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2,128 | 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:
- Kleinfelter syndrome
- Azoospermia
- Negative TESE
Exclusion Criteria:
- Absent Testes
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection | NCT02414295 | Entailment |
3,411 | 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's primary language is English.
- Male or female between 18 and 75 years of age, inclusive, at randomization.
- Diagnosis of bilateral sensorineural hearing loss (SNHL).
- Normal tympanogram in the ear intended for injection (as defined in protocol) at
Screening.
- Male or female subjects with reproductive potential agree to comply with
protocol-approved double barrier contraceptive method during and for 3 months after
study drug administration.
- The subject is in general good medical health with no clinically significant or
relevant abnormalities, including medical history, physical exam, vital signs, ECG,
and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the
Investigator.
Exclusion Criteria:
- History of chronic otitis externa or media, other chronic middle ear disorders,
barotrauma, Meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster
oticus or other infectious etiology of hearing loss.
- Presence of a genetic, syndromal or developmental auditory disorder or of an
autoimmune or serious neurological disorder that could contribute to auditory loss.
- Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis.
- History of auditory loss related to exposure to known high-dose ototoxic drugs; any
prior exposure to platinum-based medications.
- Otological disorders that would preclude safe tympanic injection.
- Presence of a cochlear implant.
- Evidence of bothersome tinnitus as determined by the Investigator.
- Intratympanic injection within 6 months of randomization.
- Use of an investigational product or intervention other than a non-interventional
registry study (including vaccine studies) within the greater of 30 days or 5
half-lives (if known) prior to Screening or expected during the study.
- History of malignancy under current active treatment or considered at substantial risk
for progression or recurrence during the study interval, as determined by the
Investigator. Note, central nervous system neoplasms or head and neck cancer are
excluded from eligibility regardless of treatment status.
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 | Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss | NCT04462198 | Contradiction |
1,194 | 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 exudative pleural effusion who require invasive procedure for diagnosis
Exclusion Criteria:
- Patients without pleural effusion
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 85 Years | Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy | NCT01196585 | Entailment |
4,999 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the
study.
- Male or Female, aged 18 to 80 years old.
- Diagnosed with Parkinson's disease, Essential Tremor or Dystonia.
- Undergoing two-stage surgery for deep brain stimulation as therapy for their movement
disorder.
Exclusion Criteria:
- Cognitive impairment (judged by the clinician on the care team or in the research team
as a participant not having sufficient mental capacity to understand the study and its
requirements). This includes anyone who, in the opinion of clinicians on the care team
or clinicians in the research team, is unlikely to retain sufficient mental capacity
for the duration of their involvement in the study.
- Intracranial bleeding, confusion, cerebrospinal fluid leak or any other complication
after the first stage of surgery.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Using DBS to Probe Basal Ganglia Dysfunction | NCT04080674 | Entailment |
1,437 | 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:
- Participants of both sexes aged between 18 and 65 years;
- Participants diagnosed with uncontrolled hypertension;
- Participants with intermediate and high risk dyslipidemia, according to the V
Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Ability to understand and consent to participate in this clinical study, manifested by
signing the Informed Consent and Informed ( IC) .
Exclusion Criteria:
- Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
- Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin
converting enzyme (ACE);
- participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V
Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- research participants with total cholesterol (TC) above 500 mg / dL or triglyceride
(TG) above 400 mg / dL;
- participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
- research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg
in orthostatic position in relation to the sitting position);
- History of congestive heart failure (CHF) functional class III or IV (NYHA);;
- any clinical, laboratory and electrocardiographic that, in the judgment of the
investigator, may interfere with the safety of research participants;
- Creatine phosphokinase (CPK) levels above the established laboratory normal range;
- Transaminases (ALT and ASL) serum above 2 times the established laboratory normal
range;
- Body mass index (BMI) ≥35 kg / m²;
- Immunocompromised participants (eg .: malignancies, patients with Acquired
Immunodeficiency Syndrome etc);
- Chronic use of drugs that may interact with the drugs of the study;
- Patients on concomitant lipid-lowering therapy;
- History hypersensitivity to the active ingredients used in the study;
- Participants who are pregnant, nursing or planning to become pregnant, or female
participants of childbearing potential who are not using a reliable method of
contraception;
- History of alcohol abuse or illicit drug use;
- Adherence to uniformization medication <80%;
- Participating in the research that has participated in clinical trial protocols in the
last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J),
unless the investigator considers that there may be direct benefit to it;
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 | Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia. | NCT02662894 | Contradiction |
5,576 | 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:
1. Pre-pubertal children with either isolated GHD, or GH insufficiency as part of
multiple pituitary hormone insufficiency, idiopathic or organic GH insufficiency
(e.g., due to pituitary tumor, pituitary or brain surgery):
- Boys: 3 years ≤ boy's age ≤ 11 years
- Girls: 3 years ≤ girl's age ≤ 10 years
2. GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10
ng/mL as described in consensus guidelines. Well documented historical GH provocation
tests can be used for study eligibility providing that the tests are performed as
defined in Appendix 2 (e.g. the same sampling time points). Data of each historical GH
stimulation test will be reviewed by Medical Monitor and Sponsor in order to assess
acceptance for the study
3. Without prior exposure to any rhGH therapy
4. Bone age (BA) is not older than chronological age and should not be greater than 9
years for girls and 10 years for boys
5. Impaired height and height velocity defined as:
- Height (HT) of at least 2.0 standard deviations (SD) below the mean height for
chronological age (CA) and gender according to the standards from Prader et. al
1989, (HT SDS ≤ -2.0)
- Annualized height velocity (HV) of at least 1 SD below the mean HV for
chronological age and gender according to the standards of Prader et al (1989).
The interval between two height measurements should be at least 6 months (but not
longer than 18 months) before inclusion
6. All subjects must have at least one cranial imaging study [magnetic resonance imaging
(MRI) or computed tomography (CT)] prior to randomization:
- To exclude intracranial causes of GHD in subjects without history of pituitary
tumor [obtained within 6 months prior to informed consent signing, or
- Subjects with a previously treated pituitary tumor must have no tumor progression
for at least the past year [obtained within 3 months prior to informed consent
signing, compared with a previous MRI or CT performed at least 12 months earlier]
- If not performed within these specified time frames prior to informed consent
signing, may be performed as a part of the screening procedures
7. Body mass Index (BMI) must be within ±2 SD of mean BMI for the chronological age and
sex according to the 2000 CDC standards
8. Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age
and sex (IGF-1 SDS≤ -1.0) according to the central laboratory reference values. One
IGF-1 retest is allowed during the Screening period if first results were not higher
than
-0.85 SDS and if GH stimulation tests results and auxology parameters met eligibility
criteria
9. Children with normal fundoscopy (ophthalmoscopy) at screening (without signs/symptoms
of intracranial hypertension as assessed by fundoscopy) - it is highly recommended to
take a photograph (if equipment is available at the study center)
10. Children with multiple hormonal deficiencies must be on stable replacement therapies
for other hypothalamo-pituitary-organ axes for at least 3 months and 6 months for
thyroid replacement therapy prior to Screening. Temporary adjustment of glucocorticoid
replacement therapy, as appropriate, is acceptable
11. Normal 46 XX karyotype for girls
12. Written informed consent of the parent or legal guardian of the subject and assent of
the subject (if the subject can read)
13. Parent or legal guardian who is capable and willing to administer the study drug
Exclusion Criteria:
1. History of radiation therapy or chemotherapy
2. Malnourished children defined as:
- Serum albumin below the lower limit of normal (LLN) according to the reference
ranges of central laboratory; and
- Serum iron below the lower limit of normal (LLN) according to the reference
ranges of central laboratory; and
- BMI<-2 SD for age and sex
3. Children with psychosocial dwarfism
4. Children born small for gestational age (SGA-birth weight and/or birth length < -2 SD
for gestational age according to the standards from Niklasson et al., 1991)
5. Presence of anti-hGH antibodies at screening
6. Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth, such as, but not limited to, chronic diseases like renal
insufficiency, spinal cord irradiation, etc.
7. Subjects with diabetes mellitus
8. Subjects with impaired fasting sugar (based on WHO; fasting blood sugar > 110mg/dl or
6.1 mmol/l) after repeated blood analysis
9. Chromosomal abnormalities and medical syndromes (Turner's syndrome, Laron syndrome,
Noonan syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, SHOX
mutations/deletions and skeletal dysplasias), with the exception of septo-optic
dysplasia
10. Evidence of closed epiphyses
11. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder
(ADHD), with the exception of hormone replacement therapies [thyroxine,
hydrocortisone, desmopressin (DDAVP)]
12. Children requiring glucocorticoid therapy, other than treated for
hypothalamo-pituitary-adrenal insufficiency in replacement doses who are taking a dose
of greater than 400 μg/d of inhaled budesonide or equivalents for longer than 1 month
during a calendar year (e.g. asthma)
13. Major medical conditions and/or presence of contraindication to rhGH treatment
14. Has a history of positive serology results to HIV, HBV and/or HCV
15. Subject who has a known or suspected hypersensitivity to rhGH
16. Other causes of short stature such as coeliac disease, hypothyroidism and rickets
17. The subject and/or the parent/legal guardian are likely to be non-compliant in respect
to study conduct
18. Subject who has received an investigational product, or has participated in a clinical
study within 60 days before screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency | NCT03309891 | Contradiction |
6,606 | 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:
- Participants with severe and moderately severe hemophilia A (FVIII ≤ 2%)
- Participants < 1 year of age
- Participants must have ≤ 3 exposure days (EDs) to any FVIII concentrate or
FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more
than 2 infusions per event), or for preventative or precautionary infusions following
possible injury
- Participants with prior circumcision are allowed to enroll only if bleeding issues
related to circumcision were the cause for the original diagnosis of hemophilia A and
no more than 2 EDs of FVIII treatment were required
- Adequate venous access (without need for central venous access device
(CVAD)-placement) as determined by the physician
- Written informed consent from legally authorized representative(s)
Exclusion Criteria:
- Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement
for surgery at the time of enrollment
- Evidence of inhibitor ≥ 0.6 Bethesda Unit (BU) in Nijmegen-modified Bethesda Assay at
study start (samples may be retested using lupus-insensitive inhibitor tests to reduce
the number of false positive inhibitor test results)
- Inherited or acquired hemostatic defect other than hemophilia A
- Any clinically significant, chronic disease other than hemophilia A
- Known hypersensitivity to ADVATE or any of its constituents
- Any planned elective surgery that cannot be postponed until after the first 20 EDs
- Participation in the Hemophilia Inhibitor Previously Untreated Patient Study
- Application of red blood cell, platelet, or leukocyte concentrates, or plasma
- Administration of any medication affecting coagulation or platelet function
- Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous
glucocorticoids)
- Participation in another clinical study involving an investigational product (IP) or
device within 30 days prior to study enrollment or during the course of this study
Male
No healthy subjects accepted to join the trial.
Subject must be at most 1 Year | Early Prophylaxis Immunologic Challenge (EPIC) Study | NCT01376700 | Contradiction |
2,377 | 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 group of 3-25 years
- Duchenne muscular dystrophy diagnosed on the basis of clinical presentation
Exclusion Criteria:
- presence of respiratory distress
- presence of acute infections such as Human Immunodeficient Virus/Hepatitis B
Virus/Hepatitis C Virus
- malignancies
- acute medical conditions such as respiratory infection, fever, hemoglobin less than 8,
bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
- pregnancy or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 25 Years | Stem Cell Therapy in Duchenne Muscular Dystrophy | NCT02241434 | Entailment |
2,762 | 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:
- Elective laparoscopic inguinal hernia repair, unilateral or bilateral
Exclusion Criteria:
- Those requiring antibiotics for the surgery;
- Those patients who have experienced surgical site infections from previous surgeries
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not? | NCT02083939 | Entailment |
2,328 | 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:
- proven DMD
Exclusion Criteria:
- severe mental retardation
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 35 Years | Upper Limb Assessment in Duchenne Muscular Dystrophy | NCT02436720 | Entailment |
1,457 | 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:
- History of dysphagia necessitating a dynamic fluoroscopic swallow study
- Age > 18 years
- Ability to complete a comprehensive dynamic fluoroscopic swallow study
- Ability to provide informed consent for study participation
Exclusion Criteria:
- Age < 18 years
- Pregnant women
- Prisoner or other institutionalized individual
- Cognitive disability precluding the ability to provide informed consent or complete a
comprehensive swallow 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.
| Evaluation of Two Different Thickening Products in Patients With Dysphagia | NCT01651975 | Entailment |
3,324 | 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:
Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane
as assessed by study clinician.
