulcer or inflammatory
bowel disease (such as Crohn's disease or ulcerative colitis)
- Patients with abnormal liver function (ALT)> 2.0 times the upper limit of normal (ULN)
or blood urea nitrogen (BUN) or serum creatinine> 2.0 times ULN)
- Patients who took excessive narcotic analgesics for pain in the affected area before
the clinical trial
- Patients scheduled for surgery during the clinical trial period
- Patients who received intraarticular injection treatment into the painful area of the
knee within 3 months prior to the first visit
- Patients who received systemic steroid treatment within 3 months prior to their first
visit
- Pregnant or 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 50 Years old.
| Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial | NCT04718649 | Contradiction |
6,736 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males, ≥12 years of age
- Severe hemophilia A or B with inhibitors
- (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level
is ≤2% at Screening; Inhibitors defined as inhibitor titer of ≥0.6 BU/mL or as
evidenced by medical records)
- A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6
months prior to Screening
- Willing and able to comply with the study requirements and to provide written informed
consent and assent
Exclusion Criteria:
- Known co-existing bleeding disorders other than hemophilia A or B
- Antithrombin (AT) activity <60% at Screening
- Co-existing thrombophilic disorder
- Clinically significant liver disease
- Active HCV infection
- HIV positive with a CD4 count of <200 cells/μL
- History of arterial or venous thromboembolism
- Inadequate renal function
- History of multiple drug allergies or history of allergic reaction to an
oligonucleotide or N-Acetylgalactosamine (GalNAc)
- History of intolerance to SC injection(s)
- Any other conditions or comorbidities that would make the patient unsuitable for
enrollment or could interfere with participation in or completion of the study, per
Investigator judgement
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors | NCT03417102 | Contradiction |
2,960 | 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. Patients classified as having clinically definite, clinically probable, or clinically
probable (laboratory-supported) ALS according to the El-Escorial diagnostic criteria
for ALS
2. Evidence of decremental response greater or equal to 5.0% in at least one nerve-muscle
pair at the initial screening visit
3. Age 18 years or greater
4. Consent to participate in the Canadian Neuromuscular Disease Registry (CNDR)
(follow-up study component only).
Exclusion Criteria:
1. Diagnosis of clinically possible or clinically suspected ALS as defined by the
El-Escorial diagnostic criteria for ALS
2. If the subject is taking riluzole the dose must be stable for 30 days prior to
randomization visit. Riluzole cannot be initiated during the study.
3. History of Parkinson's disease
4. History of traumatic brain injury
5. History of neuroleptic malignant syndrome
6. History of hypersensitivity or serious adverse reaction(s) to a neuroleptic medication
7. History of prolonged QTc interval > 500 ms
8. History of hyponatremia < 130 mmol/L
9. History of current heparin or warfarin use
10. History of hepatic and/or renal impairment that may affect pimozide metabolism
11. History of current pregnancy or breastfeeding
12. Current antipsychotic use
13. Presence of central nervous system depression, comatose states, liver disorders, renal
insufficiency, and blood dyscrasias
14. Presence of depressive disorders or Parkinson's syndrome
15. History of congenital long QT syndrome or with a family history of this syndrome and
in patients with a history of cardiac arrhythmias or Torsade de Pointes
16. Presence of acquired long QT interval, such as associated with concomitant use of
drugs known to prolong the QT interval
17. Presence of hypokalemia or hypomagnesemia
18. Presence of clinically significant bradycardia (heart rate < 50 beats per minute)
19. The concomitant use of CYP 3A4-inhibiting drugs such as azole antimycotics, antiviral
protease inhibitors, macrolide antibiotics and nefazodone
20. The concomitant use of CYP 2D6-inhibiting drugs such as quinidine is also
contraindicated
21. Concomitant use of serotonin reuptake inhibitors, such as, sertraline, paroxetine,
citalopram and escitalopram
22. Severe dysphagia with risk of aspiration
23. Has taken any compound under current or known future study as a potential therapy for
ALS less than 30 days prior to dosing OR history of exposure to stem cell therapy for
treatment of ALS at any time
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 Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALS | NCT02463825 | Entailment |
322 | 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:
- IVF-ET candidates (excluding PGD and oocyte donor);
- Body mass index from 18 to 30 kg/m2;
- Non smokers;
- Regular menstrual cycles (25-35 days);
- Presence of both ovaries;
- Antral follicle count (follicles measuring from 3 to 10 mm in diameter) ranging from
10 to 30 on cycle days 2 to 4;
- Serum AMH levels ranging from 0.5 to 5.0 ng/mL;
- Normal endometrium at ultrasound (US) and/or hysteroscopy;
- Informed consent signed
Exclusion Criteria:
- Iatrogenic ovarian insufficiency (surgery, radiotherapy, chemotherapy);
- Uterine abnormalities as demonstrated by pelvic US and/or hysteroscopy;
- Usual contra-indications for COH (cancer risk, blood coagulation disorders, etc)
- Renal insufficiency
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | NATural Ovarian Stimulation | NCT02892942 | Contradiction |
1,492 | 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:
- Have a history of swallowing difficulties associated with aging and/or previous or
current diagnosis of, but not limited to head and neck cancer (treatment may include
surgery, radiation or chemotherapy, or a combination of more than one), stroke,
cervical spine abnormality, brain tumor, cardiovascular surgery, Parkinson's disease
or multi-morbidity.
- Fulfils five criteria for direct swallowing evaluation: able to remain alert for
at least 15 minutes; able to sit in a chair or bed in at least a 60° upright
position, able to swallow saliva, able to cough voluntarily, able to clear the
throat twice.
- Have the capacity to provide informed consent.
Exclusion Criteria:
- The clients are excluded in case of: no dysphagia, known severe cognitive impairment,
terminally illness (predicted survival less than 6 months), known contraindications to
ingest foods or liquids, poorly controlled psychosis, inability to read consent form;
inability or unwillingness to give written informed content.
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.
| Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment | NCT02328196 | Entailment |
276 | 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:
- only single blastocyst transfer cycles were included
Exclusion Criteria:
- PGT-a cycles and cleavage stage embryo transfers
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Natural Cycles With Spontaneous Versus Induced Ovulation in FET | NCT03581422 | Contradiction |
1,277 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. the estimated amount of effusion is above 500 ml;
2. Drainage was not performed within 1 month before admission;
3. assigned informed consent.
Exclusion Criteria:
1. physical weakness which is difficult to withstand the thoracentesis;
2. the happening of serious pleural reaction or reexpansion pulmonary edema on previous
thoracentesis;
3. allergy to the anesthetic;
4. coagulation dysfunction, severe bleeding tendency;
5. serious mental illness who do not cooperate;
6. suspected with pleural hydatid disease;
7. skin infection around supine positioning;
8. severe heart function insufficiency who cannot lay on the back;
9. for a variety of reasons that cannot accept regular follow-up;
10. refused to sign the informed consent;
11. other conditions that is not suitable for the test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 75 Years | Impact of Large-Volume Pleural Effusions on Heart Function | NCT02548221 | Entailment |
1,539 | 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:
- Females 14-21 years old Note: Our pilot data are reassuring in that young women 18-25
years old with hypothalamic amenorrhea are not adversely affected with estrogen use.
In fact, in our prospective study, beneficial effects were observed both in young
women 18-25 years old using oral estrogen, and in 14-18 year old adolescent girls
using transdermal estrogen. We therefore feel that including girls in the 14-21 year
age range will not be hazardous to their bone health. In fact, given the lack of data
in this age group, it is important to study younger women and teenagers rather than
extrapolate data from studies in adults to this younger population. Hormone dynamics
differ in teenagers compared with adults, and bone mass accrual is even more dependent
on estrogen and IGF-1 in younger than older women who have already achieved peak bone
mass.
- Bone age (BA) >15 years Note: 99% of adult height is achieved at a BA of 15 years,
thus estrogen replacement will not result in stunting of height potential after this
age. Although we could have chosen to include girls with a BA >14 in this study, we
are limiting this to girls with a BA of >15 years. This is because 2% of growth
potential persists at a BA of 14 years, versus only 1% at a BA of 15 years (~0.6" of
potential height (130)). Thus, to avoid potential stunting of growth potential with
estrogen replacement, we have chosen to include girls with BA of > 15 years.
- BMI between 10th-90th percentiles for age.
- Amenorrhea (for AA): absence of menses for > three months (74) within a period of
oligomenorrhea (cycle length > six weeks) for >six months, or absence of menarche at
>16 years.
- Eumenorrhea (EA and controls): > nine menses (cycle length 21-35 days) in preceding
year.
- Non-athlete healthy controls will be eligible if weight bearing exercise activity is
less than two hours a week and if they are not participating in organized team sports.
- Endurance athletes Note: severity of low BMD and menstrual dysfunction differ by kind
of exercise and activity. For example, runners have a higher prevalence of menstrual
irregularity than swimmers and cyclists (131). By limiting enrollment to endurance
athletes, we will eliminate variability from the type of activity. Endurance training
is defined as > 4 h of aerobic weight-bearing training of the legs or specific
endurance training weekly, or > 20 miles of running weekly for a period of > 6 months
in the last year.
Exclusion Criteria:
- Other conditions that may affect bone metabolism
Female
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
Subject must be at most 21 Years | Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes | NCT00946192 | Contradiction |
3,597 | 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:
- Women in the fertile age (between 20-45 years), not assuming oral contraceptives from
at least three months
- Referred normal menses .Use of the same brand of sanitary protection wear for the
whole of the period.
- BMI between 18 and 30
Exclusion Criteria:
- Abnormal Bleeding Score
- Positive gynecological history of fibroids, polyps or malignancy
- Treatment with anti-coagulants, antifibrinolytics, non steroidal anti-inflammatory
agents
- Use of oral contraceptives in past three months
- Use of intrauterine devices (IUDs) in past three months .Hgb levels <12 g/dl and
Ferritin <25 ng/ml.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles | NCT01276964 | Contradiction |
3,780 | 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 at the age of 40-75 years old
2. Conforming to the diagnosis standard of the American College of Rheumatology in 2009：
knee pain and osteophyte determined with X-ray, and at least one of the following
items：
- above 50 years old
- morning stiffness less than 30 minutes
- knee joint with fricative when moving
3. The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side
was less than 40mm when walking on flat ground.
4. The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence
grading scale.
5. Patients who have treatment requirements and can obey the therapeutic schedule
6. Body mass index(BMI) ≤35kg/m2。
7. Able to follow the clinical observation and follow up.
8. The subjects are able to understand and sign the informed consent after fully
understand this study, the disease, investigational drugs, the therapeutic schedule
and the potential risks.
Exclusion Criteria:
1. Positive signs of swelling or floating patella test，and there are obvious effusion of
knee joint in clinical.
2. Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid
arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
3. Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor,
villonodular synovitis, joint trauma, etc.
4. Pregnant or lactating females.
5. Participants who suffer from serious cardiovascular disease (Sudden cerebral
infarction with sequela or myocardial infarction within recent 6 months), hepatic
disease, kidney disease；Participants whose ALT and AST are twice or more than twice
than that of the upper limit of normal value；Participants whose serum creatinine
exceed the upper limit of normal value；Participants who suffer from dysfunction of
blood coagulation (thrombocytopenia, bleeder disease, etc.)
6. Participants who have systemic infection or infectious disease.
7. Participants who suffer from serious skin defect or ulcer around the studying knee
joint.
8. Participants who suffer from typical varus or valgus deformities or lack of articular
cavity.
9. Participants with diabetes and have to inject insulin or who are not good enough to
control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
10. Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
11. Participants with score 0 or 4 of the studying knee joint evaluated by radiological
Kellgren-Lawrence grading scale.
12. Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week
before this trial or take part in other clinical trials.
13. Participants whose studying knee receives articular cavity therapy within 3 months,
containing intra articular administration, articular irrigation and arthroscopic
surgery
14. Participants with an allergy to the experimental drugs.
15. Participants who are not suitable for this trial judged by the researchers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE) | NCT02323451 | Entailment |
219 | 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:
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have a BMI within range of 18.5-35kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
Exclusion criteria:
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea,
psychiatric illness, polycythemia, or any other clinically significant current
condition.
- Are diabetic with an HbA1c >= 8.
- Are taking any androgens, such as testosterone, saw palmetto.
- Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin,
digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- Would donate more than 500 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial. - Are
unwilling to abstain from alcohol during the study.
- Have a positive urine drug screen test.
- Plan to change your smoking habits during the course of the trial.
- Have Hepatitis C, Hepatitis B, or HIV.
- Have a lab or EKG abnormality.
- High or low blood pressure.
- Have used of any investigational drug or device during the study or within 30 days
prior to 1st dosing of study medication.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men | NCT00398580 | Entailment |
896 | 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:
Staff from the Ziv Medical Center and patients
Exclusion Criteria:
Staff members that do not deal with pain treatment
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 65 Years | Quality of Pain Management at the Ziv Medical Center | NCT02001454 | Entailment |
796 | 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. Males or Females 40 years and older
2. According to the clinical diagnosis standard of the American College of Rheumatology
(ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to
over 3 conditions of followings.
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- 4 bony tenderness
- Bony enlargement
- Nopalpable warmth of synvium
3. Within 6 months from screening visit, someone who diagnosed with Kellgren & Lawrence
Grade I~III by the radioactive examination.
4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the
single or both sides of the osteoarthritis is over 40mm
5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or
other pain-killers in the past.
6. Patient who can walk by themselves without helper like cane or walker etc. (If the
patient who has used helper routinely from previous 6 months, evaluating the patient
including the helper is possible. In this case, patient needs to use same helper
continuously by end of the clinical trial test.)
7. Patient who agrees to participate in this clinical trial by themselves.
Exclusion Criteria:
1. Someone who has BMI≥32kg/m² at the screening visit.
2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can
have an effect on pain sense over 3 months habitually.
3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers,
misoprostol or proton pump inhibitors) regularly, who can't stop injecting for
clinical study period.
4. Patient has attended abnormal values from screening test(2 times excess at upper limit
of the normal values at ALT, AST, BUN, Serum Creatinine).
5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.
6. Patients having serious gastrointestinal, liver, renal, heart disease.
7. When the inflammatory disease is occurred on joint area to patient like septic
arthritis.
8. Patients having skin ailment at the injecting site of the joint region.
9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis
or systemic disease.
10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc
herniation.
11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts
affect judge of the knee joint pain.
12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
13. Patients who were administrated below drugs before baseline visit.
- Patients who were injected HA at the target knee joint in recent 9 months.
- Patients who were injected HA at other parts of the knee joint in recent 6
months.
- Patients who were injected steroids into the intra-articular knee joint.
- Patients who were administrated steroids systemically by the oral medication
(But, except inhalation)
14. Patients who have joint effusion trouble were judged as a positive by tests like
Patella tap test.
15. Patients who have target knee joint gotten surgical operation history including
Arthroscopy within past one year (In case of having other side of knee joint or hip
joint gotten surgical operation history, excepting the patients if there is
possibility which can influence the target knee joint's appraisal.
16. Patients who have an operation history about target knee joint.
17. Patients who do the height weight aerobic exercise or anaerobic exercise.
18. Patients who need to be administrated anticoagulant agent together(But, except 300mg
daily dose aspirin)
19. Patients who have hypersensitivity history about Investigational Product.
20. In the midst of women in their childbearing years, patients who disagree to do *
contraception by medically permitted method for 12 weeks from administrating
investigational product.
* The contraception by medically permitted method: Condom, In case of using injection
or insertion, In case of installing a intrauterine contraception device etc.
21. Patients who were injected other investigational product over a time within 30 days
before participated in this clinical trail.
22. Besides that, the patients who have difficulty to be participated in this clinical
trial continuously by Principle Investigator (PI)'s decision.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Clinical Trial of YYD302 for Treatment of Osteoarthritis of the Knee | NCT02965495 | Entailment |
2,485 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | - INCLUSION CRITERIA:
Participants will be eligible if they:
- Are 12 years of age or older.
- Have the ability to cooperate with an eye exam and adaptive optics imaging.
- Have the ability to understand and sign an informed consent or have a parent/legal
guardian to do so if they are minor children.
- Have an eye disease or are a healthy volunteer with a normal eye exam (no
visually-significant eye findings on examination).
EXCLUSION CRITERIA:
Participants will not be eligible if:
-They have a condition which prevents adequate images from being obtained (e.g. unstable
fixation or media opacity).
EXCLUSION CRITERIA FOR FLUORESCEIN AND/OR INDOCYANINE GREEN IMAGING
Partaicipants are not eligible for fluorescein and/or indocyanine green imaging if they:
- Are under 18 years of age.
- For participants who will undergo fluorescein imaging have a history of adverse
reaction to fluorescein.
- For participants who will undergo indocyanine green imaging have a history of adverse
reaction to indocyanine green dye, know or suspected allergies to iodine or shellfish.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
| Adaptive Optics Retinal Imaging | NCT02317328 | Entailment |
3,861 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Knee pain on most days
- Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral
osteoarthritis, as based on x-ray
Exclusion Criteria:
- Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or
walker), or uses a wheelchair
- Pain emanating more from the back or hip than from the knee, as determined by
screening questionnaire
- Low pain score on the visual analog scale (VAS) (less than 4 out of 10)
- Plans to move from the area within 10 months of study screening
- Symptomatic comorbid disease that limits activities more than knee pain does, as
determined by screening questionnaire (e.g., congestive heart failure, chronic
obstructive pulmonary disease)
- Receiving corticosteroid injections in the month before study entry, or receiving
hyaluronan in the 6-month period before study entry. No other treatments will result
in exclusion, although for patients taking glucosamine and/or chondroitin and/or a
non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments
for at least 2 months before study entry and must commit to not start a new treatment
during the study.
- Bilateral total knee replacements or plans for a total knee replacement of the
affected knee in the next 6 months
- Morbidly obese (body mass index greater than 35), as brace fitting and prevention of
slippage of the brace will be difficult
- Known other causes of arthritis, including rheumatoid arthritis, systemic lupus
erythematosus, gout, psoriatic arthritis, and pseudogout
- Skin breakdown at the site where the brace will be applied
- Failure to pass the run-in test, or the brace falls down the leg during the run-in
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.
| Knee Bracing for People With Patellofemoral Osteoarthritis | NCT00381563 | Entailment |
4,827 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- patients who have been cured of Cushing's disease at least 5 years ago.
Exclusion Criteria:
- patients who have been cured of Cushing's disease more than 15 years ago.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 55 Years | Long-term Cardiovascular Risk in Cured Cushing's Patients | NCT00881283 | Contradiction |
3,850 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Symptomatic osteoarthritis of the knee.
Exclusion Criteria:
- No disorders which could interfere with study required assessments.
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.
| Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee | NCT02187549 | Entailment |
3,636 | 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:
- Age 18 years or older and receiving treatment in the ED
Exclusion Criteria:
- sustained altered mental status (e.g., psychosis, delirium, disorientation,
unresponsive)
- hostile or agitated behavior
- sexual assault victims
- trauma patients who are on backboards or who must remain supine
- severe illness that would preclude conversation or interface with a computer (e.g.,
intubation, persistent vomiting, severe pain)
- or factors precluding follow-up, like transient residence or lack of a telephone.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Dynamic Assessment and Referral System - Evaluation | NCT01153373 | Entailment |
2,798 | 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 of both genders aging between 18-65 years with primary unilateral
uncomplicated inguinal hernia were included.
Exclusion Criteria:
- Patients with bilateral or sliding inguinal hernia.
- incarcerated or strangulated hernia
- recurrent inguinal hernia
- femoral hernia
- patients unwilling to participate in the trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair | NCT04203940 | Entailment |
2,948 | 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:
- Amyotrophic lateral sclerosis patients.
- Clinically stable, at least for one month.
Exclusion Criteria:
- Claustrophobic patients.
- Patients using continuous non-invasive ventilation treatment.
- Incapacity to tolerate supine decubitus.
- Incapacity to execute respiratory functional tests.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Relationship Between Respiratory Functional Tests and Image Thoracic Techniques in Patients With Neuromuscular Diseases | NCT01090674 | Entailment |
5,392 | 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:
- Women patient aged 30-45 years
- Diagnosed adenomyosis by transvaginal ultrasound or MRI or 3D ultrasound
- Patient complains of heavy menstrual bleeding or dysmenorrhea or both
- Living in a nearby area to make follow-up reasonably possible
- Planning for birth spacing for at least 2 years.
Exclusion Criteria:
- Pregnancy or seeking fertility
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
- Deep venous thromboembolism
- Hormonal therapy contraindications
- Endometriosis or fibroid
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 45 Years | Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri | NCT03037944 | Entailment |
3,735 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Knee osteoarthritis
- Moderate radiographic evidence by Kellgren and Lawrence grade 2-4
- Knee pain > 20 on VAS pain scale
Exclusion Criteria:
- Bilateral knee replacements
- Unwillingness to take acetaminophen for pain relief
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Toward Better Outcomes in Osteoarthritis | NCT00000425 | Contradiction |
5,514 | 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:
- Patients with newly onset or relapsed GCA
- > 50 years of age
- satisfying ACR criteria
- elevated sedimentation rate above 40 mm
- CRP > 20 mg/L
- Patients with histologically proven GCA or with large vessel vasculitis assessed by
MRI
Exclusion Criteria
- Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA/Takayasu disease
or polymyalgia rheumatica (i.e., RA, autoimmune connectivitides, other systemic
vasculitides, a.o.)
- Evidence of significant and/or uncontrolled concomitant disease
- Diagnosis of GCA > 4 weeks before screening visit and beginning of GC treatment > 4
weeks before screening (only valid for new onset GCA), or when a patient received
treatment with tocilizumab or with other biological agents (such as TNFα-blockers)
within 3 months before screening
- Any condition or general state of health which, in the Investigator's opinion, would
preclude participation in the study
- Actual or recent myocardial infarction (within the last 3 months before screening
visit)
- Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive
pulmonary disease (COPD) (FEV1 < 50% predicted or Functional dyspnoea > Grade 3 on the
MRC Dyspnoea Scale) or other significant pulmonary disease
- Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where
flares are commonly treated with oral or injectable corticosteroids
- Known active infection of any kind, or any major episode of infection requiring
hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or
completion of oral anti-infectives within 2 weeks prior to baseline
- History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within
52 weeks prior to baseline
- Any surgical procedure, including bone/joint surgery within 8 weeks prior to baseline
or planned within the duration of the study
- History of serious recurrent or chronic infection (for screening for a chest infection
a chest radiograph will be performed at screening if not performed within 12 weeks
prior to screening)
- Lack of peripheral venous access
- Body weight > 150 kg or BMI > 35
- Previous treatment with tocilizumab or any other biological agent
- Treatment with any investigational agent within 28 days of screening or 5 half-lives
of the investigational drug (whichever is the longer)
- History of severe allergic or anaphylactic reaction to any biologic agent or known
hypersensitivity to any component of tocilizumab (RoActemra)
- Receipt of any vaccine within 28 days prior to baseline (a patient's vaccination
record and need for immunization prior to receiving tocilizumab/placebo must be
carefully investigated)
- Positive tests for hepatitis B surface antigen (HBsAg), Hepatitis B core antibody
(HbcAb) or hepatitis C serology
- Positive Quantiferon-TB® test for latent Tb without subsequent INH prophylaxis
- Patients with active Tb which had to be treated for Tb within 2 years before the
screening visit
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.
| Tocilizumab for Patients With Giant Cell Arteritis | NCT01450137 | Entailment |
1,839 | 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:
- Diagnosed with gastric cancer (histological or cytological) Attending health centers
of the Red UC Christus network for at least 3 months with clinical follow-up.
Capable to read and speak spanish Willing and able to provide written informed consent to
eh study that should be dated and signed informed consent
Exclusion Criteria:
- With small biopsy samples insufficient for analysis. Whose medical records cannot be
collected or are unavaible Without signed informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Chilean Gastric Cancer Task Force (FORCE 1) | NCT03158571 | Entailment |
2,955 | 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:
- Males or females age 21-65 years;
- No history of serious neurological injury or disease; OR
- Chronic (>12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of
definite or probable ALS;
- Incomplete weakness of left or right hand muscles: score of 3 or 4 (out of 5) on
manual muscle testing of finger extension, finger flexion, or finger abduction;
- Detectable F-wave responses of the left or right abductor pollicis brevis muscle to
median nerve stimulation;
- Detectable motor evoked potentials in left or right abductor pollicis brevis muscle to
transcranial magnetic stimulation.
