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5,518 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. Clinical suspicion of GCA; Cranial symptoms, new-onset extremity claudication or
protracted constitutional symptoms (weight loss > 5 kilograms or fever >38C for > 3
weeks).
2. C reactive protein >15 mg/l or erythrocyte sedimentation rate >40 mm/h
3. FDG PET/CT verified LV-GCA (steroid-naive) defined by FDG uptake in the aortic wall
and/or supra-aortic branches with FDG uptake score ≥3.
Exclusion Criteria:
1. oral glucocorticoid treatment within the past month
2. subcutaneously, intramuscularly, intraarticularly or intravenously administered
glucocorticoid within the past 2 months
3. treatment with DMARDs or other immunosuppressive therapy ongoing or within the past 3
months
4. ongoing treatment with interleukin2
5. any disease mimicking GCA, including
- a) autoimmune diseases with possible aortitis; rheumatoid arthritis, Cogans
syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus
erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease
- b) infections with possible aortitis: syphilis, known active current or history
of recurrent tuberculosis, hepatitis or HIV
- c) other large-vessel disease: sarcoidosis, neurofibromatosis, congenital
coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis
6. body weight of >150 kg.
7. Previously diagnosed and treated for PMR or GCA
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.
| FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment | NCT03285945 | Entailment |
2,733 | 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:
- Adults admitted for ventral or incisional hernia repair
Exclusion Criteria:
- Loss-of-domain
- ASA above III
- Liver failure
- Abnormal CA-125 prior to surgery
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.
| CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair | NCT01323361 | Entailment |
2,688 | 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 entering surgical waiting list during a year (from March 1st, 2018, to
February 28th, 2019).
- Elective surgery.
Exclusion Criteria:
- Age below 16.
- Mental diseases.
- Patients not capable of understanding the study.
- Patients that reject entering the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery | NCT03860285 | Entailment |
4,857 | 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 presenting for weight loss treatment at the GWUWMP
Patients must have at least two of the signs and symptoms in Table 1 of the protocol, in
addition to weight gain. If abdominal pain, backache and/or headache are present, only one
of these symptoms can be used in any given patient, so that another feature must be
present.
Willing and able to be seen for up to 24 months
Age 18-75
EXCLUSION CRITERIA:
Weight more than 350 pounds, the maximum weight for radiologist examination tables
necessary for the evaluation of Cushing's Syndrome
Renal failure, creatinine greater than 2.6, because of possible effects on dexamethasone
metabolism
Pregnancy, because it alters interpretation of adrenal function tests
Current use of oral, inhaled or intranasal glucocorticoids or use within 30 days of study
Other significant medical disorders that may complicate participation or interpretation of
the results. For example, a patient with a collagen vascular disorder who has taken
intermittent high dose glucocorticoids, and might need to do this again, might not be
offered participation.
Use of black licorice or chewing tobacco within two weeks of the study or anticipated use
during the study
Use of phenytoin, barbiturate, loperamide or opiates within two weeks of the study or
anticipated chronic use during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Diagnostic Performance of Screening Tests for Cushing s Syndrome | NCT00361777 | Entailment |
406 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous
combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding
enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Exclusion Criteria:
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Benign or malignant liver tumor that developed during the use of oral contraceptives
or other estrogen-containing products
- Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting
triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.
- Diabetes mellitus
- Migraine or increased sensitivity of headaches during previous estrogen or oral
contraceptive study
- Depression requiring hospitalization or associated with suicidal ideation
- Chronic renal disease
- Known hypersensitivity to estrogens and/or progestogens
- Neuro-ocular disorders
- Cholestatic jaundice
- Pregnancy while taking oral contraceptives
- Persistent non compliance with taking medication
- Serious adverse experiences with oral contraceptive use
- Malabsorption due to illness or surgery
- Use of any experimental drug or device within the last 90 days before study drug
administration
- Any anticonvulsant medications
- Any use of rifampin within 3 months of enrollment
- Any use of lipid lowering agents
- Impaired liver function or disease
- Known or suspected pregnancy
- Hypertension whether treated or untreated
- Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or
greater that is untreated within the last year
- The use of an intrauterine device (IUD) or injectable or implantable estrogen,
progestogens, or androgens during the six month period before enrollment; or oral
contraceptive or sex hormone use within three cycles before enrollment.
- Breast feeding
- Known or suspected alcoholism or drug abuse
- Smoking
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function | NCT00128726 | Contradiction |
4,448 | 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:
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative
treatment (Physical therapy, activity change, anti-inflammatory treatment.
Exclusion Criteria:
- Previous surgery on the currently-affected elbow.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis) | NCT03718637 | Contradiction |
746 | 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 and female 35-55 year old,
2. diagnosis of I-II grade essential AH,
3. patients with obesity (BMI ≥ 30 kg/m²),
4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous
antihypertensive therapy),
5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous
antihypertensive therapy),
6. written informed consent form (ICF).
Exclusion Criteria:
1. patients with symptomatic organ damage (myocardial infarction, stroke, angina
pectoris, chronic kidney disease stage ≥ 4, diabetes),
2. patients with intolerance of ARB, thiazide diuretics,
3. secondary AH,
4. patients with contraindication to study drugs in accordance with Russian instruction,
5. patients currently enrolled in other clinical trials.
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 55 Years | Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity. | NCT03006796 | Contradiction |
6,294 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Is a male or female greater than or equal to18 years of age at Screening;
- Is willing and able to sign and date (or has a legally authorized representative
willing to sign and date) a written (or electronic) informed consent form or provide
equivalent consent per Food and Drug Administration guidelines on COVID-19 clinical
trials;
- Has a documented, laboratory-confirmed severe acute respiratory syndrome coronavirus-2
(SARS-CoV-2) infection as determined by polymerase chain reaction, a SARS-CoV-2
antigen test, or another commercial or public health assay, within 3 days (72 hours)
of randomization;
- Has COVID-19 of moderate severity, as defined by the following: Positive testing by
standard reverse transcription polymerase chain reaction assay or equivalent testing;
Symptoms of illness with COVID-19, which could include any of the following: cough,
fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea,
body aches, weakness/fatigue, or new loss of taste or smell; Clinical signs suggestive
of illness with COVID-19, such as respiratory rate greater than or equal to 20 breaths
per minute, saturation of oxygen greater than 93% on room air at sea level, or heart
rate greater than or equal to 90 beats per minute; and No clinical signs indicative of
severe or critical severity.
Exclusion Criteria:
- Has an NIAID ordinal scale score <5;
- Is on high-flow oxygen or any form of noninvasive ventilation, excluding continuous
positive airway pressure (CPAP) alone for sleep disorders (e.g., obstructive sleep
apnea);
- Has significant cardiovascular disease, defined by myocardial infarction, arterial
thromboembolism, or cerebrovascular thromboembolism within 3 months prior to
randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical
therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York
Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension
(diastolic blood pressure greater than or equal to 100 mmHg or systolic blood pressure
greater than or equal to 160 mmHg); history of congenital prolonged QT syndrome, or
known dyslipidemia;
- Is currently taking any investigational products, other than the study drug;
- Has any other condition that, in the opinion of the Investigator, could interfere with
(or for which the treatment might interfere with) the conduct of the clinical trial or
interpretation of the clinical trial results or that would place the subject at undue
risk by participating in the clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19. | NCT04847544 | Entailment |
4,299 | 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. | PROTOCOL ENTRY CRITERIA:
Patients over age 10 with cystic fibrosis documented as follows:
- Pilocarpine sweat chloride test at least 60 mEq/L OR
- Genotyping or transepithelial potential difference AND
- Clinical symptoms of suppurative respiratory disease or pancreatic insufficiency
Able to produce at least 3 sputum samples
- Bronchoscopy specimens acceptable
- Throat/nasal specimens not acceptable
No Pseudomonas cepacia colonization
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
| Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients | NCT00004296 | Entailment |
4,461 | 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:
- 1. Subjects older than 20 years of age who can cooperate with the experimental
volunteers.
2. Suffering from epicondylitis of the humerus for more than one month, and subjective
pain intensity (VAS) greater than 5 points.
3. There is a local tender point at the upper elbow of the elbow, and the isometric
resistance test of the forearm to make a spin will induce pain.
4. Under soft tissue ultrasound, the thickness of the common tendon of the extensor
carpi muscles is more than 0.15 mm greater than that of the healthy side.
Exclusion Criteria:
- 1. There are contraindications to general treatment, such as serious medical problems,
recent serious trauma, or pregnant women.
2. There has been a history of drug abuse (including excess alcohol) that affects pain
assessors.
3. Have received neck, upper back, or upper and lower limb surgery. 4. People with
central or peripheral nerve disease. 5. Cognitive impairment, unable to cooperate with
the experimenter. 6. Patients currently receiving other treatments for epicondylitis
of the humerus.
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.
| Fu's Subcutaneous Needling on the Myofascial Trigger Points: Lateral Epicondylitis | NCT03605563 | Contradiction |
6,798 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Severe Hemophilia A
Exclusion Criteria:
- If they are not diagnosed with severe hemophilia A.
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 75 Years | Biomarkers Serum Collection Methodology Pilot Study | NCT01318707 | Entailment |
1,526 | 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:
- Healthy male and/or female (of nonchildbearing potential) Chinese (individuals
currently residing in mainland China who were born in China and have both parents of
Chinese descent) subjects between the ages of 18 and 45 years, inclusive. (Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG and clinical laboratory tests.)
- Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight >50 kg (110 lbs). A
BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of
24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Drug dependency, a positive urine drug screen, or alcohol dependency.
- History of regular alcohol consumption exceeding 28 or more units per week. (One
unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).
- Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).
- Treatment with an investigational drug within 3 months (or as determined by local
regulations) or 5 half-lives preceding the first dose of study medication.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Axitinib Pharmacokinetics in Chinese Healthy Volunteers | NCT00919204 | Contradiction |
1,607 | 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. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Divergence of Blood Pressure By Race in Adolescent Girls | NCT00005470 | Contradiction |
146 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
testosterone levels >100 ng/dl and ≤ 300 ng/dL.
- Normal Otolaryngological nasal endoscopy examination.
- Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.
Exclusion Criteria:
- Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
hormones
- Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
months
- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
sinus surgery.
- History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
month, abuse of nasal decongestants) or sleep apnea.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Efficacy and Tolerability of an Intra-Nasal Testosterone Product | NCT00975650 | Contradiction |
6,084 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Patients attending routine genetic clinic/paediatric clinic appointments for diagnosis of
a multiple anomaly syndrome where distinctive facial features form part of their presenting
pattern.
OR:
- Biochemically or genetically confirmed diagnosis of inborn disorder of metabolism where
no well described dysmorphic facial features are known to be associated with disorder
Exclusion Criteria:
- Patients under 8 months of age where face-recognition technology has not been shown to
be effective.
- Patients who decline clinical photography as part of standard care.
- Patients who do not wish to consent to participation in the study even though they
consent to photos being taken for standard care.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Months old.
| Evaluating Face-Recognition Technology in Syndrome Diagnosis | NCT04709965 | Contradiction |
842 | 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. | All Cohorts:
To be eligible to participate in this study, a subject must meet all the following
criteria.
Inclusion Criteria-ALL Cohorts:
1. Men and women age 18 or older
2. Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip,
Knee, Shoulder, or Wrist
3. Continued OA pain in the targeted joint despite conservative measures (per treating
provider's discretion)
4. Average daily VAS Pain Score ≥3
5. Understand and provide written informed consent and Health Insurance Portability and
Accountability Act (HIPAA) authorization prior to initiation of any study-specific
procedures
6. Subject must also meet additional inclusion criteria specific to the targeted joint
cohort
Ankle Cohort:
1. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray
(weight-bearing mortise views with 20⁰ internal rotation)
2. Ankle pain for at least 6 months, despite conservative treatment or inability to
tolerate the side effects of medications
3. Normal activity level, not bedridden or confined to a wheelchair, able to walk 30
meters without the aid of a walker, crutches or cane
Hip Cohort:
1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or
3)
Knee Cohort:
1. Kellgren-Lawrence system of Grade II, III, or IV
2. Subject may have concomitant patellofemoral but they must have stage II or higher
generalized knee OA
Shoulder Cohort:
1. Grades 1, 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto
classification system as confirmed by X-ray (axillary view and true anterior-posterior
view)
2. Subjects who have failed standard non-surgical management of their shoulder arthritis
who would benefit from a shoulder arthroplasty. Failed medical management will be
defined as persistent pain and disability despite adequate standard non-operative
management for 6 months. Medical management will be defined as:
1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities
(ultrasound, cryotherapy, etc.)
3. Activity modification
4. Patients will present with a type of B2 glenoid deficiency, as defined by the
Walch classification system, with greater than 10 degrees of retroversion.
Wrist Cohort:
1. Clinical symptoms consistent with wrist OA
Exclusion Criteria- ALL Cohorts:
1. Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort
2. Viscosupplementation within 6 months of screening in the targeted joint
3. Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in
the targeted joint
4. Surgery in the targeted joint within the past 6 months (either open or scope)
5. Planned/anticipated surgery of the targeted joint during study participation
6. Systemic or intra-articular injection of corticosteroids in any joint within 3 months
before screening
7. Females of childbearing age who have not used or do not plan to use acceptable birth
control measures, for the duration of the study. Oral, injected or implanted hormonal
contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
device, surgical sterilization, transdermal delivery, congenital sterility or sexual
abstinence are considered acceptable forms of birth control. If sexually active, the
subject must have been using one of the accepted birth control methods at least one
month prior to study entry.
8. Part of a vulnerable population per Office for Human Research Protections (OHRP)
definition (pregnant women and breast-feeding women, cognitively impaired, prisoners,
etc.)
9. Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7
calendar days prior to the procedure
10. Unwilling to discontinue NSAIDS for 5 calendar days after procedure
11. Insufficient amount of subcutaneous tissue to allow recovery of at least 100mL of
lipoaspirate
12. Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal
if not on long term remission (e.g. at least 5 years or negative biopsy at last exam),
except basal cell carcinoma
13. Have received chronic (more than 7 consecutive days) treatment with systemic
corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to
an injection procedure.
14. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint. (Nonintervention observational studies are not
exclusionary.)
15. History of, or ongoing, autoimmune disorder that requires treatment with an
immunosuppressive medication
16. Subjects who have a documented history or presence of inflammatory arthritis,
rheumatoid arthritis, and sepsis in the treatment site
17. Subjects who have active synovitis in the treatment site
18. History of bleeding disorders or inflammatory joint disease
19. Inability to hold anti-platelet therapy according to treating provider prior to
procedure
20. Any medical condition that could preclude participation in the study in the opinion of
the investigator
21. Active workers' compensation case in progress with the targeted joint
22. Daily opioid use for the 3 months prior to screening or anticipated daily use while
participating on study
23. Psychiatric disorder that may prevent participation in the study in the opinion of the
investigators
24. A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid
test
25. Allergy to sodium citrate of any "caine" type of local anesthetic
26. Hemoglobin less than 10g/dL at the time of screening
27. Leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL; platelets
<100,000/µL at the time of screening
28. Subjects with a known diagnosis of osteoporosis
29. Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >2x the upper
limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN
Ankle Cohort:
1. Lower leg trauma in a location other than within the ankle
2. Arthroscopy or open surgery of the ankle joint within 6 months of screening.
3. Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines
Body Mass Index (BMI > 40)
4. Any condition other than OA of the ankle joint which, in the opinion of the
investigator, affects their ability to ambulate to a sufficient degree to interfere
with the assessment of the safety and treatment effects of the study injection.
Hip Cohort:
1. Evidence of hip dysplasia (centre edge angle less than 20⁰)
2. Previous trauma to the affected hip requiring medical or surgical treatment
3. Previous surgery on the affected hip or contralateral hip
4. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda,
circumferential labral ossification)
5. Infections or skin diseases at target hip joint
6. Significant medical co-morbidities (requiring daily assistance for activities of daily
living)
7. Any clinically significant or symptomatic vascular or neurologic disorder of the lower
extremities
8. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
Knee Cohort:
1. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
2. Clinically apparent tense effusion of the targeted knee
3. Significant valgus/varus deformities (+/- 10⁰)
Shoulder Cohort:
1. Walch B2 glenoid with less than 10⁰ of retroversion
2. Rotator cuff arthropathy
3. Significant muscle paralysis
4. Charcot's arthropathy
Wrist Cohort:
1. Subjects who have a documented history of chondrocalcinosis in the wrist
2. Subjects who have a documented diagnosis of active carpal tunnel syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells | NCT04405297 | Entailment |
1,403 | 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:
- Older patients (≥70 years) admitted to Unit 5 and 8 of Hospital de Mataró.
- With OD diagnosed by the V-VST.
- Patients that have signed the informed consent form.
- Patients without any exclusion criteria.
Exclusion Criteria:
- Patients not able to comply with the protocol.
- Patients currently participating in any clinical trial or during the 4 last weeks.
- Patients with severe dementia or inability to communicate (GDS ≥ 6).
- Patients of the Intensive Care Unit.
- Patients with low functionality (Barthel pre-admission ≤ 40).
- Patients with high mortality risk (Walter score > 6).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 70 Years old.
| Minimal-Massive Intervention in Elderly Patients With Dysphagia | NCT02396992 | Contradiction |
1,900 | 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. Patients must have histologically or cytologically confirmed metastatic adenocarcinoma
of the stomach.
2. Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >20
mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for
the evaluation of measurable disease.
3. No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is
permitted if the disease free interval has been longer than 12 months.
4. Age between 18 and 70 years. Because no dosing or adverse event data are currently
available on the use of these regimens in patients <18 years of age, children are
excluded from this study.