Exclusion Criteria:
- Craniofacial abnormalities (assessed by history and examination)
- Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
- Nasopharyngeal tumours (assessed by flexible nasendoscopy)
- Adenoid hypertrophy (assessed by flexible nasendoscopy)
- Patulous ET (assessed by history, otoscopy and tympanogram)
- Previous middle ear surgery (assessed by history and otoscopy)
- Concurrent use of anticoagulant 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.
| Feasibility Study of Balloon Eustachian Tuboplasty (BET) | NCT02631187 | Contradiction |
5,009 | 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. | Key Inclusion Criteria:
- Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral
postural tremor and kinetic tremor, involving hands and forearms, that is visible and
persistent and the duration is >5 years prior to screening.
Key Exclusion Criteria:
- Participant has presence of abnormal neurological signs other than tremor or Froment's
sign.
- Participant has presence of known causes of enhanced physiological tremor.
- Participant has concurrent or recent exposure (14 days prior to admission visit) to
tremorogenic drugs.
- Participant has had direct or indirect trauma to the nervous system within 3 months
before the onset of tremor.
- Participant has historical or clinical evidence of tremor with psychogenic origin.
- Participant has convincing evidence of sudden tremor onset or evidence of stepwise
deterioration of tremor.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Study to Evaluate SAGE-217 in Participants With Essential Tremor | NCT02978781 | Entailment |
5,706 | 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:
- Diagnosis of Turner Syndrome
Exclusion Criteria:
- Diagnosis excluding Turner Syndrome
Female
| UTHealth Turner Syndrome Research Registry | NCT03185702 | Entailment |
1,139 | 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:
- Major patient not benefiting from any legal protection measures.
- Speaking French.
- Outgoing after having received a consultation in a hospital emergency department.
- Accepting to participate in the study after being informed of the protocol.
- Having the possibility to be reached by telephone on J7.
Exclusion Criteria:
- Patient with a pathology that does not allow him or her to understand instructions or
express themselves.
- Patient under tutelage or curatorship or deprived of all freedom.
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.
| Patient Follow-up After Consultation in Emergency Department | NCT03117179 | Entailment |
3,168 | 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:
- SS patients with dry mouth symptoms
Exclusion Criteria:
- Patients with dry mouth due to other conditions
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Rebamipide AND Sjögren Syndrome | NCT01759108 | Entailment |
6,856 | 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:
- Mild to moderate AD
Exclusion Criteria:
- Severe AD
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Acupuncture Treatment for Improving Alzheimer's Dementia | NCT04064021 | Contradiction |
2,563 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- All children having chest wheezes, aged from two years to eighteen years, attending
emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to
1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University
Hospital
Exclusion Criteria:
- Refusal of endoscopic nasal examination by care givers.and patients with definite
diagnosis of wheeze (bronchiolitis,pneumonia)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 18 Years | Nasal Findings in Reactive Airway Diseases | NCT03131323 | Entailment |
4,695 | 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:
- Hysterectomy planned for a benign gynecologic reason
- Patient is scheduled to have surgery with one of the minimally invasive gynecologic
surgeons at George Washington University Hospital. (Dr. Moawad, Dr. Marfori, or Dr.
Vargas)
- Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or
a total laparoscopic hysterectomy (TLH)
- Patient is capable of informed consent
- Patient must be between 18 and 65 years of age
- Uterus greater than 12 centimeters in height and 4 centimeters in width or 12 weeks in
size
Exclusion Criteria:
- Hysterectomy is indicated for malignancy
- Procedure is anything other than RA-TLH or TLH
- Surgeon is not one of hte minimally invasive surgeons at GWUH
- Surgery is scheduled for a hospital other than GWUH
- Patient does not meet the age requirements.
- Patient is not capable of informed consent
- Uterus is less than 12 cm in heightand 4 cm in width
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes | NCT02703246 | Entailment |
5,415 | 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: One or more of the following:
1. VWF ≤ 30 IU/d, in 2 or more occasions.
2. Presence of multimeric abnormalities.
3. If isolated FVIII deficiency demonstration of decreased FVIII binding.
4. Presence of some VWF mutation.
5. ↑ RIPA at low concentrations of ristocetin.
Exclusion Criteria:
1. Presence of any data suggesting AVWS.
2. Absence of a signed patient informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 80 Years | Molecular and Clinical Profile of Von Willebrand Disease in Spain | NCT02869074 | Entailment |
1,239 | 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:
- Monolateral or Bilateral Pleural Effusion (any cause)
- Able to achieve a sitting position
- Chest CT scan within 24 hours available
- Informed consent available
Exclusion Criteria:
- No informed consent available
- Age under 18
- No recent Chest CT scan available
- Unable to keep the sitting position
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.
| Ultrasound Estimation of Pleural Effusion in the Sitting Patients | NCT02809872 | Entailment |
6,452 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Must understand and voluntarily sign an informed consent form.
2. Must be male or female and aged ≥ 18 years at time of consent.
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Must have clinically typical confirmed diagnosis of erythematotelangestatic rosacea.
5. Females of childbearing potential (FCBP)‡ must have one negative urine pregnancy tests
at screening. In addition, sexually active FCBP must agree to use TWO of the following
adequate forms of contraception while on study medication: oral, injectable, or
implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier
contraceptive with spermicide; or vasectomized partner while on the study. A FCBP must
agree to have pregnancy tests every 4 weeks while on study medication.
6. Males (including those who have had a vasectomy) must agree to use barrier
contraception (latex condoms) when engaging in sexual activity with FCBP while on
study medication.
Exclusion Criteria:
1. Inability to provide voluntary informed consent.
2. Pregnant or breastfeeding female.
3. A skin examination reveals the presence of another skin disease and/or condition
(excessive facial hair, excessive scarring, sunburn, or other disfigurement) located
on the face that would confound the evaluation of the rosacea.
4. Current or past ocular rosacea, such as conjunctivitis, iritis and keratitis of
sufficient severity to require topical or systemic antibiotics.
5. Subjects with recurrent gastritis, renal dysfunction or ulcer disease (peptic or
duodenal).
6. Treatment with topical antibiotics, topical steroids, topical retinoids and other
topical rosacea treatments on the face within 14 days of baseline and throughout the
study.
7. Treatment with any systemic medication or therapy known to affect inflammatory
responses within the 30 days prior to baseline and throughout the study.
8. Treatment with systemic retinoids within 6 months prior to study entry (e.g.,
acitretin, isotretinoin).
9. Use of laser or light based rosacea treatments within the past 2 months.
10. History of hypersensitivity or allergies to any ingredient in the study drug.
11. Current drug or alcohol abuse.
12. Have participated in any clinical trial involving an investigational drug or cosmetic
product or procedure within the past 30 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Combination Therapy for the Treatment of Rosacea | NCT00945373 | Entailment |
6,387 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Adults aged ≥18 years,
2. Informed consent obtained for participation,
3. A mild, moderate or severe (±critical cases) RT-PCR confirmed COVID-19 cases,
4. RT-PCR negative healthy volunteers.
Exclusion Criteria:
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 90 Years | Cytokine Storm Among Bangladeshi Patients With COVID-19 | NCT04598334 | Entailment |
89 | 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:
- Generally healthy older men 50 years old or older
- Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an
average of equal to or less than 300 ng/dl on two occasions)
- Prostate volume equal to or more than 30 cc by prostate MRI
- Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less
than 10 ng/mL
- Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy
- International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than
or equal to 20 at screening
- Comply with study procedures for the full 10 months
- No contraindications to MRI
Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the
Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and
University of Washington Medical Center in Seattle.
Exclusion Criteria:
- A history of prostate or breast cancer
- Invasive therapy for BPH in the past
- History of acute urinary retention in the 3 months prior to screening
- Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)
- Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)
- Use of androgenic or antiandrogenic drugs in the past year
- History or evidence of prostate cancer including suspicious DRE or history of
high-grade PIN on prostate biopsy.
- Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)
- Known untreated obstructive sleep apnea
- Hematocrit greater than 52
- Severe skin disease which may interfere with testosterone gel absorption
- Hypersensitivity to any of the drugs used in the study
- History of a bleeding disorder or need for chronic anticoagulation
- Participation in a drug study concurrently or in the last 90 days
- History or current evidence of drug or alcohol abuse within 12 mo.
- Weight more than 300 lbs.
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| TRADE-Testosterone Replacement and Dutasteride Effectiveness | NCT00194675 | Contradiction |
4,909 | 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:
- Male or non-pregnant and non-breast feeding female
- Females of childbearing potential must have a serum β-human chorionic gonadotropin
(β-hCG) level consistent with non-pregnant state and agree to use (and/or have their
partner use) two acceptable methods of birth control beginning at screening,
throughout the trial (including washout intervals between treatment periods) and until
after the post-study follow-up visit
- Females not of childbearing potential must be either a) postmenopausal (have not had a
menstrual period for at least 1 year and have a follicle stimulating hormone [FSH]
value in the postmenopausal range) or b) surgically sterile (i.e., have had
hysterectomy, oophorectomy or tubal ligation)
- In good health based on medical history, laboratory tests and other assessments
- Body Mass Index (BMI) ≥19 and ≤32 kg/m^2
- Non-smoker or smokes ≤10 cigarettes/day or equivalent (2 pipes/day, 1 cigar/day) and
agrees not to smoke while confined at the study center
Exclusion Criteria:
- Mentally or legally incapacitated, has significant emotional problems at the time of
screening visit or expected during the conduct of the trial or has a history of
clinically significant psychiatric disorder of the last 5 years
- History of clinically significant endocrine, gastrointestinal, cardiovascular,
hematological, hepatic, immunological, renal, respiratory, genitourinary or major
neurological abnormalities or diseases
- History of cancer (malignancy)
- History of significant multiple and/or severe allergies (e.g., food, drug, latex
allergy), or has had an anaphylactic reaction or significant intolerability to
prescription or non-prescription drugs or food
- Positive for hepatitis B surface antigen, hepatitis C antibodies or human
immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL)
within 4 weeks prior to screening
- Has participated in another investigational trial within 4 weeks prior to screening
- Is unable to refrain from or anticipates the use of any medication, including
prescription and non-prescription drugs or herbal remedies beginning approximately 2
weeks prior to administration of the initial dose of trial drug, throughout the trial
(including washout intervals between treatment periods), until the post-study
follow-up visit
- Has received subcutaneous or sublingual immunotherapy within the past 1 year
- Consumes >3 glasses of alcoholic beverages per day
- Consumes excessive amounts, defined as >6 servings of coffee, tea, cola, energy
drinks, or other caffeinated beverages per day
- Currently a regular user (including "recreational use") of any illicit drugs or has a
history of drug (including alcohol) abuse within approximately 12 months
- Has a recollection of previously receiving sugammadex, Bridion™, SCH 900616, ORG
25969, or MK-8616
- History of chronic urticaria or angioedema
- Is or has an immediate family member (spouse or children) who is a member of
investigational site or sponsor staff directly involved with this trial
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101) | NCT02028065 | Contradiction |
5,764 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | - INCLUSION CRITERIA:
Inclusion Criteria for all groups
Must have a primary care professional who will continue standard of care/evaluation in
tandem with the protocol to whom information and recommendations can be communicated.
Inclusion Criteria for Group 1: Healthy Volunteers
Adult males or females aged 18-50 at time of enrollment.
Inclusion Criteria for Group 2: AD patients
A. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24
B. Moderate to severe AD SCORAD greater than or equal to 25(25)
C. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of
enrollment to serve as a target site.
Inclusion Criteria for Group 3: Healthy (pediatric) Controls
A. Males or females 2 18 years of age.
Inclusion Criteria for Groups 4, 5, & 6: AD/HIES/WAS/DOCK8 patients
A. Must have mutation-proven diagnosis, with or without eczematous dermatitis.
EXCLUSION CRITERIA:
Exclusion Criteria for all groups:
1. Any subjects with unstable or uncontrolled or chronic medical conditions requiring
treatment or hospitalization. Individual determinations will be made at the discretion
of the medical investigator.
2. Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy,
monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives
(whichever is the longer time period) of initiating this protocol.
3. Any subjects who have cancer, and are currently or have previously received treatment
with chemotherapy or radiation for treatment of malignancies within the previous 6
months.