Exclusion Criteria:
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as tricyclic
antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- History of moderate to severe head trauma (loss of consciousness for greater than one
hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior
imaging);
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic
metallic implants, or cardiac pacemaker/defibrillator;
- Significant coronary artery or cardiac conduction disease;
- Recurrent history over the last 6 months of autonomic dysreflexia;
- History of bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous
48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy;
- Unsuitable for study participation as determined by study physician.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 65 Years | Brain and Nerve Stimulation for Hand Muscles in Spinal Cord Injury and ALS | NCT02469675 | Entailment |
1,356 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Hard or firm stools for twice or less per week
- Age were from newborn to 3 months
- Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
- The narrowed distal bowel on barium enema was characterized as normal or short-segment
Hirschsprung disease with a 24h barium retention
Exclusion Criteria:
- Children >3months of age
- Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms
of a ruptured hollow viscus
- Barium enema showed long-segment or total colonic aganglionic bowel
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 3 Months | A Trial on Conservative Treatment for Infants' Hirschsprung Disease | NCT01985646 | Contradiction |
2,247 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion criteria:
- Compliance and completion of the canakinumab PFS core study
- Unchanged significant clinical medical history from entry into core study
Exclusion criteria:
- Physician judgment of unsuitability for the study
- Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may
apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients | NCT01431638 | Entailment |
4,924 | 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:
- Diagnosed with Parkinson's Disease (ICD-10-GM G20.-) or Essential Tremor (G25.0)
- Comparison group: Other movement disorders including atypical Parkinsonian disorders
and healthy participants
Exclusion Criteria:
- Unable to obtain informed consent
- Skin-related conditions at one of the wrists or any other medical conditions that
could harm the participant's health by wearing the smartwatch at both wrists.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders | NCT03638479 | Entailment |
4,218 | 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 idiopathic infertility or unexplained
Exclusion Criteria:
- history of varicocele, genitourinary inflammation or infection
- history of cigarette smoking.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Reduction of Sperm DNA Fragmentation by Oral Ginger | NCT02032251 | Contradiction |
3,819 | 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. Age 18 to 65 years
2. Body mass index (BMI) ≤33 kg/m2
3. Grade 2And above imaging of osteoarthritis
4. History of knee pain or swelling should have at least 4 months
Exclusion Criteria:
1. treated with steroids and Anti-coagulant or anti-platelet aggregation
2. history of infectious, systemic diseases, Immune deficiency and coagulation disorders
3. Patients with Hb ≤11, Plt ≤ 150000
4. Varus > 10 , valgus > 10
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 Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee | NCT01926327 | Entailment |
1,402 | 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:
- Subjects with written informed consent to participate in the study
Exclusion Criteria:
- Subjects with an apparent swallowing disorder
- Subjects with clinically evident cerebrovascular diseases
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| Visual and Auditory Breathing-swallowing Coordinated Training | NCT04590391 | Contradiction |
2,905 | 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. | For the patients :
Inclusion Criteria:
- Man or woman with sporadic ALS and a possible, probable or definite diagnosis
regarding the revised Escorial criteria (Forbes et al., 2001). Patients are followed
quarterly according to national recommendations. At the end of the follow up period (1
year for each patient), all patients remaining in the " possible " group of diagnosis
will be excluded.
- Disease onset (date of onset of muscle weakness) < 18 months at the time of inclusion.
- Age: 30 to 80 years-old, inclusive.
- Patient treated by riluzole at a steady dosage since at least 3 months.
- Patient accepting to give informed consent
Exclusion criteria will be :
- A previous treatment with VD in the preceding 2 years, whatever the dose used.
- Patient with an already known autoimmune disorder
- Patient with severe ALS involvement suggesting that survival over the 1 year follow up
is highly unlikely (ex : tetraplegia, use of non-invasive ventilation for more than 10
hrs/day, ALSFRS-R (ALS Functional Rating Scale) score < à 20).
- Pregnant or breast-feeding woman.
- Patient without social security insurance
For the Controls:
Controls will be spouses of our ALS patients. Such a group has the advantage of similar
life style conditions, and frequently similar geographical origin. Controls and ALS
patients will match for age and gender. Controls will also fulfill the following inclusion
and exclusion criteria
Inclusion criteria
•Subject accepting to give informed consent
Exclusion criteria
- Subject with an already known neurodegenerative disorder
- Subject with an already known autoimmune disorder
- Subject who received a treatment with VD in the preceding 2 years, whatever the dose
used.
- Pregnant or breastfeeding woman
- Subject without social security insurance
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 80 Years | T Cell Phenotypes in Amyotropic Lateral Sclerosis (ALS), Influence of Vitamin D | NCT02756104 | Entailment |
6,991 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Signed an Institutional Review Board (IRB) approved informed consent document
2. Aged 50 - 89 years inclusive.
3. Meeting the diagnosis of probable AD consistent with:
- Revised National Institute on Aging-Alzheimer's Disease Association (NIA-ADA)
criteria and
- Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria.
4. Mild to severe severity (Mini-Mental Status Exam [MMSE] scores 7 - 24 inclusive).
5. Rosen-Modified Hachinski Ischemia Score of ≤4.
6. Have a suitable caregiver to supervise the at-home administration of study drugs and
observe for AEs.
7. Patients treated with donepezil 5 or 10 mg/day (given once daily) for at least 4 weeks
just prior to Day1 for Population (group) 1 or;
8. Patients never been treated with donepezil before (donepezil naïve) or who have not
received any other AChEI for the past 6 months for Population (group) 2.
9. Patients in generally good health as indicated by their medical history and physical
examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.
Exclusion Criteria:
1. Women of child bearing potential.
2. History or presence of a seizure disorder.
3. Current unstable peptic ulcer disease, urinary or gastric retention; asthma or
obstructive pulmonary disease.
4. History or presence of bladder outflow obstruction, gastrointestinal obstructive
disorder or reduced GI motility, or narrow-angle glaucoma.
5. History or presence of gastrointestinal, hepatic, or renal disease, or other condition
known to interfere with the absorption, distribution, metabolism or excretion of
drugs.
6. Renal and hepatic dysfunction with:
- Total Bilirubin: >1.5 x UNL
- AST: >2.5 x UNL
- ALT: >2.5 x UNL
- Serum Creatinine: >1.5 x UNL
- Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation)
7. History or presence of myasthenia.
8. History or family history of Prolonged QT Syndrome.
9. History of unexplained syncope or family history of unexplained syncope or sudden
death.
10. Myocardial infarction or hospitalization for congestive heart failure within 6 months.
11. ECG findings of:
- Complete Left Bundle Branch Block;
- Ventricular pacing;
- 2nd degree or 3rd degree AV block;
- Atrial fibrillation or atrial flutter;
- HR <45 or >100;
- PR >220 msec; or
- QTcF >450 msec in male, >470 msec in female
12. Known hypersensitivity to donepezil, solifenacin or related drugs.
13. History of drug significant allergy.
14. History of substance abuse, known drug addiction, or positive test for drugs of abuse
or alcohol.
15. Patients treated with the following medications within 8 weeks of screening
- AChEIs (other than donepezil),
- Peripherally acting anticholinergics (such as drugs for the treatment of
overactive bladder disorder),
- Psychoactive medications (including antipsychotics, antidepressants, anxiolytics
or sedative hypnotics) having significant anticholinergic effects and/or believed
to affect cognitive function.
Other medications are acceptable, at the investigators discretion, if dosage is held
stable for at least 4 weeks prior to screening and throughout the study.
16. Patients considered unlikely to co-operate in the study, and/or poor compliance
anticipated by the investigator.
17. Patients hospitalized within 4 weeks of screening.
18. Any other clinically relevant acute or chronic diseases which could interfere with
patients' safety during the trial, or expose them to undue risk, or which could
interfere with study objectives.
19. Patients who have participated in another clinical trial with an investigational drug
within previous 30 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 89 Years | A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type | NCT02549196 | Entailment |
3,178 | 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:
- Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or
other autoimmune disease
Exclusion Criteria:
- Intraocular or refractive surgery in the study eye within 3 months prior to study
start
- Unwilling to discontinue use of contact lenses during the run-in and duration of the
study
- Pregnancy or lactation
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007) | NCT00548301 | Entailment |
1,658 | 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:
- I1. Sufficiently conversant in the English language to satisfy I3.
- I2. Able and willing to comply with all study requirements.
- I3. Able and willing to provide written informed consent to participate (including by
parent or legal guardian if under 16 years old).
Exclusion Criteria:
- There are no exclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 3 Years old.
| Vital Sign Comparison Between Lifelight and Standard of Care - Development | NCT04003662 | Entailment |
4,150 | 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:
- Between 20 and 75 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a
medical evaluation including medical history, physical examination, laboratory tests
and cardiac monitoring.
- Normal spirometry at Screening (forced expiratory volume in 1 second and forced vital
capacity >=80% of predicted - measurements to be taken in triplicate and the highest
value must be >=80% of predicted).
- A subject with a clinical abnormality or laboratory parameter(s) outside the reference
range for the population being studied may be included only if the investigator, in
consultation with the medical monitor if needed, agree and document that the finding
is unlikely to introduce additional risk factors and will not interfere with the study
procedures.
- Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18 to 35
kg/square meter (m^2) (inclusive).
- Male subjects. Male subjects with female partners of child bearing potential must
comply with the following contraception requirements from the time of first dose of
study medication until at least 10 days after the last dose of study medication.
- Vasectomy with documentation of azoospermia.
- Male condom plus partner use of one of the contraceptive options: Contraceptive
subdermal implant, Intrauterine device or intrauterine system, Combined estrogen
and progestogen oral contraceptive, Injectable progestogen, Contraceptive vaginal
ring and Percutaneous contraceptive patches.
- Female subjects. Female subjects are eligible to participate if they are not pregnant
(as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at
screening and a serum or urine hCG test on admission), not lactating, and at least one
of the following conditions applies:
- Non-reproductive potential defined as: Pre-menopausal females with one of the
following: Documented tubal ligation, Documented hysteroscopic tubal occlusion
procedure with follow-up confirmation of bilateral tubal occlusion ,
Hysterectomy, Documented Bilateral Oophorectomy; Postmenopausal defined as 12
months of spontaneous amenorrhea (in questionable cases a blood sample with
simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent
with menopause (refer to laboratory reference ranges for confirmatory levels).
Females on hormone replacement therapy (HRT) and whose menopausal status is in
doubt will be required to use one of the highly effective contraception methods
if they wish to continue their HRT during the study. Otherwise, they must
discontinue HRT to allow confirmation of post-menopausal status prior to study
enrolment.
- Female of reproductive potential (FRP) must agrees to the use of male condom with
spermicide in addition to one of the following methods from the list of highly
effective contraceptive methods from 30 days prior to the first dose of study
medication and until at least 10 days after the last dose of study medication:
Contraceptive subdermal implant; Intrauterine device or intrauterine system;
Combined estrogen and progestogen oral contraceptive; Injectable progestogen;
Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner
sterilization with documentation of azoospermia prior to the female subject's
entry into the study, and this male is the sole partner for that subject.
The list does not apply to FRP with same sex partners or for subjects who are and will
continue to be abstinent from penile-vaginal intercourse on a long term and persistent
basis, when this is their preferred and usual lifestyle. Periodic abstinence (e.g.
calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
The investigator is responsible for ensuring that subjects understand how to properly use
these methods of contraception.
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the consent form and protocol.
Exclusion Criteria:
- Asthma or a history of asthma (except in childhood, which has now remitted).
- Alanine Aminotransferase (ALT) and bilirubin >1.5 Upper Limit of Normal (ULN)
(isolated bilirubin >1.5xULN is acceptable if fractionated and direct bilirubin <35%)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT interval by Fridericia's formula (QTcF) > 450 milliseconds (msec).
- Unable to refrain from the use of prescription drugs (except contraceptives and HRT)
or non-prescription drugs (except acetaminophen), including vitamins, herbal and
dietary supplements from 7 days before the first dose of study medication until the
follow-up visit, unless in the opinion of the Investigator and GlaxoSmithKline (GSK)
Medical Monitor the medication will not interfere with the study procedure or
compromise subject safety.
- The subject has received any type of vaccination within 4 weeks of their first dose of
study medication, or is expected to be vaccinated within 4 weeks after their last dose
of study medication.