5. Life expectancy of greater than 3 months.
6. ECOG performance status < 2 (Karnofsky >60%; see Appendix A).
7. Patients must have normal organ and marrow function as defined below:
- Leukocytes >3,000/microliter
- Absolute neutrophil count >1,500/microliter
- Platelets >100,000/microliter
- Total bilirubin < 1.5 x ULN
- AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases < 5 x ULN if known liver
metastases
- Creatinine clearance <1.5 x ULN
8. Not pregnant. Not breast feeding. If the patient or partner is of childbearing
potential, the couple will use adequate birth control in accordance with local IRB
policies:
For woman of childbearing potential:
Patient must have negative blood pregnancy test. If sexually active, woman must either
be post-menopausal (over age 50 and have not had a menstrual period for one year or
more, or blood FSH level in the post-menopausal range) OR agree to use appropriate
contraceptive measures for the duration of the study and for 21 days after stopping
study treatment. The only birth control methods for women that are acceptable for this
study are: (1) surgical sterilization (previous removal of the uterus or both ovaries
or a tubal ligation) OR (2) an intrauterine device (IUD), (3) double barrier methods,
(4) oral contraceptives.
For men:
Medically acceptable contraceptives include: (1) surgical sterilization, or (2) a
condom used with a spermicide. If the female partner becomes pregnant while patient is
on treatment or within 21 days after stopping treatment, the study physician must be
informed.
9. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Patients may not be receiving any other chemotherapy agents.
2. Patients with known active brain metastases. Patients with treated brain metastases
are permitted if stable off steroids for at least 30 days. A screening head CT/MRI is
not required in asymptomatic patients for this protocol.
3. History of allergic reactions to 5-FU, oxaliplatin, docetaxel, or cisplatin.
4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements.
5. Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with the chemotherapies.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Genotype Guided Chemotherapy in Gastric Cancer Patients | NCT02204306 | Entailment |
3,515 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Diagnosed with adrenal insufficiency due to hypopituitarism
- In steady twice or thrice daily (10-40 mg) hydrocortisone replacement treatment
- Written informed consent
- For women: Use of reliable methods of contraception in clinical trials in accordance
with the definition by the Danish Health and Medicines Authority; intrauterine devices
or hormonal methods (oral contraceptives, contraceptive implants, transdermal patches,
hormonal vaginal devices or injections with prolonged release).
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Acromegaly
- Cushing's Disease
- Diabetes Mellitus
- Other major confounding disease
- Known or expected hypersensitivity to any of the excipients
- Lack of compliance (attendance and medication)
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.
| Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism | NCT02282150 | Contradiction |
5,911 | 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:
- Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning
feeling rising from the stomach or lower chest up towards the neck"
- Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating,
dyspepsia, early satiety, or effortless regurgitation.
- Prior abnormal 4-hour gastric emptying scan within the past 3 years
Exclusion Criteria:
- History of esophageal or gastric surgery
- Severe gastroparesis with any of the following: vomiting with dehydration requiring IV
hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding
jejunostomy tubes
- Presence of gastric electrical stimulator
- Symptoms of retching with vomiting more than 2 days per week
- Diagnosis of diabetes
- Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
- Disorders of small bowel absorption
- Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
- Diagnosis of acid hypersecretory syndrome
- Disorders affecting proton pump inhibitor metabolism (such as liver failure)
- Known allergy or side effects to proton pump inhibitor
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis | NCT00492622 | Contradiction |
3,151 | 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:
- 18 years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular
symptoms during the last month:
1. Burning or stinging
2. Sandy or gritty feeling
3. Foreign body sensation
4. Tearing
5. Light sensitivity
6. Intermittent or fluctuating vision
7. Tired eyes
Exclusion Criteria
- Allergy to cornstarch or Dacron
- Allergy to topical anesthetic or fluorescein dye
- Prior eye injury, trauma, or ocular surgery within the last 3 months
- Known blockage of the lacrimal drainage system
- Contact lens wear in the last month
- Previous corneal refractive surgery including RK, LASIK or PRK surgery
- Have an active ocular infection or history of a recent ocular infection in the last
month
- Have active intraocular inflammation or history of intraocular inflammation, e.g.
Uveitis
- Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
- Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy,
or topical ocular cyclosporine in the last month
- Pregnant or lactating
- Use of any topical ophthalmic medications, including artificial tears 2 hours prior to
enrollment
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye | NCT01692964 | Contradiction |
4,406 | 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:
- Those who admit Kirsehir Ahi Evran University Hospital and is diagnosed with lateral
epicondylitis,
- Participants with unilateral or bilateral lateral epicondylitis and pain and
functional limitations due to this condition,
- who can read and write in Turkish,
- participant's admission participating in the study,
- participants who do not have exclusion criteria,
Exclusion Criteria:
- receiving any injection therapy to the elbow area in the last 3 months,
- participants with complaints less than 3 months(acute lateral epicondylitis)
- previously surgery on the elbow area,
- having a history of acute trauma or fracture in the elbow area,
- have local dermatological problems,
- have a local infection in the treatment area,
- those who are allergic to dextrose,
- with coagulation disorders or using anticoagulant drugs,
- with an autoimmune disease,
- with type 1 or type 2 diabetes mellitus,
- have unregulated hypertension,
- have immune dysfunction,
- with malignancy or diagnosed with a malignancy in the last 5 years,
- pregnancy or lactation,
- having cervical radiculopathy in the same extremity,
- with cognitive dysfunction,
- patients with paralysis in the same extremity,
- lack of cooperation due to cognitive impairment,
- participant's refusal to participate in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Low and High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis | NCT04680936 | Contradiction |
6,948 | 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. Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National
Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011[8];
2. Male or female, 50 years and older ;
3. All inpatients or outpatients recruited into this study must meet MMSE score ≤24
points, patients with MMSE score as 21-24 points will be enrolled into mild group,
patients with MMSE score as 10-20 points will be enrolled into moderate group,
patients with MMSE score less than 10 points will be enrolled into severe group.
4. Have a reliable caregiver who can accompany the patient to the site to complete the
required study procedures;
5. Provide the informed consent.
Exclusion Criteria:
1. Patients with disturbance of consciousness of any causes;
2. Patients with severe aphasia or physical disability who were unable to complete
neuropsychological examination;
3. Patients with mental illness;
4. Patients with a history of alcoholism and drug addiction, or traumatic brain injury,
epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders
causing cognitive impairment;
5. Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency,
endocrine disorders, vitamin deficiency);
6. Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and
vascular diseases (stroke foci) as confirmed by imaging examination;
7. Subjects who are unwilling or unable to abide by the study requirement.
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.
| Memantine Treatment in Alzheimer's Disease Patients | NCT03168997 | Entailment |
2,169 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subject is able to understand the study procedures, the risks involved and willing to
provide written informed consent before the first study related activity.
- Subject is willing to adhere to the visit/protocol schedules.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
- Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject meets one of the following criteria:
- Subjects who are not currently taking an approved ULT must have an sUA value of ≥ 8
mg/dL (476 µmol/L).
- Subjects entering the study on a medically appropriate dose of febuxostat or
allopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).
- Subject must be able to take gout flare prophylaxis with colchicine or non-steroidal
anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
- Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5
mm and ≤ 20 mm in the longest diameter.
- Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
- Subject with known hypersensitivity or allergy to febuxostat.
- Subject who is taking any approved urate-lowering medication other than allopurinol or
febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening
Visit.
- Subject who previously received pegloticase.
- Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150
mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- Subject with a history or suspicion of drug abuse within the past 5 years.
- Subject with a history of myositis/myopathy or rhabdomyolysis.
- Subject that requires or may require systemic immunosuppressive or immunomodulatory
treatment.
- Subject with known or suspected human immunodeficiency virus (HIV) infection.
- Subject with a positive test for active hepatitis B or hepatitis C infection.
- Subject with a history of malignancy within the previous 5 years with the exception of
non-melanoma skin cancer that has been treated with no evidence of recurrence, treated
cervical dysplasia or treated in situ Grade 1 cervical cancer.
- Subject within the last 12 months with: unstable angina, New York Heart Association
thrombosis; or subjects currently receiving anticoagulants.
- Subject with uncontrolled hypertension.
- Subject with an estimated creatinine clearance < 30 mL/min.
- Subjects with a creatine kinase > 2.5 x ULN at any time during the Screening Period.
- Subject with active peptic ulcer disease requiring treatment.
- Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
- Subject receiving chronic treatment with more than 325 mg of salicylates per day.
- Subject taking valpromide, progabide, or valproic acid.
- Subject who has received an investigational therapy within 8 weeks or 5 half-lives
(whichever is longer) prior to the Screening Visit.
- Subject with any other medical or psychological condition, which in the opinion of the
Investigator and/or Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements, or to
complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat | NCT01510769 | Contradiction |
5,049 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Patients who fulfil the 2017 Movement society concusses statement criteria for essential
tremor
Exclusion Criteria:
- Isolated focal tremor (voice, head)
- Orthostatic tremor with a frequency of more than 12 Hz
- Task and position specific tremor
- Sudden onset and stepwise deterioration of tremor
- History of substance abuse or dependence in the past
- Co-morbid medical conditions capable of producing or enhancing tremors
- Use of a medication with potential effect on tremor
- History of neurological disorders, brain tumors, brain surgery or abnormal
neurological examination
- Epileptic disorders
- Cardiac pacemakers
- Metallic hardware in the head or scalp (surgical clips)
- Eczema or skin abrasion at the intended site of stimulation
- Currently pregnant or plan for pregnancy in the next 6 months
- Patients with prior experience with tDCS
- Major psychosocial problems or medical problems rendering informed consent impossible
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.
| Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor | NCT03952117 | Entailment |
1,261 | 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:
- Radiologically measurable and clinically evaluable disease
- Absence of rapid disease progression or threat to vital organs or critical anatomical
sites requiring urgent alternative medical intervention
- Confirmed at least one tumor lesion with location accessible to safely biopsy per
clinical judgment (special requirements apply for Part C; Participants with only one
target lesion and no non-target lesions can enroll after documented agreement with the
Medical Monitor).
- Life expectancy of greater than or equal to (>=12) weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Participants with unilateral pleural effusion (other than non-small cell lung cancer
[NSCLC] indication) should fulfill the following criteria for pulmonary and cardiac
functions: Global Initiative for Chronic Obstructive Lung Disease (GOLD)
classification 0 - 1 level and New York Heart Association (NYHA) classification class
1 or better
- Forced expiratory volume 1 (FEV1) >70% and forced vital capacity (FVC) >70% of
predicted value; participants with lung metastases should present with DLCO >60% of
predicted value
- Adequate cardiovascular, hematological, liver and renal function
- All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure
must have resolved to grade less than or equal to (<=) 1, except alopecia (any grade)
and Grade 2 peripheral neuropathy
- Negative serum pregnancy test within 7 days prior to study treatment in premenopausal
women and women less than (<) 12 months after menopause
- For women who are not postmenopausal and have not undergone surgical sterilization:
agreement to remain abstinent or use two adequate non-hormonal methods of
contraception, including at least one method with a failure rate of <1 percent (%) per
year, during the treatment period and for a period of time after the last dose of
study drug(s) as defined in the protocol
- For men: agreement to remain abstinent or use contraceptive measures and agreement to
refrain from donating sperm during the treatment period and for at least for at least
2 months after the last dose of study treatment
- For Part A exclusively (RO6874281 monotherapy), confirmed advanced and/or metastatic
solid tumor, with at least one tumor lesion of location accessible to biopsy per
clinical judgment of the treating physician, and confirmed progression at baseline;
for whom no standard therapy that would confer clinical benefit to the participant
exists
- For Part B exclusively (RO6874281 in combination with trastuzumab), participants with
metastatic or recurrent or locally advanced human epidermal growth factor receptor 2
(HER2)-positive breast cancer, as defined by the College of American Pathologists HER2
testing guidelines, who have progressed on at least two lines of HER2-directed
therapies in the metastatic setting and the last therapy prior to going on study has
to contain a HER2-directed antibody; baseline left ventricular ejection fraction
(LVEF) of >=50% (measured by echocardiography) predose on Cycle 1 Day 1
- For Part C exclusively (RO6874281 in combination with cetuximab), participants with
recurrent, unresectable or metastatic squamous cell carcinoma of the head and neck.
Participants can have had standard or experimental treatment, including but not
limited to radiation therapy, chemotherapy, or immunotherapy
- Participants with Gilbert's syndrome will be eligible for the study
Exclusion Criteria:
- History of, active, or suspicion of autoimmune disease (exceptions apply)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1,
except for alopecia, vitiligo, or endocrinopathies managed with replacement therapy
- Symptomatic or untreated central nervous system (CNS) metastases
- History of treated asymptomatic CNS metastases with any of the following: Metastases
to the brain stem, midbrain, pons, medulla, cerebellum, or within 10 millimeters (mm)
of the optic nerves and chiasm; history of intracranial or spinal cord hemorrhage;
lacking radiographic demonstration of improvement upon the completion of CNS-directed
therapy and evidence of progression between completion of therapy and the baseline
radiographic study; ongoing requirement for dexamethasone; stereotactic or whole brain
radiation within 28 days before the start of study treatment; last CNS radiographic
study less than 4 weeks since completion of radiotherapy and less than 2 weeks since
the discontinuation of corticosteroids; CNS metastases treated by resection or brain
biopsy performed within 28 days before the start of study treatment
- Participants with an active second malignancy
- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results, including diabetes
mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or
other disease with ongoing fibrosis
- Participants (all indications) with confirmed bilateral pleural effusion and NSCLC
participants with confirmed uni- or bilateral pleural effusion by X-ray are not
eligible
- Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of
study drug administration
- Active or uncontrolled infections
- Known human immunodeficiency virus (HIV) or known active hepatitis B virus or
hepatitis C virus infection
- History of chronic liver disease or evidence of hepatic cirrhosis
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that give reasonable suspicion of a disease or condition that would
contraindicate the use of an investigational drug
- Major surgery or significant traumatic injury <28 days prior to the first RO6874281
infusion (excluding biopsies) or anticipation of the need for major surgery during
study treatment
- Dementia or altered mental status that would prohibit informed consent
- Pregnant or breastfeeding women
- Known hypersensitivity to any of the components of RO6874281
- Concurrent therapy with any other investigational drug
- Immune-related endocrinopathies
- Immunomodulating agents <28 days prior to first dose of study drug
- Treatment with systemic immunosuppressive medications
- Severe dyspnea at rest due to complications of advanced malignancy or requiring
supplementary oxygen therapy
- For Part B exclusively, known hypersensitivity to any of the components of trastuzumab
- For Part C exclusively, known hypersensitivity to any of the components of cetuximab
- For Parts A, B, and C, eligibility of participants who require blood transfusion
before and after the start of the study treatment should be discussed by the Sponsor
and investigator
- For Parts B and C, Participant eligibility for treatment with trastuzumab or cetuximab
should be verified against trastuzumab or cetuximab labeling documents.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) | NCT02627274 | Entailment |
4,988 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Subjects must be between the ages of 18 and 80 inclusive.
2. Each subject must have current manifestations of ET symptoms based on the Tremor
Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or
severe tremor in head or arms for at least 3 years duration. - No present causes of
enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug
withdrawal states. - No direct or indirect trauma to the nervous system within 3
months preceding the onset of tremor. - No historic or clinical evidence of
psychogenic tremor origin.
3. Subjects with a history of seizures are eligible.
4. Subjects must be in generally good health as evidenced by previous medical history and
clinical examination.
5. Patients will be allowed to take Beta-blockers but will not be allowed to take any
other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening
dose of a benzodiazepine to improve sleep is acceptable. They must have been on a
stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and
will not be allowed to change the dose of that medication throughout the controlled
portion of the study. Any medication discontinued during screening in order to comply
with these criteria must be stopped for 5 half-lives prior to study initiation.
6. Subjects must be accessible by telephone.
7. If the subject is a female of childbearing age, she must have had a hysterectomy,
tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the
following methods of contraception for at least one month prior to study entry (or a
negative urine pregnancy test within one week of study entry): - Hormonal
contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility
8. Prior to participation in this study, each subject must sign an informed consent.
Exclusion Criteria:
1. Patients do not meet TRIG criteria for probable ET.
2. Subjects who are not able to abstain from alcohol for 24 hours prior to each
evaluation.
3. Patients who can not maintain an identical dose of any medicine that may affect tremor
during their entire study involvement.
4. Subjects who have exhibited any psychotic symptomatology.
5. Subjects who have known renal deficiencies.
6. Subjects who have been intolerant of pregabalin in the past
7. Prior surgical treatment for tremor.
8. Patients currently taking more than a single drug for ET.
9. Patients taking anti-seizure medications.
10. Breast feeding or pregnant females.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Pregabalin in the Treatment of Essential Tremor | NCT00646451 | Entailment |
5,876 | 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:
- Out -patients with age of 20-80 years old (inclusive) in Taiwan of both genders
- Patients who had been previously diagnosed as erosive GERD (i.e. grade A~D according
to the modified Los-Angeles Classification. Endoscopic examination results within 21
days before randomization visit (V2) are acceptable.
- Patients with history of heartburn (or regurgitation) for ≥ 3 months before entering
study
- Patients with history of GERD-related sleep disturbances for ≥ 1 month before entering
study
- Patients with nighttime heartburn (or regurgitation) graded as moderate, or severe, on
≥ 3 nights in the last 7 days of screening period
- Patients with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of
screening period
- Patients with the global PSQI score >5
- Patients have signed the informed consent form
Exclusion Criteria:
- Patients with non-erosive GERD, Barrett's esophagus or esophageal stricture
- Patients with any conditions other than GERD that could be the primary cause of sleep
disturbance (e.g. sleep apnoea, obstructed airway, severe depression, severe anxiety,
panic attacks, chronic obstructive pulmonary disease requiring oxygen therapy)
- Patients with active esophageal, gastric or duodenal ulcers
- Patients with history of esophageal, gastric or duodenal surgery
- Patients with active cancers of any kind
- Female patients who are pregnant or lactating
- Patients who were allergy to any of the study drugs
- Patients taken a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent,
H2-blocker, alginate preparations or antacid within 2 days before screening
- Patients with a history of drug addiction or alcohol abuse within the past 12 months
- Patients with any other conditions or diseases that investigator considers it is not
appropriate to enter the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances | NCT02277886 | Contradiction |
4,225 | 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/Women age >40 years.