4. Any subject with a history of bone marrow transplant or gene therapy.
Exclusion Criteria specific for Group 2: AD patients
A. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at
least 7 days prior to body site sampling. Unable to temporarily discontinue use of
topical steroids or calcineurin inhibitors for greater than or equal to 7 days to
small areas of skin intended for sampling. (Topical therapies/emollients for AD may be
continued to non-adjacent, nontarget sites.)
B. Underlying immunodeficiency, either as primary disease or secondary to treatment.
Exclusion Criteria specific for Groups 4, 5, & 6: HIES/WAS/DOCK8 patients:
A. Unable to remain off topical steroids and emollients for preferably 7 days but at
least 24 hours prior to body site sampling.
Exclusion Criteria specific for Groups 1 & 3: Healthy Volunteers and Healthy
(pediatric) Controls:
A. Underlying immunodeficiency, either as primary disease or secondary to treatment.
B. Other documented chronic dermatologic disease, such as AD or psoriasis that may
interfere with evaluation of the cutaneous microbiome. Common transient conditions,
such as acne, are permissible.
C. Subjects who provide direct healthcare or reside in healthcare facilities or in
non-hospital settings such as assisted living facilities, homeless shelters, jails and
prisons as well as subjects with frequent exposure to laboratory animals.
D. Subjects with asthma.
5. Any female with symptoms and/or serum hormone levels consistent with perimenopause
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 50 Years | Studies of Skin Microbes in Healthy People and in People With Skin Conditions | NCT00605878 | Contradiction |
4,475 | 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. Pain around the lateral part of the elbow joint for more than 4 weeks.
2. Pain on palpation of the proximal part of the common extensor tendon.
3. Pain reproduced with resisted dorsiflexion of the wrist.
4. Dash score > 30.
5. Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular
appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal,
increased tendon thickness).
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) > 2 (mild systemic disease).
- Patients with symptoms consistent with differential diagnoses such as:
- referred pain,
- radiohumeral synovitis and bursitis,
- posterior interosseous nerve entrapment (radial tunnel syndrome),
- osteoarthritis of the elbow, and
- prior injections or acupuncture around the elbow joint within the last 6 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Treatment of Lateral Elbow Tendinopathy | NCT02521298 | Entailment |
5,427 | 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. | DISEASE CHARACTERISTICS: Histologically proven newly diagnosed moderate or high grade
osteosarcoma without metastases No prior treatment, including complete resection No
parosteal or periosteal sarcoma No osteosarcoma associated with Paget's disease No
nonresectable tumors or tumors that may result in marginal or interlesion resection Must be
enrolled on protocol POG-9851
PATIENT CHARACTERISTICS: Age: 30 and under Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than
3 times normal Renal: Creatinine normal Phosphate at least 3.0 mg/dL without
supplementation Cardiovascular: Shortening fraction at least 28% by echocardiogram If
echocardiogram unsatisfactory, must have ejection fraction at least 50% No history of
pericarditis or myocarditis No symptomatic arrhythmia or symptomatic cardiac conduction
disturbances
PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy Surgery: See Disease Characteristics
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 30 Years | Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma | NCT00003937 | Entailment |
6,673 | 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. Subjects (his/her parent/legal representative), must have given a written informed
consent.
2. Male children: age <12 years.
3. Severe or moderate Haemophilia A (FVIII <2%).
4. High responders (clinical history of inhibitor peak > 5BU) or low-responders (clinical
history of inhibitor peak < 5 BU) with potential bleedings, assessed by responsible
physicians as not to be treated with high FVIII doses.
5. Any level of inhibitor at study enrollment.
6. Willingness and ability to participate in the study.
7. No other experimental treatments (involving or not FVIII concentrates).
Exclusion Criteria:
1. Any clinically relevant abnormality, in hematological, biochemical and urinary routine
examinations, or any condition or treatment which in the investigator's opinion, makes
the patient not eligible for the study.
2. Intolerance to active substances or to any of the excipients of FVIII / VWF
concentrates.
3. Concomitant systemic treatment with immunosuppressive drugs.
Male
No healthy subjects accepted to join the trial.
Subject must be at most 12 Years | Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients | NCT02479087 | Contradiction |
2,425 | 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:
- Persons with muscular dystrophies
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Efficacy of Using Far Infrared Radiation to Manage Muscular Dystrophies | NCT00674843 | Entailment |
5,307 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory, postmenopausal women, inclusive.
- Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute
value (grams/square centimeter [g/cm^2]) for the lumbar spine of between -3.5 and
-2.0, inclusive.
- Without language barrier, reliable, and willing to make themselves available for the
duration of the study and to follow study procedures.
- Willing to take study drug and daily supplements (calcium and Vitamin D).
- Normal laboratory tests or laboratory test results determined not clinically
significant by the investigator. Serum phosphate and serum calcium must be within
normal limits, and platelet level greater than 100,000 cubic millimeters (mm^3).
Exclusion Criteria:
- Have received treatment with any of the following medications more recently than 3
months prior to screening Androgen, Calcitonin, Estrogen (including over the counter
preparations known to have estrogenic activity), Progestin (including over the counter
preparations known to have progestogenic activity), selective estrogen receptor
modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.
- Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH
analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- Have received treatment with any oral bisphosphonate within the last year.
- Have received therapeutic doses of systemic corticosteroids for more than one month
during the 6 months prior to screening.
- Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3
months during the last 3 years, or for more than a total of 2 years, or any within the
last 6 months.
- Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <9.2
nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/L)] at screening. If
the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL
and <20 ng/mL, participants will receive a loading dose of Vitamin D (at a dose of
approximately 100,000 international units (IU) given orally) prior to enrollment.
- Have any known bone disorder other than low BMD or osteoporosis.
- Have a history of osteoporotic fractures, including known prevalent vertebral fracture
or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy
x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.
- Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA
evaluation of lumbar vertebrae in the L-1 through L-4 region.
- Have a history of Bell's palsy, other cranial nerve disorders, or have a history of
Temporomandibular Joint and Muscle Disorders (TMJDs).
- Have any history of cancer within the previous 5 years, except for excised superficial
lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
- Have history or presence of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
constituting a risk when taking the study medication or of interfering with the
interpretation of data.
- Have acute or chronic liver disease ([bilirubin >34 micromoles per liter (µmol/L) or
>2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per
liter (U/L), or alkaline phosphatase >300 U/L)].
- Have impaired kidney function serum creatinine >135 µmol/L or >2.0 mg/dL.
- Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or
significant allergy to any other monoclonal antibody.
- History of excessive consumption of alcohol or abuse of drugs within the last year.
- Have poor medical condition or psychiatric risks for treatment with an investigational
drug.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | A Study of LY2541546 in Women With Low Bone Mineral Density | NCT01144377 | Entailment |
1,521 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
1. Males and females who are 18 years of age and older and are able to comprehend
instructions and follow the study procedures and are willing to sign an Informed
Consent Form (ICF).
2. Patients with symptomatic Zenker's Diverticulum.
3. Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological
examinations.
4. Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological
examinations.
Exclusion Criteria:
1. Lack of written consent for participation in the study.
2. Size of Zenker's Diverticulum <1,5 cm or >4 cm on radiological examination.
3. Active cancer.
4. Esophageal stricture.
5. Eosinophilic esophagitis (EoE).
6. Pre-cancerous changes in the esophagus.
7. Previous surgical or endoscopic treatment of Zenker's Diverticulum.
8. Presence of chewing deficiencies and/or neurogenic dysphagia.
9. Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility
disorders.
10. Severe systemic diseases which are contraindication to general sedation.
11. Severe coagulopathy.
12. Pregnancy and breastfeeding.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy. | NCT04514042 | Entailment |
3,554 | 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:
- 18 to 80 years of age
- male and female
- hypothalamic pituitary disorders (study subjects)
- history of regular, age appropriate menses (control subjects)
- male subjects with normal serum testosterone and follicle stimulating hormone (FSH)
(control subjects)
- normal FSH in post-menopausal subjects (control subjects)
- normal thyroid stimulating hormone (TSH), free thyroxine (T4), prolactin (control
subjects)
Exclusion Criteria:
- unable to give consent
- pregnancy
- active acromegaly
- pheochromocytoma
- active Cushing's disease
- pituitary insult within past 6 weeks
- elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- renal failure
- history of malignancy
- severe acute illness
- uncontrolled hypertension
- Diabetes mellitus (DM) type 1
- Hemoglobin (Hgb) A1c >9% in last 3 months in Type 2 DM
- severe coronary artery disease
- women <50 years of age with untreated hypogonadism
- men with untreated hypogonadism
- growth hormone treatment in the past 3 months
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 80 Years | The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis | NCT01282164 | Entailment |
2,596 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written
consent.
Exclusion Criteria:
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent hernias.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair | NCT01590940 | Contradiction |
6,901 | 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:
- Inclusion criteria for dementia patients:
- documented diagnosis of probable Alzheimer's or other type of dementia, medically
stable, and visual/hearing capabilities to watch television.
- Inclusion criteria for family members/caregivers:
- provide care or be a family member of dementia patient, have knowledge of the
person, and be able to provide old photographs of dementia patient.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia | NCT00759863 | Entailment |
1,267 | 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. | DISEASE CHARACTERISTICS: Cytologically confirmed unilateral malignant pleural effusion or
exudative effusion with positive biopsy from any tumor type No chylous effusion Drainage of
effusion with chest tube or soft catheter required Lung re-expansion demonstrated on chest
x-ray Continuing drainage less than 250 mL/24 hours (or equivalent measured over 4 hours)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic:
(within 2 weeks prior to entry) WBC greater than 2,000 Platelets greater than 50,000
Hepatic: Not specified Renal: (within 2 weeks prior to entry) Creatinine less than 2.5
mg/dL OR Creatinine clearance greater than 40 mL/min Other: No pregnant or nursing women
Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY: No prior sclerosing agents on the affected side No prior
intrapleural therapy No change in systemic therapy for at least 2 weeks prior to
randomization Biologic therapy: Not specified Chemotherapy: No prior systemic bleomycin
Systemic chemotherapy allowed after pleurodesis Endocrine therapy: Hormone therapy allowed
after pleurodesis Radiotherapy: No significant radiotherapy to affected hemithorax
Irradiation of painful bone lesions allowed on the affected side if field does not include
a significant portion of the pleura Surgery: See Disease Characteristics No prior
thoracoscopic lysis of adhesions on the affected side
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.
| Bleomycin, Doxycycline, or Talc in Treating Patients With Malignant Pleural Effusions | NCT00002872 | Entailment |
2,406 | 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:
- children registered in selected public kindergarten
- grade/class B kindergarten
- willing to follow the study
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Nutrition Education Module for Preschooler Children | NCT03910257 | Entailment |
715 | 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:
- M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater
than 3 months as presented by pain in knee.
- Body mass index (BMI) must be 25 to 29.9 kg/m2.
- WOMAC pain score for index joint: 10 to 16.
- Physically active subjects as indicated by day to day involvement in the mentioned
physical activity namely:
- Daily walk of 500 to 1000 meters.
- Routine activities such as descending/ ascending stairs, standing up from a chair;
bending to floor; travelling by public transport, domestic cleaning etc.
- Climbing 1 or more fleets of stairs.
- Osteoarthritis grade I/ II (Kellgren-Lawrence classification) as confirmed by
radiographic evidence.
Exclusion Criteria:
- Subjects with a history of any joint replacement surgery.
- Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50
mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint
health/ local analgesics or other traditional pain relieving therapies such as message
or acupuncture etc. during the study duration will be excluded.
- Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or
diastolic ≥ 100 mm Hg) at screening.
- Subjects with history of thyroid hormone derangement will have to provide a recent
(within 3 months) thyroid profile report indicative of euthyroid status.
- Use of any immunosuppressive drugs in the last 12 months.
- Use of any corticosteroids drugs in the last 3 months.
- Subject unwilling to refrain from analgesic measures at least 48 hours before each
site visit.
- FBS >140 mg/dl.
- History of restless leg syndrome.
- Glucocorticoid injection or hyaluronic acid injection in affected joint within 3
months prior to enrolment.
- Subjects with a chronic pain syndrome and in the judgment of the Investigator is
unlikely to respond to any therapy.
- Smokers and tobacco users.
- Alcohol consumption of more than 200 ml/ week
- History of surgery in lower limb.
- Subjects suffering from diabetic neuropathy.