- Current smoker or a history of smoking within 6 months of Screening, or a total pack
year history of >5 pack years. (number of pack years = [number of cigarettes per
day/20] x number of years smoked)
- History of regular alcohol consumption within 6 months of the study defined as: An
average weekly intake of >14 alcoholic drinks for males or >7 alcoholic drinks for
females. One alcoholic drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360
milliliters [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof
distilled spirits.
- Unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit
juice, pummelos, exotic citrus fruits, or grapefruit hybrids from 7 days before all
doses of study medication and until collection of the final pharmacokinetic sample in
each study period.
- History of sensitivity to any of the study medications, or components thereof
(including lactose and Magnesium stearate) or a history of drug or other allergy that,
in the opinion of the investigator or Medical Monitor, contraindicates their
participation.
- Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment.
Subjects with a positive Hepatitis C antibody due to prior resolved disease can be
enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA)
polymerase chain reaction (PCR) test is obtained.
- A positive test for Human Immunodeficiency Virus(HIV) antibody (according to local
policies).
- A positive drug/alcohol screen at screening or on admission (Day -1). - Where
participation in the study would result in donation of blood or blood products in
excess of 500 mL within a 90 day period.
- The subject has participated in a clinical trial and has received an investigational
product (excluding participation in Part A of this study) within the following time
period prior to the first dosing day in the current study: 30 days, 5 half-lives or
twice the duration of the biological effect of the investigational product (whichever
is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects | NCT02691325 | Contradiction |
200 | 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. Secondary hypogonadal males between the ages of 18 and 65
2. Men currently using topical testosterone products should wash-out for at least 7 days
before Visit 1.
3. All clinical laboratory tests within normal ranges (any clinically significant
deviation of laboratory results will require approval of sponsor)
4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed
with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men
age 55-65
5. LH < 15mIU/mL (at Visit 1 only)
6. Ability to complete the study in compliance with the protocol
7. Ability to understand and provide written informed consent.
Exclusion Criteria:
1. Use of an injectable pelleted testosterone within 6 months prior to study (men
currently on topical testosterone products may be enrolled in the study after a 7-day
washout period).
2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase
inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone
products during the study
3. Use of Clomid in the past year
4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects
treated for Type II diabetes will be allowed into the study.
5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
6. Clinically significant abnormal findings on screening examination, based on the
Investigator's assessment.
7. Use of an investigational drug or product, or participation in a drug or medical
device research study within 30 days prior to receiving study medication.
8. Known hypersensitivity to Clomid
9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based
on 0-4 scale or any trace of posterior subcapsular cataract)
10. Any condition which in the opinion of the investigator would interfere with the
participant's ability to provide informed consent, comply with study instructions,
possibly confound interpretation of study results, or endanger the participant if he
took part in the study
11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
primary hypogonadism, or tumors of the pituitary)
12. Current or history of breast cancer
13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled
out by prostate biopsy, or a PSA > 3.6
14. Presence or history of known hyperprolactinemia with or without a tumor
15. Chronic use of medications use such as glucocorticoids
16. Chronic use of narcotics
17. Subjects know to be positive for HIV
18. End stage renal disease
19. Subjects with cystic fibrosis (mutation of the CFTR gene)
20. Enrollment in a previous Androxal study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism | NCT01534208 | Entailment |
5,510 | 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 GCA or TAK (defined below)
- History of active GCA or TAK within the past 2 months
- Age of 15 years or older
- Willing to use an effective means of birth control throughout the study
Specific Inclusion Criteria for Participants with GCA:
- Participants must meet three of the following five criteria, including either
Criterion 4 or 5:
1. Age at disease onset was equal to or greater than 50 years
2. Disease onset was recent or experiencing a new type of localized pain in the head
3. Erythrocyte sedimentation rate greater than 40mm in the first hour, as determined
using the Westergren method
4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
5. Temporal artery or large vessel biopsy showing vasculitis characterized by a
predominance of mononuclear cell infiltration or granulomatous inflammation,
usually with multinucleated giant cell or characteristic changes of large vessel
stenosis or aneurysm by arteriography
Specific Inclusion Criteria for Participants with TAK:
- Presence of abnormalities that are consistent with TAK identified using arteriography,
plus at least one of the following criteria:
1. Age at disease onset was less than 50 years
2. Pain in the legs or arms
3. Decreased brachial artery pulse (one or both arteries)
4. Difference of more than 10mm Hg in blood pressure between the arms
5. Bruit over subclavian arteries or aorta
Exclusion Criteria:
- Evidence of active infection (including chronic infection)
- Pregnant or breastfeeding
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
- Inability to comply with study guidelines
- Inability to provide informed consent
- Cytopenia, as defined by a platelet count of less than 80,000/mm3, an absolute
neutrophil count of less than 1,500/mm3, and hematocrit less than 20%
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or
creatinine clearance of 20 ml/min or less
- Other uncontrolled disease that could prevent safe study completion
- History of any malignant neoplasm except adequately treated basal or squamous cell
carcinoma of the skin or solid tumors treated with curative therapy and disease-free
for at least 5 years
- Receipt of an investigational agent or device within 30 days prior to study entry
- A live vaccination within 4 weeks prior to study entry
- Presence of a positive tuberculin skin test with induration of at least 5mm
- Radiographic evidence suggestive of tuberculosis
- Poor tolerability of blood draws or lack of adequate access to veins for medication
administration and blood draws
- History of treatment with rituximab within 12 months prior to study entry or history
of treatment with rituximab more than 12 months prior to study entry, where the B
lymphocyte count has not returned to normal
- History of treatment with infliximab within the past 49 days, adalimumab within the
past 28 days, or etanercept within the past 21 days.
- Presence of any of the following diseases or conditions:
1. Microscopic polyangiitis
2. Churg-Strauss syndrome
3. Polyarteritis nodosa
4. Cogan's syndrome
5. Behcet disease
6. Sarcoidosis
7. Kawasaki disease
8. Tuberculosis or atypical mycobacterial infection
9. Deep fungal infection
10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics
vasculitis
11. Cryoglobulinemic vasculitis
12. Systemic lupus erythematosus
13. Rheumatoid arthritis
14. Mixed connective tissue disease or any overlap autoimmune syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
| Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis | NCT00556439 | Entailment |
2,131 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- Signed informed consent/assent (as per local requirements), males aged 11-18 yrs.
(after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm
in diameter (by ultrasound or caliper measurement) that has not decreased during the
prior 3 month period by medical history and has been present for 12 months or less
(date of onset based on best estimate of treating physician after discussion with
patient and or patient's parent/guardian), normal renal liver and thyroid function, no
evidence of hormone producing tumor, no evidence of hypogonadism or androgen
resistance.
Exclusion Criteria:
- Patients who have been given medications known to cause gynecomastia within the
previous 6 months, involvement in the planning and conduct of the study (includes AZ
staff and investigative site staff), previous enrollment in the present study,
investigators opinion patient would be unable to comply with study protocol.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 11 Years old.
Subject must be at most 18 Years | Open Label Arimidex in Gynecomastia | NCT00241436 | Entailment |
1,321 | 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:
- Boys and girls.
- Aged 3 to 18 years old.
- Subjects with a Sensenbrenner's syndrome diagnosis and followed from 2005
- Parents/ legal guardian must provide non opposition prior to participation in the
study
Exclusion Criteria:
- Patients whose parents / legal guardian have object to using the data usually
collected for care
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 13 Years | Sensenbrenner Clinical Study | NCT04184531 | Contradiction |
6,109 | 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. | Subject Inclusion Criteria:
An individual must meet the criteria below to be eligible.
- Individual is attending or invited to visit a participating collection site.
- Individual is 18 years or older at the time of consent.
- Individual is feeling well at the time of consent or specimen collection and does not
have any of the following symptoms of COVID-19 per the current CDC guidance such as
cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle
or body aches, headache, sore throat, new loss of taste or smell, congestion or runny
nose, nausea or vomiting, or diarrhea.
- Individual is willing to participate in study procedures and able to provide written
informed consent in the English language.
Subject Exclusion Criteria:
An individual cannot meet the below criteria.
- Individual is confirmed to have COVID-19 and continues to require isolation in
accordance with current CDC guidelines at the time of consent or specimen collection.
- Individual is asymptomatic but suspected to have COVID-19 due to recent close contact
(as currently defined by the CDC) with a person with COVID-19 and continues to require
quarantine in accordance with current CDC guidelines at the time of consent or
specimen collection. [5]
- Individual had symptoms of COVID-19 less than 10 days before time of consent or
specimen collection."
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population | NCT04561102 | Contradiction |
6,709 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males, age 18 to 65 years.
- Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
- ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
Exclusion Criteria:
- Evidence of current or past inhibitor antibody:
- History of any congenital or acquired coagulation disorders other than hemophilia A.
- Platelet count <75,000/mm*3.
- Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- Active liver disease verified by medical history or persistently elevated alanine
aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal
range or severe liver disease as evidenced by, but not limited to any of the
following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein
hypertension including presence of otherwise unexplained splenomegaly and history of
esophageal varices.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | BAY94-9027 PK Study Comparing to Another Long Acting Product | NCT03364998 | Contradiction |
3,964 | 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. | Individual will be included if they:
1. Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) based on
fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing
within the past 12 months,
2. are between 35-65 years of age
3. report a frequent pain score between 4-7 (range: 0-10) during the week preceding
enrollment
4. report mobility limitations because of their knee pain
5. are currently not taking any prescription pain medication other than nonsteroidal
antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be
documented.
6. are willing not to use any cream, gel, or topical solution during the administration
of treatment other than the approved ultrasound gel provided to the subject at the
initiation of the study
7. are deemed appropriate by their physician to participate.
Individuals will be excluded if they:
1. cannot successfully demonstrate the ability to put on and take off the device
2. are cognitively impaired
3. have bone-on-bone crepitus
4. have severe OA or patients with little to no cartilage on the knee
5. have knee replacement or other surgical intervention
6. take variable prescription medication
7. are non-ambulatory
8. participated in a clinical trial for an investigational drug and/or agent within 30
days prior to screening
9. are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or
antidepressants (ie: Amitriptyline).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 Years | Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis | NCT01993693 | Entailment |
4,818 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion criteria:
- Male and female patients at least 18 years old
- Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH)
production:
- Persistent hypercortisolemia established by two consecutive 24 h UFC levels at
least 1.5x the upper limit of normal
- Normal or elevated ACTH levels
- Pituitary macroadenoma (>1 cm) on MRI or inferior petrosal sinus sampling (IPSS)
central to peripheral ACTH gradient >2 at baseline and >3 after
corticotropin-releasing hormone (CRH) stimulation
- Recurrent or persistent Cushing disease defined as pathologically confirmed
resected pituitary ACTH-secreting tumor or IPSS central to peripheral ACTH
gradient >2 at baseline and >3 after CRH stimulation, and 24 hour UFC above the
upper limit of normal reference range beyond post-surgical week 6
- Patients on medical treatment for Cushing disease. The following washout periods
must be completed before screening assessments are performed:
- Inhibitors of steroidogenesis (metyrapone, ketoconazole): 2 weeks
- Somatostatin receptor ligand pasireotide: short-acting, 2 weeks;
long-acting, 4 weeks
- Progesterone receptor antagonist (mifepristone): 2 weeks
- Dopamine agonists (cabergoline): 4 weeks
- CYP3A4 strong inducers or inhibitors: varies between drugs; minimum 5-6
times the half-life of drug
Exclusion criteria:
- Patients with compromised visual fields, and not stable for at least 6 months
- Patients with abutment or compression of the optic chiasm on MRI and normal visual
fields
- Patients with Cushing's syndrome due to non-pituitary ACTH secretion
- Patients with hypercortisolism secondary to adrenal tumors or nodular (primary)
bilateral adrenal hyperplasia
- Patients who have a known inherited syndrome as the cause for hormone over secretion
(i.e., Carney Complex, McCune-Albright syndrome, Multiple endocrine neoplasia (MEN) 1
- Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the
previous 1 months within normal range
- Patients with pseudo-Cushing's syndrome, i.e., non-autonomous hypercortisolism due to
overactivation of the hypothalamic-pituitary-adrenal (HPA) axis in uncontrolled
depression, anxiety, obsessive compulsive disorder, morbid obesity, alcoholism, and
uncontrolled diabetes mellitus
- Patients who have undergone major surgery within 1 month prior to screening
- Patients with serum K+< 3.5 while on replacement treatment
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
- Patients who have clinically significant impairment in cardiovascular function or are
at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV),
unstable angina, sustained ventricular tachycardia, clinically significant
bradycardia, high grade atrioventricular (AV) block, history of acute MI less than one
year prior to study entry
- Patients with liver disease or history of liver disease such as cirrhosis, chronic
active hepatitis B and C, or chronic persistent hepatitis, or patients with alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 x ULN, serum
total bilirubin more than ULN, serum albumin less than 0.67 x lower limit of normal
(LLN) at screening
- Serum creatinine > 2 x ULN
- Patients not biochemically euthyroid
- Patients who have any current or prior medical condition that can interfere with the
conduct of the study or the evaluation of its results, such as
- History of immunocompromise, including a positive HIV test result (ELISA and
Western blot). An HIV test will not be required, however, previous medical
history will be reviewed
- Presence of active or suspected acute or chronic uncontrolled infection
- History of, or current alcohol misuse/abuse in the 12 month period prior to
screening
- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method of birth control. If a woman is
participating in the trial then one form of contraception is sufficient (pill or
diaphragm) and the partner should use a condom. If oral contraception is used in
addition to condoms, the patient must have been practicing this method for at least
two months prior to screening and must agree to continue the oral contraceptive
throughout the course of the study and for 3 months after the study has ended. Male
patients who are sexually active are required to use condoms during the study and for
three month afterwards as a precautionary measure (available data do not suggest any
increased reproductive risk with the study drugs)
- Patients who have participated in any clinical investigation with an investigational
drug within 1 month prior to screening or patients who have previously been treated
with seliciclib
- Patients with any ongoing or likely to require additional concomitant medical
treatment to seliciclib for the tumor
- Patients with concomitant treatment of strong CYP3A4 inducers or inhibitors.