- Diagnoses of COPD according to criteria of the American Thoracic Society (ATS), a
disease state characterized by the presence of chronic airway obstruction due to
chronic bronchitis (cough/sputum on most days a week for 3 months in a year for at
least two successive years) and/or emphysema
- Diagnosis of moderate or severe COPD exacerbation (see "Definitions")
- FEV1 > 0.8 L and ability to produce sputum after hypertonic saline production
- Post bronchodilator FEV1/Forced Vital Capacity (FVC) ratio <70 % and post
bronchodilator FEV1< 80% pred.
- A smoking history of >10 pack years
Exclusion Criteria:
- Pneumonia as determined by X-ray
- > 48 h intake of prednisolon/antibiotics
- Need for mechanical ventilation (either invasive or non-invasive)
- Treatment with immune-modulating agents for any disease
- Experimental interventions for COPD last half year
- Former/concomitant diagnosis of asthma
- Any significant other pulmonary disease or disorder
- Other significant disease or disorder (like alpha-1-antitrypsine deficiency,
significant bronchiectasis, cardiovascular, gastrointestinal, liver, renal,
neurological, musculoskeletal, endocrine, metabolic (including diagnosed diabetes),
malignant, psychiatric, major physical impairment), which, in the opinion of the
investigators may either put the patient at risk because of participation in the
study, or may influence the results of the study, or the patient's ability to
participate in the study.
- Existing pregnancy/ current willingness for becoming pregnant
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
| mRNA and miRNA Airway Inflammatory Markers | NCT03924843 | Contradiction |
788 | 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. | Key Inclusion Criteria:
1. Male or female ≥18 years of age at the screening visit
2. Clinical diagnosis of OA of the knee or hip based on the American College of
Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index
joint at the screening visit
3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
4. A history of 12 weeks of analgesic use for OA of the knee or hip
5. History of regular use of analgesic medications for OA pain
Key Exclusion Criteria:
1. History or presence at the screening visit of non OA inflammatory joint disease
2. History or presence on imaging of arthropathy, stress fracture, recent stress
fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital
hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence
of bone fragmentation or collapse, or primary metastatic tumor with the exception of
chondromas or pathologic fracture during the screening period
3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
4. Patient is not a candidate for MRI
5. Is scheduled for a joint replacement surgery to be performed during the study period
6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the
screening visit.
7. History or presence at the screening visit of multiple sclerosis, autonomic
neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex
sympathetic dystrophy
8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy
9. Pregnant or breast-feeding women
10. Women of childbearing potential who have a positive pregnancy test result or do not
have their pregnancy test result at baseline
Note: Other protocol defined Inclusion/Exclusion criteria 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.
| Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip | NCT02683239 | Entailment |
5,538 | 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. | For GCA group:
Inclusion Criteria:
- Men and women ≥ 18 years of age Patient affiliated to social security regimen
- Informed and having signed the consent form to take part in the study.
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of
Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome
and having
- Either temporal artery biopsy showing characteristic GCA abnormality
- Or inflammatory arteritis on imaging examination
Exclusion Criteria:
- Persons under protection of the court or guardianship
- Inability to understand or to follow study procedures
- Dementia
- cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or
in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery
biopsy
- Any conditions that might interfere with MPs level: diabetes, recent endo-arterial
gesture, current treatment with corticosteroids.
- Participation in another ongoing clinical trial Current anticoagulant therapy
- Active infectious disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of Circulating Microparticles in Giant Cell Arteritis | NCT02333708 | Entailment |
6,861 | 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 include:
- A documented diagnosis of Alzheimer's disease;
- MMSE score between 10 and 26 inclusive;
- A reliable caregiver to ensure compliance.
Exclusion criteria include:
- diabetes, unstable medical illness, myocardial infarction or cancer diagnosed within
the previous 12 months, or treatment with systemic steroids.
- Patients being treated for depression or other psychiatric symptomatology are
eligible, if their symptoms are under control on a stable dose of medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease | NCT00013923 | Contradiction |
3,084 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Intellectual disability
- Aged >= 10 years
- Attend Special School or Units of Special Education in Southern Queensland
Exclusion Criteria:
- No intellectual disability
- Not aged >= 10 years
- Do not attend Special School or Unit of Special Education in Southern Queensland
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 20 Years | Health Intervention for Adolescents With Intellectual Disability | NCT00519311 | Entailment |
3,922 | 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:
- Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
- Patients with knee osteoarthritis who underwent PRP injection at least three days ago,
- Being volunteer
Exclusion Criteria:
- Any intra-articular application and / or physiotherapy and rehabilitation in the last
6 months,
- Have any other orthopedic problems involving the lower extremities
- Having cognitive problems,
- Having additional neurological, rheumatologic and / or oncological problems
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 65 Years | Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis | NCT04387396 | Entailment |
831 | 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 for Open-Label phase:
1. Males or females
2. Must be between the ages of 40-80
3. Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria
for Osteoarthritis of the Knee:
- 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 five years prior to entry into the study
4. Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of
the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or
tramadol.
5. Must be taking one of the above medications on a regular basis in the 30 days prior to
Visit 2 (S0).
6. Must meet the following criteria for severity of pain at Visit 2 (Day S0):
- Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
- Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale
(range: 0-10) compared to the rating at Visit 1 (Day SX)
7. Must have a erythrocyte sedimentation rate (ESR) < 40 mm/hr
8. Must have oral and written language comprehension at a level sufficient to comply with
the protocol and complete study-related materials
9. Must have signed and dated an approved written Informed Consent form in French,
Spanish, English or Romanian, which has also been signed and dated by the Investigator
(unless otherwise required by the ethics committee), prior to study participation
Exclusion Criteria for Open-Label phase:
1. Has known rheumatoid arthritis or any other rheumatic disease
2. Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory
joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly;
fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis;
heritable arthritic disorders; or collagen gene mutations
3. Has a history of bursitis of the knee (target knee)
4. Has a history of pain in the ipsilateral hip (target knee)
5. Has had a meniscal tear in the target knee within the last 12 months
6. Has had cartilage reconstruction procedure in the target knee
7. Has had a therapeutic arthroscopy procedure in the target knee within the last 12
months
8. Has a Body Mass Index (BMI) greater than 37
9. Has had a major illness, requiring hospitalisation during the 3 months before
commencement of the screening period
10. Is unwilling to stop taking pain medication other than the study medication (for
arthritis or other types of pain) or is unwilling to stop taking other medications for
the treatment of OA
11. Has previously failed treatment with tramadol or discontinued treatment with tramadol
due to adverse events
12. Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for
treatment of OA or other chronic conditions
13. Has received Corticosteroid Injections in the target knee within the last 3 months or
Viscous injections in the target knee within the last 6 months
14. Has had treatment within the last 3 weeks with any of the following medications:
monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds
(e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake
inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that
reduces seizure threshold
15. Has had treatment with another investigational agent within the last 30 days
16. Has a history of seizure disorder other than Infantile Febrile Seizures
17. Has a previous or current opioid dependency
18. Has a bowel disease causing malabsorption
19. Is pregnant, lactating or of childbearing potential and is unwilling to utilise a
medically approved method of contraception during participation in this clinical trial
20. Has significant liver disease, defined as active hepatitis or elevated liver enzymes
>3 times the upper boundary of the normal range
21. Has significant renal disease (defined as creatinine clearance <30 mL/min
22. Has a history of current or past substance abuse or dependence, other than nicotine
23. Has a known and documented allergy to tramadol or any structurally similar drugs (e.g.
opiates)
24. Has a known and documented allergy to acetaminophen or any structurally similar drugs
25. Has any other condition that, in the opinion of the Investigators, would adversely
affect the patient's ability to complete the study or its measures.
Inclusion criteria for the double-blinded phase:
- Patients must continue to meet the open-label eligibility criteria and
- Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of
≥ 2 points on the NRS compared to Visit 3(Day R14) and
- Must not have taken any of the prohibited medications during the Open-label Phase.
Exclusion criteria for the double-blinded phase:
- Patient Request
- Adverse Events that contraindicate further administration of the study medication
- Any other situation where in the opinion of the Investigator continued participation
in the study would not be in the patient's best interest.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis | NCT00833794 | Entailment |
3,880 | 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:
- Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
- Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial
tibiofemoral joint (joint space narrowing in the medial compartment > lateral
compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be
documented with a report from an x-ray of the study joint taken either at screening or
within 1 year prior to screening
- Subject meets American College of Rheumatology (ACR) clinical classification criteria
for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of
the following: oAge >50 oMorning stiffness <30 minutes oCrepitus on active motion
oBony tenderness oBony enlargement oNo palpable warmth of synovium.
Exclusion Criteria:
- Subject has a documented history of an allergic reaction (hives, rash, etc.) or a
clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids
including oxycodone
- Significant pain outside the index knee, including significant hip or back pain that
can not be distinguished from OA pain or that interferes with ability to walk.
(Patients with bilateral knee OA will be allowed into the study. The index knee should
be defined as the more painful knee
- Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by
clinical examination
- Subject who are unable to discontinue all formulations of prior analgesics other than
acetaminophen during the Washout Period of the study, or who are anticipated to be
unable to discontinue rescue medication for 24 hours prior to the respective visits.
(Low dose aspirin may be taken for cardiac prophylaxis
- Excessive signal knee joint laxity indicative of functional ligamentous deficiency
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib. | NCT00484718 | Entailment |
5,455 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Females aged between 18 and 50 years (inclusive)
- Stay in Beijing for more than 6 months
- Signed ICF was obtained
Exclusion Criteria:
- Not achieve the menarche
- With the last menstruation more than one year ago
- Experienced amenorrhea, currently take hormone therapy to induce menstruation
- Had undergone a hysterectomy
- Currently breastfeeding a baby
- Being pregnant
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing | NCT02304510 | Entailment |
1,247 | 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:
- Patients with MPD aged ≥18 years
- Karnofsky performance status ≥70%
- Patients with malignant pleural disease (MPD), pathologically confirmed at MSKCC
(radiographic confirmation is acceptable for screening phase eligibility), and defined
as one of the following (patients who have not yet received treatment may enroll in
the screening portion only):
1. Malignant pleural mesothelioma - previously treated with at least one prior
treatment regimen.
2. Non-small cell lung cancer metastatic to the pleura-previously treated with at
least one prior treatment regimen (chemotherapy or targeted agent) and documented
progression of disease. Patients with disease outside of the pleura will be
discussed among study PI and Co-PIs prior to considered eligible for the study.
Disease outside of the pleura must not require any immediate therapy per PI's
discretion.
3. Breast cancer metastatic to the pleura- previously treated with at least one
prior treatment regimen (chemotherapy or targeted agent) and documented
progression of disease. Patients with disease outside of the pleura will be
discussed among study PI and Co-PIs prior to be considered eligible for the
study. Disease outside of the pleura must not require any immediate therapy per
PI's discretion.
- Only patients with a diagnosis of malignant pleural mesothelioma will be included in
cohort 9 and in the Phase II portion of the study
- Expression of mesothelin must be confirmed by meeting one of the following criteria.
1. Mesothelin expression (>10% of the tumor expressing mesothelin) by
immunohistochemical (IHC) analysis
2. Elevated serum SMRP levels (>1.0 nM/L).
- Free flowing pleural effusion requiring management by placement of a pleural catheter.
Patients with a functional pleural catheter already in place are eligible for the
study, as long as there are no clinical concerns of infection.
OR
- No free-flowing pleural effusion: an Interventional Radiologist has agreed that
radiology-guided intrapleural or peritumoral injection of the CAR T cells is feasible.
- Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor) or therapeutic
radiotherapy must have been completed at least 14 days prior to administration of T
cells. Continuation of hormonal therapy (ie for breast cancer) is acceptable. Prior
immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or
CTL4-antagonist or similar agent) must have been completed more than 1 month1prior to
the T cell infusion.
- Chemotherapy must have been completed at least 7 days prior to leukapheresis
- Palliative radiotherapy must be completed at least 2 days prior to administration of
cyclophosphamide
- Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal
(laparotomy with organ resection) operation must have occurred at least 28 days before
study enrollment. Patients who have undergone diagnostic VATS or laparoscopy can be
included in the study.
- All acute toxic effects of any previous therapeutic or palliative radiotherapy,
chemotherapy, or surgical procedures must have resolved to grade I or lower according
to CTCAE (version 4.0).
- Lab requirements (hematology)
- White blood cell (WBC) count ≥3000 cells/mm3
- Absolute neutrophil count ≥1500 neutrophils/mm3
- Platelet count ≥100,000 platelets/mm3 Lab requirements (serum chemistry)
- Bilirubin ≤ 1.5x upper limit of normal (ULN)
- Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) ≤.5x ULN
- Serum creatinine ≤ 1.5x ULN or Cr > 1.5x ULN, but calculated clearances of >60
- Negative screen for human immunodeficiency virus (HIV), hepatitis B virus (HBV)
antigen, and hepatitis C virus (HCV). If testing was performed during the previous 3
months, there is no need to repeat testing, as long as documentation of results is
provided to the study site. Subjects must receive counseling and sign a separate
informed consent form for HIV testing.
- Subjects and their partners with reproductive potential must agree to use an effective
form of contraception during the period of drug administration and for 4 weeks after
completion of the last administration of the study drug. An effective form of
contraception is defined as oral contraceptives plus 1 form of barrier or
double-barrier method contraception (condom with spermicide or condom with diaphragm).
- Subjects must be able to understand the potential risks and benefits of the study and
must be able to read and provide written, informed consent for the study
Exclusion Criteria:
- Untreated or active CNS metastases (progressing or requiring anticonvulsants or
corticosteroids for symptomatic control); patients with a history of treated CNS
metastases are eligible, provided that all of the following criteria are met:
- Presence of measurable or evaluable disease outside of the CNS;
- Radiographic demonstration of improvement upon completion of CNS-directed therapy
and no evidence of interim progression between completion of CNS-directed therapy
and the screening radiographic study;
- Completion of radiotherapy ≥8 weeks prior to the screening radiographic study;
- Discontinuation of corticosteroids and anticonvulsants ≥4 weeks prior to the
screening radiographic study.
- Non-small cell lung cancer metastatic to the pleura that extends outside of the pleura
requiring immediate therapy
- Breast cancer metastatic to the pleura that extends outside of the pleura requiring
immediate therapy
- Prior history of seizure disorder
- Patients currently receiving treatment for concurrent active malignancy Continuation
of hormonal therapy (i.e. for breast cancer) is acceptable. Prior immunotherapy with
checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or CTL4-antagonist or similar
agent) must have been completed more than 1 month prior to the T cell infusion.
- Autoimmune or antibody-mediated disease, including but not limited to systemic lupus
erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal
arteritis (Patients with a history of hypothyroidism will not be excluded)
- History of myocarditis or congestive heart failure (as defined by New York Heart
Association Functional Classification III or IV), as well as unstable angina, serious
uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6
months prior to study entry
- Subjects with left ventricular ejection fraction (LVEF) less than 50%
- Patients with active interstitial lung disease (ILD)/pneumonitis or a history of
ILD/pneumonitis requiring treatment with systemic steroids
- Baseline pulse oximetry is less than 92% on Room air
- Pregnant or lactating women
- An infection requiring antibiotic treatment within 7 days before the start of
treatment (day 0)
- A requirement for daily systemic corticosteroids for any reason or a requirement for
other immunosuppressive or immunomodulatory agents. Topical, nasal, and inhaled
steroids are permitted.
- Administration of live, attenuated vaccine within 8 weeks before the start of
treatment (day 0) and throughout the study
- Any other medical condition that, in the opinion of the PI, may interfere with a
subject's participation in or compliance with the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin | NCT02414269 | Entailment |
472 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Healthy males or females aged between 18-40 years.
2. Willing and able to complete all study procedures, visits and restrictions.
3. Capable of giving written informed consent.
4. Has been determined healthy by medical history, physical and vital signs examinations.
5. Has normal results for the following screening tests: complete blood count (CBC),
sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar
(FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total
bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
phosphatase (ALP) and urinalysis.
6. Females of reproductive potential (defined as women who have not been postmenopausal
for at least 24 consecutive months [i.e., who have had menses within the preceding 24
months], or women who have not undergone surgical sterilization; specifically
hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation), must have
a negative serum or urine pregnancy test with a sensitivity of at least 40 mIU/mL at
Screening and prior to drug dosing on Day 1.
7. All participants must agree not to participate in a conception process (e.g., active
attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
If participating in sexual activity that could lead to pregnancy, the participant must
agree to use two reliable methods of contraception simultaneously while receiving
study treatment and for 6 months after stopping study drug. Subjects must either be
abstinent or a combination of TWO of the following methods MUST be used appropriately:
- Condoms (male or female) with or without a spermicidal agent;
- Diaphragm or cervical cap with spermicide;
- Intrauterine device (IUD);
- Hormonal-based contraception. Participants who are not of reproductive potential
(women who have been postmenopausal for at least 24 consecutive months or have
undergone hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal
ligation or men who have documented azoospermia) are eligible without requiring
the use of contraceptives. Acceptable documentation of sterilization, menopause
or male partner's azoospermia must be provided; serum follicle stimulating
hormone (FSH) measurement can be used to document menopausal range.
Exclusion Criteria:
1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion
of the Investigator interfere with the results of the study or threaten the health of
volunteers.
2. Clinically significant ECG abnormality according to ECG exam at Screening, subject's
medical history or family history judged by the Investigator that the presence of, or
an increased risk of cardiac abnormality.
3. Positive result for HIV, HCV or HBV at Screening.
4. Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or
cocaine) or alcohol screen at Screening.
5. Active alcohol or and/or drug abuse that, in the opinion of the site investigator,
would interfere with adherence to study requirements.
6. Received the excluded medications (as shown in Appendix 3) within 14 days or 28 days
prior to the first dose of study drug, or within the 5 half-lives of individual
medication, whichever is longer.
7. Participated in a clinical study and received any investigational drug or vaccine or
medical device within 90 days prior to the first dose of study drug.
8. Pregnancy or breast feeding, male partners of pregnant females. Inability to
understand the Protocol or follow its instructions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers | NCT03730311 | Contradiction |
1,383 | 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:
- All children with Hirschsprung's disease that will receive a corrective pull through
procedure
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 18 Years | Genetic Mosaicism in Hirschsprung's Disease | NCT01927809 | Entailment |
55 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men between 45 and 80 years age
- Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at
least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV)
disease or are at an increased risk for CV disease.