- Subjects suffering from deep vein thrombosis.
- Pregnant / lactating women and women who are planning to get pregnant.
- Recent (< 3 months) participation in a clinical study.
- History of major chronic hepatic, cardiovascular, neurological or immunosuppressive
conditions or the presence of any infections.
- Subjects with localized trauma to the lower limb.
- A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by
withdrawal symptoms.
- Subjects planning to travel in the next 35 days or engage in any non-routine activity
that is likely to strain the knees.
- Subject a history of malignancy, active gastrointestinal disease, chronic or acute
renal/hepatic disorders, or significant coagulation disorders.
- Subjects on vitamins, nutritional supplement or herbal product since last 2 weeks.
- Subjects otherwise judged by the investigator to be inappropriate for inclusion 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 40 Years old.
Subject must be at most 65 Years | To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study | NCT03262805 | Contradiction |
3,321 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Between 20 aged and 45 aged in healthy male and female
2. Body weight more than 55kg in male, 50kg in female
3. Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.If
female, must include more than one among the items
1. The menopause (there is no natural menses for at least 2 years)
2. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or
other methods of infertility condition)
3. The male partner infertility before screening (Demonstrated azoospermia after
vasectomy)and if this man is the only partner of the female subject.
4. you are using one of the following contraceptive measure for 3 months before
screening, and Necessarily you agree that used continuously contraceptive measure
during the clinical trial and for 1 month after the final dosing investigational
product.(But, should not use a device of contraception or oral contraceptive drug
that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium
drug interactions during the clinical trials)
- Abstinence.
- Physical interrupt method (such as a condom, contraceptive diaphoretic or
cervical cap)
5. In case of women of childbearing age, the serum β-hCG pregnancy test is negative,
and urine β-hCG test is negative before taking the investigational product.
5.If men has sexual life with women of childbearing age, Necessarily he agrees that use
condoms during clinical trials and do not sperm donation during clinical trials and until
one month after the final dosage of investigational products 6.Those who fully understand
about this clinical trial after enough hearing, and then decided to join the clinical
trials by themselves and to comply with the precautions written consent.
Exclusion Criteria:
1. Have clinically significant disease that hepatobiliary system(severe hepatic
impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune
system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular
system (heart failure, etc.).or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can affect drug absorption (Crohn's
disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
3. hypersensitivity reaction to drug or clinically significant hypersensitivity reaction
in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin
calcium) or additives.
4. An impossible one who participates in clinical trial including screening tests(medical
history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test
result) before 28 days the taking Investigational Products.
5. Defined by the following laboratory parameters:
1. AST, ALT> 1.25* upper limit of normal range
2. Total bilirubin > 1.5* upper limit of normal range
3. CPK > 1.5* upper limit of normal range
4. eGFR(using by MDRD method) < 60 mL/min/1.73m2
6. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after
5minuts break.
7. Drug abuse or have a history of drug abuse showed a positive for urine drug test.
8. Pregnant or lactating women.
9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or
smoker(cigarette>10cigarettes/day)
10. Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before
the beginning of study treatment but investigator determine that the taking drug
affect this study or could affect the safety of the subjects.
11. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates
etc.) within 30 days.
12. Taking foods containing grapefruit within 7 days before the beginning of study
treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days
before the beginning of study treatment)
13. Subject who treated with any investigational drugs within 60days before the beginning
of study treatment (However, biologicals applies for 90 days, but can be based on a
more extended period of time by considering the half-life)
14. Previously donate whole blood within 60 days or component blood within 30days.
15. An impossible one who participants in clinical trial by investigator's decision
including laboratory test result or another reason.
16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine | NCT01842230 | Contradiction |
6,078 | 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:
- all newborn infants born at the Carmel Medical Center following parental consent, and
at Soroka Medical Center.
Exclusion Criteria:
- No parental consent; Facial deformation not related to chromosomal or genetic
anomalies; babies transferred to the neonatal intensive care unit that need
ventilatory support.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 2 Weeks | Face Anthropometric Pattern Recognition Technology for Computer Aided Diagnosis of Human Genetic Disorders. | NCT00705055 | Contradiction |
1,196 | 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:
- Symptomatic malignant pleural effusion requiring intervention
Exclusion Criteria:
- <18 years of age
- pregnant or lactating patients
- expected survival <3 months
- chylothorax
- previous attempted pleurodesis
- pleural infection
- leukocytopaenia (<1.0 x 10^9/L)
- uncorrectable bleeding diathesis
- inability to give informed consent or comply with the protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management | NCT02045121 | Entailment |
3,938 | 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:
- Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with
diagnosis of knee OA, as determined by the American College of Rheumatology (ACR)
clinical/radiographic classification criteria for OA of the knee.
- Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have
a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or
hysterectomy), and have a confirmed negative serum pregnancy test at the screening
visit prior to randomization.
Exclusion Criteria:
- History of other diseases that may involve the study joint, including inflammatory
joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections,
neuropathic disorders, avascular necrosis, Paget's disease, or tumors.
- Women of childbearing potential, or who are pregnant or lactating.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain | NCT00418782 | Entailment |
6,003 | 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:
- Current evidence of symptomatic GERD in accord with the Montreal definition
- Patients must have had troublesome heartburn and/or regurgitation (with or without
dyspepsia symptoms) of at least mild or moderate intensity on at least five days
during the week before the start of screening
Exclusion Criteria:
- Patients who have a history of drug, solvent or alcohol abuse
- Patients who have suffered cardiac chest pain within the last year.
- Patients who have suffered a recent, significant unexplained weight loss of more than
6 Kg in the last 6 months.
- Female patients of childbearing potential who, for the duration of the study, are
either unwilling or unable to take adequate contraceptive precautions or are unwilling
to be sexually abstinent
- Pregnancy or lactating mother.
- Patients with a history and/or symptom profile and/or discovered on endoscopy
suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD
(Los Angeles [LA] classification grades C-D), Barrett's esophagus, acute peptic ulcer
and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric
stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious
anaemia, indication for H-pylori eradication therapy, known gastro-intestinal bleeding
(hematochezia or hematemesis) within the last 3 months, and severe diseases of other
major body systems.
- Patients who were observed on endoscopy to have a hiatus hernia with a diameter which
exceeds 3cm.
- Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for
treating gastrointestinal disease, ulcermin or misoprostol preparations within 7 days
prior to screening or throughout the study.
- Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2
antagonists during the 5 days prior to screening or systemic glucocorticosteroids,
non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can
be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or
quadruple therapy for eradication of H-pylori during the last 28 days.
- Patients taking or requiring to take macrolide antibiotics, such as erythromycin,
azithromycin, from the day before screening.
- Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
- Patients with severe constipation, or history of intestinal obstruction.
- In the opinion of the Investigator, patients with damaged heart or kidney diseases and
patients who require a low sodium diet.
- Any previous history of allergy or known intolerance to any of the IMP's
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study | NCT01869491 | Entailment |
2,416 | 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:
- Getting a Duchenne Muscular Dystrophy diagnosis,
- Being in ambulatuar phases and independently climbing four stairs
- To be cooperate to physioterapist's directions
Exclusion Criteria:
- Having severe contracture in the lower extremity
- Having undergone surgery in the past 6 months
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy | NCT03589573 | Entailment |
2,420 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Patients with Duchenne muscular dystrophy
Exclusion Criteria:
- Patients without the ability of independent ambulation
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 18 Years | The Effect of Telerehabilitation of Patients With Duchenne Muscular Dystrophy | NCT04782440 | Entailment |
456 | 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:
- Indication for NC-IVF
- Wish for NC-IVF
- Menstruation every 26-32 days
- Accessibility of both ovaries for a follicle aspiration
- 18-42 years of age
- Written informed consent
- Indication for IUI or TSI
- Wish for IUI or TSI
Exclusion Criteria
- <18 and >42 years of age
- Gastro-intestinal diseases
- Known Ibuprofen Intolerance
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 42 Years | Can Ibuprofen Delay Ovulation in Natural Cycle-IVF? | NCT02571543 | Contradiction |
1,499 | 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:
- Known or suspected gastrointestinal disorders.
- Patients greater than or equal to 18 years of age capable of providing informed
consent.
- Existence of a referring community physician who would be able to manage care outside
of the NIH.
EXCLUSION CRITERIA:
- Significant medical illnesses that the investigators feel may interfere with potential
evaluations.
- Any medical, psychiatric, or social conditions which, in the opinion of the
investigators, would make participation in this protocol not in the best interest of
the 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 99 Years | Evaluation of People With Gastrointestinal Disease | NCT01639924 | Entailment |
3,970 | 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:
- a diagnosis of primary OA of the knee according to the ACR criteria, including
radiologic evidence of OA
- age >40 years
- symptomatic disease for at least 6 months prior to enrollment
- persistent pain despite receiving the maximum tolerated doses of conventional medical
therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory
drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the
visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during
the month prior to study enrollment
- ability to attend followup appointments
Exclusion Criteria:
- secondary causes of OA
- local or systemic infection
- diabetes mellitus
- systemic arthritis
- allergy to anesthetic agent or contrast material
- coagulopathy
- anticoagulant therapy
- had previous IA steroid injection
- avascular necrosis of bone
- patients who are on specific OA pharmacological therapy (NSAIDS, opioids) for more
than 2 weeks prior enrollment
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.
| Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial | NCT01877278 | Entailment |
6,002 | 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! | Main inclusion criteria:
- Written informed consent
- Outpatients of at least 18 years of age
- GERD
- Patients with symptoms of GERD
Main exclusion criteria:
- Signs, indicating other gastrointestinal diseases
- Other concomitant diseases
- Special restrictions for female patients
- Previous medication
- Concomitant 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.
| Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/UK-506) | NCT00261339 | Entailment |
623 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Age 35-65
- Prediabetes, or diabetes relatively well-controlled (Hemoglobin A1c [HbA1c] ≤ 8.0%)
with a single oral agent as defined by oral glucose tolerance testing (OGTT) using
criteria of the American Diabetes Association.
- Serum ferritin values in the upper 50% of the normal range, 110-400 ng/mL for males,
or 80-240 for females.
Exclusion Criteria:
- hereditary hemochromatosis;
- cancer (except cases currently with no evidence of disease);
- serum creatinine >1.5;
- anemia (Hgb < lower limit of normal);
- chronic inflammatory conditions (rheumatologic conditions such as rheumatoid arthritis
or giant cell arteritis, or chronic infections such as hepatitis B or C) that could
affect ferritin;
- erythrocyte sedimentation rate or C-reactive protein>1.5 times the upper limit of
normal (UNL);
- serum transaminases 2 x UNL;
- hemophilia,
- warfarin therapy,
- history of GI bleeding;
- current glucocorticoid therapy.
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 65 Years | Effect of Iron Reduction by Phlebotomy for Type 2 Diabetes | NCT02468037 | Contradiction |
1,706 | 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. An employee of AdventHealth (AH), or a physician with privileges there, who has
participated in PEACE Rounds at AdventHealth.
2. Over the age of 18
3. Able to provide informed consent
4. Must speak and understand English
Exclusion Criteria:
1. Discernable cognitive impairment
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.
| Exploration of Patient Ethics and Communication Excellence (PEACE) Rounds | NCT03874676 | Entailment |
3,329 | 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:
- Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Exclusion Criteria:
- Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between
the two ears at any frequency up to 4 kHz).
- Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4
kHz).
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 80 Years | Hearing Study: Sensitivity to Features of Speech Sounds | NCT03666676 | Contradiction |
627 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Biological profile suggestive of hepcidin deficiency:
- increase of transferrin saturation coefficient (> 50 %) verified on at least 2
times, and calculated from the transferrinemia.
- Proved hepatic iron overload: by the dosage of the iron hepatic concentration
either on block hepatic biopsic, or by MRI according to the method of
quantification of the iron validated overload (by adopting a threshold of 100
µmol /g)
- Patient's written consent for examination of genetic characteristics for
diagnosis and collection development for genetic and not genetic research within
the framework of an abnormality of the iron metabolism
- Patient written inform consent.
Exclusion Criteria:
- HFE hemochromatosis: homozygosity C282Y/C282Y
- Treatment with iterative phlebotomy
- Hematologic diseases with dyserythropoiesis and/or repeated transfusions
- Haptoglobin low, below normal directing towards the diagnosis of chronic hemolysis,
myelodysplasia
- Prolonged oral or parenteral iron supplementation
- Current or past excessive regular drinking
- Patient minor or under legal protection measure
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.
| Cohort of Patients With Rare Iron Overloads Excluding C282Y Homozygosity | NCT02619955 | Contradiction |
994 | 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:
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for
chronic pain.
