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2,080 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Individuals over the age of 18 with a diagnosis of definite or probable IPF or
definite or probable fibrotic NSIP as defined by the ATS/ERS consensus classification
Exclusion Criteria:
- Patients with co-existent conditions known to be associated with the development of
fibrotic lung disease will be excluded.
- This includes
- connective tissue disease
- suspected drug-induced lung disease
- asbestosis or other asbestos related disease (pleural plaques, mesothelioma,
asbestos pleural effusions)
- granulomatous disease including sarcoidosis.
- Patients with an auto-immune profile considered diagnostic for a specific connective
tissue disease will be excluded, even in the absence of systemic symptoms.
- Non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody
etc. will not be used to exclude individuals from the study.
- Patients with co-morbid disease that in the opinion of the investigators gives them an
expected life expectancy of less than one year will be excluded from the study.
- Patients involved in clinical trials assessing novel IPF therapies will be excluded
from enrolment in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study | NCT01110694 | Entailment |
6,795 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Severe hemophilia A
- Previously treated patients with at least 150 exposure days to any Factor VIII product
Exclusion Criteria:
- Hypersensitivity to any recombinant Factor VIII product
- History of or current Factor VIII inhibitor
- Bleeding episode or other reason requiring Factor VIII treatment within 3 days of
study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 64 Years | Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A | NCT00168051 | Entailment |
5,221 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion criteria：
- Age>=50
- New hip fracture from orthopedic ward
- Newly identified vertebral fracture (either morphological or clinical)/ old hip
fracture without osteoporosis treatment referred by team physicians either inpatients
or outpatients
- Willing to accept 10 years of follow-ups.
Exclusion criteria
- Traumatic or pathologic fractures
- Atypical femoral shaft fracture
- Participating in other medication intervention trials
- Less than 2 years of life expectancy judged by team physicians
- Incapable of accepting evaluation for cognitive, communication, and physical problems
judged by team physicians or coordinators.
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 100 Years | Randomized Fracture Liaison Services | NCT03178799 | Entailment |
6,735 | 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:
- Study population will include: adult males ≥18 years of age with a diagnosis of severe
hemophilia A and currently active high titer FVIII inhibitors (>5 BU). Females will be
excluded because hemophilia A is an X-linked disorder that is extremely rare in
females.
1. Confirmed diagnosis of severe hemophilia A by undetectable plasma factor VIII:C
by a one-stage PTT-based assay and coatest chromogenic factor VIII assay. Only
subjects with the presence of a high titer factor VIII inhibitor (>5 BU) will be
included for enrollment.
2. Subject may be prescribed prophylactic therapy with factor VIII bypassing agents
or factor VIII mimetics prior to referral for inclusion in the study.
3. Subjects who are treated on demand using factor VIII bypassing agents must have a
history of four or more bleeding episodes requiring treatment in the six-month
period prior to referral for inclusion in the study.
4. Adequate bone marrow reserve as demonstrated by ANC >1.5/cu.mm; Hemoglobin
>9g/dL; Platelets >100,000/microliter.
5. Adequate renal function, defined as creatinine clearance>60 ml/min
(Cockroft-Gault formula)
6. Adequate liver function, defined as defined as total bilirubin ≤1.5 times the
upper limit of normal (ULN) (excluding Gilbert's syndrome), both AST and ALT ≤3
times ULN at the time of screening, and no clinical signs or known
laboratory/radiographic evidence consistent with cirrhosis.
7. Subject must sign an informed consent after explanation of the study and having
questions answered.
8. Subject must be willing and able to document type of bleeding episodes and
treatment in a paper or electronic diary during the study.
9. Subject must be willing to return for regular follow-up visits during the 15-year
study.
Exclusion Criteria:
- A potential subject who meets any of the following exclusion criteria is ineligible to
participate in the study.
1. Therapy with factor VIII with the intent of immune tolerance induction within 30
days prior to inclusion within the study.
2. Enrollment in another interventional clinical trial within 60 days prior to study
inclusion.
3. Medical contraindication to PBSC cytokine mobilization, use of GCSF, PBSC
apheresis procedure or conditioning regimen.
4. Medically significant organ dysfunction that would prevent compliance with
conditioning or would severely limit the probability of survival based on
clinical status.
5. Those with a known co-existing clinically significant thrombophilic disorder, or
as determined by the presence of any of the below identified on screening
laboratory assessments:
- FV Leiden
- Protein S deficiency
- Protein C deficiency
- Prothrombin mutation (G20210A)
- D-dimer >3 x the upper limit of normal (ULN) at Screening All known patients
with the above and any patient with a personal or significant family history
of thrombotic events (DVT, PE, arterial clots) as deemed by the principal
investigator will be screened for the above disorders.