Exclusion Criteria:
- Participants with congenital or acquired hypogonadism for whom long-term therapy with
placebo would not be medically appropriate
- Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha
reductase inhibitors)
- Participants who have been treated with testosterone in the past 6 months and for whom
testosterone therapy is contraindicated
- Confirmed testosterone < 100 ng/dL
- Body Mass Index (BMI) > 50
- Hemoglobin A1c (HbA1C) > 11%
- Hematocrit (Hct) > 50%
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
- History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart
failure (Class III and IV).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men | NCT03518034 | Contradiction |
2,397 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Age 4 and above
- Diagnosis of DMD with a confirmed out-of-frame dystrophin gene deletions that could be
corrected by skipping exon 45, 51, or 53 based on past genetic testing.
Exclusion Criteria:
- Investigator assessment of inability to comply with blood and skin sample collection
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping | NCT01772043 | Entailment |
4,890 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Patients referred to our outpatient endocrinology clinic for medical evaluation due to
CS suspicion or adrenal incidentaloma evaluation
Exclusion Criteria:
1. Serum creatinine level concentration above 1.5 mg/deciliter
2. Systemic, dermal or nasal steroid use
3. Chronic inflammatory disease
4. Any infectious disease requiring hospitalization or more that 2 weeks of antibiotic
treatment in the previous 3 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Accuracy of Late Night Urinary Free Cortisol/Creatinine and Hair Cortisol in Cushing's Syndrome Diagnosis | NCT02791698 | Entailment |
2,297 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age
- Clinical features of DMD that include proximal predominant weakness and/or gait
disturbance
- Presence of a truncating mutation of the DMD gene OR a muscle biopsy that demonstrates
<5% dystrophin in the patient or an affected relative
- Normal left ventricular ejection fraction by screening echocardiogram
- Ability to cooperate for testing
- No prior glucocorticoid treatment
- No concomitant experimental therapies
Exclusion Criteria:
- Subject amenable to or currently being treated with eteplirsen
- Hyperkalemia at screening
- History of or ongoing renal failure (elevated creatinine, oliguria, anuria)
- Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness
or tingling of extremities)
- Current treatment with an ACEi
- Severe peptic ulcer disease or recent gastrointestinal perforations
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Spironolactone Versus Prednisolone in DMD | NCT03777319 | Contradiction |
6,071 | 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:
- Able to provide written informed consent in English.
- Willing to have height and weight measured and provide demographic information (e.g.
age, race, sex)
- Experience heartburn symptoms at least 2 days a week during the past 3 months.
- Use OTC product(s), supplements, or dietary manipulation to relieve heartburn symptoms
in the last 3 months.
- Willing to take the study soy supplement before resorting to OTC product(s) to control
heartburn symptoms.
- Willing to complete questionnaires, records, and diaries associated with the study and
to complete all clinical visits.
- Willing to provide information about dietary intake; 3-day online 24-hr recalls during
baseline, intervention, and washout.
- Willing and able to provide a valid social security for study payment purposes.
Exclusion Criteria:
- Do not meet the above criteria.
- Soy allergy
- Severe heartburn problem (cannot be ignored and often limits your concentration on
daily activities) during the last week
- Diagnosed or currently being treated for any gastrointestinal diseases including GERD,
gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
- Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during
the study duration.
- Currently participating in another clinical 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 60 Years | Fermented Soy and Heartburn Symptom Relief | NCT03867591 | Entailment |
1,040 | 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:
- Compliance with the ACR criteria
- Medial knee OA defined as "No osteoarthritis", "Doubtful narrowing of joint space
and/or possible osteophytes", "Definite osteophytes and possible narrowing of joint
space", "Multiple osteophytes, definite narrowing of joint space and some sclerosis
and deformity of bone ends". This corresponds to the Kellgren and Lawrence (KL) grades
0, 1, 2 and 3 respectively
- Willingness to participate in exercise and use of analgesics
- A maximum of 75/100 points in the KOOS Pain subscale
- BMI of 32 or less
Exclusion Criteria:
- Medial greater than lateral joint space width
- Medial knee OA of KL grade 4
- Knee surgery or steroid injection within the past 6 months
- Already taking max dose NSAIDs or acetaminophen
- Any physician-determined condition that is a contraindication for use of
acetaminophen, NSAIDs or to exercise
- Problems affecting the lower extremity overriding the problems from the knee
- Knee surgery planned in the next 6 months
- Known ACL tear within the past 6 months
- ACL reconstruction
- Diagnosis of systemic arthritis
- Difficulty complying with treatment schedule
- Inability to fill out questionnaires
- Inability to ambulate without an assistive device
- Ankle, knee or hip replacement
- Tibial/femoral osteotomy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT | NCT01638962 | Entailment |
1,940 | 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. Patients must be 18 years of age or older.
2. Histologically documented locally advanced or metastatic gastric or GEJ adenocarcinoma
not previously treated with palliative systemic therapy.
3. Patients must be capable of providing consent to enrolment and treatment.
4. Patients with a performance status of ECOG 0-1 will be eligible for enrolment (see
appendix 1).
5. Measurable disease must be present according to RECIST criteria V1.1 (see appendix ).
6. Women of child bearing potential (WOCBP) must have a negative serum (or urine)
pregnancy test at the time of screening. WOCBP is defined as any female who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.
Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the
absence of other biological or physiological causes.
7. Patients (men and women) of childbearing / reproductive potential should use highly
effective birth control methods, as defined by the investigator, during the study
treatment period and for a period of 6 months after the last dose of study drug. A
highly effective method of birth control is defined as those that result in low
failure rate (i.e. less than 1% per year) when used consistently and correctly. Note:
abstinence is acceptable if this is established and preferred contraception for the
patient and is accepted as a local standard.
8. Female patients who are breast-feeding should discontinue nursing prior to the first
dose of study treatment and until 30 days after the last dose of study drug.
9. Male patients should agree to not donate sperm during the study and for a period of at
least 6 months after last dose of study drug.
10. Absence of any condition hampering compliance with the study protocol and follow- up
schedule; those conditions should be discussed with the patient before registration in
the trial.
11. Patients may have received prior surgery if this surgery was ≥ 4 weeks before study
entry and patients must have recovered from the toxic effects of this treatment.
12. Patients who have treated brain metastasis (via local radiation standards or surgical
resection or local ablative techniques) and who are either off steroids or on a stable
dose of steroids for at least one month (30 days), AND who are off anticonvulsants,
AND have radiological documented stability of lesions for at least 3 months may be
eligible. Each case should be discussed with the study Chair.
13. Patients who have received prior chemotherapy or radiation delivered as part of
initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone
and/or concurrently delivered with radiation and/or surgery) are permitted as long as
that treatment was completed at least 6 months prior to study start date.
14. Patients may have received prior palliative radiotherapy (unless radiation was
curative therapy to pelvis or to ≥ 25% of bone marrow stores) if this radiation was ≥
4 weeks before study entry and patients must have recovered from the toxic effects of
this treatment.
15. Patients with unknown Her2/neu status, or negative Her2/neu status based on IHC and/or
FISH/CISH (Testing does not need to be done unless it is standard of care at
participating centres).
16. The following adequate organ function laboratory values must be met:
Hematological:
Absolute neutrophil count (ANC) >1.5 x10^9/L Platelet count >100 x10^9/L Hemoglobin >8 g/dL
(may have been transfused)
Renal:
serum creatinine ≤ upper limit of institutional normal OR calculated creatinine clearance
of ≥ 50 mL/min using the Cockcroft-Gault formula (or local institutional standard method)
Hepatic:
Total serum bilirubin <1.5x ULN AST and ALT <2.5x ULN (or ≤ 5 x ULN for patients with
documented metastatic disease to the liver)
Exclusion Criteria:
1. Patients who have received prior palliative chemotherapy for their advanced gastric or
GEJ tumor.
2. Prior curative or palliative radiation treatment to the pelvis or radiation therapy to
≥ 25% of bone marrow stores.
3. History of bowel obstruction due to peritoneal metastases or clinically documented
ascites requiring paracenteses.
4. Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of
the cervix or uterus or non-melanoma skin cancer or in-situ carcinoma of the prostate
(Gleason score ≤ 7, with all treatment being completed 6 months prior to enrollment,
unless at least 5 years have elapsed since last treatment and the patient is
considered cured).
5. Active bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as
ongoing signs/symptoms related to the infection without improvement despite
appropriate antibiotics, antiviral therapy, and/or other treatment.
6. Known infection with hepatitis B or C, or history of human immunodeficiency virus
(HIV) infection, or subject receiving immunosuppressive or myelosuppressive
medications that would, in the opinion of the investigator, increase the risk of
serious neutropenic complications.
7. Any serious medical condition within 6 months prior to study entry such as myocardial
infarction, uncontrolled congestive heart failure, unstable angina, active
cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases,
uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder,
serious infection, active peptic ulcer disease, or other medical condition that may be
aggravated by treatment.
8. Pre-existing neuropathy ≥ grade 2 from any cause.
9. Patients with unstable metastasis to the central nervous system (CNS). A CT scan or
MRI is NOT required to rule out brain metastases unless there is clinical suspicion of
CNS involvement.
10. Pregnant or lactating women; women of child bearing potential must have a negative
serum pregnancy test within 7 days of trial registration. Women or men of child
bearing potential must use effective contraception (defined by the treating physician)
which must be documented in study CRFs.
11. History of allergic reaction to planned study medications.
12. Patient has a ≥ 20% decrease in serum albumin level between baseline visit, if
available, and within 72 hours prior to first study treatment dose.
13. Patient is on coumadin.
14. History of interstitial lung disease.
15. History of connective tissue disorders (e.g. lupus, scleroderma, polyarteritis
nodosa).
16. Enrollment in any other clinical protocol or investigational study with an
interventional agent or assessments that may interfere with study procedures.
17. Any significant medical condition, laboratory abnormality, or psychiatric illness,
that would prevent the subject from participating in the study, places the subject at
unacceptable risk if he/she were to participate in the study, or any condition that
confounds the ability to interpret data from the study.
18. Positive Her2/neu status (NOTE: if this is discovered after patient has already been
enrolled on study, patient may continue on study per the discretion of the treating
physician.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Phase II Trial of iTTo in Advanced Gastric and GEJ Adenocarcinoma | NCT04808791 | Entailment |
6,946 | 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. | Community population: age ≥ 55 years, male or female, with consent to participant the
study.
Hospital population: subjects are all over 18 years old. Through clinical evaluation,
neuropsychological test, imaging examination, blood and cerebrospinal fluid examination,
etc, we will comprehensively evaluate the cognitive function and various test measures.
(1) MCI and its subtypes
Inclusion criteria:
1. Diagnosis according to 2004 Peterson's MCI criteria.
2. CDR = 0.5.
3. Memory loss is prominent, and may also be with other cognitive domain dysfunction.
4. Insidious onset, slow progress.
5. Not reaching the level of dementia.
Exclusion criteria:
1. With history of stroke and a neurological focal sign, the imaging findings are
consistent with cerebral small vessal disease (Fazekas score ≥ 2 points).
2. Other neurological diseases that can cause brain dysfunction (such as depression,
brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple
sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
3. Other systemic diseases that can cause cognitive impairment (such as liver, renal and
thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis,
HIV infection, alcohol and drug abuse, etc.).
4. Mental and neurodevelopmental retardation.
5. Contraindications to MRI.
6. Suffering from a disease that cannot be combined with cognitive examination.
7. Refuse to draw blood.
8. Refuse to sign the informed consent at baseline
(2) Sporadic Alzheimer's disease (SAD)
Inclusion criteria:
1. Dementia is diagnosed according to the criteria described by the Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The
diagnosis of AD is made using the National Institute of Neurologic and Communicative
Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association
(NINCDS-ADRDA) or National Institute on Aging and the Alzheimer's Association (NIA-AA)
criteria.
2. Subjects and their informed persons can complete relevant and follow- up examinations.
3. Subjects or their authorized legal guardians sign the informed consent.
Exclusion criteria:
1. With a family history of dementia.
2. Other neurological diseases that can cause brain dysfunction (such as depression,
brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple
sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
3. Other systemic diseases that can cause cognitive impairment (such as liver, renal and
thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis,
HIV infection, alcohol and drug abuse, etc.).
4. Mental and neurodevelopmental retardation.
5. Contraindications to MRI.
6. Suffering from a disease that cannot be combined with cognitive examination.
7. Refuse to draw blood.
8. Refuse to sign the informed consent at baseline
(3) Familial Alzheimer's disease (FAD)
Inclusion criteria:
1. Written informed consent obtained from participant or legal guardian prior to any
study-related procedures.
2. Members in FAD pedigree (FAD is defined as at least two first- degree relatives suffer
from AD).
3. Aged 18 (inclusive) or older.
4. At least two persons who can provide reliable information for the study. Note:
Dementia is diagnosed according to the criteria described by DSM-IV-R. The diagnosis
of AD is made using NINCDS-ADRDA or NIA-AA criteria. A diagnosis of MCI is assigned
according to Petersen criteria.
Exclusion criteria:
1. Dementia caused by other factors such as depression, other psychiatric illnesses,
thyroid dysfunction, encephalitis, multiple sclerosis, brain trauma, brain tumor,
syphilis, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease and
other types of dementias such as vascular dementia (VaD), frontotemporal dementia
(FTD), dementia with Lewy bodies (DLB), and Parkinson's disease dementia (PDD).
2. MRI and laboratory tests do not support or rule out a diagnosis of AD.
3. Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as
unstable angina, uncontrollable asthma, active gastric bleeding) and cancer.
4. Participant has severe psychiatric illness or severe dementia that would interfere in
completing initial and follow-up clinical assessments.
5. With history of alcohol or drug abuse.
6. Pregnant or lactating women.
7. No reliable insiders.
8. Refuse to sign the informed consent at baseline.
(4) Vascular dementia (VaD)
Inclusion criteria:
Diagnosis for probable VaD according to NINDS-AIREN diagnostic criteria.
MRI inclusion criteria:
All patients who meet clinical inclusion criteria should accept MRI scans which include an
assessment of hippocampal volume.
1. multiple (≥3) supratentorial subcortical small infarcts (3-20 mm in diameter) with or
without any degree of white matter lesion (WML); or moderate to severe WML (Fazekas
score ≥ 2), with or without small infarction; or ≥ 1 subcortical small infarct in key
regions, such as caudate nucleus, globus pallidus, or thalamus.
2. no cortical and watershed infarction, hemorrhage, hydrocephalus, or WML with specific
causes (such as multiple sclerosis).
3. no hippocampus or entorhinal cortex atrophy (MTA score = 0 point).
Exclusion criteria:
1. Other neurological diseases that can cause brain dysfunction (such as depression,
brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple
sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
2. Other systemic diseases that can cause cognitive impairment (such as liver
insufficiency, renal insufficiency, thyroid insufficiency, severe anemia, folic acid
or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.).
3. With a history of mental illness or those with congenital mental retardation.
4. Suffering from a disease that cannot be combined with a cognitive examination.
5. Contraindications to MRI.
6. Refuse to draw blood.
7. Refuse to sign informed consent.
(5) Normal control
Inclusion criteria:
1. Aged 18 (inclusive) or above.
2. Normal MMSE and MoCA evaluations. MMSE>19 points for illiteracy, >24 points for those
educated less than 7 years, >27 points for those educated equal to or more than 7
years. MoCA>13 points for illiteracy, >19 points for those educated less than 7 years,
>24 points for those educated equal to or more than 7 years.
Exclusion criteria:
1. Subjects with abnormal MMSE or MoCA scores.
2. Subjects with a history of cerebral infarction, traumatic brain injury or related
manifestations in MRI.
3. Other neurological diseases that can cause brain dysfunction (such as depression,
brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple
sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.).
4. Other systemic diseases that can cause cognitive impairment (such as liver, renal and
thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis,
HIV infection, alcohol and drug abuse, etc.).
5. Mental and neurodevelopmental retardation.
6. Suffering from a disease that cannot be combined with a cognitive examination.
7. Contraindications to MRI.
8. Refuse to draw blood.
9. Refuse to sign the informed consent at baseline.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| China Cognition and Aging Study | NCT03653156 | Entailment |
3,395 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which
has rapidly progressed.
- Are in good general health.
- Are sterile or use contraception (if a woman of child-bearing age).
- Are able to speak and understand English or Spanish.
Exclusion Criteria:
- Have had any previous reaction to prednisone, or history of psychiatric reaction to
corticosteroids.
- Have used corticosteroids for more than 30 days within the past 90 days. Patients who
have been off corticosteroids for at least 30 days may be eligible.
- Have any significant heart, lung, digestive, blood, or neurologic disorders.
- Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus,
active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease,
kidney failure, history of shingles, or known (other) autoimmune disease.
- Have had a positive test for HIV, hepatitis C or B.
- Have any type of middle ear disorder.
- Are breast-feeding or 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.