Exclusion Criteria:
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
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.
| Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain | NCT04031092 | Entailment |
650 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Chronic hemodialysis
- Elevated serum ferritin with low to normal transferrin saturation (TSAT)
- Moderate to severe anemia
- Receiving epoetin alfa treatment
Exclusion Criteria:
- Known sensitivity to Ferrlecit®
- Medical conditions that would confound the efficacy evaluation
- Recent blood transfusion
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.
| DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) | NCT00224081 | Contradiction |
3,271 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- BMI: 18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening
- Must agree to follow specific methods of contraception, if applicable
Healthy Participants (Part A and Part B)
- Healthy male and female participants as determined by no clinically significant
deviation from normal in medical history, physical examination (PE),
electrocardiograms (ECGs), and clinical laboratory determinations
- Males and Females, ages 18, or local age of majority, to 50 years, inclusive at
screening
Participants with Sjögren's Syndrome (Part C)
- Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic
condition based on the 2016 American College of Rheumatology-European League Against
Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS)
- Seropositive for anti-Sjögren's syndrome antigen A antibody
- Males and females, ages 18, or local age of majority, to 65 years, inclusive at
screening
Exclusion Criteria:
- Woman who are pregnant or breastfeeding
- Inability to tolerate venipuncture and/or inadequate venous access
Healthy Participants (Part A and Part B)
- Any significant acute or chronic medical illness
- Any other significant medical, psychiatric, and/or social reason as determined by the
investigator
Participants with Sjögren's Syndrome (Part C)
- Systemic immune-mediated disease other than pSS, such as rheumatoid arthritis (RA),
systemic lupus erythematosus (SLE), mixed connective tissue disease, or systemic
sclerosis, that can better explain the majority of the symptoms (i.e., secondary
Sjögren's syndrome)
- Another immune-mediated disease or inflammatory condition that could interfere with
assessment of response of pSS to therapy (e.g., immunoglobulin G4 (IgG4)-related
disease, systemic sclerosis, inflammatory bowel disease, gout)
- Any other medical condition associated with sicca syndrome (e.g., history of head and
neck radiation treatment, diabetes mellitus, sarcoidosis, chronic graft-versus host
disease), participants with sicca symptoms secondary to ongoing medication use based
on the investigator's assessment
Other protocol-defined inclusion/exclusion criteria apply
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome | NCT04684654 | Entailment |
3,513 | 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:
- Chronic primary adrenal insufficiency
- Adequate hormone replacement therapy (>3 years)
- Age >18 years
- Patient's informed consent
Exclusion Criteria:
- Hormone replacement therapy with an other glucocorticoid than hydrocortisone
- Pharmacotherapy with glucocorticoids
- Congenital adrenal hyperplasia
- Coronary heart disease
- Heart failure
- Systemic disease with (potential) cardiac involvement (e.g. amyloidosis, lung
fibrosis)
- Pregnancy
- Chronic alcohol abuse
- Malignant disease
- Arterial hypertension
- Chronic renal failure (MDRD <60)
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.
| Cardiovascular Status in Adrenal Insufficiency | NCT03426319 | Contradiction |
2,402 | 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 group of 3-25 years
- Duchenne muscular dystrophy diagnosed on the basis of clinical presentation
Exclusion Criteria:
- Respiratory Distress
- Acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C
Virus malignancies
- Acute medical conditions such as respiratory infections, fever, hemoglobin less than 8
bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
- Pregnancy or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 25 Years | Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy | NCT03067831 | Entailment |
2,410 | 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. | Main Inclusion Criteria:
- Ambulatory or non-ambulatory
- Diagnosis of DMD with confirmation of minimal to no dystrophin
- Corticosteroid naive or on therapy for at least 12 months (stable dose and regimen)
Main Exclusion Criteria:
- Recent, substantial change in use of cardiac medications or medications affecting
muscle function
- Inability to undergo magnetic resonance imaging (MRI)
- Significantly compromised cardio-respiratory function
- Prior treatment with another investigational product in past 6 months
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 20 Years | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy | NCT01847573 | Entailment |
4,387 | 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:
- Be of legal age, and be between 18 and 39 years of age.
- Signed Written Informed Consent and Investigator to record this on Case Report Form
(CRF) in appropriate space.
- Require a visual correction in both eyes (Monovision not allowed)
- Require a soft contact lens spherical correction between -0.50 and -9.00D.
- Have an astigmatic correction less than 1.50D in both eyes.
- Be able to wear the lens powers available for this study.
- Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does
not regularly swim more than once a week)
- Be correctable to a visual acuity of 20/30 or better in each eye.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this
study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No clinically significant slit lamp findings
- No other active ocular disease.
- No previous ocular surgery.
Exclusion Criteria:
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of
which would affect vision or successful lens wear.
- No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema,
corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or
any other abnormality of the cornea that would contraindicate contact lens wear.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease
(e.g., HIV).
- PMMA or RGP lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately
prior to enrolment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
- Participation in any concurrent clinical trial.
- Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision
Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
- Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2
corneal scars which appear to be contact lens related (e.g. not trauma related).
- Has had an eye injury or surgery within the last eight weeks.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Clinical Trial of Several Contact Lenses in Extended Wear | NCT00762788 | Entailment |
2,394 | 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:
- DMD diagnosed with mutational testing and/or complete absence of dystrophin on muscle
biopsy
- Proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor
and going up steps)
- Male
- Age > 5 years of age
- Bone maturation (assess by bone age x-ray): </= 11 years of age
- Daily GC (prednisone or deflazacort) therapy for > 12 months
- Ambulatory
- Informed consent
- Willingness and ability to comply with all protocol requirements and procedures
Exclusion Criteria:
- Current or prior treatment with growth hormone or IGF-1 therapy
- Non-ambulatory
- Pubertal (based on clinical Tanner staging examination)
- Congestive cardiac failure
- History of intracranial hypertension
- Daytime ventilatory dependence (non-invasive or tracheostomy)
- Concomitant therapy - any other medications/supplements that would be considered, in
the opinion of the investigators, to affect muscle function, need to have been started
3 months prior to enrollment
- Patients enrolled in other clinical drug trials
- Any physical or mental conditions which may, in the investigators'opinions, render the
subject unable to complete the tasks of the study appropriately
- There will be no selection by ethnicity
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy | NCT01207908 | Entailment |
3,249 | 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:
- Gender: male or female between 18~70 years old without wearing contact lens.
- Diagnosis and classification: all patients should have the symptoms and signs of
severe dry eye (conforming to grade 3 or 4 in DEWS2007). Should have at least two
positive symptoms such as dryness, foreign body sensation, burning, asthenopia, red
eye or secretion. Tear film breakup time (TFBUT) shorter than 5 seconds and/or
Schirmer I less than 5 mm/5 min. Corneal fluorescein staining more than 6 scores and
(or) more than 3 scores of bulbar conjunctiva lissamine green liquor.
- Both eyes of all patients were preliminarily examined, the patients with single eye
that meets the criterion were also investigated. Objective indicators were
investigated on each eye. While the ocular surface disease index (OSDI) scores and
SF-36 results were evaluated on an individual base.
- All patients should not participate in other medical tests in the past 2 weeks.
- Should either not be treated with other medicine at present, or have been treated with
other medicine but had paused more than 2 weeks
Exclusion Criteria:
- Pregnant or maternity: exclude the patients who are or will be pregnant or during
breast feeding.
- Other surface diseases: exclude the patients who are suspected or complicated by other
obvious ocular surface diseases.
- Severe systemic diseases: exclude the patients with severe primary diseases in heart,
brain blood vessel, liver, kidney, hematopoietic system and so on.
- Intraocular surgery or trauma: exclude the patients with intraocular surgery or trauma
during 6 months.
- Hormone replacement therapy : exclude post-menopausal women who are treated in hormone
replacement therapy.
- Lacrimal punctum: exclude the patients who have been treated with lacrimal punctum in
1 month.
- Glaucoma or high IOP: exclude the patients who have glaucoma or high intraocular
pressure (IOP) sores.
- Exclude the patients who are sensitive to steroid.
- Exclude the patients who can't wear the therapeutic bandage contact lens during the
clinical study.
- Immunosuppressive therapies: exclude the patients who are using systemic steroid or
immunosuppressive therapies which may influent the results of the evaluation of the
therapeutic effect.
- Excluding the patients who may not be suitable for the clinical examination.
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 | Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome | NCT02147509 | Entailment |
2,609 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- males/females professional or non-professional athletes
- age 18-50 years
- unilateral or bilateral groin pain lasting > 6 weeks
- physical examination and MRI indicating sportsman's hernia
- pain above inguinal ligament in the deep inguinal ring
- grade I-II edema at pubic symphysis on MRI scan is allowed
Exclusion Criteria:
- patients not willing to participate
- inguinal or femoral hernia
- MRI reveals other major pathology
- former surgery to the actual groin
- allergy to polypropylene or other contra-indication 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.
Subject must be at most 50 Years | TEP Versus Open Repair of Sportsman's Hernia | NCT01876342 | Contradiction |
6,155 | 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:
- Age 65 years of age and older
- current season influenza immunization
- available for follow-up visits
- willing and able to sign written informed consent
Exclusion Criteria:
- HIV infection
- malignancy (under active observation or treatment)
- unstable cardiovascular diseases
- renal abnormalities (serum creatine >200umol/l)
- pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the
last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory
illness)
- acute or active chronic liver disease
- neurologic or psychiatric disease (progressive or currently under treatment
- active tuberculosis
- multiple sclerosis
- bleeding disorders
- planned surgery over the course of the trial
- on immunosuppressive therapy
- taking oral steroids at dose = to prednisone 10 mg/day or more
- taking phenelzine, pentobarbital, haloperidol, warfarin, heparin
- use of natural health products(except the study product and vitamins and minerals with
a dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea or
ginseng-containing products (tea, capsules, extracts, tablets)
- current alcohol/drug abuse
- major surgery in the past 6 months
- allergies to ginseng
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors | NCT00240461 | Contradiction |
336 | 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 reproductive age (18-39 years old) with BMI 18-30 kg/m2
- Regular menses for the last 3 months
- Cycle duration 24 to 35 days
- Women using copper IUD, sterilization, or barrier methods as current or preferred
birth control method, and women reporting exclusive sex with women
- English- or Spanish-speaking
Exclusion Criteria:
- Any contraindications to progesterone contraception per teh CDC Medical Eligibility
Criteria (Category 3 or 4)
- On medications that can alter, or be altered by, progesterone contraceptive steroid
hormone (e.g., aminoglutethimide or other anti-steroid medication)
- Use of any hormonal contraceptive pill, patch, or vaginal ring in the month prior to
recruitment
- Use of depot-medroxyprogesterone acetate in teh 10 months prior to recruitment
- Currently pregnant and/or breastfeeding
- History of allergic reaction to depot medroxyprogesterone acetate (rash, urticaria,
anaphylaxis)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Depot Medroxyprogesterone Acetate as Emergency Contraception | NCT03395756 | Contradiction |
2,126 | 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:
- Klinefelter
- 15-40 years of age
Exclusion Criteria:
- inability to understand the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 40 Years | Subcapsular Orchiectomy in Men With Klinefelter Syndrome | NCT01750632 | Entailment |
1,527 | 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 for both partners of the male couple:
- self-reported that currently self-identifies as a male
- self-reported in a sexual relationship with another self-identified male
- self-reported relationship length between 1 and 12 months
- self-reported anal sex with relationship partner in past 2 months
- owns and uses an Internet-connected smartphone or tablet
- resides in the U.S.
- self-reported ability to read and understand English-language
Exclusion Criteria:
- Does not meet one or more the inclusion criteria
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Acceptability, Feasibility and Preliminary Impact of OurPlan, an mHealth HIV Prevention Intervention for Male Couples | NCT04836091 | Contradiction |
5,823 | 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:
- • Subject must be at least 22 years of age and must be less than 75 years of age with
a life expectancy > 3 years.
- Subject is a suitable surgical candidate, i.e., is able to undergo general
anesthesia and laparoscopic surgery.
- Subject has documented typical symptoms of gastroesophageal reflux disease (GERD)
for longer than 6 months (regurgitation or heartburn that is defined as a burning
epigastric or substernal pain that responds to acid neutralization or
suppression).
- Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for
≥ 4.5% of the time Note: Subjects will have discontinued any GERD medications for
at least 10 days prior to testing.
- Subject has a symptomatic improvement on proton-pump inhibitor (PPI) therapy
demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10
on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6-point
improvement when comparing his/her on-PPI and off-PPI GERD-HRQL score.
- Subject has GERD symptoms in absence of PPI therapy (minimum 10 days).
- If the subject is of child-bearing potential, she must have a negative pregnancy
test within one week prior to implant and must agree to use effective means of
birth control during the course of the study.
- Subject is willing and able to cooperate with follow-up examinations.
- Subject has been informed of the study procedures and the treatment and has
signed an informed consent form.
Exclusion Criteria:
- • The procedure is an emergency procedure.
- Subject is currently being treated with another investigational drug or
investigational device.
- Subject has a history of gastroesophageal surgery, anti-reflux procedures, or
gastroesophageal/gastric cancer.
- Subject has undergone any previous endoscopic anti-reflux intervention for GERD.
- Subject has suspected or confirmed esophageal or gastric cancer.
- Subject has any size hiatal hernia >3cm as determined by endoscopy.
- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
- Subject has esophagitis Grade C or D (LA Classification).
- Subject has a Body Mass Index (BMI)>35.
- Subject has symptoms of dysphagia more than once per week within the last 3
months.
- Subject is diagnosed with Scleroderma or an esophageal motility disorder such as
but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm
or Hypertensive LES.
- Subject has a history of or known esophageal stricture or gross esophageal
anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
- Subject has esophageal or gastric varices.
- Subject has a history of or known Barrett's esophagus.
- Subject cannot understand trial requirements or is unable to comply with the
follow-up schedule.
- Subject is pregnant or nursing or plans to become pregnant during the course of
the study.
- Subject has a medical illness (e.g., congestive heart failure) that may cause the
subject to be non-compliant with or unable to meet the protocol requirements or
is associated with limited life expectancy (i.e., less than 3 years).
- Subject is diagnosed with a psychiatric disorder (e.g., bipolar, schizophrenia,
etc.); however, subjects who exhibit depression but are on appropriate
medication(s) may be included.
- Subject has suspected or known allergies to titanium, stainless steel, nickel, or
ferrous materials.
- Subject has an electrical implant or metallic abdominal implants.
- Subject is not a surgical candidate for open laparotomy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 74 Years | Omega Cuff for GERD Feasibility Study | NCT04793035 | Contradiction |
3,955 | 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:
- Male or female patient, older than 40 years of age, with knee osteoarthritis, based on
clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:
1. Pain on movement of the affected knee for more than 15 days in the previous month
with at least partial relief at rest;
2. Presence of osteophytes at least 1 mm in radiological imaging;
- Knee osteoarthritis symptoms for at least six months prior to randomization.
Exclusion Criteria:
- Concomitant arthropathy that may confuse or interfere with assessing the efficacy or
pain;
- Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the
absence of radiological findings already described;
- History of significant injury on collateral ligament, or anterior cruciate, or
meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
- Arthroscopy of the affected knee in last 6 months;
- Serum creatinine ≥ 1.8 mg/dL;
- Diagnosis of diabetes mellitus;
- Presence of any serious disease that could compromise the study, at the investigator
discretion;
- History of adverse event or allergy to acetaminophen, glucosamine sulfate or
chondroitin sulfate;
- Inability to understand and report the study questionnaire and the Visual Analogic
Scale;
- Inability to understand and consent to participate in this clinical study, expressed
by signing the Informed Consent (IC);
- Woman in pregnancy.
- If female of childbearing potential, has a negative urine pregnancy test at Visit 0
and do not use, or do not agree to use, for the duration of the study, a medically
acceptable form of contraception as determined by the investigator;
- Alcohol intake ( > 3 doses/day);
- Oral or intramuscular corticosteroids four weeks prior to study entry;
- Intra-articular injections with corticosteroids, into the studied knee, within the
past three months;
- Intra-articular injections in any other joint within the past four weeks;
- NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less,
once daily) is allowed for cardio-protective benefit;
- Intra-articular injections of hyaluronic acid within the past 12 months;
- Use of topical analgesic in the joint studied or any other oral analgesic (with the
exception of acetaminophen and other NSAID) two weeks prior to randomization;
- Implementation of any other medical treatment for osteoarthritis one month prior to
study entry;
- Participation in last one year of clinical protocols, unless it can be direct benefit
to patient;
- Use of glucosamine and/or chondroitin sulfate three and six months prior the study
entry, respectively;
- Initiation of physical therapy two months prior to the study period;
- Use of tetracycline and oral anticoagulants;
- Use of vitamin D in doses in doses above the recommended;
- Patients in alternative therapies;
- Allergy to sulfonamides;
- Presence of psychiatric disorders that could compromise 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 40 Years old.
| Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis | NCT02010918 | Entailment |
5,592 | 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:
- Ages 3 to 11 years (inclusive).
- Must have had normal growth hormone (GH) response (i.e., peak GH concentration ≥10
ng/mL) to GH provocative tests such as Arginine Insulin Tolerance Test (AITT) or
Arginine Clonidine Tolerance Test (ACTT).
- Pre-pubertal status (i.e. Tanner stage 1 for breast development for girls and
testicular enlargement for boys and pubic hair for both sexes).
Exclusion criteria:
- Ages younger than 3 years or older than 11 years.
- Medical history of a neurologic, endocrinologic, genetic, or metabolic problem known
to have a direct effect on height growth. This includes, but is not limited to,
children with Down syndrome, Turner syndrome, Russel-Silver syndrome, Prader-Willi
syndrome, Pseudohypoparathyroidism, chronic kidney disease, malabsorptive syndromes,
cancer survivors, etc.
- Currently being treated or previously treated with Growth hormone, or history of oral
steroid treatment within the last 3 months.
- Being in puberty.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Nutritional Stimulation of Growth in Children With Short Stature Without Growth Hormone Deficiency | NCT04226586 | Contradiction |
6,260 | 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:
- Patients admitted to participant institutions with respiratory symptoms or diagnosed
as compatible with COVID-19.
Exclusion Criteria:
- None.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 120 Years | Characteristics of Patients and Healthcare Workers With COVID-19 in Meta State, Colombia | NCT04456426 | Contradiction |
6,040 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients with GI disorders who have failed standard therapy
- Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux
disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related
laryngitis, and respiratory symptoms; or c) severe dyspepsia
- Completion of a comprehensive evaluation, including clinical history and physical
examination, to eliminate other causes of their symptoms
- Patient has signed the informed consent document agreeing to the use of the study
drug, domperidone
- White blood cell (WBC) with differential greater than 3,000/ml
- Alkaline phosphatase less than 1.5 x upper limit of normal
- Alanine aminotransferase (ALT) less than 2 x upper limit of normal
- Aspartate aminotransferase (AST) less than 2 x upper limit of normal
- Bilirubin less than or equal to 2 x upper limit of normal
- Blood urea nitrogen (BUN) less than 2 x upper limit of normal
- Creatinine less than 1.5 x upper limit of normal
- Stable hemoglobin greater than or equal to 8.0 g/dl
- Potassium between range of 3.0 to 5.5
- Magnesium level between 1.6-2.6 mg
Exclusion Criteria:
- Patients with the following cardiac diagnoses: ventricular tachycardia or
fibrillation; Torsades de pointes; clinically significant bradycardia; sinus node
dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450
milliseconds for males, QTc > 470 milliseconds for females); valvular, ischemic, or
pulmonary heart disease; cardiomyopathy; history of heart failure
- Patients who are receiving antiarrhythmic medications with action on repolarization
times (with prolongation of the QTc interval such as amiodarone, disopyramide,
dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)
- Patients who are receiving monoamine oxidase (MAO) inhibitors
- Patients with a history of or active liver failure
- Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or
potassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6
- GI hemorrhage or obstruction experienced within the previous 6 weeks
- Presence of a prolactinoma (prolactin-releasing pituitary tumor)
- Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as
not post-menopausal for 12 months or without previous surgical sterilization, must
have a negative urine pregnancy test within 30 days of the first administration of
domperidone and must either commit to continued abstinence from heterosexual
intercourse or use an effective method of birth control during the course of the
study)
- Known allergy to domperidone
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Domperidone in Treating Patients With Gastrointestinal Disorders | NCT01696734 | Entailment |
5,490 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Patients suffering from signs and symptoms consistent with TA and who have not
undergone previous temporal artery biopsy will be included.
Exclusion Criteria:
- Patients suffering from isolated polymyalgia rheumatica will be excluded.
- Patients who are already undergoing steroid treatment will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Sensitivity and Specificity of Color Doppler Directed Temporal Artery Biopsy as Compared to Standard Random Biopsy in the Diagnosis of Temporal Arteritis | NCT00361192 | Contradiction |
2,555 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | - INCLUSION CRITERIA:
Enrolled in protocol 02-I-0055.
A person who is at least 14 years old.
Acute onset (within 14 days of visit to NIH) of an annular, erythematous, expanding
erythema migrans (EM)-like rash that attains a size of at least 5 cm in diameter, when no
alternative explanation for the rash can be found, and thought by the study physician to
have a high likelihood to be due to STARI (due to exposure history, tick identification).
History of tick bite at the rash site, or potential exposure to ticks in the southeastern
and south central United States within 14 days prior to rash onset (including Maryland and
Virginia).
Consent to storage of biologic samples for later testing.
EXCLUSION CRITERIA:
A person who, in the judgment of the investigator, would be at increased risk from the skin
biopsy procedure and unlikely to be able to mount a serological response to the agent (for
example, bone marrow transplant, B cell deficiency).
EXCLUSION FROM SKIN BIOPSY PORTION OF STUDY:
A person who meets the case definition but whose EM-like rash occurs on the face, neck,
scalp, or over the tibia will not be enrolled for purposes of obtaining a skin biopsy
specimen. Such a person may enroll for purposes of providing a clinical history and blood
samples only. This exclusion also applies to patients with a history of forming large thick
scars after skin injuries or surgery, or who have a history of excessive bleeding after
cuts or procedures or are taking anticoagulants, or have severe skin disease. Also,
patients who have received more than 24 hours of antibiotic treatment for the rash will be
excluded from the biopsy. Patient with a history of allergy to lidocaine will also be
excluded from the biopsy portion 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 14 Years old.
| Investigation of Southern Tick-Associated Rash Illness (STARI) | NCT00358761 | Contradiction |
5,507 | 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:
- Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.
- Have a firm clinical diagnosis of GCA or PMR, or (for patients identified
prospectively) GCA or PMR should be more likely than any alternative explanation for
the patient's symptoms.
- Able and willing to give informed consent. Patients will be 50 years of age or over,
unless both biopsy-proven and a clinically classical case of GCA.
Exclusion Criteria:
• Patient unwilling or unable to give fully 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 50 Years old.
| Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR) | NCT04102930 | Entailment |
3,057 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Fragile X Syndrome with a molecular genetic confirmation of the full FMR1 mutation.
- Results from previously completed testing are acceptable with written
documentation of the genetic results.
- Results from PCR or Southern blot tests are acceptable
- Results from cytogenetic testing are not acceptable but subject may be eligible
if molecular genetic testing is redone.
- A full mutation with mosaicism is allowed if:
- Subject manifests full phenotypic profile of Fragile X syndrome
- CGG Repeats >200 are detected
- Southern blot prevails over PCR, if Southern blot shows >200 repeats and PCR
results show <200 repeats.
- The following results would not meet criteria:
- Deletions
- Point mutations
- Mosaicism without detection of >200 CGG repeats or absence of full
phenotypic profile in an individual with mosaicism
2. Males, aged 12-45 years
3. Subjects with a Clinical Global Impression - Severity (CGI-S) score of 4 or greater at
Screening
4. Subjects with a total score of 30 or greater on the Aberrant Behavior Checklist (ABC)
at Screening.
5. Current treatment with no more than 3 psychotropic medications. This includes
medications used to treat problems with sleep onset and sleep continuity. Melatonin
for difficulties with sleep onset is permissible and is excepted from the count of
psychotropic medications. Similarly, anti-epileptic medications are permitted and are
not denoted as "psychotropic medications" if they are used for treatment of seizures.