- Patients who were receiving mitotane and/or long-acting somatostatin receptor ligands
octreotide long-acting release (LAR) or lanreotide
- Patients who have received pituitary irradiation within the last 5 years prior to the
baseline visit
- Patients who have been treated with radionuclide at any time prior to study entry
- Patients with known hypersensitivity to seliciclib
- Patients with a history of non-compliance to medical regimens or who are considered
potentially unreliable or will be unable to complete the entire study
- Patients with presence of Hepatitis B surface antigen (HbsAg)
- Patients with presence of Hepatitis C antibody test (anti-HCV)
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.
| Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease | NCT03774446 | Contradiction |
4,951 | 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:
- Diagnosis of ET, as decided by the movement disorder specialist; Substantial
incapacity; Duration of symptoms > 5 years; Age 18 - 75; unsatisfying effect from
β-blockers, or be unable to tolerate the medical therapy.
Exclusion Criteria:
- Cognitive impairment; Co-morbidity or non-compliance likely to jeopardize the result
or to confuse the evaluation; Normal surgical exclusion criteria.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Swedish Essential Tremor (SWEET) Trial | NCT03832712 | Entailment |
6,616 | 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:
- BMI between ≥18 kg/m² and <30 kg/m² at time of screening
- Body weight between ≥45 kg and <100 kg
- Baseline vWF:Ag between ≥60% and <170% (0.6-1.7 IU/mL)
Exclusion Criteria:
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood
dyscrasia, including but not limited to thrombocytopenia, thrombocytopathy,
thromboasthenia, hemophilia, von Willebrand's disease, vascular purpura, bleeding gums
and/or frequent nose bleeding, easy/spontaneous bruises, meno- or metrorrhagia,
history of gastrointestinal bleeding or excessive bleeding after minor injury such as
shaving.
- Family history of congenital vascular malformation (e.g., Marfan's Syndrome) and/or
bleeding disorder (e.g., hemophilia, von Willebrand's disease, Christmas disease)
- Any surgical intervention (including tooth extraction) or trauma within the 4 weeks
preceding screening for the study or any planned surgical intervention during the
participation in the study
- Treatment with vitamin K, direct oral anticoagulant (DOAC), warfarin, high dose
heparin within 2 weeks before screening
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 | Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects. | NCT03172208 | Contradiction |
3,917 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- symptomatic and radiographic knee OA
Exclusion Criteria:
- severe patella femoral knee pain that would make cycling difficult
- medical condition which would prohibit an exercise program
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 75 Years | The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial | NCT00917618 | Entailment |
5,908 | 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 20 and over (at the time of consent given)
- Gender and inpatient or outpatient: Irrelevant
- Patients diagnosed with Grade A or Grade B mild reflux oesophagitis (according to the
Los Angels classification) through endoscopic test
- Patients who complained about "heartburn symptom" within one week prior to the
enrollment
Exclusion Criteria:
- Patients whose "heartburn symptom" has been disappeared (not been observed at all)
during the observation period (Check before official enrollment)
- Patients in ill compliance with dosing the investigational product for the observation
period (Not more than 75%, check from the patient dairy before official enrollment)
- Patients the investigator/sub-investigator assessed difficult to complete the patient
diary during the treatment period because the patient diary for the observation period
has too many deficiencies. (Check before official enrollment)
- Patients with complication of gastric/duodenal ulcer (scarring acceptable)
- Patients with complication of Barrett lining over the site exceeding 3 cm of
esophageal distal portion
- Patients who have received the normal dose of H2 receptor antagonist or proton pump
inhibitor (PPI) for 8 weeks in vain
- Patients whose Helicobacter pylori was successfully eradicated within 24 weeks
- Patients with medical history of upper gastrointestinal tract excision
- Patients with complication of angina pectoris
- Patients who have received treatment of any other investigational product within 12
weeks
- Patients who showed any of the following values at the laboratory tests before
official enrollment: Hemoglobin: < 9.5 g/dL, WBC: < 3,000/mm^3, Thrombocytes: <
75,000/mm^3, AST and ALT : ≥ 100 IU/L, Creatinine: ≥ 1.5 mg/dL These should be
assessed using the current test values from the blood drawn within 4 weeks prior to
official enrollment.
- Patients with complication of serious cardiac disorder (Grade 3 or above under PAB/SD
Notification No. 80) For example, patients with triplet or more ventricular premature
contractions (multi-sources) or using a pacemaker
- Patients with medical history of serious hypersensitivity to drugs (Grade 3 or above
under PAB/SD Notification No. 80)
- Patients who receive treatment of cancer
- Women of confirmed or potential pregnancy, those who wish to become pregnant, and
breast feeding women
- Patients having any other condition that, in the opinion of the
investigator/sub-investigator disqualifies them for the trial
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.
| Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - | NCT00229424 | Contradiction |
1,774 | 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:
- Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented
with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia,
substernal pain, epigastric pain, epigastric burning, early satiety, postprandial
fullness.
- Whose previous symptoms should last for at least 3 months and be at least 3 days per
week in frequency with moderate severity.
- Able to fill in the questionaires.
Exclusion Criteria:
- gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy
- severe cardiac or pulmonary diseases, diabetes or rheumatic diseases
- history of operations in the upper GI tract
- renal failure or abnormal liver function
- use of non-steroidal anti-inflammatory drugs (NSAIDs)
- allergy to esomeprazole
- Pregnancy or lactating mother
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 Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department | NCT02506634 | Contradiction |
5,038 | 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:
- diagnosis of essential tremor made according to the newest consensus statement on the
classification of tremors
- patients initiated on propranolol or primidone
Exclusion Criteria:
- a history of seizures
- a history of mental illness,
- having a cardiac pacemaker
- having metal material in the head (except dental material in the mouth)
- having a medication pump
- pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Pathophysiology of Tremor-modulating Mechanisms of Propranolol and Primidone in Essential Tremor | NCT04692844 | Entailment |
4,707 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- women with adenomyosis
- at early- to mid-secretory phases
Exclusion Criteria:
- postmenopausal
- malignancy
Female
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Progestin Treatment for Endometrial Stromal Cells in Adenomyosis | NCT00155051 | Entailment |
5,040 | 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:
Parkinson's disease
- Male or female with age over 40 years
- Clinical diagnosis of Parkinson's disease
- Ability to give informed consent
Essential tremor
- Male or female with age over 40 years
- Clinical diagnosis of Essential tremor
- Ability to give informed consent
Healthy volunteers
- Male or female with age over 40 years
- No any symptoms or sign suggesting Parkinson's disease or essential tremor
- Ability to give informed consent
Exclusion Criteria:
Parkinson's disease and essential tremor
- Current pregnancy and breast feeding
- Current or past medical history of cardiac and neuropsychiatric disease
- Clinical evidence of dementia
- Inability to hold antiparkinsonian medication
- History of surgical therapy for tremor
- Severe or unstable medical or psychiatric condition
- Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)
- Prior participation in other research protocol within 30 days
Healthy volunteers
- Current pregnancy and breast feeding
- Current or past medical history of cardiac and neuropsychiatric disease
- Severe or unstable medical or psychiatric condition
- Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within
6 months
- Prior participation in other research protocol within 30 days
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients | NCT00468078 | Entailment |
4,174 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Non-smoking, healthy male or female, age greater than or equal to (>=) 18 years and
<55 years old at the time of informed consent. To be considered non-smokers,
Participants must have discontinued smoking for at least 4 weeks before dosing
2. Japanese Participants must have been born in Japan of Japanese parents and Japanese
grandparents, must have lived no more than 5 years outside of Japan, and must not have
changed their life style or habits, including diet, while living outside of Japan
3. Body mass index (BMI) >=18 and <30 kilograms per meter square (kg/m^2) at Screening
Exclusion Criteria:
1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
positive beta-human chorionic gonadotropin [β-hCG] test). A separate baseline
assessment is required if a negative screening pregnancy test was obtained more than
72 hours before the first dose of study drug
2. Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of
contraception, which includes any of the following:
- Total abstinence (if it is their preferred and usual lifestyle)
- An intrauterine device or intrauterine hormone-releasing system (IUS)
- A contraceptive implant
- An oral contraceptive (Participant must have been on a stable dose of the same
oral contraceptive product for at least 28 days before dosing and must agree to
stay on the same dose of the oral contraceptive throughout the study and for 28
days after study drug discontinuation)
- Have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception throughout the
entire study period and for 28 days after study drug discontinuation
3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female
partners meet the exclusion criteria above (that is, the female partners are of
childbearing potential and are not willing to use a highly effective contraceptive
method throughout the study period and for 5 times the half-life of the study drug
plus 90 days after study drug discontinuation)
4. Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical treatment within 4 weeks of
dosing
5. Evidence of disease that may influence the outcome of the study within 4 weeks before
dosing; example, psychiatric disorders and disorders of the gastrointestinal tract,
liver, kidney, respiratory system, endocrine system, hematological system,
neurological system, or cardiovascular system, or participants who have a congenital
abnormality in metabolism
6. Any history of gastrointestinal surgery that may affect PK profiles of E2730, example,
hepatectomy, nephrectomy, and digestive organ resection
7. Any clinically abnormal symptom or organ impairment found by medical history, physical
examinations, vital signs, ECG finding, or laboratory test results that require
medical treatment at Screening
8. A prolonged QT interval of the ECG/Corrected QT interval (QT/QTc) (QTcF greater than
[>] 450 milliseconds [ms]) demonstrated by a repeated ECG at Screening or Baseline
(based on average of triplicate ECGs). A history of risk factors for torsade de
pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or
the use of concomitant medications that prolonged the QT/QTc interval
9. Persistent systolic BP >139 or <90 millimeter of mercury (mmHg) or diastolic BP >89 or
<50 mmHg at Screening or Baseline
10. Heart rate <45 beats/minute or >100 beats/minute at Screening or Baseline
11. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior
as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent
scale or via interview with a psychiatrist
12. Any lifetime history of psychiatric disease (including but not limited to depression
or other mood disorders, bipolar disorder, psychotic disorders, including
schizophrenia, panic attacks, anxiety disorders ). The absence of a history of
psychiatric disease should be documented by a checklist in the electronic case report
form (eCRF)
13. Any current psychiatric symptoms as indicated by a standard screening tool
14. Any suicidal ideation with intent with or without a plan at Screening or within 6
months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal
Ideation section of the C-SSRS)
15. Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS)
16. Known history of clinically significant drug allergy at Screening
17. Known history of food allergies or presently experiencing significant seasonal or
perennial allergy at Screening
18. Known to be human immunodeficiency virus (HIV) positive at Screening
19. Active viral hepatitis (A, B, or C) and syphilis as demonstrated by positive serology
at Screening
20. History of drug or alcohol dependency or abuse, or those who have a positive drug test
at Screening or Baseline
21. Exposure within the last 14 days to an individual with confirmed or probable corona
virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most
recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any
other reason to consider the participants at potential risk for an acute COVID-19
infection
22. Currently enrolled in another clinical study or used any investigational drug or
device within 28 days or 5 half-lives, whichever is longer, preceding informed consent
23. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or
donation of plasma within 1 week of dosing
24. Any personal or family history of seizures (including febrile seizures) or epilepsy or
episode of unexplained loss of consciousness
25. Any history of neurological or other medical conditions which in the opinion of the
investigator has the potential to reduce seizure threshold (example, history of head
concussion, traumatic brain injury, alcohol abuse, substance abuse, developmental
abnormalities in the brain)
26. Any epileptiform discharges on resting EEG (including during hyperventilation and
photo-stimulation)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants | NCT04676685 | Contradiction |
6,503 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Male or female subjects age 18 or older.
2. Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or
4-severe.
3. Presence of 12 - 50 inflammatory lesions and persistent erythema with or without
telangiectasia.
4. Subjects must read, understand, and sign the Informed Consent.
5. Subjects must be willing and able to comply with study procedures and visit schedule
requirements.
6. Women of childbearing potential that are willing to use an acceptable method of
contraception during the study.
Exclusion Criteria:
1. Active or localized or systemic infections.
2. Subjects must not be immunocompromised.
3. Known unresponsiveness or allergy to azelaic acid.
4. Subjects unlikely to comply with the protocol, e.g. mental condition rendering the
patient unable to understand the nature, scope, and possible consequences of the
clinical study, uncooperative attitude or unlikelihood of completing the study (e.g.
drug or alcohol abuse).
5. Subjects must not be pregnant or breastfeeding.
6. Presence of dermatoses that might interfere with the ability to diagnose and/or
evaluate rosacea.
7. Presence of other types of rosacea.
8. Laser surgery on the face for the treatment of telangiectasia or other conditions
within 6 weeks of study enrollment.
9. Use of medications or products for the treatment of rosacea or other medical
conditions within the following time periods prior to study enrollment. Use of these
medications will be prohibited during the trial.
Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months
Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks
Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6
weeks
10. Refusal to sign the Informed Consent document or Photo Release document and/or refusal
to comply with all follow-up requirements.
11. Use of medications that are known to cause flushing.
12. Dose changes in the last 90 days or initiation of beta-blockers, vasodilators,
vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other
drugs known to cause acneform eruptions.
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea | NCT03418610 | Entailment |
45 | 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. Agrees to written as well as audio-visual informed consent.
2. Ability to understand the risks/benefits of the protocol
3. Male between 35-65 years of age.
4. Diagnosed with Symptomatic hypogonadism
Exclusion Criteria:
1. Uncooperative Subjects
2. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.
3. Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of
normal; elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L
or1.2mg/dl)
4. Patients suffering from CAD
5. History of malignancy
6. History of hypersensitivity to any of the investigational drugs
7. Receiving any other testosterone booster therapy/medication/supplement within the last
2 months
8. History of coagulopathies
9. High alcohol intake (>2 standard drinks per day)
10. History of psychiatric disorder that may impair the ability of subjects to provide
written informed consent.
11. Any medical condition, where the investigator feels participation in the study could
be detrimental to the subjects overall well-being.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | The Efficacy Study of FUROSAP: A Testosterone Booster Supplement In Humans. | NCT02702882 | Contradiction |
3,306 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Patients have been recruited into the study by referral from an ophthalmologist or
pediatrician.
Entrance into the study was dependent upon clinical evidence of decreased or absent
pigmentation in skin, hair, and/or eyes.
The definition was purposefully broad to include the broad range of phenotype variations
and clinical heterogeneity.
The purpose of the study id to be able to document iris and retina/choroidal pigmentation
and correlated these finding with visual function.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Visual Function and Ocular Pigmentation in Albinism | NCT00001153 | Entailment |
5,399 | 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:
- Subject has voluntarily given written informed consent (before conduct of any
study-related procedures)
- The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A
VWD (VWF:RCo <= 10% and FVIII:C <20%)
- The subject has a medical history of at least 25 exposure days to VWF/FVIII
coagulation factor concentrates
- The subject has a Karnofsky score >= 70%
- The subject is between 18 to 60 years of age (on the day of signing the informed
consent)
- NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a
negative pregnancy test and agree to practice contraception using a method of proven
reliability from the day of screening until the study completion visit
- APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a
negative pregnancy test and agree to practice non-hormonal-based contraception using a
method of proven reliability (IUD acceptable) from the day of screening until 96 hours
after the last investigational drug infusion
- NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy
(hormone-based contraception acceptable) interfering with coagulation factor
pharmacokinetics until 96 hours after the last investigational drug infusion
- APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering
with coagulation factor pharmacokinetics until 96 hours after the last investigational
drug infusion
Exclusion Criteria:
- The subject has been diagnosed with a hereditary or acquired coagulation disorder
other than VWD (including qualitative and quantitative platelet disorders and/or an
international normalized ratio (INR) > 1.4)
- The subject has been diagnosed with an ADAMTS13 deficiency with less than 10% ADAMTS13
activity
- The subject has a history or presence of VWF inhibitor
- The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by
Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
- The subject has a known hypersensitivity to mouse or hamster proteins
- The subject has a medical history of immunological disorders, excluding seasonal
allergic rhinitis/conjunctivitis, food allergies or animal allergies
- The subject has a medical history of a thromboembolic event
- The subject is HIV positive with an absolute CD4 count < 200/mm3
- The subject has been diagnosed with cardiovascular disease (New York Heart Association
(NYHA) classes 1-4)
- The subject has been diagnosed with insulin-dependent diabetes mellitus
- The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic
rhinitis/conjunctivitis)
- The subject has been diagnosed with liver disease, as evidenced by, but not limited
to, any of the following: serum ALT three times the upper limit of normal,
hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained
splenomegaly, history of esophageal varices)
- The subject has been diagnosed with renal disease, with a serum creatinine level >= 2
mg/dL
- In the judgment of the investigator, the subject has another clinically significant
concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose
additional risks for the subject
- The subject has been treated with an immunomodulatory drug, excluding topical
treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
- The subject has been treated with drugs known to induce thrombotic thrombocytopenic
purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel,
Ticlopidine)) within 60 days before enrollment
- The subject is receiving or anticipates receiving another investigational and/or
interventional drug within 30 days before enrollment
- The subject is a lactating female
- The subject has a history of drug or alcohol abuse within the last 5 years
- The subject has a progressive fatal disease and/or life expectancy of less than 3
months
- The subject is identified by the investigator as being unable or unwilling to
cooperate with study procedures
- The subject suffers from a mental condition rendering him/her unable to understand the
nature, scope and possible consequences of the study and/or evidence of an
uncooperative attitude
- Subject is in prison or compulsory detention by regulatory and/or juridical order
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease | NCT00816660 | Entailment |
1,586 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Right-handed (assessed by Edinburgh Handedness Inventory)
- Healthy volunteers (self report)
- Absence of neurological and psychiatric diseases
- No history of severe musculoskeletal injury to wrists and fingers
- Without using drugs or neuroactive substances regularly
Exclusion Criteria:
- Pregnancy
- Presence of metallic implant close to the target stimulation area
- Acute eczema under the target stimulation area
- Pacemaker
- History of seizures or epilepsy
- Hemodynamic instability
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Non-invasive Cerebellar Stimulation on Motor Learning | NCT02559518 | Contradiction |
4,442 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral
epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included
if their clinical picture at physical therapy meets criteria for lateral
epicondylitis.
- If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such
as elbow pain), we will confirm the diagnosis at the first therapy visit with
tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger
extension at the lateral epicondyle.
- Pain for 4 weeks or more.
- All participants must be between the age of 18 and 70 years old and have had pain for
4 weeks or more.
Exclusion Criteria:
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the
affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the
affected elbow,
- Vascular disorders to include: history of DVT, history of endothelial dysfunction,
peripheral vascular disease
- Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy)
in the prior 3 months to the affected site
- Current fracture in affected arm
- History of crush injury to affected arm
- Any surgery on affected arm in last 1 year
- Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within
last year on contralateral upper extremity).
- History of lymphectomy (such as axillary exploration with breast surgery, lymph node
biopsy in the affected axilla/arm)
- Pregnancy
- Active infection
- Current cancer diagnosis/treatment
- Sickle cell anemia or trait
- Kidney dialysis
- History of syncope/passing out with pressure to body (such as massage, or blood
pressure cuff).
- inability to consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis | NCT03978897 | Contradiction |
1,811 | 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:
- Subject older than 18 years and younger than 80 years
- Subject referred for upper gastro-intestinal endoscopy under general anesthesia for
anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or
submucosal dissection
- Subject with health insurance
- Written informed consent
Exclusion Criteria:
- Patient younger than 18 years or older than 80 years
- Pregnancy or breast feeding
- Previous history of esophago-gastric surgery or vagotomy
- Previous history of Parkinson disease or diabetes mellitus
- Contra-indication to upper gastro-intestinal endoscopy
- Esophageal varices
- Esophageal diameter smaller than 5 mm
- Contra-indication to general anesthesia
- Hiatal hernia greater than 3 cm on endoscopy
- Esophageal or gastric cancer otherwise than superficial lesion with indication of
submucosal dissection
- Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or
gastroesophageal reflux disease (GERD)-Q score greater or equal to 8
- Nausea, vomiting or epigastric pain
- Dysphagia with Sydney score greater ou equal to 50
- Incapability to give consent
- No written informed consent
- Participation to another study at the same time
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.
| Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP) | NCT02905669 | Contradiction |
3,889 | 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. The patient provides consent to be part of the research.
2. The diagnosis of Knee Osteoarthritis was made based on clinical criteria/radiology
American College of Rheumatology (ACR) 2012 with radiology grading according to
Kellgren-Lawrence 2-3
Exclusion Criteria:
1. The Patient has received other forms of intraarticular injection therapy.
2. The patient has received Non Steroid Anti inflammation drug (NSAID) therapy for one
week before the start of the intervention.
3. The patient has one or more contraindications for prolotherapy (e.g., Abscess,
cellulitis, or septic arthritis).
Drop Out Criteria :
1. The patient has undergone a strenuous physical activity that precipitates a degree of
complication (i.e., joint effusion).
2. The use of NSAID within one week after the intervention.
3. The patient does not adhere to the intervention.
4. The patient developed or being diagnosed with osteoarthritis or other forms of
inflammatory disease in other joints.
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.
| Prolotherapy Intervention Effect in Patient With Knee Osteoarthritis | NCT04557943 | Entailment |
5,400 | 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:
- Women and girls with an active diagnosis of a congenital bleeding disorder (as
designated by the institution inputting data);
1. Deficiencies of factors VIII, IX, II, V, VII, VII, IX, X, XI, FV+VIII, XIII,
Plasminogen Activator Inhibitor 1(PAI-1), hypo-, a-, or dys-fibrinogenemia
2. von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type
3, Low VWF)
3. Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier
Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome,
Dense granule deficiency)
4. Ehlers Danlos Syndrome
- Post-menarchal: has had at least 1 period at the time of study entry
- Participating in the ATHNdataset
Exclusion Criteria:
- Male gender
- Acquired bleeding disorder
- Thrombotic disorder
- Non-English speaking
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 65 Years | Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders | NCT03834727 | Entailment |
6,849 | 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:
- Woman or man> 18 years,
- Signature of informed consent,
- Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or for
exclusion of neuromuscular pathology.
Prospectively, following the results of the muscle biopsy, the subjects will divided into
three groups meeting the following criteria:
- "DM" group: DM according to the ENMC criteria;
- "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy,
non-specific myositis or inclusion myositis according to the ENMC criteria;
- Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and
ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level,
iv) absence of electromyographic abnormality, v) histological Muscle mass.