Subject must be at most 70 Years | Autoimmunity in Inner Ear Disease | NCT00000361 | Contradiction |
6,238 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Hospitalized patients with Positive COVID 19 test suffering from Fever, cough,
shortness of breath, chills, muscle pain, the new loss of taste or smell, vomiting or
diarrhea, and/or sore throat
Exclusion Criteria:
- Patients in critical cases who admitted to the ICU, bacterial pneumonia, and
respiratory distress grade III, IV, and patients on a mechanical ventilator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Photodynamic Therapy for the Treatment of COVID-19 | NCT04416113 | Contradiction |
295 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage
I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post
molar GTN or choriocarcinoma (as defined below); patients may have had a second
curettage but must still meet GTN criteria below:
- Post molar GTN
- For the purposes of this study, patients must have undergone evacuation of a
complete or partial hydatidiform mole and then meet the criteria for GTN
defined as:
- A < 10% decrease in the hCG level using as a reference the first value
in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml
minimum) OR
- A > 20% sustained rise in the hCG taking as a reference the first value
in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml
minimum) OR
- A persistently elevated hCG level a period of 6 months or more
following the initial curettage (> 50 mIU/ml minimum)
- Choriocarcinoma
- Histologically proven non-metastatic choriocarcinoma OR
- Histologically proven metastatic choriocarcinoma if the metastatic site(s)
is restricted to one (or more) of the following: vagina, parametrium, or
lung
- World Health Organization (WHO) risk score 0-6
- Patients must be willing to practice effective contraception for the duration of the
study
- White blood cell count (WBC) >= 3,000 cells/mcL
- Granulocytes >= 1,500/mcL
- Platelets >= 100,000/mcL
- Creatinine =< 2.0 mg/dcL
- Bilirubin =< 1.5 x institutional normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x
institutional normal
- Alkaline phosphatase =< 3 x institutional normal
- Patients who have met the pre-entry requirements
- Before enrolling a patient, the institution must verify the availability of an
adequate supply of methotrexate for a full course of therapy
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
- Patients who do not have GTN
- Patients with non-gestational choriocarcinoma
- Patients who have previously been treated with cytotoxic chemotherapy; however,
patients who received prior low-dose methotrexate for treatment of an ectopic
pregnancy will be eligible for this study
- Patients who have received prior pelvic radiation
- Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic
tumor (ETT)
- Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
- Patients whose circumstances at the time of study entry do not permit completion of
the study or required follow-up
- Patients who wish to breast-feed during treatment
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia | NCT01535053 | Contradiction |
6,755 | 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. Adult males age 18 or older.
2. Hemophilia A (FVIII activity 40% or less).
3. Overweight or obesity defined as a BMI of 25.0-29.9 and ≥ 30 mg/m2, respectively.
Exclusion Criteria:
1. Prior history of, or currently detectable, FVIII inhibitor defined as greater than or
equal to 0.6 Bethesda Units (BU); however, a subject with a past low-level
non-responding inhibitor defined as less than 5 BU, with no increase in titer
following FVIII exposure, and not detectable within 12 months of the study, despite
FVIII exposure during that period, will be allowed to enroll on study.
2. Allergy to FVIII products.
3. Current rFVIII requirements do not include at least a 72-hour period without rFVIII
administration.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Weight-based Dosing in Hemophilia A | NCT02586012 | Entailment |
1,583 | 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:
Children aged 4-17 years old Children with normal (3%-97%) height values for their age
Children with normal (3%-97%) weight values for their age Children with normal (5%-85%) BMI
value for their age Children of Caucasian ethnical origin A signed Informed Consent Form
that was obtained from at least one parent or legal guardian, prior to ultrasound study.
An assent from the child to perform the SonicBone's BA device measurement
Exclusion Criteria:
Children taking any medication that might change bone metabolism or mineralization within
the last year (glucocorticosteroids, sex steroids, oral contraceptives, anticonvulsants,
calcium and vitamin D in superphysiological doses) Children with suspected bone diseases,
metabolic diseases, chronic diseases or multiple fractures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 4 Years old.
Subject must be at most 17 Years | Ultrasound Evaluation of Bone Age in Healthy Children | NCT01980693 | Contradiction |
2,869 | 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. Clinical diagnosed and confirmed ALS patients, with regular follow up and oral form
riluzole at National Taiwan University or Shuang- Ho Hospital for more than 6 months.
2. Age ≧20 years old
Exclusion Criteria:
1. Patients who had already ventilator dependent, not regular followed up for more than 6
months or against medical advice, refuse to follow up at neurology department will be
excluded in this study.
2. Patients with now or previous usage of Tamoxifen
3. Patients with any contraindications of Tamoxifen usage
4. Patients with other internal medicine illiness
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 | Tamoxifen Treatment in Patients With Motor Neuron Disease | NCT02166944 | Entailment |
1,235 | 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:
- Patients presented with pleural effusion
- Patients who undergo thoracentesis and fluid analysis for diagnosis and management
Exclusion Criteria:
- Patients who refuse to be enrolled
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Longitudinal Follow up of Patients With Pleural Effusion | NCT04670562 | Entailment |
1,465 | 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:
Participation in this study is possible only if all of the inclusion criteria below are
satisfied.
1. Patients who provide written consent on the consent form for use of personal
information after listening to explanations regarding the purpose, method, etc. of
this study
2. Adult males and females aged 19 years or above
3. Patients who correspond to one of the following:
1. Patients who are planning to be treated with a combination drug containing fimasartan
and statins after being newly diagnosed with essential hypertension and primary
hypercholesterolemia
2. Patients who are planning to switch to a combination drug of fimasartan and statins,
among those who have been diagnosed with essential hypertension or primary
hypercholesterolemia and are receiving hypertension treatment that is containing an
ARB or dyslipidemia treatment that is containing a statin
3. Patients who are planning to switch to a combination drug of fimasartan and statins,
among those who have been diagnosed with essential hypertension and primary
hypercholesterolemia and are receiving hypertension treatment that is containing an
ARB and dyslipidemia treatment that is containing a statin 4. The following test
results available within 4 weeks prior to the enrollment date
- Total Cholesterol (TC)
- HDL-C ③ Triglyceride (TG) ④ LDL-C or LDL-C (Friedewald formula*)
- non-HDL-C (Total cholesterol - HDL-C (mg/dL)) *LDL-C = Total
cholesterol - HDL-C - (triglyceride/5) (mg/dL)
Exclusion Criteria:
Patients cannot participate in this study if any of the following exclusion criteria is
applicable.
1. Contraindication according to the drug labeling of the combination drug ingredients
(fimasartan, amlodipine) for hypertension containing fimasartan
2. Contraindication according to the drug labeling of statins (rosuvastatin,
atorvastatin)
3. Secondary hypertension or suspected secondary hypertension - Aortic coarctation,
hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma,
Cushing's syndrome, polycystic kidney disease, etc.
4. Secondary dyslipidemia or suspected secondary dyslipidemia
- Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome,
etc.
5. Patients currently hospitalized or scheduled to be hospitalized
6. If an investigational drug has been administered within 12 weeks of the enrollment
date, or if participation in another clinical study during this study participation
period is planned
7. Patients who are deemed ineligible for study participation at the discretion of the
investigators for other reasons
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| A Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia | NCT04554953 | Entailment |
5,010 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Subject has reviewed, signed and dated a written informed consent form and use of
protected health information [Health Insurance Portability and Accountability Act
(HIPAA) Authorization], including videotaping consent.
2. Subject is 18 or older.
3. Subject has a diagnosis of definite or probable essential tremor (ET) as defined by
the Tremor Investigational Group, with involvement of the hands and arms of at least 2
years duration, without present causes of enhanced physiologic tremor, no recent
exposure to tremorogenic drugs or drug withdrawal states, no direct or indirect trauma
to the nervous system within 3 months preceding the onset of tremor, and no historic
or clinical evidence of psychogenic tremor origin.
4. Tremor severity score of at least 2 in at least one upper extremity on the
Fahn-Tolosa-Marin Tremor Rating Scale, or at least 1.5 on the TETRAS scale.
5. Subject is taking the same dose of one to three anti-tremor medications for at least 4
weeks prior to screening, has an inadequate response to that/those medication(s), and,
barring any unforeseen circumstances, will continue for the duration of the study on
the same dose(s) of anti-tremor medication(s), OR Has failed at least one course of an
anti-tremor medication and cannot tolerate available anti-tremor medication(s), OR Is
naive to anti-tremor treatment and refuses to take available anti-tremor medications.
6. If a woman of childbearing potential:
A. Must be unable to become pregnant or use adequate birth control; B. Must be defined
as status post hysterectomy or tubal ligation, or 2 years post-menopausal, OR C.
Otherwise documented to be incapable of pregnancy, or have practiced one of the
following methods of contraception for at least two months prior to screening: 1)
hormonal contraceptives, 2) spermicide and barrier method, 3) intrauterine device, 4)
partner sterility, 5) abstinence, and have a negative pregnancy test during screening.
7. Subject is accessible by telephone.
8. Subject can comply with study visits, study drug compliance, and study procedures.
9. Subject is on stable doses of all other medications for at least 4 weeks prior to the
first baseline visit, and, barring any unforeseen circumstances, for the duration of
the study
-
Exclusion Criteria:
1. Subject's tremor is adequately controlled on a current treatment.
2. Subject is pregnant, plans to become pregnant during the study or within 2 months of
completing the study or who is presently lactating or breast-feeding.
3. Subject has other medical conditions that may cause or explain subject's tremor, such
as but not limited to, Parkinson's disease, hyperthyroidism, pheochromocytoma, head
trauma or cerebrovascular disease within 3 months prior to the onset of essential
tremor; multiple sclerosis, polyneuropathy or family history of Fragile X syndrome.
4. Subject taking medication(s) that might produce tremor or interfere with the
evaluation of tremor, such as but not limited to: CNS-stimulants, stimulant
decongestants, beta-agonist bronchodilators, lithium, amiodarone, metoclopramide,
theophylline, valproate, Irregular use ("as needed" or "prn") of benzodiazepines,
sleep medications or anxiolytics; (However, regular use of a benzodiazepine, sleep
medication or anxiolytic to improve sleep or performance is allowed as long as tremor
persists against the background of regular medication use)
5. Subject has had surgical intervention for their tremor in the past (e.g., ablative
thalamotomy or gamma knife thalamotomy), or has had a botulinum toxin injection in the
6 months prior to screening
6. Subject has used an experimental drug within the 4 weeks prior to screening (or within
5 half-lives, whichever is longer) for any reason, OR has used a device for the
treatment of essential tremor in the 4 weeks prior to screening, OR has ever used deep
brain stimulation for any reason
7. Subject cannot abstain from the use of the following drugs for the stated period of
time prior to a clinic visit: caffeine (8 hours) and alcohol (12 hours).
8. Subject cannot abstain from use of alcohol prior to driving vehicle or operating heavy
machinery.
9. Subject with a history in the last 2 years of alcohol or substance abuse (DSM 305); or
history of consuming more than 2 glasses of wine (or equivalent) per day in the last
28 days prior to screening.
10. Subject with a history of significant psychiatric disorder (e.g., mania, bipolar
depressive disorder, schizophrenia, schizoaffective disorder, or other major
psychiatric disorder), significant coagulation, immunologic, gastrointestinal,
respiratory, cardiovascular (e.g., uncontrolled hypertension, myocardial infarction in
the last 18 months, significant bundle branch block, congestive heart disease),
endocrine (e.g., uncontrolled diabetes, hyperthyroidism) disorder, or current or
chronic infection, significant Screening laboratory or ECG abnormalities, or any acute
or chronic illness or abnormality which in the opinion of the Investigator precludes
study participation. Subject with Right Bundle Branch Block, pacemakers, controlled
asthma or controlled hypertension and/or controlled diabetes (hemoglobin A1c < 8%) are
acceptable, as are subjects with thyroid disease, provided they are euthyroid on
treatment. Subject with single or recurrent episodes of major depressive disorder (DSM
IV 296.20 -.25 or 296.30-.35) that have been successfully managed with a stable dose
(over 60 days) of an antidepressant may be considered for entry.
11. Subject with liver disease that is more than mild. This is defined as transaminase
levels AST and ALT greater than 50% above normal.
12. Subject with severe renal disease, defined as having creatinine clearance less than 39
ml/min.
13. Subject has had a suicide attempt, suicidal ideation with intent, or history of
aggression, including but not restricted to violence or threat of violence, within the
past 2 years.
14. Subject with a recent history of hematologic/oncologic disorders (within 2 years),
other than successfully resolved cutaneous basal cell or squamous cell carcinomas.
Stability after treatment for prostate cancer is also acceptable.
15. Subject with clinically significant impaired balance or considered at increased risk
for falls.
16. Subject is taking phenytoin, carbamazepine, oxycarbazine, rifampin, St John's wart,
ketonazole or consuming grapefruit juice.
17. Subject with history of taking perampanel in the past. -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor | NCT02668146 | Entailment |
4,389 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | - INCLUSION CRITERIA:
- Participants must be at least 12 years old.
- Participants must have a clinically diagnosed craniofacial condition.
- Participants must be able to speak and write in English. However, if individuals have
trouble writing (i.e. dyslexia or dysgraphia), they can tape record their personal
reflections, which will be transcribed verbatim for analysis.
EXCLUSION CRITERIA:
- If the individual is younger than 12 years of age.
- If the individual does not speak English.
- If the individual has been photographed by Rick Guidotti or another professional
photographer in the past.
- If the individual has been video-interviewed by Diane McLean.
- If the individual has cognitive impairments that would preclude successfully
completing the various steps of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 20 Years | Positive Exposure: A Photography and Video Intervention for Individuals With Craniofacial Differences | NCT00340964 | Entailment |
1,098 | 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:
- first episode of syncope
Exclusion Criteria:
- previous episodes of syncope
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
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.
| Prevalence of Pulmonary Embolism in Patients With Syncope | NCT01797289 | Entailment |
3,105 | 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:
- Inclusion Criteria:
To enroll in the clinical study, potential subjects must:
1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring
contraception.
2. Be within the age range of 18 to 35 years old (inclusive) at enrollment.
3. In the opinion of the Investigator, be at low risk for both human immunodeficiency
virus (HIV) and sexually transmitted infections (STIs) based on review of high-risk
behaviors and exposures according to the Centers for Disease Control STI Guideline.
4. At the time of enrollment, have a single male sex partner for ≥3 months.
5. Have a negative urine pregnancy test at enrollment.
6. Have normal, cyclic menses with a usual length of 21 to 35 days over the last two
cycles or at least two consecutive spontaneous menses (21 to 35 days in length) since
delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy
prior to the date of consent. In addition:
1. If the subject recently discontinued breastfeeding, she must have demonstrated
return to regular cycling and have had at least three consecutive, spontaneous
menses post-lactation prior to the date of consent.
2. If the subject received prior administration of injectable contraceptives (e.g.,
depot-medroxyprogesterone acetate [DMPA], Depo Provera), there must be at least
10 months since the last injection and the subject must have had at least two
consecutive, spontaneous menses prior to the date of consent.
3. If a contraceptive implant was recently removed, the subject must have had at
least two consecutive, spontaneous menses prior to the date of consent.
4. If an intrauterine device (IUD) was recently removed, the subject must have had
at least one spontaneous menses following removal and prior to the date of
consent.
7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per
cycle.
8. Be willing to use the study drug as the only method of contraception over the course
of the study (with the exception of emergency contraception [EC] in the event a
subject engages in vaginal intercourse but believes that the study drug was not used
properly or she is at risk for pregnancy for any other reason).
9. Be capable of using the study drug properly and agree to comply with all study
directions and requirements, including retaining the wrappers and returning them to
the clinical site at the next study visit.
10. Be willing to keep a daily electronic diary (eDiary) to record coital information,
study drug use information, use of concomitant medications including other vaginal
products and other contraceptives, menses, and sign and symptom data for the subject
or as reported to her by her partner.
11. Agree not to participate in any other clinical studies during the course of the study.
12. Be capable and willing to give written informed consent to participate in the study.
Exclusion Criteria:
Exclusion Criteria:
To enroll in the clinical study, potential subjects must not:
1. Have had three or more urinary tract infections (UTIs) in the past year from the date
of consent.
2. Have a UTI by urine culture, chlamydia, gonorrhea, or symptomatic yeast vaginitis or
symptomatic bacterial vaginosis (BV) diagnosed by wet mount, or trichomoniasis, unless
treated and proof of cure is documented within the screening period.
3. Have used vaginal or systemic antibiotics or antifungals within 14 days prior to
enrollment, with the exception of vaginal or systemic antibiotics or antifungals
completed for the treatment of a UTI, BV, or yeast vaginitis diagnosed at screening
within seven days of the Enrollment Visit.
4. Have a history of any recurrent vaginal infections/disorders (either greater than or
equal to four times in the past year or greater than or equal to three times in the
previous six months from the date of consent).
5. Be pregnant, have a suspected pregnancy, or desire to become pregnant during the
course of the study.
6. Have a history of diagnosed infertility or of conditions that may lead to infertility,
without subsequent non-assisted reproductive technology intrauterine pregnancy.
7. Have any maternal contraindications to pregnancy (medical condition) or chronic use of
medications for which significant evidence of fetal risk exists.
8. Have known or screen test positive for HIV infection.
9. Have three or more outbreaks of genital herpes simplex virus (HSV) within the last
year from the date of consent or be receiving suppressive therapy.
10. Have visible genital condylomata (warts).
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal finding on physical examination including
pelvic examination or baseline laboratory assessments which in the opinion of the
Investigator, precludes study participation.
13. Have clinically significant signs of vaginal or cervical irritation on pelvic
examination.
14. Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical
procedures during the period of the study.
15. Have an abnormal Papanicolaou test (Pap test) based on the following criteria:
a. Pap test in the past 12 months from the date of screening with atypical squamous
cells of undetermined significance (ASC-US) unless at least one of the following
criteria is met: i. Less than 21 years of age. ii. A repeat Pap test at least six
months later was normal. iii. Reflex human papillomavirus (HPV) testing was performed
and was negative for high-risk HPV.
iv. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring
treatment or treatment was performed and follow up at least six months after the
treatment showed no evidence of disease.
b. Pap test in the past 12 months from the date of screening with low grade squamous
intraepithelial lesion (LSIL) unless at least one of the following criteria is met: i.
Less than 21 years of age. ii. A colposcopy (with or without biopsy) found no evidence
of dysplasia requiring treatment or treatment was performed and follow up at least six
months after the treatment showed no evidence of disease.
c. Pap test in the past 12 months from the date of screening with atypical squamous
cells in which high grade squamous intraepithelial lesion cannot be excluded (ASC-H),
atypical glandular cells, high grade squamous intraepithelial lesion (HSIL), or ≥30
years old who are cytology negative and HPV 16- or HPV 18-positive unless colposcopy
and/or treatment was performed and follow up at least six months after the colposcopy
and/or treatment showed no evidence of disease.
d. Pap test in the past 12 months with malignant cells.
16. Consume (on average) more than three drinks of an alcoholic beverage per day.
17. In the opinion of the Investigator, have a history of substance abuse in the last 12
months.
18. Have taken an investigational drug or used an investigational device within the past
30 days from the date of consent.