6. Active invasive malignancy (Non-melanoma skin cancers and carcinoma in situ are
not excluded).
7. Known bone marrow disorders or abnormal bone marrow cytogenetics.
8. Fertile males who are unwilling to use contraceptive techniques during and for
the twelve months following treatment.
9. Life expectancy severely limited by disease(s) other than hemophilia A.
10. Patients with HIV, hepatitis B, hepatitis C (with an AST/ALT > 3 times the upper
limit of normal).
11. Other active infectious disease that is a contraindicat ion for immunosuppressive
therapy.
12. Patients who have elective surgery scheduled during the study period.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A | NCT03818763 | Contradiction |
1,227 | 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. Patients undergoing investigation or treatment for thoracic cancers with
oncogene-targeted therapies
2. Aged 18 years or older
3. Either a) have suspected tumor progression or other condition that dictates a
standard-of-care palliative, therapeutic, or diagnostic intervention including but not
limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or
ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS)
pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor
specimen appropriate molecular analysis or b) have previously had biopsy/surgical
intervention with tumor tissue at University of Colorado or an outside institution
available for medullar analysis.
4. Patients must have the ability to understand and willingness to sign an informed
consent document.
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer | NCT01580982 | Entailment |
2,190 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- The participant, or the participant's legally acceptable representative, signs a
written informed consent form/Health Insurance Portability & Accountability Act
(HIPAA) Authorization prior to the initiation of any study procedures.
- Must have a history or presence of gout defined as having one or more of the following
conditions of the American Rheumatism Association (ARA) preliminary criteria for the
diagnosis of gout
- A tophus proven to contain urate crystals by chemical or polarized light
microscopic means and/or
- Characteristic urate crystals in the joint fluid and/or
- History of at least 6 of the following clinical, laboratory and x-ray phenomena*:
*More than one flare criteria will be excluded for the purpose of this study if
the participant has a history of only a single acute gout flare.
- More than one attack of acute arthritis*
- maximum inflammation developed within 1 day
- monoarticular arthritis
- redness observed over joints
- first metatarsophalangeal joint painful or swollen
- unilateral first metatarsophalangeal joint attack
- unilateral tarsal joint attack
- tophus (proven or suspected)
- hyperuricemia
- asymmetric swelling within a joint on x-ray
- sub-cortical cysts without erosions on x-ray
- joint fluid culture negative for organisms during attacks
- *More than one flare criteria will be excluded for the purpose of this study if
the participant has a history of only a single acute gout flare.
- Is male and at least 18 years of age OR;
- Female ≥45 years of age and at least 2 years post-menopausal AND has a Follicle
Stimulating Hormone (FSH) level ≥40 IU/L OR
- Female receiving hormone replacement therapy (HRT) must be ≥55 years of age (FSH
level not required).
- Has hyperuricemia defined as serum Uric Acid (sUA) level ≥7.0 mg/dL at Screening.
- Has a history of ≤2 (1 or 2) flares. In participants with a history of 2 flares, must
have had only one flare in any 12 month period. The primary affected joint will be
based on the location of the first gout flare which must be located within right or
left metatarsophalangeal (MTP), interphalangeal (IP), ankle, metacarpophalangeal
(MCP), Proximal Inter-Phalangeal (PIP), or distal inter-phalangeal (DIP) joints prior
to Screening.
- Is capable of understanding and complying with protocol requirements, including
scheduled clinic procedures.
Exclusion Criteria:
- Previously on urate-lowering therapy (allopurinol, febuxostat or probenecid).
- Has secondary hyperuricemia (eg due to myeloproliferative disorder or organ
transplant).
- Has a history of xanthinuria.
- Has a known hypersensitivity to any component of the febuxostat formulation.
- Has rheumatoid arthritis.
- Has active peptic ulcer disease.
- Has a history of cancer, except basal cell carcinoma of the skin, which has not been
in remission for at least 5 years prior to the first dose of study medication.
- Has experienced either a myocardial infarction (MI) or stroke within 90 days prior to
the Screening visit.
- Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values
greater than 2.0 the upper limit of normal during the Screening period.
- Has a significant medical condition and/or conditions that would interfere with the
treatment, safety or compliance with the protocol at the discretion of the
Investigator.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse with 5 years prior to the Screening visit. Participant consumes >14 alcoholic
beverages/week.
- Has received any investigational medicinal product within 30 days prior to the
Screening visit. In addition, the participant has been previously randomized into this
study and received at least one dose of double blind study drug treatment.