Exclusion Criteria:
- - Taking an immunomodulatory treatment within 6 months before inclusion,
- Paraneoplastic form of the disease,
- Presence of associated interstitial pneumonitis,
- Neuromuscular pathology different from inflammatory myopathy,
- Unbalanced cardiovascular disease,
- Impossibility of giving the subject informed information (subject in an emergency
situation, difficulty in understanding the subject, ...),
- Subject under safeguard of justice,
- Subject under tutelage or under curators,
- Pregnancy (positive pregnancy test)
- Breastfeeding.
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.
| Exercise Capacity of Patients With Dermatomyosis | NCT03293615 | Entailment |
6,575 | 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:
- Body weight >/= 40 kilograms (kg) at the time of screening
- Diagnosis of congenital hemophilia A of any severity and documented history of
high-titer inhibitor ( that is [i.e.], >/= 5 Bethesda Units [BU])
- Documentation of treatment with episodic or prophylactic bypassing agents for at least
the last 24 weeks
- >/= 6 bleeds in the last 24 weeks prior to screening (if on an episodic bypassing
agent regimen) or >/=2 bleeds in the last 24 weeks prior to screening (if on a
prophylactic bypassing agent regimen)
- Adequate hematologic, hepatic and renal function
- For women who are not postmenopausal or surgically sterile: agreement to remain
abstinent or use single or combined highly effective contraceptive methods
Exclusion Criteria:
- Participants with inherited or acquired bleeding disorder other than hemophilia A
- Participants with ongoing (or plan to receive during the study) immune tolerance
induction therapy or prophylaxis with Factor VIII (FVIII), with the exception of
participants who have received a treatment regimen of FVIII prophylaxis with
concurrent bypassing agent prophylaxis
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which antithrombotic
treatment is not currently ongoing) or current signs of thromboembolic disease
- Participants with other conditions (for example [e.g.], certain autoimmune diseases)
that may increase the risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Known human immunodeficiency virus (HIV) infection with cluster of differentiation 4
(CD4) count < 200 cells per microliter (cells/mcL) within 24 weeks prior to screening
- Use of systemic immunomodulators (e.g., interferon or rituximab) at enrolment or
planned use during the study, with the exception of antiretroviral therapy
- Participants who are at high risk for thrombotic microangiopathy (TMA; e.g., have a
previous medical or family history of TMA), in the investigator's judgment
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study or that would, in the opinion of the
investigator or Sponsor, preclude the participant's safe participation in and
completion of the study or interpretation of the study results
- Planned surgery (excluding minor procedures such as tooth extraction or incision and
drainage) during the study
- Receipt of emicizumab in a prior investigational study; An investigational drug to
treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
administration; A non-hemophilia-related investigational drug within last 30 days or 5
half-lives, whichever is shorter; An investigational drug concurrently
- Unwillingness to use highly effective contraception methods for the specified duration
in the protocol (females only, unless required otherwise by the local health
authority)
- Clinically significant abnormality on screening evaluations or laboratory tests that,
in the opinion of the investigator, may pose an additional risk in administering study
drug to the participant
- Pregnancy or lactation, or intent to become pregnant during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors | NCT02622321 | Contradiction |
3,820 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study v1.0 | NCT02524470 | Entailment |
953 | 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. Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis
of the knee consistent with the ACR Clinical Classification Criteria for Arthritis of
the Knee (Altman, R. et al., 1991):
- Current knee pain,
- Less than 30 minutes of morning stiffness with or without crepitus on active
motion.
- Confirmation either by arthroscopy or radiologist's report (X-rays showing
osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation})
within one year prior to entry into the study.
2. ESR < 40 mm/hour
3. WOMAC Pain Subscales total score of more than or equal to 150 mm at baseline.
4. Oral and written language comprehension at a level sufficient to comply with the
protocol and complete study-related materials.
5. The Patient has signed and dated the REB approved, written, informed consent prior to
study participation.
Exclusion Criteria:
1. Known rheumatoid arthritis or any other rheumatoid disease.
2. Secondary arthritis, i.e. any of the following: septic arthritis; inflammatory joint
disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia;
Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable
arthritic disorders; or collagen gene mutations.
3. Obesity Class II (BMI more than or equal to 35) (NIH, 2000)
4. Major illness requiring hospitalization during the 3 months before commencement of the
screening period.
5. Unwillingness to cease taking medication other than the study medication for arthritic
pain, any other concomitant pain, or OA medications.
6. Patients who have previously failed tramadol HCl therapy or those who discontinued
tramadol HCl due to adverse events.
7. Patients who are taking or within the last 3 weeks have taken the following
medications: monoamine oxidase inhibitors; tricyclic antidepressants and other
tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective
serotonin reuptake inhibitors; or other drugs which reduce seizure threshold.
8. Patients who are taking or have taken another investigational agent within the last 30
days.
9. Patients with a history of seizure disorder other than Infantile Febrile Seizures.
10. Patients who are opioid dependent.
11. Patients with bowel disease causing malabsorption.
12. Patients who are pregnant or lactating or patients of child-bearing potential who are
unwilling to utilize a medically approved method of contraception during participation
in this clinical trial.
13. Patients with significant liver disease, defined as active hepatitis or elevated liver
enzymes >3 times the upper boundary of the normal range.
14. Patients with significant renal disease, defined as creatinine clearance <30 mL/min as
estimated by the method of Levey et al., 1999.
15. Current substance abuse or dependence, other than nicotine.
16. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g.
opiates.
17. Any other condition that, in the opinion of the investigators, would adversely affect
the patient's ability to complete the study or its measures.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up | NCT00912015 | Entailment |
5,604 | 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:
- 8-10 years old
- healthy
- African American
- parent willing to participate in data collection
- internet access
- personal email address
Exclusion Criteria:
- mental, physical, or medical conditions that limit fruit-vegetable consumption,
physical activity, or ability to fully participate in the program and/or complete
baseline and post assessment data collection
- taking medications that influence dietary behaviors, appetite, and/or physical
activity
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 10 Years | Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation | NCT01481948 | Contradiction |
4,203 | 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 normospermia who are initiating testosterone replacement and are over 18
years of age will provide semen samples to NYU Fertility Center.
Exclusion Criteria:
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial
heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the
eye, or steel implants.
- Substance abuse, medical, psychological, or social conditions that may interfere with
the patient's participation in the study.
- All women are excluded as such patients do not have the relevant anatomy being
considered in this study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male | NCT02756325 | Contradiction |
4,506 | 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:
- Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese
grandparents 21-40 years of age (both inclusive)
- Willing to stop using combined oral contraceptives (COC) in relation to the first
DECAPEPTYL Depot administration on Day -28
- Agrees to use a double barrier method of contraception between Day -63 and Day 28, if
not abstinent. A double barrier method of contraception should also be used after Day
28 until menses resumes or until another contraceptive method has been established
- Normal menstrual cycles with a range of 24-35 days in the absence of oral
contraceptives
- Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1
- Body mass index (BMI) of 18.5 -25 kg/m^2 (both inclusive)
- Negative serology for human immunodeficiency virus (HIV) antibody, hepatitis B
(surface antigen), hepatitis C antibody, and syphilis bacteria
- Healthy according to medical history, physical examination, gynaecological
examination, ECG, blood pressure, and laboratory profile of blood and urine
- Negative urine drug screen and alcohol breath test at screening and on Day -1
- Non-smoker or light smoker (≤ 5 cigarettes/day) for at least 6 months prior to trial
Exclusion Criteria:
- Presence or a history of clinically significant diseases of the renal, hepatic,
gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history
of clinically significant reproductive, psychiatric, immunological, endocrine or
metabolic diseases
- Cancer within the last 5 years except for adequately managed basal cell carcinoma and
squamous cell carcinoma of the skin
- Pregnancy or breastfeeding
- Current or a history of endocrine abnormalities such as hyperprolactinaemia,
polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland
or hypothalamus, thyroid or adrenal disease
- Clinically significant findings on the trans-vaginal ultrasound, cytology,
gynaecological or breast examination at screening or on Day -1 including ovarian cysts
or tumours of the ovaries or uterus
- Contraindications for the use of gonadotropins and gonadotropin-releasing hormone
(GnRH) agonists
- Previously treated with gonadotropins within the last 6 months prior to screening
- History within the last two years or current abuse of alcohol or drugs
- Presence or history of severe allergy or anaphylactic reactions
- Intake of prescribed medication, over-the-counter (OTC) medication, or herbal
medicines, with the exceptions of COC, cromoglycate, and paracetamol according to the
labelling, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to
first dose of DECAPEPTYL Depot. Topical treatments of bacterial or fungal infection
are allowed if stopped before first dose of IMP
- Intake of any non-registered investigational drug within the last 12 weeks preceding
screening, or longer if judged by the investigator to possibly influence the outcome
of the current trial
- High daily consumption of caffeine-containing beverages (e.g. more than five cups of
coffee or equivalent) with a risk of withdrawal symptoms arising during the trial that
may confound the safety evaluation
- Blood donation or major blood loss (greater than equal to [≥]500 mL) within the last 8
weeks, or plasma donation with the last 4 weeks preceding the first day of IMP dosing
- Current non-smokers or light smoker with a history of long-term, heavy smoking (>10
pack-years)
- Previously dosed in this trial
- Mental incapacity or language barrier precluding adequate understanding or
co-operation
- Considered by the investigator to be unsuitable to participate in the trial for any
other reason
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years | Rekovelle PK Trial in Chinese Women | NCT04150861 | Contradiction |
6,971 | 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:
- adult patients, 50-90 years of age;
- diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;
- meets DSM-IV criteria for Alzheimer-type dementia;
- stabilised on approved medications for treatment of Alzheimer Disease for >=4 months
prior to baseline.
Exclusion Criteria:
- active major depressive disorder, or a history of bipolar disorder;
- history of schizophrenia;
- concurrent participation in a non-pharmacological trial with a key objective of
improving cognition;
- prior randomisation in any R1450 trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years | A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease. | NCT00531804 | Entailment |
6,950 | 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:
Diagnosed Alzheimer´s disease
Exclusion Criteria:
Other neurological comorbidity, substance abuse
No condition on gender to be admitted to the trial.
| Processing of Music in Alzheimer Patients | NCT04132193 | Entailment |
2,858 | 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. Able to understand and give written informed consent.
2. Male or female patients aged 35 years or greater (inclusive) and less than 75 years of
age at the time of ALS diagnosis.
3. Patients with a confirmed ALS diagnosis: "definite ALS" or "probable ALS" or
"possible" diagnostic criteria per the revised El Escorial Criteria as determined by a
neurologist subspecializing in ALS (e.g., the Principal Investigator by study site).
4. Stable background therapy (e.g., stable dosing of riluzole within the prior 6-weeks)
per Investigator discretion.
5. At the time of Screening disease duration less than or equal to 24-months from symptom
onset OR within 12-moths of a confirmed ALS diagnosis.
6. Forced vital capacity (FVC) >/= 60% of predicted value as adjusted for gender, height,
and age at the Screening Visit.
7. Patients who are ambulatory (e.g., normal ambulation, early ambulation difficulties,
or walks with assistance) on the ALSFRS-R scale.
Exclusion Criteria:
1. At Screening patients who utilize, or in the Investigator's judgment will be
imminently dependent upon during the course of this study:
1. Non-invasive ventilation
2. Gastrostomy (e.g., use of percutaneous endoscopic gastrostomy tube)
3. Use of wheel chair
2. Patient who have previously undergone tracheostomy.
3. Patient with a history of significant other major medical condition based on the
Investigator's judgment.
4. Based on the investigator's judgment, patients who may have difficulty complying with
the protocol and/or study procedures.
5. Patient with clinically significant abnormalities in hematology, blood chemistry, ECG,
or physical examination not resolved by the Baseline visit which according to
Investigator can interfere with study participation.
6. Patient participating in any other investigational drug trial or using investigational
drug (within 12 weeks prior to screening and thereafter)
7. Females who are pregnant or nursing or who plan to get pregnant during the course of
this clinical trial or within 6 months of the end of this trial.
8. Positive screen for drugs of abuse or known alcohol abuse.
9. Women of child-bearing potential, or men, who are unwilling or unable to use accepted
methods of birth control during the study or for 6 months following completion of
study participation.
10. Women with a positive pregnancy test, are lactating, or are planning to become
pregnant during the study.
11. Patients with implanted metal objects in their body that may be affected by an MRI
procedure.