19. In the opinion of the Investigator, have issues or concerns that may compromise the
safety of the subject, impact the subject's compliance with the protocol requirements,
or confound the reliability of the data acquired.
20. Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in
research activities, or their close relative.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | AMP002 Phase III Contraceptive Study | NCT03243305 | Contradiction |
587 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy
-
Exclusion Criteria:
- orthostatic hypotension, contraindication to either mifepristone or misoprostol,
treatment during current pregnancy to provide surgical or medical evacuation of the
uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic
infection,known or suspected clotting defect or receiving anticoagulants,
cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current
participation in another clinical trial, prior participation in this trial, suspected
or confirmed endometrial AV malformation, clinical indication requiring the
karyotyping of products of conception
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Mifepristone and Misoprostol for Fetal Demise | NCT00177372 | Entailment |
2,115 | 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:
Couples with failure to conceive for at least 12 months and starting with EM or Couples
starting with 1st/ 2nd/3rd cycle of IUI (with/without ovarian stimulation) or Couples
starting with 1st/ 2nd/3rd cycle of IVF/ICSI
Furthermore:
- Male with age 18-50 years
- Female partner with age 18-43 years
- Willing and able to give informed consent
Exclusion Criteria:
- Planned or performed diagnostic testicular biopsy (TESE) or percutaneous epididymal
sperm aspiration (PESA)
- Use of donor-, cryopreserved- or electro-ejaculated semen
- Ovulation induction (OI) without IUI
- IVF for an absolute tubal factor
- Embryo-transfers after cryopreservation
- Embryo-transfer after pre-implantation genetic diagnosis
- Known genetic abnormalities related to infertility
- Known urological abnormality such as a varicocele or bilateral cryptorchism
- Use of other vitamin supplements
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | The Impact of a Nutritional Supplement (Impryl®) on Male Fertility | NCT03337360 | Contradiction |
2,352 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. For Non-ambulatory study, boys must be unable to walk without assistive devices for
greater than or equal to one year.
2. Age at onset of study for non-ambulatory boys and men: greater than or equal to 7
years through age 22 years.
3. Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with
biopsy/genetic confirmation in a primary relative.
Exclusion Criteria:
1. For Non-ambulatory study, the inability to understand and cooperate with the testing
would exclude a subject. -
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 22 Years | This is a Study to Get More Information About Non Ambulatory Boys & Men With Duchenne Muscular Dystrophy | NCT01098708 | Entailment |
3,041 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Twenty participants included with auditory hallucination:
- Boy or girl
- French
- Over six years old and under eighteen years old
- DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder,
attention deficit hyperactivity disorder, without schizophrenia diagnosis,
without mental retardation (Intelligence Quotient (IQ)>70),
- Parental and child consent, affiliated to social security.
- Twenty participants included without auditory hallucination:
- Boy or girl
- French,
- Over six years old and under eighteen years old
- DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder,
attention deficit hyperactivity disorder, without schizophrenia diagnosis,
without mental retardation (IQ>70)
- Parental and child consent, affiliated to social security.
Exclusion Criteria:
- schizophrenia diagnosis,
- neurologic, genetic or neurosensory disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 Years | The Physalis Child : Identification of Cognitive and Emotional Factors | NCT02567500 | Entailment |
5,206 | 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. Ambulatory, postmenopausal women aged 45 to 90 years inclusive at the time of entry
into the trial, whose last menstrual period or bilateral oophorectomy occurred at
least 5 years prior to entry into the trial. Women below the age of 55 years in whom a
bilateral oophorectomy cannot clearly be documented must have their postmenopausal
status confirmed by a serum FSH level greater or equal to 30 IU/L and serum estradiol
level lower or equal to 20 pg/ml or lower or equal to 73 pmol/L.
2. Free of severe or chronically disabling conditions other than osteoporosis.
3. Able to use a pen-type injection delivery system satisfactorily in the opinion of the
investigator and willing to be trained on and use the pen-injector on a daily basis.
4. Without language barrier, cooperative, expected to return for all follow-up
procedures, and have given informed consent after being informed of the risks,
medications, and procedures to be used in the study.
5. Posterior-anterior lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or
total hip BMD measurement at least 2.5 standard deviations (SD) below the average bone
mass for young women (T-score below or equal to -2.5 standard deviations). The lumbar
spine and hip BMD assessment and the determination of the patient's eligibility for
entry into the screening phase will be made by the individual investigator. Any lumbar
vertebra that cannot be analyzed due to artifacts, severe crush fracture, osteophytes,
or other abnormalities, should be excluded from the analysis. A minimum of two lumbar
vertebrae in the L-1 through L-4 region must be evaluable by DXA if this is the only
anatomical site where the BMD cut-off level less than -2.5 SD is demonstrated. A DXA
assessment performed within three months prior to Visit 1 may be acceptable for
patient's eligibility.
6. Normal or clinically insignificant abnormal laboratory values (as defined by the
investigator) including serum calcium, PTH(1 84), alkaline phosphatase.
EXCLUSION CRITERIA:
7. History of unresolved skeletal diseases that affect bone metabolism other than
postmenopausal osteoporosis including Paget's disease, renal osteodystrophy,
osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected),
and intestinal malabsorption.
8. In the opinion of the investigator, have any medical or anatomical condition that
potentially could put the patient at additional risk of an adverse event due to the
biopsy procedure (for example, coagulation abnormality, anticoagulant medication,
extreme obesity, etc).
9. Have undergone two previous iliac bone biopsies (one in each iliac crest). Patients
with one previous iliac bone biopsy are eligible provided that the new sample is
obtained from the contralateral iliac crest.
10. History of malignant neoplasms in the 5 years prior to Visit 1, with the exception of
superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been
definitively treated. Patients with carcinoma in situ of the uterine cervix treated
definitively more than 1 year prior to entry into the study may be randomized.
11. Increased baseline risk of osteosarcoma; this includes subjects with Paget's disease
of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic
irradiation, i.e. prior external beam or implant radiation therapy. As an elevation of
serum skeletal alkaline phosphatase activity may indicate the presence of Paget's
disease, an unexplained elevation of this enzyme activity will also be exclusionary.
12. Abnormal thyroid function not corrected by therapy. Normal thyroid function may be
documented by a normal TSH during the screening phase or a combination of clinical and
biochemical parameters which, in the judgment of the investigator and the Lilly
Clinical Research Physician, sufficiently establishes the presence of normal thyroid
function.
13. Active liver disease or clinical jaundice.
14. Significantly impaired renal function as defined by either of the following criteria:
- Serum creatinine that, in the opinion of the investigator, indicates significant
renal impairment.
- Measured or calculated endogenous creatinine clearance less than 30 mL/min using
the following Cockcroft Gault formula for creatinine clearance (ClCr) for women:
ClCr (mL/minute) = [[(140-age) x weight (kg)]x0.85] / [72 x serum Cr (mg/dL)]
15. Current or past treatment with any bisphosphonate, parathyroid hormone or its analogs,
androgens or other anabolic steroids or therapeutic doses of fluorides at any time
prior to Visit 2.
Past treatment (more than 12 months before Visit 2) with a selective estrogen receptor
modulator (SERM), nasal or injectable calcitonin, oral, transdermal, or injectable
estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists or
tibolone is allowed. Previous or current use of fluoridated water or topical dental
fluoride treatments are permitted.
16. Treatment with Vitamin D greater than 50,000 IU/week, or with any dose of calcitriol
or Vitamin D analogs or agonists in the 6 months prior to Visit 2.
17. Treatment with systemic corticosteroids in the last month prior to Visit 2 or for more
than 14 days in the 1 year prior to Visit 2. Ophthalmic, otic, topical, orally
inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used
without these restrictions. However, orally inhaled or nasally inhaled corticosteroids
in doses greater than 840 micrograms/day beclomethasone dipropionate or equivalent for
more than 14 days in the last year prior to randomization will be disqualifying.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 90 Years | Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial | NCT00239629 | Entailment |
1,475 | 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:
- Females of childbearing potential who are sexually active must agree to use adequate
contraception from screening throughout the duration of the study and for 30 days
following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors
but without type 1 or 2 diabetes.
- Is on a stable dose of simvastatin, either 20 or 40 mg, for at least 4 weeks prior to
Screening.
- Prior to Randomization, the participant has a mean low density lipoprotein cholesterol
level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2
consecutive samples.
- Prior to Randomization, the subject has mean triglyceride level greater than or equal
to 400 mg/dL for 2 consecutive samples.
- Is willing and able to comply with the recommended, standardized diet.
Exclusion Criteria:
- Has annine aminotransferase or aspartate aminotransferase level greater than 1.5 times
the upper limit of normal, identified during screening.
- Has a serum creatinine greater than 133 mmol/L, identified during screening.
- Has a creatine kinase greater than 3 times the upper limit of normal, identified
during screening.
- Has active liver disease or jaundice.
- Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol
uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study
completion or any fibrates for 6 weeks before Visit 1.
- Has a previous history of cancer that has been in remission for less than 5 years
prior to the first dose of study medication.
- Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or
inappropriately treated hypothyroidism affecting lipid metabolism.
- Has a history of myocardial infarction, angina pectoris, unstable angina, transient
ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal
aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or
multiple risk factors that confer a 10-year risk for cardiovascular heart disease
greater than 20% based on Framingham risk scoring.
- Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as
determined by medical history.
- Has a positive human immunodeficiency virus status or is taking antiretroviral
medications, as determined by medical history and/or subject's verbal report.
- Has received any investigational medication 30 days prior to screening, (for drugs
with a long half-life, within a period of less than 5 times the drug's half-life) or
is participating in an investigational study.
- Has received lapaquistat acetate in a previous clinical study or as a therapeutic
agent.
- Has a history or presence of clinically significant food allergy that would prevent
adherence to the specialized diet.
- Has a known heterozygous or homozygous familial hypercholesterolemia or known type III
hyperlipoproteinemia (familial dysbetalipoproteinemia).
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension
- Has had inflammatory bowel disease or any other malabsorption syndrome, or has had
gastric bypass or any other surgical procedure for weight loss.
- Has a history of drug abuse or a history of high alcohol intake within the previous 2
years.
- Has type 1 or 2 diabetes mellitus.
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.
| Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia. | NCT00256178 | Entailment |
1,441 | 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:
- Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper
abdominal pain, anemia (patients referred by their primary care physicians with a
diagnosis of low hemoglobin (< 10 G/DL, and or dyspepsia
Exclusion Criteria:
- Weight loss (Weight loss of > 10% of their mean body weight over last 6 months)
- Dysphagia
- Gastrointestinal bleeding
- Gastrointestinal malignancy
- Recent EGD (in the past 5 years)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Demographics and Findings of Upper Endoscopy Patients | NCT00576992 | Contradiction |
1,175 | 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:
Patients with pleural effusion, who has not been treated
Exclusion Criteria:
Patients with pleural effusion, who has already been treated
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Diagnosis and Mechanism of Pleural Effusion | NCT03997669 | Entailment |
6,532 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male subjects
- 12 to 62 years-of-age
- History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or
FIX
- 4 or more bleeding episodes in the last 6 months before enrollment.
Exclusion Criteria:
- Clinically relevant coagulation disorder other than congenital hemophilia A or B with
inhibitors
- History of coronary and/or peripheral atherosclerotic disease
- Disseminated intravascular coagulopathy, or stage 2 hypertension
- Angina pectoris
- Myocardial infarction
- Transient ischemic attack
- Stroke
- Congestive heart failure
- Thromboembolic event
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 62 Years | A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 | NCT01625390 | Contradiction |
1,212 | 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:
- Patients with symptomatic pleural effusion in whom the symptoms excepted to be
relieved by pleural fluid drainage.
- Presence of intrapleural adhesions as documented sonographically.
- Difficult thoracentesis.
- Failure of satisfactory pleural fluid drainage 24 hours following intercostal tube
(ICT) placement provided that the tube was properly positioned and not obstructed.
- Written consent, free and informed.
Exclusion Criteria: patients have contraindications for any of our procedures will be
excluded.
- Contraindications for streptokinase instillation i.e. (Previous allergic reaction,
bronchopleural fistula, trauma or surgery within 48 hrs, history of hemorrhagic
stroke, coagulation defects and previous streptokinase thrombolysis).
- Patients who are unfit for general anaesthesia.
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.
| Evaluating Different Modalities for Pleural Adhesiolysis at Assuit University Hospital | NCT03172052 | Entailment |
1,688 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1）Informed consent form signed; 2) To be able to complete the study; 3) Subjects (including
partners) are willing to take contraceptive measures; 4) 18-55 years of age; 5) Male
subjects are no less than 50 kg.Female subjects are no less than 45 kg. Body mass index is
18-28kg / m2; 6) Normal cardiac function, defined as left ventricular ejection fraction
(LVEF) ≥ 50%; 7) Physical examination and vital signs are normal.
Exclusion Criteria:
1. Cigarettes Smoking subjects.
2. Allergic constitution (multiple drugs and food allergies);
3. History of drug use and/or alcohol abuse;
4. Blood donation or massive blood loss (> 450 mL) within three months before screening;
5. Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine
within 14 days before screening;
6. Diet or exercise have changed recently;
7. Using study drugs within three months;
8. Risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
9. ECG abnormalities (QTc > 470ms for males, > 480ms for females);
10. Female subjects are in lactation. Pregnancy test is positive;
11. Other Clinical laboratory tests abnormalities;
12. Viral screening test is positive, including HBV, HCV, HIV, and Treponema pallidum;
13. Developing Acute disease;
14. Eating chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours
prior to the use of the study drug;
15. Taking any alcoholic products. Alcohol test is positive..
16. Drug test is positive. History of drug abuse or drug use in the past five years;
17. Inability for intravenous injection or blood collection;
18. Using biological products (including live vaccines) within the last 3 months. Planing
to use vaccines during the study period. Having received corticosteroid or human
plasma product system treatment within 1 month.
19. Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the
simplified MDRD formula);
20. History of glaucoma, eye disease.
21. History of cancer or other serious systemic diseases, especially heart, liver, kidney,
digestive tract, nervous system, metabolic abnormalities, immune abnormalities or
mental disorders;
22. History of immunodeficiency or hypofunction;
23. Received major surgery within 2 years.
24. Other subjects by investigator opinion..
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 | Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects. | NCT04641364 | Entailment |
1,925 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
• Histologically and/or cytologically documented, newly diagnosed cancers for the following
cohorts:
- Breast carcinomas
- Gastric carcinomas
- Renal carcinomas
- Prostate carcinomas
- Melanoma
- Lung carcinomas: NSCLC and SCLC
- Hepatocellular carcinomas
- Colorectal carcinomas
- Head and neck carcinomas
- Pancreatic carcinomas
- Ovarian adenocarcinomas
- Glioblastoma
- Endometrial adenocarcinomas
- Bladder carcinoma
- Superficial Oesophago-gastric carcinomas
- Diffuse Large B-cell Lymphomas
• Patient older than 18 years.
• Measured creatinine clearance > 30 mL/min or creatinine ≤ 1.5 x ULN
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN,
unless liver metastases are present, in which case they must be ≤ 5 x ULN. For the
hepatocellular carcinoma cohort, see details below
• Serum bilirubin ≤ 1.5 x ULN. For the hepatocellular carcinoma cohort, see details
below
• Patients who gave its written informed consent to participate to the study
• Patients affiliated to a social insurance regime
• Specific inclusion criteria for curative treatment strategy cancer patients:
- Indication of a treatment strategy with curative intent (surgery; radiotherapy;
chemotherapy; hormonotherapy; targeted agents…)
• Specific inclusion criteria for non-curative treatment strategy cancer patients:
- Indication of a treatment strategy with no curative intent (radiotherapy;
chemotherapy; hormonotherapy; immunotherapy; targeted agents …)
The following tumor type specific inclusion criteria must be met in addition to the
inclusion criteria listed above:
Breast carcinomas
- Invasive breast ductal carcinoma, or
- Invasive breast lobular carcinoma • Curative intent treatment patient cohort:
- Planned to be treated with neo-adjuvant and/or adjuvant chemotherapy, surgery
with/without anti-hormone treatment
Gastric carcinomas
- Intestinal-type adenocarcinoma, or
- Diffuse cell type adenocarcinoma • Curative intent treatment patient cohort:
- Planned to be treated with neo-adjuvant and/or adjuvant chemotherapy, and surgery
Renal carcinomas
- Any histology of renal cancer is accepted (non-clear cell renal cancer could be
included)
• Curative intent treatment patients cohort:
- Planned to be treated with partial or total nephrectomy
- A pathology proof of renal cell carcinoma is not necessary provided if patients
present typical radiologic characteristics of renal cancer on imaging
Prostate carcinomas
- Curative intent treatment patients cohort:
o Localized prostate cancer with high risk features : StageT2b or T3 and/or Gleason >=
4+3 and/or PSA >= 20 and/or N+
o Planned to be treated with radical prostatectomy or radiotherapy (potentially
associated with androgen deprivation therapy). Brachytherapy and/or focused
ultrasounds are not allowed.
- Non-curative intent treatment patients cohort:
- Patients with metastatic castration resistant prostate cancer (mCRPC) defined by
validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel
or second generation hormone (i.e. abiraterone or enzalutamide)
Melanoma
- Stage I-IV melanoma, including ocular and mucosal melanoma
• Curative intent treatment patients cohort:
- Planned to be treated with surgery with/without adjuvant treatment
Lung carcinomas: NSCLC and SCLC
- Cytologically or histologically confirmed NSCLC (all subtypes) or SCLC. • Curative
intent treatment patients cohort:
- NSCLC histology only
- Stage I-II according to 8th TNM classification
- Stage IIIA-B according to 8th TNM classification
- Histological/cytological diagnosis before curative surgery.
- Planned to be treated with radical treatment (surgery and/radiotherapy with/without
concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant
treatment • Non-curative intent patients cohort:
- NSCLC stage IV according to 8th TNM classification
- SCLC stage IV according to 8th TNM classification
Hepatocellular carcinomas
- Aspartate aminotransferase / ASAT and Alanine aminotransferase / ALAT levels are
accepted up to ≤ 5 x ULN
- Serum bilirubin ≤ 50 µM/L
- Absence or chronic hepatic encephalopathy, absence of refractory ascites, prothrombin
rate ≥40% (or factor V ≥ 40% in case of antivitamin K therapy, albuminemia ≥ 25 g/L).