- Has an estimated Glomerular filtration rate (eGFR) <60 mL/min calculated using the
Modification of Diet in Renal Disease (MDRD) formula by the Central Laboratory.
- Has a serum creatinine at Screening greater than 2.0 mg/dL.
- Has a known history of infection with hepatitis B, hepatitis C or human
immunodeficiency virus.
- Is a study site employee, or is an immediate family member (ie, spouse, parent, child,
and sibling) of a study site employee involved in conduct of this study.
- Is unable to understand verbal or written English or any other language for which a
certified translation of the approved informed consent form is available.
- Is required to take excluded medications.
- Magnetic Resolution Imaging:
- Has a known hypersensitivity to gadolinium
- Has history of severe asthma
- Has an electronically, magnetically or mechanically activated implanted device
- Has any object that could present a potential hazard or interfere with MRI
interpretation secondary to the artifact (i.e. metallic foreign bodies)
- Has a significant medical condition considered by the Investigator (or
radiologist) to interfere with the participant's ability to receive gadolinium
(eg Sickle cell anemia).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout | NCT01078389 | Contradiction |
2,913 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Male or female between the ages of 18 and 85 with clinical diagnosis of ALS
- Forced Vital Capacity (FVC) > 60% of predicted
- Less than 3 years of ALS since the onset of the first symptom with clinical evidence
of limb muscle atrophy and weakness.
- Subjects taking Riluzole must have been at a stable dose for at least 30 days with no
evidence of toxicity
- Female of childbearing potential and male of child-creating potential must agree to
use a medically acceptable physical barrier (condom, diaphragm, and cervical cap)
through the treatment phase and for at least 30 days after the last study treatment.
Exclusion Criteria:
- Women who are pregnant or currently breast-feeding
- Dependent upon invasive or non-invasive artificial ventilation
- Patients with bulbar onset ALS or with other active neuromuscular/ neurodegenerative
diseases.
- Type 1 or Type 2 diabetes.
- Evidence of chronic or active heart, liver, kidney, or lung diseases, or Age-related
macular degeneration.
- Current or history of known immune or immunodeficiency disorders
- Patients with cognitive impairment with significant decision making incapacity, or
major depression, or schizophrenia, or dementia (e.g. Alzheimer's disease).
- Malignancy or history of malignancy, except it has been in complete remission for at
least 5 years
- Pre-cancerous conditions (e.g. Barrett's Esophagus, dysplasias) or benign tumors which
have the potential for significant growth due to VEGF stimulation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | NCT00748501 | Entailment |
2,736 | 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:
- Primary unilateral groin hernia in adult
Exclusion Criteria:
- recurrence warfarin treatment bilateral groin hernia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair | NCT00184483 | Entailment |
6,884 | 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:
- Intact activities of daily living
- Fluent in German
- Normal/corrected-to-normal vision
- Written informed consent
Exclusion Criteria:
- Dementia
- Current/lifetime severe psychiatric or neurological disorder
- History of seizures
- Psychotropic medication
- Currently/lifetime drug or alcohol abuse
- Brain damage
- Magnetisable implants
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 80 Years | Real-time fMRI Neurofeedback in Patients With MCI | NCT04020744 | Contradiction |
5,800 | 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:
- Individuals with dermatological condition (including conditions that affect the skin,
hair and/or nails). This includes, but is not limited to, acne, eczema, alopecia,
psoriasis, vitiligo, rosacea, dermatitis, hyperpigmentation, hidradenitis suppurativa
(HS), hyperhidrosis, hirsutism, neurofibromatosis, onychomycosis, melasma, cysts,
herpes, ichthyosis, and lichen sclerosus.
- Individuals self-reporting that their body image is affected by their skin condition.
- Sufficient English to complete the measures and writing exercises
- Access to the internet.
Exclusion Criteria:
- As the focus of this research is on skin disease, individuals living with visible
differences as a consequence of trauma (e.g. scarring from burns or scarring from
traumatic injury) are not eligible to participate in this study.
- Individuals who do not feel their body image is affected by having a dermatological
condition.
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.
| Testing a Body-functionality Intervention for Body Image in Individuals With Skin Conditions | NCT04445974 | Entailment |
1,448 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Females of childbearing potential who are sexually active must agree to use adequate
contraception from screening throughout the duration of the study and for 30 days
following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors
but without type 1 or 2 diabetes.
- At Randomization, participants must fulfill the above criteria and also have a mean
fasting low density lipoprotein cholesterol levels greater than or equal to 3.36
mmol/L and less than or equal to 5.6 mmol/L and mean triglyceride levels less than or
equal to 4.52 mmol/L.