12. Patients who are claustrophobic or otherwise unlikely to be able to complete the MRI
scanning procedures.
13. Patients with a history of gold allergy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS) | NCT03843710 | Entailment |
2,972 | 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:
- Subjects will be individuals with neurologic or neuromuscular disease who are deemed
well-enough for sample collection.
Exclusion Criteria:
- Subjects who are not willing to undergo sample collection, genetic analysis, or
unwilling to share clinical information or their samples.
- Pregnant women will also be excluded.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 1 Year old.
Subject must be at most 90 Years | Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases | NCT02780531 | Entailment |
2,833 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral
sclerosis according to the El Escorial revised criteria
- spinal onset
- aged 18 to 85 years inclusive
- disease duration ≤ 24 months
- disease progression in the past 3 months
- FVC ≥ 70% of predicted
- score ≥ 2 at the item "swallowing"of the ALS Functional Rating Scale Revised
- score ≥ 2 at the item "walking"of the ALS Functional Rating Scale Revised
- in treatment with steady regimen of riluzole for a minimum of 1 month before study
entry, and desiring its continuation
- able to give informed consent
- written informed consent
Exclusion Criteria:
- bulbar onset
- previous poliomyelitis
- motor neuron diseases other than ALS
- clinical involvement of other neurological systems
- pregnancy, lactation,or unwillingness to contraception if required
- possible contraindications to tDCS: metals in the head (excluding the mouth);
electromedical devices; seizures; drugs or neurological conditions lowering seizure
threshold; alcoholism; severe heart diseases
- any severe disease other than ALS
- experimental drugs within 1 month prior to enrollment
- drugs potentially modifying the response to tDCS
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 | Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis | NCT01569958 | Entailment |
6,470 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Subjects must be able to understand the requirements of the study and be willing to
give written informed consent.
2. Male and female subjects aged 18 years and above.
3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in
good general health as determined by the Investigator.
4. Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
5. Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and
pustules) of rosacea over the face.
6. Subjects must have not more than 2 nodules.
7. Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA
scale.
8. Females must have a negative urine pregnancy test at the screening and baseline visit.
9. Females must either be postmenopausal with no menses for at least 12 months or
surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective
method of contraception with a pearl index of <1% up to 1 month after last dose.
10. Subjects must be in good general health as determined by the investigator and
supported by the medical history and normal or not clinically significant abnormal
vital signs (blood pressure and pulse).
Exclusion Criteria:
1. Females who are pregnant or nursing or planning to become pregnant during the study.
2. Male whose female partner is planning to conceive a child.
3. Subjects who have been treated for rosacea within the 30 days prior to the Baseline
Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
4. Subjects who have been treated with systemic retinoids within 6 months prior to the
Baseline visit.
5. Subjects who have participated in a trial involving any investigational product in the
90 days prior to the Baseline Visit.
6. Subjects with any disease or medical condition that would interfere with the study
outcome or place the subject at undue risk.
7. Subjects who use or have used systemic steroids within the 30 days prior to the
Baseline Visit or any other immunosuppressive medication.
8. Subjects who are on anti-coagulants or those who are likely to require anti-coagulants
during the study period.
9. History of drug or alcohol abuse in the last year.
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 Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules | NCT03340961 | Entailment |
5,979 | 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:
A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in
the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point
categorical scale), which has been present at least 3 times per week for 12 weeks,
unrelated to exercise.
C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating
(abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea;
however, the dominant symptom must be epigastric pain/discomfort.
D. Capable of and willing to give informed consent and comply with all study requirements.
Exclusion criteria:
A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C.
Patients requiring chronic treatment with any medication inducing GI symptoms (e.g.,
certain antibiotics, codeine, etc.).
D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or
presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions.
G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable
bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.
I. History or presence of other known organic disease that might explain the dyspepsia
symptoms (e.g., symptomatic gallstones).
J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater
than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of
beer or 16 fluid ounces of wine) per day.
M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence
of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors
(PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks
maximum).
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 55 Years | Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients | NCT00222131 | Entailment |
4,954 | 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:
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain
stimulator placement
- Age ≥ 18 years
Exclusion Criteria:
- Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound
procedure for treatment of tremor
- Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
- Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain
surgery, etc.)
- Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
- Pregnant
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.
| Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor | NCT03875404 | Entailment |
6,434 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Provide IRB approved written informed consent/assent.
2. Male or non-pregnant female, ≥ 18 years of age.
3. Diagnosis of rosacea with moderate to severe erythema on the face defined as: a score
of ≥ 3 on the Clinician's Erythema Assessment (CEA) and a score of ≥ 3 on the
Patient's Self-Assessment (PSA) on Visit 1/Day 1 (Baseline) prior to the first
application of study medication at hour 0.
4. Willing and able to understand and comply with the requirements of the study.
5. Be in general good health and free from any clinically significant disease, other than
rosacea, that might interfere with the study evaluations.
6. Females of childbearing potential in addition to having a negative urine pregnancy
test, must be willing to use an acceptable form of birth control during the study
Exclusion Criteria:
1. Females who are pregnant, breast feeding, or planning a pregnancy within the study
participation period.
2. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
or hepatic impairment, scleroderma, Sjögren's syndrome or depression.
4. Other facial conditions that in the Investigator's opinion might interfere with a
rosacea diagnosis and/or assessment including but not limited to: acne conglobata,
acne fulminans, rhinophyma, facial pustulosis of the chin, peri-oral dermatitis,
demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus
erythematosus, actinic keratosis, acne, dermatitis, psoriasis, squamous cell
carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid
folliculitis, or bacterial folliculitis .
5. Any uncontrolled, chronic or serious disease or medical condition that would prevent
participation in a clinical trial or, in the judgment of the Investigator, would put
the subject at undue risk or might confound the study assessments (such as planned
hospitalization during the study).
6. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
compromise the subject's ability to comply with study requirements.
7. Excessive facial hair (such as beards, sideburns, moustaches, etc.) that would
interfere with diagnosis or assessment of rosacea.
8. History of hypersensitivity or allergy to any ingredient in the study medication.
9. Previous enrollment in this study.
10. Non-responders to prior treatment with topical brimonidine.
11. Currently using any product containing brimonidine tartrate or oxymetazoline.
12. Start or change of dose of hormonal treatments.
13. Start or change of dose of tricyclic or tetracyclic antidepressants, cardio
glycosides, beta blockers or calcium channel blockers or other anti-hypertensive
agents 3 months (90 days) prior to baseline or throughout the study. Use of such
therapy must remain constant during the study.
14. Current treatment with or start of any of the following class of drugs: monoamine
oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or
alpha-agonists, medicines for psychosis, medicines for hyperactivity
15. Use within 6 months (180 days) prior to baseline or during the study of oral retinoids
or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins
are allowed).
16. Use within 12 weeks (84 days) prior to baseline or during the study of systemic
immunomodulators
17. Use of medicated make-up throughout the study and/or significant change in the use of
consumer products within 4 weeks (28 days) of study entry and throughout the study.
18. Participation in any clinical study involving an investigational product or device in
the 4 weeks (28 days) prior to baseline or throughout the study.
19. Use of following topicals on the face within 14 days prior to baseline or during the
study of antibiotics and/or prescription anti-inflammatory agents including ophthalmic
20. Over the counter (OTC) topical anti-acne medications 7 days prior to baseline
21. Chronic, daily use of OTC anti-inflammatory medications for more than 7 days (does not
include low-dose aspirin for cardiac prophylaxis), 7 days prior to baseline and
throughout the study. Subjects may use acetaminophen for pain relief, as needed
throughout the study.
22. Use of tanning booths, sun lamps, sunbathing, phototherapy or excessive ultraviolet
(UV) exposure to the sun 7 days prior to baseline and throughout the study.
23. Use of Niacin ≥500 mg per day within 7 days of study start and throughout the study.
24. Use of topical astringents or abrasives within 2 days of study start and throughout
the study.
25. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure
(swimming, etc.) within 24 hours of all study visits (Visit 1 through Visit 3).
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.
| Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea | NCT02385240 | Entailment |
6,542 | 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. Participant is < 6 years old at the time of screening
2. Participant is previously untreated with < 3 exposure days (EDs) to ADVATE, BAX 855 or
plasma transfusion at any time prior to screening
3. Participant has severe hemophilia A (Factor VIII (FVIII) < 1%) as determined by the
central laboratory, or a historical FVIII level < 1% as determined at any local
laboratory, optionally supported by an additional FVIII gene mutation consistent with
severe hemophilia A
4. Participant is immune competent with a CD4+ count > 200 cells/mm^3, as confirmed by
the central laboratory at screening
5. Parent or legally authorized representative is willing and able to comply with the
requirements of the protocol
Additional inclusion criteria for Part B (immune tolerance induction (ITI))
1. Parent or legal representative has/have voluntarily provided signed informed consent
for ITI portion
2. Participant has a confirmed positive high titer inhibitor (> 5.00 Bethesda unit (BU))
or has a positive confirmed low titer inhibitor (≥ 0.6 BU) as determined by the
central laboratory based on a second repeat blood sample with
1. poorly controlled bleeding despite increased BAX 855 doses, or
2. requires bypassing agents to treat bleeding
Exclusion Criteria
1. Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen
modification of the Bethesda assay) as confirmed by central laboratory at screening
2. Participant has a history of FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen
modification of the Bethesda assay or the Bethesda assay) at any time prior to
screening
3. Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease)
4. Participant has been previously treated with any type of FVIII concentrate other than
ADVATE or BAX 855, or was administered ADVATE, BAX 855 or plasma transfusion for ≥ 3
EDs at any time prior to screening
5. Participant receives >2 EDs of ADVATE in total during the periods prior to enrollment
and during the screening period, until the baseline infusion.
6. The participant's weight is anticipated to be < 5 kg at the baseline visit
7. Participant's platelet count is < 100,000/mL
8. Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene
glycol (PEG) or Tween 80
9. Participant has severe chronic hepatic dysfunction [eg, > 5 times upper limit of
normal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or a
documented international normalized ratio (INR) > 1.5] in his medical history or at
the time of screening
10. Participant has severe renal impairment (serum creatinine > 1.5 times the upper limit
of normal)
11. Participant has current or recent (< 30 days) use of other PEGylated drugs prior to
study participation or is scheduled to use such drugs during study participation
12. Participant is scheduled to receive during the course of the study a systemic
immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to
hydrocortisone greater than 10 mg/day or α-interferon) other than anti-retroviral
chemotherapy
13. Participant has participated in another clinical study involving an investigational
product (IP) or investigational device within 30 days prior to enrollment or is
scheduled to participate in another clinical study involving an IP or investigational
device during the course of this study
14. Parent or legally authorized representative has a medical, psychiatric, or cognitive
illness or recreational drug/alcohol use that, in the opinion of the investigator,
would affect participant safety or compliance
15. Parent, legally authorized representative or participant are a member of the team
conducting this study or is in a dependent relationship with one of the study team
members. Dependent relationships include close relatives (ie, children,
partner/spouse, siblings, parents) as well as employees of the investigator or site
personnel conducting the study.
Additional exclusion criteria for Part B (ITI)
1. Spontaneous disappearance of the inhibitor prior to ITI
2. FVIII inhibitor titer ≥ 0.6 BU is not confirmed by a second new blood sample and
determined at the central laboratory
3. Inability or unwillingness to comply with the protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 5 Years | Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Recombinant FVIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years of Age With Severe Hemophilia A | NCT02615691 | Contradiction |
67 | 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:
- Age greater than or equal to 50 years but not older than 80 years of age;
- Serum testosterone level <13.8 nmol/l;
- Sperm concentration > 40 Million/ml;
- Willing to give written informed consent.
Exclusion Criteria:
- Testicular diseases or having had any surgical procedures applied to the testes;
- History or currently existing serious disease of any type, in particular liver, kidney
or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- Current androgen, anabolic steroid or sex hormone treatment or any treatment with such
compounds in the previous 6 months;
- Blood donation within the 12-week period before the initial study dose.
- History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis,
atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal
septum deviation, recurrent epistaxis) or sleep apnea;
- Elevated serum PSA levels (> 4 ng/ml for subjects >= 50 years of age);
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Influence of Administration Route of Testosterone on Male Fertility | NCT00705796 | Contradiction |
Subsets and Splits