• Curative intent treatment patients cohort:
- Indication of a treatment strategy with curative intent, except liver transplantation:
surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm)
or multibipolar radiofrequency if nodule ≤4 cm).
• Non-curative intent patients cohort:
- Indication of a treatment strategy with no curative intent: transarterial
intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or
monoclonal antibodies) or immune therapy.
Colorectal carcinomas • Curative intent treatment patients cohort:
o Lieberkühn adenocarcinoma associated with metastases planned to be treated with
peri-operative chemotherapy +/- targeted agent and interval surgery
Head and neck carcinomas
- Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx,
larynx
• Curative intent treatment patients cohort:
- Planned to be treated with a radical treatment (surgery and/or radiotherapy
potentially associated with concurrent chemotherapy) with/without
neo-adjuvant/adjuvant chemotherapy.
Pancreatic carcinomas • Curative intent patients cohort:
o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery followed by
adjuvant chemotherapy
Ovarian adenocarcinomas • Curative intent patients cohort:
- High grade epithelial adenocarcinomas
- No indication of primary cytoreductive surgery due to disease extend
- Planned to be treated with neo-adjuvant chemotherapy followed by interval debulking
surgery
Glioblastoma
- Curative intent patients cohort:
- Planned to be treated with surgical resection, followed by adjuvant temozolomide
and radiotherapy
Endometrial adenocarcinomas • Non-curative intent patients cohort:
- Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell,
undifferentiated carcinoma and carcinosarcoma) cancers
- Planned to be treated with non-curative systemic treatment for metastatic or advanced
disease
Bladder carcinoma
- Transitional cell carcinoma • Curative intent treatment patients:
- Patients with localized muscle invasive bladder cancer (>=PT2)
- Planned to be treated with neo-adjuvant cisplatin based chemotherapy (MVAC or dd-MVAC)
Superficial Oesophago-gastric carcinomas
- Curative intent patients cohort:
- Superficial oesophago-gastric carcinomas of Stage T1 planned to be treated by
endoscopic surgery
Diffuse Large B-Cell Lymphoma (DLBCL) • Curative intent patients cohort: o Patients planned
to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin,
Prednisone)
Exclusion Criteria:
Specific non-inclusion criteria for curative treatment strategy cancer patients:
- previous therapies for cancer for ≤ 5 years.
- history of previous cancers, except for adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer of the cervix, treated and with no evidence of
disease for ≥ 5 years
Specific non-inclusion criteria for non-curative treatment strategy cancer patients:
- history of previous cancers for ≤ 5 years, except for relapse of the current cancer
after curative-intent treatment strategy
- Previous therapies for cancer in metastatic setting.
Tumor type specific non-inclusion criteria:
Breast carcinoma:
• non adenocarcinoma tumor
Gastric carcinoma:
• non adenocarcinoma tumor
Melanoma:
• Melanoma in situ.
Lung carcinoma:
- SCLC for curative-intent cohort
- Stage IV NSCLC with EGFR activating mutation, BRAF V600E mutation, ALK or ROS1 fusion.
Hepatocellular carcinoma:
- Fibro-lamellar hepatocellular carcinoma.
- Mixed cholangio-carcinoma.
- Patients listed for liver transplantation.
Colorectal carcinoma:
• non adenocarcinoma tumor
Head and neck carcinoma:
• Carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell
carcinoma of the skin or salivary gland, or non-squamous histology.
Pancreatic carcinoma:
• non adenocarcinoma tumor
Ovarian adenocarcinoma:
- borderline tumors
- Germ cell tumors
- Carcinosarcoma, sex cord stromal tumors, clear-cells carcinomas
- Low-grade carcinomas
Glioblastoma:
- Unresectable glioblastoma,
- Patient ineligible to post-operative temozolomide radiochemotherapy
Endometrial adenocarcinoma:
• Non adenocarcinoma tumor
Superficial Oesophago-gastric carcinoma:
• non adenocarcinoma tumor
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.
| Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients | NCT03787056 | Entailment |
1,907 | 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. provision of written informed consent;
2. male or female; and aged ≥ 18 years;
3. Histologically verified, untreated, metastatic or locally advanced inoperable
adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal
junction;
4. At least one radiographically documented measurable lesion according to Response
Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life
expectancy ≥ 3months;
6. No previous palliative chemotherapy;
7. Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils
(ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is
permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL),
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the
UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL,
normal electrocardiography (ECG).
Exclusion Criteria:
1. pregnant or lactating patients, or reproductive women without effective contraception;
2. Patients with only non-measurable disease: small lesions (longest diameter < 10mm or
pathological lymph nodes with ≥ 10 to < 15mm short axis), Bone lesions, leptomeningeal
disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or
lung; abdominal masses/abdominal organomegaly identified by physical exam that is not
measurable by reproducible imaging techniques.
3. Symptomatic of brain metastasis;
4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension,
heart disease, or chronic active hepatitis (HBV carrier can be enrolled if
circumstance permits );
5. No previous radiotherapy for measurable lesions.
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.
| Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma | NCT02370849 | Entailment |
5,702 | 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:
- girl with Turner syndrome
- prepubertal, Tanner stage I breast
- height velocity less than 6 cm/year and height less than or equal to the tenth
percentile for sex and age in general population
- at least 6 months (preferably 12 months) of accurate height measurements available for
calculation of pre-study height velocity
- if thyroxine deficient, to have received replacement therapy, and for six months prior
to enrollment have had normal thyroid function tests
Exclusion Criteria:
- prior treatment with growth hormone
- presence of a Y component in karyotype with gonads in situ
- diabetes mellitus
Female
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 13 Years | Somatropin Treatment to Final Height in Turner Syndrome | NCT00191113 | Entailment |
6,521 | 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:
- Diagnosed as congenital hemophilia A or B, and meet the following conditions: a. FⅧ<1%
or FIX activity<2%; b. FⅧ inhibitor or FⅨ inhibitor titer in the screening period>5 BU
(Nijmegen modified Bethesda method of detection).
- Age ≥18 and ≤75 years, male or female.
- No other drugs for the treatment of hemophilia have been used within 48 hours (2 days)
before administration, including prothrombin complex and any FVII products,
cryoprecipitate, fresh plasma and whole blood, etc.
- No obvious bleeding symptoms during PK medication (no active bleeding).
- Subjects of childbearing age agree to take effective contraceptive measures throughout
the trial period, and continue to 28 days after the last medication.
- Volunteer to participate in this study, sign an informed consent form, have good
compliance, and be able to cooperate with the experimental observation.
Exclusion Criteria:
- Any other bleeding disease except Congenital hemophilia A or B.
- Patients with any previous medical history or symptoms of arterial or venous
thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic
stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension
embolism) or disseminated intravascular coagulation (DIC).
- Baseline and previous values of FⅦ inhibitor or rFVIIa inhibitor is positive.
- Vitamin K deficiency.
- Human immunodeficiency virus (HIV) positive and cluster of differentiation 4 (CD4)
count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml.
- Subjects plan to perform elective surgery during the trial period.
- Those who are allergic to test drugs or any excipients.
- Severe anemia and need blood transfusion.
- Platelet count <80×10^9/L.
- Obvious liver or kidney damage: ALT or AST>2.5×ULN, or total bilirubin>1.5×ULN or
serum creatinine>1.5×ULN.
- Have a history of cardiac surgery and need anticoagulation therapy; severe heart
disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the
current New York Heart Association cardiac function grade II-IV.
- Hypertension that cannot be controlled with drug treatment: systolic blood pressure>
150 mmHg or diastolic blood pressure> 90 mmHg.
- Participated in other clinical studies (except FVIIa, FⅧ and FⅨ trials) within one
month before the first medication.
- Diagnosed with hereditary diseases such as fructose intolerance, glucose malabsorption
or sucrose-maltase deficiency.
- Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases,
greater abnormal laboratory values, and those who are considered unsuitable by the
researcher.
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 | Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia. | NCT04768699 | Contradiction |
2,775 | 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 may take part in this study if the answer is YES to all of these questions:
- Female or male between 17-65 years of age
- Going to have one of the following surgeries:
- umbilical hernia repair
- inguinal hernia repair
- small incisional or abdominal wall hernia repair
- laparoscopic cholecystectomy (gallbladder removed)
- Going home after their surgery the same day
- Have signed consent form.
Exclusion Criteria:
Patients have had or have:
- Been diagnosed with peptic ulcer disease or bleeding stomach ulcer in the recent past
and are not currently on a proton pump inhibitor (special antacid medication, eg.
Losec®, Pantoloc®, Prevacid®, Nexium®).
- Suffered from asthma
- Allergies to codeine, non-steroidal anti-inflammatory drugs (Advil®, Ibuprofen),
aspirin, or acetaminophen
- Been taking other prescription pain medications prior to their surgery
- A history of chronic pain disorder
- Fibromyalgia (a chronic pain illness with symptoms of muscle aches, pain, stiffness,
general fatigue and sleep problems)
- Active kidney disease or failure
- Known liver disease
- Are females who are pregnant or nursing
- A problem with alcohol or drug abuse.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
Subject must be at most 65 Years | A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery | NCT00245375 | Entailment |
3,379 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Subject must fail a hearing screening (any threshold >34 decibels hearing level at
2000 or 3000 Hertz in either ear) or show equivalent or greater degree of hearing loss
on most recent audiogram.
- Free of obvious outer or middle ear disease (as measured by otoscopy)
- Between the ages of 45 and 85
- Pass a health literacy screening
- Pass a thinking skills screening
Exclusion Criteria:
- Experience seeing an audiologist for a hearing evaluation or management
- Experience using a hearing aid
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 85 Years | Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening | NCT04122183 | Contradiction |
3,905 | 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:
- Age from 40 to 85 years; of either sex
- Primary femorotibial osteoarthritis according to American College of Rheumatology
(ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray
criteria in the target knee at screening
- Pain score in the target knee and/or the need for regular symptomatic treatment of
knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory
drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or
tramadol on most days in the previous month (that is, more than half of the days in
the previous month)
- A history of pain due to Osteoarthritis in the target knee for at least 6 months
- A protocol-specified pain score for the target knee in response to Question 1 of the
WOMAC pain index ("how much pain have you had [in the target knee, over the past 48
hours] when walking on a flat surface?") after washout of at least 5 half-lives of
analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids,
and/or tramadol
- Women of childbearing potential must use a form of contraception with a failure rate
of less than 1 percent per year throughout the trial
Exclusion Criteria:
- Malalignment of greater than 5 degrees in the femorotibial axis of the target knee
- Clinical signs of inflammation (redness) in the target knee
- Intra-articular administration of corticosteroids or hyaluronic acid into either knee
within 6 months before Screening
- Planned knee surgery (affecting either the target or the contralateral knee) within
the next two years
- Concomitant conditions or treatments deemed to be incompatible with trial
participation
- Any contraindication to MRI according to MRI guidelines, including the inability to
undergo a knee MRI exam because of inability to fit in the scanner or knee coil
- Pregnancy or breastfeeding
- Participation in another clinical trial within the 30 days (or 5 half-lives of the
investigated compound, whichever is longer) before screening
- Legal incapacity or limited legal capacity
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee | NCT01919164 | Entailment |
4,866 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Patients with endogenous Cushing's syndrome:
- Cushing disease patients with persistent or recurrent disease (after pituitary
surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to
defer surgery;
- Patients with ectopic ACTH syndrome (either occult, after surgery failure, or
inoperable or metastatic);
- Patients with Cushing's syndrome from adrenal causes
Exclusion Criteria:
1. Pseudo Cushing's syndrome
2. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least
three 24-hour urinary sampling measurements over the previous 2 months
3. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small
cell lung carcinoma
4. Life expectancy less than 3 months
5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting
ectopic tumor or bilateral adrenalectomy planned before the week 12 visit
6. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)
7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less
than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI
for patients with Cushing's disease
8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy
(for otherwise eligible patients, blood pressure medication may be adjusted to meet
this criterion)
9. Severe hypokalemia (< 2.5 mmol/L) despite corrective measures
10. White blood cell counts <3 x 109 /L; hemoglobin <10 g/dL; platelets <100 x 109 /L
11. Any other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that in the judgment of the investigator, would present excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into this
study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome | NCT02297945 | Entailment |
3,097 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Male, non-smoking patients between 18 and 35 years of age (both inclusive).
- Patients with fmr1 full mutation (> 200 CGG repeats)
- Patients with a Clinical Global Impression Severity Score (CGI-S) of > 4 (moderately
ill)
- Patients with a score of >20 in the ABC-C scale (at screening)
- Patients with a mental age of ≥ 48 months as measured by the Stanford-Binet test
Exclusion Criteria:
- Patients with DSM-IV diagnosis of schizophrenia, history and/or presence of psychosis,
confusional states and/or repeated hallucinations.
- Patients with a history of seizures in the past 5 years without any therapeutic
treatment controlling the disorders.
- Patients under stable anti-convulsant therapies that experienced seizures in the 2
years prior to randomization
- Patients with ECG abnormalities, autonomic dysfunctions, bronchospastic diseases, drug
or atopic allergy
- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of drugs
- Patients using (or have used within four weeks before randomization) concomitant
medications that are potent inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, etc.)
Other protocol-defined inclusion/exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients | NCT00718341 | Entailment |
3,742 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
Patients aged ≥ 40 years with symptoms of knee osteoarthritis
Exclusion Criteria:
rheumatoid arthritis, spondyloarthropathy
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 62 Years | Strontium Ranelate and KOA | NCT03937518 | Contradiction |
2,924 | 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. | Main inclusion criteria include:
- Patients diagnosed with laboratory supported probable, clinically probable or definite
ALS according to the World Federation of Neurology Revised El Escorial criteria
- Patient with a familial or sporadic ALS
- ALS disease duration from diagnosis no longer than 24 months at the screening visit
- Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days
prior to the baseline visit
- Patient with an ALSFRS-R score progression between onset of the disease and screening
of > 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a
12-week run-in period between screening and randomization.
- Patient with a score, at screening, of at least 26 overall, including a score of at
least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component
items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R
individual component items
Main exclusion criteria include:
- Patient with dementia or significant neurological, psychiatric, systemic or organic
disease, uncontrolled or that may interfere with the conduct of the trial or its
results
- Patient with a FVC < 60% predicted normal value for gender, height, and age at
screening and baseline
- Pregnant, or nursing female patient
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 81 Years | Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients | NCT03127267 | Entailment |
1,281 | 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:
- Patients with an MPE (i.e. one in which malignant cells are identified in the pleural
fluid or pleural biopsy); or a large exudative pleural effusion without other causes
in a patient with known disseminated extra-thoracic malignancy
Exclusion Criteria:
- Patients with Age <18 years; pleural infection; pregnant or lactating; inability to
consent or comply with the protocol; anticipated pleural drainage procedure within one
week subsequent to recruitment.
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.
| Activity Behaviours in Patients With Malignant Pleural Effusion | NCT03482570 | Entailment |
5,704 | 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:
- Are regularly enrolled in municipal schools in the city of Petrolina-Pernambuco;
- They are classified as overweight or obese according to the criteria used by the
researchers;
- Do not present restrictions to the practice of physical activities;
- Do not use medications that may interfere with your search results.
Exclusion Criteria:
- That they refuse to participate at some point in the data collection;
- That they have some restriction to the practices developed in the research, acquired
during the course of the study;
- That they present a number greater than 50% of absences in the proposed activities;
- That parents or guardians miss four meetings or more.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 9 Years | Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren | NCT03041142 | Entailment |
4,521 | 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 dysmenorrhea as defined as cramping pain during every menstrual cycle
- Age: 18 to 25 years
- Up to now no prior history of a gynecological disease that could be a reason for
dysmenorrhea
- Women with menstruation in the last six weeks and a duration of menstruation cycles
between 3 and 6 weeks
- Women with moderate and severe pain defined as a score equal or higher than 6 on the
numeric rating scale for the worst pain intensity during the last menstruation.
- Written and oral informed consent
- Women must be able to complete the baseline questionnaire in paper form, the
electronic questionnaire via App and a electronic diary via App.
- Presence of a Smartphone and agreement to do data entry through the App
Exclusion Criteria:
- Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in
the next 8 months
- Known or planned pregnancy in the next 8 months.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 25 Years | Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone | NCT01582724 | Contradiction |
2,071 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:1) Infants and young children (age <= 3 months to < 5 years) and either
2) or 3) below.
2) Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia,
bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a
pediatric pulmonologist at LPCH.
3) Oncology condition (e.g. young children with or without cancer, who are being screened
for lung metastasis) and are being followed by pediatric oncologists at LPCH.
4) For minors, informed consent by parent or legal guardian.
5) Ability to comply with study visit procedures as judged by the investigator. Exclusion
Criteria:1) Acute wheezing and/or respiratory distress at Study visit.
2) Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or
respiratory rate with onset in 1 week preceding Study visit.
3) Oxygen saturation < 90% on room air at study visit.
4) Any medical condition that in the opinion of the investigator precludes subject
participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 5 Years | Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing | NCT01158495 | Entailment |
5,234 | 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:
- Osteoporotic patients aged 18-80 years old, inclusive.
- Diagnosed Osteoporotic vertebral compression fracture(s) in at least one vertebra
caused by an atraumatic event or a minimal traumatic event such as falling from
standing height or less, or by other minimal trauma besides a fall (see section 4.2
Table I for definitions), and visible by either X-ray radiography, CT or MRI.
- At least six (6) weeks and no more than six (6) months from the onset of severe back
pain suspected to be caused by the OVCF.
- Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).
- Subjects able to adhere to the visit schedule and protocol requirements and be
available to complete the study.
- Subject that had signed the ICF.
Exclusion Criteria:
- More than six (6) months from the onset of severe back pain suspected to be caused by
OVCF.Subjects after vertebroplasty or kyphoplasty.
- Hypercalcemic subjects (calcium > 10.50 mg/dL).