- Is willing and able to comply with the recommended, standardized diet.
Exclusion Criteria:
- Has active liver disease or jaundice.
- Has a history of cancer, other than basal cell carcinoma, that had been in remission
for less than 5 years prior to the first dose of study drug.
- Has an endocrine disorder, such as Cushing Syndrome, hyperthyroidism, or
inappropriately treated hypothyroidism affecting lipid metabolism.
- Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as
determined by medical history and/or the subject's verbal report.
- Has a positive human immunodeficiency virus status or was taking antiretroviral
medications, as determined by medical history and/or the subject's verbal report. .
- Has participated in any other clinical studies with lapaquistat acetate, was
concurrently participating in another investigational study, had participated in an
investigational study within the past 30 days or, for drugs with a long half-life,
within a period of less than 5 times the drug's half-life.
- Has a known hypersensitivity or history of intolerance to lapaquistat acetate or
ezetimibe.
- Has a history or presence of clinically significant food allergy that would prevent
adherence to the specialized diet.
- Has a known heterozygous or homozygous familial hypercholesterolemia or known Type III
hyperlipoproteinemia (familial dysbetalipoproteinemia).
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain and/or
discontinuation of HMG-CoA reductase inhibitors due to myalgia at any time.
- Has uncontrolled hypertension despite medical treatment.
- Has inflammatory bowel or any other malabsorption syndrome or had had gastric bypass
surgery or any other surgical procedure for weight loss.
- Has a history of drug abuse or a history of high alcohol intake within the previous 2
years.
- Has any other serious disease or condition at Visit 1 or Randomization that might
reduce life expectancy, impaired successful management according to the protocol, or
make the participant unsuitable to receive study drug.
- Has a history of coronary heart disease or coronary heart disease-risk factors
comprised of:
- Diabetes mellitus type 1 or 2
- History or presence of myocardial infarction, angina pectoris, unstable angina,
coronary angioplasty, coronary or peripheral arterial surgery (bypass graft),
aortic aneurysm, transient ischemic attacks, or cerebrovascular accident;
- Multiple risk factors that confer a 10-year risk of coronary heart disease
greater than 20% based on the Framingham risk score.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia. | NCT00268697 | Entailment |
4,915 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. You provide informed consent.
2. You are over 21 years of age.
3. You are diagnosed with a postural-intention (essential) tremor for at least 3 years
and meet strict diagnostic criteria and have been seen and examined by a movement
disorders fellowship trained neurologist.
4. You have had a significant disabling medical-refractory upper extremity tremor with no
evidence of supraspinal central nervous system disease or injury (tremor not
adequately controlled by medications for at least three (3) months before implant).
5. You have had a postural or kinetic tremor severity score of at least 2 out of 4 in the
extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
Tremor (CRST).
6. You have had a CRST score of 2 or above in any one of the items 16-23 from the
Disability subsection of the CRST: speaking, feeding other than liquids, bringing
liquids to mouth, hygiene, dressing, writing, working and social activities.
7. Your tremor is refractory adequate trials of at least two medications, one of which
should be either propranolol or primidone. An adequate medication trial is defined as
a therapeutic dose of each medication or the development of side effects as the
medication dose is titrated.
8. You are available for appropriate follow-up times for the length of the study.
Exclusion Criteria:
1. Any previous neurosurgical intervention including deep brain stimulation or ablative
brain lesions.
2. Medication related movement disorders.
3. Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such
as bradykinesia, rigidity, or postural instability.
4. Any behaviors consistent with ethanol or substance abuse as defined by the criteria
outlined in DSM-V.
5. Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney
disease, continuous neurological disease, hematological disease, or frailty that
impact tolerability of the surgery as judged by the screening physicians.
6. Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating
lesions, or infectious lesions. Also excluded will be subjects with severe atrophy.
7. Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache,
nausea, vomiting, lethargy, papilledema).
8. A history of seizures within the past year.
9. A dementia rating scale score (DRS) <130 signifying significant cognitive dysfunction
and a potential for inability to cooperate with tasks involved in the study.