Use of anti-epileptics for other indications such as the treatment of mood disorders
counts towards the limit of permitted medications. Concurrent use of omega-3 fatty
acids is also permissible and does not count towards the allowed number of concomitant
psychotropic medications. A complete list of permitted concomitant psychotropic
medications can be found in Appendix A.
6. Concomitant medications for chronic medical conditions are permissible. Examples of
chronic medical conditions include gastroesophageal reflux disease (GERD) and asthma.
Every effort should be made to keep the doses and dosing regimens of these medications
stable in the 4 weeks preceding Screening and during the period between Screening and
the commencement of study medication.
1. Permitted psychotropic concomitant medications (except for anti-epileptic
medications-see below) must be stable, in terms of dose and dosing regimen, for
at least 4 weeks prior to Screening and must remain stable during the period
between Screening and the commencement of study medication.
2. Anti-epileptic medications must be at a stable dose and dosing regimen for 12
weeks prior to Screening and must remain stable during the period between
Screening and the commencement of study medication
7. Behavioral treatments excluding psychotherapy (see exclusion criteria) must be stable
for 4 weeks prior to Screening and must remain stable during the period between
Screening and the commencement of study medication
a. For each enrollee, every effort should be made to maintain stable regimens of
allowed concomitant medications and allowed behavioral therapies from the time of
commencement of single-blind study medication until the last study assessment.
8. Sufficient expressive language capabilities to complete the Expressive Language
Sampling Task.
9. Individuals with a history of seizures should have a stable pattern of seizure
activity in the 3 months preceding Screening.
Exclusion Criteria:
1. Treatment within the two weeks prior to Screening with monoamine (MAO) inhibitors,
lithium, minocycline, acamprosate, racemic baclofen, investigational metabotropic
glutamate receptor subtype 5 (mGluR5) medications, d-cycloserine, oxytocin,
carbetocin, tricyclic antidepressants and bupropion.
2. Patients planning to commence psychotherapy, including cognitive behavior therapy
(CBT), during the period of the study or those who had begun psychotherapy, including
CBT, within 6 weeks prior to Screening.
3. History of, or current, cardiovascular, renal, hepatic, respiratory and/or
gastrointestinal disease, which may interfere with the absorption, distribution,
metabolism or excretion of the study medication, or which may interfere with the
interpretation of the safety/tolerability or efficacy of the study medication.
4. History of, or current cerebrovascular disease or clinically significant brain trauma.
5. History of, or current clinically significant endocrine disorder, e.g. hypo or
hyperthyroidism, or diabetes.
6. History of, or current malignancy.
7. Current major depressive disorder (patients have to be free of the most recent episode
for 3 months prior to enrollment).
8. History of a DSM-5-defined substance use disorder in the 3 months prior to Screening.
9. Clinically significant abnormalities in safety laboratory tests, vital signs or ECG,
as measured at Screening.
10. QT/QTcF Exclusions (any of the following):
- QTcF > 450 msec. Three ECGs should be obtained at the time of Screening, 5
minutes apart from each other, and the results should be averaged.
- History of risk factors for torsade de pointes (e.g. heart failure, clinically
significant hypokalemia or hypomagnesemia, or a family of long QT syndrome).
- A serum potassium at screening <3.0 mmol/L.
- QT/QTcF prolongation previously or currently controlled with medication, in which
normal QT/QTcF intervals could or can only be achieved with medication
- Current treatment with other medications that have demonstrated QT/QTc
prolongation and have this risk described in the Warnings and Precautions section
of their Prescribing Information
11. Patients with significant hearing and/or visual impairments that may affect their
ability to complete the test procedures.
12. Current treatment with insulin
13. Hgb A1C values outside of the normal reference range at Screening
14. Current or past treatment with insulin like growth factor IGF-1
15. Current or past treatment with growth hormone
16. Enrollment in another clinical trial within the 30 days preceding Screening
17. Previously randomized in this clinical trial
18. Allergy to strawberry
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 45 Years | A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome | NCT01894958 | Entailment |
1,634 | 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. Age > 18 years.
2. Wrist pathology based on clinical examination/imaging studies undergoing wrist
arthroscopy for further evaluation/treatment.
3. Willingness to participate in the study
Exclusion Criteria:
- 1. Age < 18 years.
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.
| Wrist Arthroscopy Study | NCT04457362 | Entailment |
5,424 | 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 :
-- Male and/or female participant, between 18 and 65 years of age, inclusive at the time of
informed consent.
- The participant has been diagnosed with hereditary type 3 VWD or type 2N VWD as
documented in historical medical records OR a documented genotype known to produce VWD
type 3 or 2N VWD.
- Type 3 VWD participants are included if they have a medical history of at least 25
exposure days to VWF-containing coagulation factor concentrates - - - -
Exclusion criteria:
- Hereditary or acquired coagulation disorder other than VWD (including qualitative and
quantitative platelet disorders, and thrombocytopenia < 100,000 cells/uL at Screening)
- The participant has a FVIII activity levels >20 IU/dL, at Screening
- History or presence of a VWF inhibitor or clinical suspicion of a VWF inhibitor
- History of a positive FVIII inhibitor test, defined as ≥0.6 BU/mL (by Nijmegen
modified Bethesda assay) or a clinical suspicion of a FVIII inhibitor
- Positive FVIII inhibitor test, defined as ≥0.6 BU/mL, at Screening
- History of hypersensitivity or anaphylaxis associated with any FVIII- or VWF-
containing product
- The participant has received or anticipates receiving systemic immunosuppressive or
immunomodulatory treatment within 12 weeks prior to Baseline.
- The participant requires the use of acetylsalicylic acid, non-NSAID anti-platelets,
and NSAIDs above the maximum dose product
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a 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.
Subject must be at most 65 Years | To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) | NCT04770935 | Entailment |
5,051 | 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 for ET subjects:
1. Outpatients with essential tremor as diagnosed and confirmed by movement disorder
specialist
2. Women of child-bearing potential must provide a negative pregnancy test at entry into
the study
3. Stable doses of all medications for at least 14 days prior to study entry and for the
duration of the study,
4. At least a 1cm amplitude tremor as judged by the screener using a ruler
Inclusion Criteria for Healthy Volunteers:
1. Healthy subjects without tremor and without significant neurologic disease suggestive
of cerebellar ataxia or other neurodegenerative diseases
2. Ages 18-80
Exclusion Criteria:
1. Any unstable illness or concomitant medical condition that, in the investigator's
opinion, precludes participation in this study, including disorders that may affect
gait or balance (i.e., stroke, arthritis, etc).
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed
consent (Montreal Cognitive Assessment Score score less than or equal to 21).
5. Legal incapacity or limited legal capacity.
6. Tremor derived from any cause other than essential tremor (Parkinson's disease,
drug-induced, anxiety-induced) in the clinical assessment at screening
7. Currently taking lithium or amiodarone or any other drug judged to be contributing to
tremor as judged by the investigator (may be a cause of tremor)
8. No medication is an absolute exclusion from TMS. Medications will be reviewed by the
responsible MD and a decision about inclusion will be made based on the following:
- The patient's past medical history, drug dose, history of recent medication
changes or duration of treatment, and combination with other Central Nervous
System active drugs.
- The published TMS guidelines review of medications to be considered with TMS
9. History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or
family history of treatment resistant epilepsy with the exception of a single seizure
of benign etiology (e.g. febrile seizures) in the judgement of the investigator
10. TMS and MRI-Specific exclusion criteria including:
- Known metal in the head (such as a surgical aneurysm clip) or a history of prior
neurosurgical procedures.
- Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic
means, such as cochlear implants, pacemakers, medication pumps, vagal
stimulators, deep brain stimulators, neurostimulators, biostimulators, or
ventriculo-peritoneal shunts.
- Subjects who have or might have bullet fragments or other shrapnel (veterans or
workers exposed to metal in their work environment).
- Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic
eyeliner)
- Subjects expressing significant claustrophobia.
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 80 Years | Transcranial Stimulation for Essential Tremor | NCT03025529 | Entailment |
4,641 | 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: any benign uterine pathology such as:
- fibroid uterus
- endometrial hyperplasia with failed hormonal therapy
- DUB with failed medical and hormonal treatment
- uterine prolapse.
Exclusion Criteria:
- gynecologic malignancy
- presence of contraindications to laparoscopy.
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Laparoscopic Hysterectomy With Prior Uterine Artery Ligation | NCT04522232 | Entailment |
5,860 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male and female subjects ages 18 or older
- Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
- Undergoing upper endoscopy and wireless pH monitoring (standard of care)
- Erosive disease: presence of esophageal mucosal injuries documented
- Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
- Control group: normal subjects without symptoms of GERD
Exclusion Criteria:
- Anti-reflux therapy within 7 days prior to the pH study
- Previous neck, esophagus, or stomach surgery
- Major motility disorders
- Previous neck, esophagus, or stomach cancer or radiations
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)? | NCT01204931 | Contradiction |
1,213 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the
criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a
Karnofsky index score of more than 60 and life expectancy of more than one year).
2. Rapidly accumulated undiagnosed pleural effusion .
3. Age : 30-75 years old.
Exclusion Criteria:
1. Transudative pleural effusion.
2. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic ,
post-tuberculous pleural effusion )
3. Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count
<80,000/mm 3 )
4. Active pleural or systemic infection.
5. Neoplastic infiltration of the skin at the site of pleural catheter insertion.
6. Malignant pleural effusion with trapped lung or loculated pleural effusion.
7. Previous lobectomy or pneumonectomy on the affected side.
8. Karnofsky index score> 50.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 Years | Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis | NCT03781908 | Entailment |
530 | 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:
- Undergoing frozen embryo transfer
- Endometrial prepared by exogenous hormonal regimen
- Permanent resident in Vietnam
Exclusion Criteria:
- Having > 2 embryo transfer attempts
- Having embryo(s) from donors cycles
- Having embryo(s) from IVM
- Having embryo(s) from PGT/PGS
- Having endometrial abnormalities: polyp, sub-mucosal fibroid, cesarean scar defects,
endometrial hyperplasia, endometrial fluid accumulation, endometrial adhesion.
- Participating in another IVF study at the same time
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Progesterone Versus Progesterone Plus Dydrogesterone in FET | NCT03998761 | Contradiction |
1,870 | 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 proven adenocarcinoma of the stomach or gastroesophageal junction
without gross or microscopic evidence of residual disease after surgery with curative
intent;
- Subtotal or total gastrectomy with at least D1 dissection;
- Gastroesophageal junction adenocarcinoma extending to the stomach with the center
lying 2 to 5 cm below the anatomic esophago-gastric junction;
- Patients with nodal involvement (pN+) or patients without nodal involvement (pN0) with
pT2b-3-4. It is recommended to examine at least 15 lymph nodes;
- Age between 18 and 75 years;
- ECOG performance status 0-1;
- No previous chemotherapy and/or radiotherapy;
- Complete staging procedures within 3 months prior to randomization;
- Laboratory requirement (within 8 days prior to randomization):
- Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin >
10g/dL);
- Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5xUNL,
Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL associated
with alkaline phosphatase > 2.5XUNL are not eligible.)
- Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the
calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min.
- Recovery from acute effects of surgery. The first infusion of study chemotherapy
should be administered 3 to 8 weeks after surgery treatment;
- Written informed consent signed and dated before randomization procedures, including
expected cooperation of the patients for the treatment and follow-up, must be obtained
and documented according to the local regulatory requirement.
Exclusion Criteria:
- Non-radical surgery as assessed microscopically (no tumor-free margin of resection,
positive biopsy of peritoneal suspicious lesions);
- Synchronous metastases, even curatively resected;
- Pregnant or lactating patients; patients with reproductive potential must implement
adequate contraceptive measures;
- Prior or concurrent history of:
- positive HIV serology,
- chronic diarrhoea,
- chronic bowel inflammation or subobstruction,
- neoplasm other than gastric cancer, except for: curatively treated non-melanoma
skin cancer, in situ carcinoma of the cervix,
- previous history of myocardial infarction within 1 year from study entry,
- hypersensitivity reaction to polysorbate 80;
- Presence of other systemic disease limiting drug administration and influencing
patient survival:
- uncontrolled hypertension,
- high-risk uncontrolled arrhythmia,
- unstable angina pectoris;
- Symptomatic
- peripheral neuropathy,
- altered hearing > 2 grade by NCIC-CTG criteria;
- Active uncontrolled infection.