- Subjects with renal diseases.
- Subjects with active malignancy or other active metabolic bone disease which is not
osteoporosis.
- Subjects with cognitive impairments.
- Pregnant or breastfeeding women.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures | NCT01482858 | Entailment |
3,786 | 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. Patients ≥40 and ≤ 80years of age.
2. Patients who meet the American College of Rheumatology clinical plus radiographic
classification criteria for idiopathic osteoarthritis of the knee, which are defined
as follow:
a patient who had knee pain and radiographically diagnosed osteophytes and met at
least one of the followings.
- Age> 50 years.
- Morning stiffness for less than 30 minutes.
- Crepitus during movement of the weight-bearing knee.
3. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3
months prior to screening.
4. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2
inhibitor for the treatment of arthritis of the knee for at least 5 days a week during
4 weeks prior to screening.
5. Patients who had a score of 100mm pain VAS ≤80 mm at screening.
6. Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
7. Patients should be able and willing to provide the written informed consent.
Exclusion Criteria:
1. Patients with a history of surgery or arthroscopy of the study joint within the
previous 6 months.
2. Patients with trauma of study joint within the previous 12 months.
3. Patients with symptomatic hip osteoarthritis, other condition that would interfere
with study assessments.
4. Patients with any other type of arthritis, active malignancies or any active GI,
cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
5. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory
drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
6. Patients with uncontrollable hypertension.
7. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate
aminotransferase > 1.5 times the Upper Lange of normal at screening.
8. Patients with a history of drug or alcohol abuse.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients | NCT01576419 | Entailment |
196 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male with primary or secondary hypogonadism at least 18 years of age and for study
part C2 weighs ≥143.3 lb (≥65 kg)
- Morning screening serum testosterone concentration <300 ng/dL
Exclusion Criteria:
- American Urological Association (AUA) Symptom Score ≥15 or significant prostatic
symptoms
- History of carcinoma, tumors or induration of the prostate or the male mammary gland
including suspicion thereof
- Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the
prostate (size >75 cm3 as measured by transrectal ultrasonography)
- Past or present liver tumors or acute or chronic hepatic disease with impairment of
liver function; liver function tests (alanine aminotransferase [ALT], aspartate
aminotransferase [AST]) exceeding 1.5 times upper limit of normal
- History of deep vein thrombosis in the past 5 years or any history of cerebrovascular
accident
- Severe acne
- Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm
Hg) or coronary heart disease not stabilized by therapy as assessed by the
investigator
- Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes
mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C)
level is >9%
- Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7
days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit
and throughout the study (exclusive of administered study drug)
- Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by
any application method within the 28 days prior to first administration of study drug
and throughout the study (exclusive of administrated study drug)
- Medication with substances which might interfere with testosterone metabolism within
28 days before the first administration of study drug
- History of sleep apnea Insulin-dependent diabetes mellitus
- Use of steroidal anabolic drugs or supplements by any application method within the
28-days prior to the first administration of the study drug and throughout the study
(exclusive of the administered study drug)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men | NCT00467870 | Entailment |
524 | 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:
- subject is capable of reading, understanding and complying with the protocol and has
signed the informed consent document prior to undergoing any study related procedures;
- subject is male or female and is 18 (at the time of consent) to 65 years of age,
inclusive (subjects are required to meet the latter age limits by the time of first
dosing);
- subject, if female, must be non-lactating, and have a negative serum pregnancy test
result during the Pretreatment Period. Women of child-bearing potential must be
willing to stay in the clinic from Day -10 until the end of the dosing period to
confirm non-pregnant status.
- subject, if female, must be surgically sterile (must be documented); post-menopausal
(defined as at least 2 years without menses with screening FSH in expected range) or
must be using acceptable methods of non-hormonal contraception (Mirena is acceptable).
For this study, estrogen-containing contraceptives are not acceptable. Postmenopausal
women must not have had any vaginal spotting or bleeding in the past year;
- subject has not had any hormonal agents or devices within 4 weeks prior to enrollment
(Mirena is acceptable. n.b. Mirena can cause irregular menstrual cycles; however, this
would not be exclusionary for the purposes of this protocol);
- subject, if a woman of child-bearing potential, must have had two consecutive normal
menstrual cycles immediately prior to enrollment;
- subject must be in good health as determined by a physician (i.e., via medical history
at the Pretreatment Screening Period, physical examination and screening laboratory
results at the Pretreatment Screening and Baseline Periods);
- subject must weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30,
inclusive, at Pretreatment Screening Period;
- subject must have had normal clinical laboratory test results or, if abnormal, the
clinical laboratory tests are not clinically significant in the Investigator's
opinion, during the Pretreatment Periods;
- subject must have negative drug and alcohol toxicology screens during the Pretreatment
Screening Period; and
- subject must have negative HIV antibody and hepatitis panel screening results during
the Pretreatment Screening Period.
- For men over 44 years of age, Prostate Specific Antigen (PSA) is less than or equal to
2.0 ng/mL;
- For women over 44 years of age, mammography (within 3 months prior to Day 1) and
pelvic ultrasound, with results showing no significant abnormality in the opinion of
the Investigator, and specifically no suggestion of breast or endometrial neoplasm;
- subject must have Protein C and Protein S activity levels above the lower limit of
normal;
- subject must have a negative test for Factor V Leiden.
Exclusion Criteria:
- subject has a history of any chronic condition of clinical significance, in the
Investigator's opinion, that would preclude participation in the study (e.g. any
clinically significant cardiovascular, hepatic, renal, or gastrointestinal
abnormality);
- subject has a total bilirubin level greater than 0.9 mg/dL, a conjugated bilirubin
greater than 0.4 mg/dL or an unconjugated bilirubin greater than 0.8 mg/dL at
Screening; Fasting cholesterol level at screening is greater than 280 mg/dL; Fasting
triglyceride level at screening is greater than 1.5 x the upper limit of normal;
- subject has any history of thromboembolic events or estrogen-dependent benign or
malignant neoplasm;
- subject has resting systolic blood pressure >140 mm Hg or <90 mm Hg, or diastolic
blood pressure >90 mm Hg or <60 mm Hg during the Pretreatment Screening Period;
- subject has a resting pulse >100 beats/minute or <45 beats/minute during the
Pretreatment Screening Period;
- subject does not have a normal 12-lead electrocardiogram (ECG) during the Pretreatment
Screening Period, or, if abnormal, the ECG is clinically significant in the opinion of
the Investigator;
- subject is unwilling to comply with study rules, including attempting to void at
specified times (prior to ECG time points) or maintain quiet, undistracted, awake,
motionless supine posture during specified time points or exhibits anxious, excitable,
hostile, or emotionally reactive affect;
- subject cannot tolerate a controlled, quiet study conduct environment, including
avoidance during specified time points of music, TV, movies, games and activities that
may cause excitement, emotional tension or arousal;
- subject has a history of sudden cardiac death in the immediate family, or a personal
history of cardiac disease, treated hypertension, congestive heart failure, or
unexplained syncope;
- subject has a previous history of cancer, other than basal cell carcinoma or stage 1
squamous cell carcinoma that has not been successfully treated;
- subject has taken any prescription or over-the-counter medication within 1 week prior
to the Pretreatment Baseline Period (Day -1), or anticipates the need for any
medication during the course of the study;
- subject has a history of intolerance to estrogen medication;
- subject has a history of substance abuse, drug addiction, or alcoholism within 3 years
prior to the Pretreatment Baseline Period. (According to the DSM IV, alcohol abuse is
defined as average consumption of more than 4 alcoholic drinks per day.);
- subject anticipates an inability to abstain from alcohol, caffeine or Yerba mate tea,
or from grapefruit, grapefruit juice, or flavonoid-rich foods from 48 hours prior to
the administration of study medication and throughout the duration of the study. Coca
tea and mate de coca are not allowed within 1 week prior to Screening;
- subject has a history of smoking or any use of a tobacco product within 6 months prior
to the Pretreatment Baseline Period;
- subject has donated blood or blood products within 30 days prior to the Pretreatment
Baseline Period;
- subject is mentally unstable or is incapable of being compliant with the protocol;
- subject has received an investigational test substance within 60 days prior to the
administration of investigational test article, or anticipates receiving any
investigational test substance other than S-equol during the course of this study; or
- subject has been previously enrolled in this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers | NCT00998920 | Contradiction |
4,201 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male and female subjects in generally good health in the opinion of the investigator
as determined by vital signs, medical history, and a targeted physical exam based on
medical history.
- Subjects must be able to verbalize understanding of the consent form, provide written
informed consent and verbalize willingness to complete study procedures
- Be 18 to 65 years of age (inclusive), in the past 12 months.
- Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater
than 35.
- No recent history of smoking in the past two years regardless of clinical relevance.
- No history of alcoholism or alcohol abuse regardless of clinical relevance.
- Electrocardiogram (ECG) with no clinically significant abnormalities recorded at
screening visit: PR interval within 120 and 200 ms, QRS interval < 120 ms, and QTc
interval ≤ 440 ms.
- Blood pressure within normal limits (systolic 90-140mmHg; diastolic 50-90 mmHg) and
heart rate between 45 and 100 beats per minute.
- Chest X-ray and FEV1 results show no clinically significant abnormalities.
- Negative HIV, HBV, and HCV screening tests.
- Hemoglobin within provided range (see Appendix 2).
- White blood cell count and platelet count within provided range (see Appendix 2).
- Alkaline phosphatase (ALKP), total bilirubin, alanine aminotransferase (ALT),
aspartate aminotransferase (AST), creatinine phosphokinase (CPK), within provided
range (see Appendix 2).
- Serum glucose within provided range (see Appendix 2). If non-fasting glucose is
abnormal, a fasting glucose measurement may be measured in its place. If this is
within the provided range, then subject may be enrolled.
- Serum creatinine within provided range (see Appendix 2).
- Activated partial thromboplastin time (APTT), Fibrinogen within provided range (see
Appendix 2).
- Urine glucose, protein, and hemoglobin tested by dipstick urinalysis are negative or
not greater than trace. Menstruating females failing inclusion due to positive urine
dipstick hemoglobin may be retested following cessation of menses.
- Female subjects must be post-menopausal (one year or greater without menses),
surgically incapable of childbearing, or practicing an acceptable method of birth
control. Acceptable methods may include intrauterine device, spermicide and barrier,
abstinence and hormonal contraception. A female subject must agree to practice an
acceptable method of birth control during study period and for 12 weeks after study
terminates. She must have had a negative serum pregnancy test during the screening
visit and a negative urine pregnancy test on the day of treatment prior to study drug
dosing.
- If male, agrees to use medically accepted form of contraception from time of
enrollment to 12 weeks after study termination
- Subjects must test negative for drugs and alcohol
Exclusion Criteria:
- Have received any investigational drug or vaccine within 8 weeks prior to study drug
dosing or have had a serious adverse reaction or hypersensitivity to any drug
- Have received blood products within 6 months of study enrollment
- Have been on a liquid protein diet in the last month.
- Are allergic or intolerant to lactose.
- Have sickle cell disease
- Have used prescription drugs, excluding hormonal contraception, within 7 days prior to
admission (at the investigator's discretion) or non-prescription drugs (including
herbal supplements) within 7 days prior to admission (at the investigator's
discretion).
- Existence of any surgical, medical,or laboratory condition that, in the judgment of
the clinical investigator, might interfere with the safety, distribution, metabolism
or excretion of the drug
- Subjects with concurrent respiratory diseases (e.g., asthma, allergic rhinitis,
chronic obstructive pulmonary disease, cystic fibrosis, or emphysema, anaphylaxis).
- Subjects who have experienced a previous episode of acute upper respiratory tract
infection, pneumonia, otitis, bronchitis, or sinusitis within 2 weeks prior to
screening.
- Subjects with concurrent sustained respiratory symptoms (running nose, sore throat,
sneezing, coughing, or wheezing).
- Subjects who have an oral temperature above 37.8°C (100°F).
- Subjects with previous or current history of the following conditions: renal, hepatic,
cardiac, pulmonary, hematologic, muscular, neurological, metabolic, or immunological
disorders, hepatitis or cirrhosis, transplant recipients, HIV-infection, or other
immunosuppressive illness.
- Subjects with cancer or history of hematologic malignancy. Cancer is defined as any
active neoplastic diseases excluding noninvasive basal cell carcinoma.
- Subjects who have surgery within 30 days of initiation of the study.
- Female subjects who are pregnant or breast-feeding.
- Subjects who have donated or lost more than 500 mL of blood in the three months prior
to screening.
- Subjects who have clinically significant medical or psychological conditions that
would compromise the subject's safety, influence the results of the study, affect the
subject's ability to participate in the study, or impair the subject's ability to
provide informed consent.
- Subjects who have a history of drug dependence, or psychiatric illness within 2 years
of study enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | DAS181 Single Dose Escalation Study in Healthy Adults | NCT00876161 | Contradiction |
376 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- patients with pregnancy between 8 to 20 weeks of gestation,
- who were diagnosed with threatened abortion.
Exclusion Criteria:
- patients with multiple pregnancies,
- molar pregnancy,
- ectopic pregnancy,
- amenorrhea with different etiologies of pregnancy,
- maternal history of systemic diseases and uterine anatomic abnormalities
- patients who did not have their outcome data through week 20 of gestation due to
relocation.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Corpus Luteum and Uterine Artery Doppler With Serum P and CA125 in Threatened Abortion | NCT02420769 | Contradiction |
6,244 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion criteria:
- PLHIV without antiretroviral therapy but with COVID-19 infection
- PLHIV with antiretroviral therapy and COVID-19 infection
- HIV-negative patients, sex- and age matched, infected with COVID-19;
- older than 18 years
Exclusion criteria:
- Those with known co-infections such as hepatitis B and C
- with a viral load of HIV RNA >1000 copies/ml under ART or with advanced symptoms of
AIDS
- negative for SARS-CoV-2 RNA
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.
| Effects of COVID-19 on Endothelium in HIV-Positive Patients in Sub-Saharan Africa | NCT04709302 | Contradiction |
423 | 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:
- Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the
whole ovary and/or increased ovarian volume (>10ml) (it is sufficient that 1 ovary
fits these criteria)
- No major uterine or ovarian abnormalities
Exclusion Criteria:
- Medical contra-indication for pregnancy
- High (>grade 2) grade endometriosis
- Cases with extremely poor sperm (OAT)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 37 Years | Amphiregulin Versus Non-Amphiregulin Supplementation to Maturation Culturing Medium in IVM. | NCT03915054 | Contradiction |
3,489 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
2,536 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- children presenting to the Center for Family Medicine or Regional Pediatrics between
the ages of 6 months and 18 years old with atopic dermatitis
Exclusion Criteria:
- unwillingness of parent to consent to study protocol, pregnancy or lactation, eczema
with superinfection present, known history of allergy to Vitamin B12 or components of
the base cream, topical treatment with corticosteroids in the 4 weeks prior to
enrollment
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 18 Years | Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis | NCT00465699 | Entailment |
4,182 | 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. | Patients:
Inclusion Criteria:
- suspected lung cancer patients with mediastinal adenopathy
- at least 2 enlarged mediastinal or hilar lymph nodes (one >1.0 cm and one >1.5 cm in
short axis on CT Chest, one of the lymph nodes must be in position 7 or 4R
- eighteen years of age or older
Exclusion Criteria:
- Lack of informed consent
- any contraindication to bronchoscopy
- any significant severe co-morbidities (i.e. severe obstructive lung disease, active
cardiac disease such as angina)
Learners:
Group 1 (EBUS-TBNA simulator training):
Inclusion Criteria:
- pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months
of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)
Exclusion Criteria:
- lack of informed consent
Group 2 (Clinical EBUS-TBNA training):
Inclusion Criteria:
- pulmonary medicine trainees in the 2nd half of their final year of pulmonary training
or recent graduates (within one year), with >50 bronchoscopy procedures experience who
completed a one-month elective with the Interventional Pulmonary Medicine (IPM)
service with ≥15 and ≤25 EBUS-TBNA procedures experience (n=4).
Exclusion Criteria:
- lack of 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.
| Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training. | NCT01269931 | Contradiction |
3,446 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
Hearing impaired
Exclusion Criteria:
Not Hearing Impaired
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Audiology Visits After Screening for Hearing Loss: An RCT | NCT00105742 | Entailment |
2,597 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- male ≥19 years old
- symptomatic and palpable inguinal hernia
- candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein
technique
- will comply with required follow-up study visits
- willing and able to provide written informed consent
Exclusion Criteria:
- BMI ≥35
- life expectancy of <3 years
- strangulated hernia
- urologic disorder and/or previous urologic surgery in the testicular area (with the
exception of prostate surgery)
- active abdominal surgical condition such as bowel obstruction or perforation
- local or systemic infection or peritonitis
- known disease that impairs wound healing
- anti-platelet therapy (other than aspirin) for >7 days preceding the surgical
procedure
- previous ipsilateral groin incision
- receiving immunosuppressive therapy and/or has undergone radiation therapy to the
affected groin area
- uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
- advanced cirrhosis with Child-Turcott Class of C or higher
- severe COPD requiring home oxygen
- diagnosed with chronic pain syndrome or is undergoing treatment for pain management
- candidate for another major surgical procedure with the inguinal hernia repair
- enrolled in another investigational study that may confound the results of this study
- known drug abuser
- on anti-psychotic medications
- Worker's Compensation case
Male
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Study of Surgical Mesh for Inguinal Hernia Repair | NCT00924755 | Contradiction |
1,230 | 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:
- Aged ≥18 years.
- A confirmed, clinician made diagnosis of the following (supported by standard accepted
diagnostic criteria):
- Malignant pleural effusion: confirmed cancer
- lung cancer
- mesothelioma
- or metastatic cancer
- Non-malignant pleural effusion: effusion confirmed to be caused by alternative
diagnosis
- Malignant ascites: confirmed cancer
- Non-malignant ascites: ascites confirmed to be caused by alternative diagnosis
- Willing and able to give informed consent for participation in the study.
Exclusion Criteria:
- Unable to comprehend the study
- Unable to provide informed consent
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis | NCT04533854 | Entailment |
Subsets and Splits