- Definite contra-indications for the use of corticosteroids: unstable diabetes
mellitus, active peptic ulcer;
- Concurrent administration of:
- corticosteroids or equivalent except as use for the prophylactic medication
regimen, treatment of acute hypersensitivity reactions or unless chronic
treatment (initiated > 6 months prior to study entry) at low doses (< 20mg
methylprednisolone or equivalent);
- any other experimental drug under investigation: concurrent treatment with any
other anticancer therapy, growth factors with preventive intent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach | NCT01640782 | Entailment |
5,885 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Male or Female between 18 and 60 years
2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease
(heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal
pain)
3. Subject without any medication (except oral contraception)
4. Subject without previous digestive surgery history (except appendicectomy)
5. Capability to pass manometric probes through each nostril
6. Subject with health insurance
7. Written informed consent
8. No participation to another study at the same time
Exclusion Criteria:
1. Age under 18 years or upper 60
2. Pregnant woman or lactation
3. Incapability to give consent
4. No written informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry | NCT00931593 | Contradiction |
5,329 | 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
- Provision of informed consent
- Age: 18 years or older
- Subjects with a single-rooted tooth indicated for extraction bounded by stable,
natural teeth
- Tooth planned for extraction must have a dehiscence defect in the surrounding bone,
observed clinically and/or radiographically, that affects at least 50% of the bone
height
- Subjects must be interested in replacing the tooth with a single implant-supported
fixed restoration
- Subjects must be able and willing to follow instructions related to the study
procedures
- Subjects must have read, understood and signed an informed consent form
EXCLUSION CRITERIA
- Mandibular incisors
- Subjects with a history of organ failure (e.g. liver, kidney)
- Subjects with severe hematologic disorders, such as hemophilia or leukemia
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as
osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone
metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or
chronic intake of glucocorticoids
- Pregnant women (as indicated by positive serum HCG test) or nursing mothers
- Subjects with conditions that would result in compromised healing (e.g. poorly
controlled diabetes, active heavy tobacco use [>10 cigs/day])
- Subjects who, at the discretion of the investigators, would be unsuitable candidates
for the study due to safety, psychological or practical reasons (e.g. known allergies
to any product used for the study, limited mouth opening, etc.)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Treatment of Post-Extraction Dehisced Socket - A Case Series Study | NCT02980211 | Contradiction |
3,050 | 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:
- Patients with one of the following rare diseases associated with : Angelman syndrome,
Smith-Magenis syndrome, X Fragile syndrome, rare diseases of the cerebellum, rare
epilepsies, PW-like syndromes or other rare diseases with eating disorders
- Patients aged minimum 3 years and maximum 50 years.
- Patients with overweight (or obesity) and/or hyperphagic behavior.
Exclusion Criteria:
- Administrative problems: impossibility of giving parents or legal guardians informed
information ; no coverage by a Social Security scheme.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 50 Years | Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity | NCT04768803 | Entailment |
5,274 | 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:
- the risk of osteoporosis
- the risk of falls
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years | Development of Intervention Model for Osteoporosis and Fall Prevention in Taiwan | NCT01206491 | Entailment |
6,013 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- 1. Subject is 21 - 70 years of age at the time of informed consent 2. Subject has
documented symptoms of GERD (heartburn and/or regurgitation) for longer than 12
months, which respond at least partially to proton pump inhibitors (PPIs) 3. Subject
is under continuous PPI therapy for at least 6 months 4. Subject has a diagnosis of
GERD based on at least 2 of the following criteria:
1. Past demonstration of reflux esophagitis grade A, B or C (LA classification)
2. Abnormal esophageal acid exposure during esophageal pH-impedance monitoring
(defined as distal esophageal pH < 4 for > 4 % of the monitoring time) performed
after at least 7 days off of PPIs
3. Positive symptom association between GERD symptoms and reflux episodes (symptom
association probability ≥ 95%) demonstrated at pH-impedance monitoring)
Exclusion Criteria:
- Subjects who meet any of the following exclusion criteria cannot be enrolled in the
study:
1. Subject underwent previous surgery involving the gastroesophageal junction, such
as a Nissen fundoplication
2. Subject underwent previous endoscopic intervention for the treatment of GERD
and/or Barrett's esophagus
3. Subject has a hiatal hernia larger than 3 cm as determined by endoscopy
4. Subject has history of gastroparesis
5. Subject has any non-GERD esophageal motility disorders that in the opinion of
investigator precludes an anti-reflux procedure
6. Subject has history of or known esophageal stricture or significant esophageal
anatomic abnormalities (obstructive lesions, etc.)
7. Subject has Barrett's epithelium or any grade of dysplasia
8. Subject has documented history of esophagitis Grade D (LA Classification)
9. Subject has a history of suspected or confirmed esophageal or gastric cancer
10. Subject has esophageal or gastric varices
11. Subject has symptoms of dysphagia more than once per week every week within the
last 3 months
12. Subject is unable to tolerate withdrawal from PPI medications
13. Subject has a body mass index (BMI) > 35 kg/m2
14. Subject has any significant multisystem diseases
15. Subject has an autoimmune or a connective tissue disorder (scleroderma,
dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST),
Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2
years
16. Subject has Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus
(T2DM) defined as HbA1c > 9.5 in the previous 6 months or at screening/baseline
17. Subject has had a significant cerebrovascular event within the last 6 months
18. Female subject of child-bearing potential and is pregnant or nursing, or intends
to become pregnant during the trial period, who is not using a reliable form of
birth control
19. Subject is currently enrolled in other potentially confounding research
20. Subject has an active infection as determined by the investigator
21. Subject has a history of any malignancy in the last 2 years
22. Subject has a life expectancy less than 3 years
23. Subject has a diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
24. Subject has any condition that, at the discretion of the investigator or sponsor,
would interfere with accurate interpretation of the study endpoints or preclude
participation in the trial
25. Subject has a diagnosis of eosinophilic esophagitis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 70 Years | Endomina Suturing Device as a Treatment of GERD. | NCT03999502 | Entailment |
5,985 | 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:
- outpatients
- chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation),
evaluated by standard questionnaire
- undergo upper digestive endoscopy
Exclusion Criteria:
- age less than 18 years old or more than 90 years old
- unable to complete upper endoscopy
- known diagnosis of gastroesophageal malignancy
- follow-up visit for known gastroesophageal lesion identified by previous upper
endoscopy
- failure to obtain informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms | NCT00730106 | Entailment |
4,629 | 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:
- Candidates for laparoscopic hysterectomy for benign indications
Exclusion Criteria:
- Malignancy of the uterus, cervix or adnexa
- pre-malignant changes of the uterus, cervix or adnexa
- history of severe cervical dysplasia (CIN II or above)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy | NCT00734812 | Entailment |
4,778 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Visit emergency department and stay in observation unit.
- Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory
vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders -
Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis.
Exclusion Criteria:
1. Serious comorbid conditions (for example, life-threatening condition or progressive
central disorder).
2. Patients who cannot communicate reliably with the investigator or who are not likely
to obey the instructions of the trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 90 Years | Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial | NCT02358239 | Entailment |
1,310 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Infertile women who undergo IVF with PGT
- BMI:18~30 kg/m2
Exclusion Criteria:
- Primary ovarian insufficiency
- Congenital uterine anomaly
- Severe male infertility (azoospermia)
- One of the couples with chromosome abnormality
- Malignancy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 44 Years | Clinical Application of Non-invasive PGT-A | NCT04856696 | Contradiction |
3,086 | 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:
- Age 4 to 17 years
- Presence of intellectual disability
- Need of peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
Exclusion Criteria:
- Presence of abrasion, infection or break in skin in the area of Buzzy® placement
- Cold hypersensibility
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 17 Years | Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability | NCT02434731 | Entailment |
2,486 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Eye impairment
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.
| Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition | NCT00013377 | Entailment |
6,303 | 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:
- Age over 60 years old.
- Patient with at least 3 of the symptoms of COVID-19 encountered among the 11 below
dating from a maximum of 4 days defined below :
1. Fever > 37.5 C for at least 3 days
2. Cough
3. Sore throat/cold
4. Headache
5. Anosmia, dysgeusia
6. Myalgias, arthralgias, bone pain
7. Respiratory difficulties (feeling dyspnea at rest)
8. Chest pain (sternal)
9. Digestive complaints (diarrhea, nausea, vomiting)
10. Tachycardia (palpitation)
11. Conjunctivitis (red eyes)
- Patient who has taken a naso-pharyngeal sample (antigenic test, RT-PCR, RT-LAMP or
other samples validated by the upcoming HAS) In the case of a negative test, the
concept of contage (with a certain or probable COVID patient) dates back less than 10
days.
- No seriousness signs during the consultation and for at least 72 hours.
- Patient able to understand the procedure and follow it and have tools for a
video-consultation.
- Affiliation to the social security system.
- Voluntary to participate to the study, informed consent form signed after appropriate
information
Exclusion Criteria:
- The absence of general practitioner.
- Any sign of seriousness incompatible with home care.
- Severe chronic kidney failure or dialysis (i.e. DFGe <30).
- drink cure Contraindication (500 ml/d for 21 days).
- Contraindication to any drug in the study, including a known allergy, especially
magnesium.
- Uncontrolled and clinically significant heart disease, whether its origin
(arrhythmias, angina, uncompensated congestive heart failure).
- Subject participating to an other clinical study interventional.
- Person deprived of liberty or under legal guardianship.
- No one in the same household who participated in this study.
- Patient refusing hospitalization.
- Persons subject to sections L1121-7 and L1121-8 of the CSP (minor, person deprived of
liberty by judicial or administrative decision, person subject to a legal protection
measure) or not able to communicate his consent verbally.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care | NCT04716985 | Entailment |
633 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Patients with clinical diagnosis of hereditary hemochromatosis
2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary
hemochromatosis
3. Patients with serum ferritin and TSAT levels above treatment guidelines
4. Female patients of child bearing potential must have a negative pregnancy test and
must be using a highly effective method of contraception during participation in the
study, and for 30 days after the last dose of study drug
5. Males must be surgically sterile (vasectomy), or using a highly effective method of
contraception during participation in the study, and for 30 days after the last dose
of study drug
6. Patient must be willing and able to provide written informed consent
Exclusion Criteria:
1. Patients receiving iron chelation therapy within 7 days prior to the first dose of
study drug
2. Patients initiating phlebotomy treatments less than 3 months prior to the first dose
of study drug
3. Pregnant or lactating women
4. Patients taking an immunosuppressive agent without prior Sponsor approval
5. Patients participating in an unapproved investigational drug or investigational
therapeutic device within 30 days of study drug
6. Patients who are unwilling or unable to comply with the study protocol requirements
7. Patients with type 1 or poorly controlled type 2 diabetes
8. Patients with a concomitant disease, disability or condition, including laboratory
abnormality and ECG findings, which may interfere with the conduct of the study, or
which would, in the opinion of the Investigator, pose an unacceptable risk to the
patient in this study, including, but not limited to, clinically significant
arrhythmias, alcohol dependency or abuse, drug dependency or abuse, or psychiatric
disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis | NCT03395704 | Contradiction |
4,801 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Participants must have self-reported symptoms of visually-induced dizziness
- Participants must have normal self-reported cognitive function
- Participants must speak English fluently
- Weigh less than 225 pounds
- Be able to support their body weight in an upright posture for 15 minutes at a time
- Be able to follow the guidelines regarding permitted and prohibited additional
treatments outlined in the study protocol.
Exclusion Criteria:
- Participants must not be participating in vestibular and balance rehabilitation
therapy
- Pregnant or planning to become pregnant while in "on study" status
- Best-corrected visual acuity > 20/70
- Any self-reported, uncompensated, binocular vision abnormality, such as strabismus,
amblyopia, or diplopia
- Peripheral neuropathy
- Self-reported history of frequent syncope (>1/month).
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 59 Years | Sensory Training for Orientation and Balance | NCT04331561 | Entailment |
2,562 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- All subjects have been recorded as patients in emergency departments between 2010 and
2015.
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Development and Validation of a Regional Multi-scale System for the Prediction of the Patient Flow in the Emergencies and the Need for Hospitalization | NCT03051737 | Entailment |
5,584 | 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:
- Overweight and obese adolescents in the Trondheim area, referred to medical treatment
at St. Olav's Hospital
Exclusion Criteria:
- Any coexisting medical illnesses
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 16 Years | Cardiovascular Risk Factors in Overweight Adolescents | NCT00184236 | Contradiction |
Subsets and Splits