10. Any attempt or intent of suicide in the last six months.
11. Presence or history of psychosis.
12. Significant or active mood disorders including depression. For the purpose of this
study, we consider a significant mood disorder to include any subject who has:
1. Scores ≥ 20 on the Patient Health Questionnaire - 9 (PHQ-9).
2. Currently under the care of a psychiatrist
3. Currently participating in cognitive-behavioral therapy
4. Been hospitalized for the treatment of a psychiatric illness within 12 months
5. Ever received transcranial magnetic stimulation
6. Ever received electroconvulsive therapy
n. In addition, patients who are pregnant or plan to become pregnant will be excluded from
this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Responsive Deep Brain Stimulator for Essential Tremor | NCT02649166 | Entailment |
2,526 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Diagnosis of moderate or severe atopic dermatitis based on Eczema Area and Severity
Index (EASI) score (moderate=6-22.9; severe=23-72)
- At least one active patch of atopic dermatitis at time of study
- Parent/guardian able to give informed consent
Exclusion Criteria:
- Systemic medication or oral steroids within past 3 months (includes light therapy),
- Started new atopic dermatitis treatment regimen within the past month,
- Using wet/dry wraps > once/week
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 6 Years | Tencel vs. Standard Cotton Therapeutic Garments as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children | NCT03843437 | Entailment |
701 | 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:
- 18 years old and over
- Written consent.
- For DIOS Group : at least one criteria of the metabolic syndrome as defined by the
International Diabetes Federation, associated with hepatic iron overload measured by
MRI (at least 50 µmol/g) or by hepatic biopsy.
- For Genetic Haemochromatosis type 1 Group: homozygosity mutation C282Y in HFE gene ;
patients undergoing therapeutic phlebotomies.
Exclusion Criteria:
- Persons under guardianship
- Body-weight less than 45 kg
- Hemoglobin less than 9 g/dL.
- Intestinal malabsorption of any cause
- Current use or previous use during the last 2 months of iron supplement.
- Current use or previous use during the last 2 months of treatment interacting with
iron absorption (increasing like C vitamin or decreasing like iron chelators)
- Other causes of hyperferritinemia : chronic inflammatory syndrome, porphyria,
hyperferritinemia-cataract-syndrome, chronic alcohol consumption, chronic hemolysis.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effects of Polyphenols on Iron Absorption in Iron Overload Disorders. | NCT03453918 | Entailment |
4,193 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
non-smoker
- no history of pulmonary disease
- absence of dyspnoea, cough, thoracic pain
- no self-reported smoking history
- normal lung function testing
- normal shape of flow-volume curve
- normal shape of flow-pressure curve
- FEV1/FVC >70% (forced expiratory volume in 1 second / forced vital capacity)
- TLC > 80% of predicted (total lung capacity)
- TLCO/VA > 80% of predicted (transfer factor corrected for ventilated alveolar
volume)
- R5 < 150% of predicted (resistance at 5Hz, impulse oscillometry)
smoker
- as above, but with self-reported smoking history >10 pack years
Exclusion Criteria:
- unwilling or unable to give informed consent
- history of any respiratory disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters | NCT04099225 | Contradiction |
5,069 | 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:
- All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd
fracture in the vertebral column.
Exclusion Criteria:
- No image available
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 | Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis | NCT01653873 | Contradiction |
5,196 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Be sedentary (less than 2 hours physical activity of low intensity per week)
- Fracture risk Densitometry Risk factors (FRAX) index between 3 and 10%
- Consent form signed
Exclusion Criteria:
- Bone concomitant disease (such as Paget's disease, osteomalacia),
- Endocrinopathy defined on biological criteria (such as Cushing's disease,
hyperparathyroidism, hyperthyroidism, hypogonadism),
- Smoking habits (more than 5 cigarettes per day), chronic alcoholism,
- Treatments received in the previous 6 months affecting bone metabolism such as
anabolics, anti-osteoporotic treatment, corticosteroids.
- Having a prosthesis (femur and knee),or recently placed metal bouts or plates
- acute thrombotic problems,
- severe heart- and vascular diseases,
- recent injuries due to operation or polyclinical intervention,
- acute hernia, discopathy, spondylolysis,
- epilepsy,
- severe migraine,
- pacemaker,
- every neurodegenerative or neuromuscular disease,
- dementia
Female
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 75 Years | Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women | NCT01982214 | Entailment |
5,349 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Subject is at least 18 years of age but no more than 75 years of age.
- Subject has a posterior (molar or premolar) socket created by atraumatic extraction
with a post extraction socket of a minimum of 5 mm in both the mesial-distal (M-D) and
buccal-lingual (B-L) dimensions that requires bone grafting.
- Subject has sufficient buccal bone plate at the site of the planned tooth extraction
(ie, the residual socket should be of a form that would retain bone graft material),
as judged by the Principal Investigator.
- Females of childbearing potential must have a documented negative urine pregnancy
test. All subjects must agree to use acceptable methods of contraception for the
duration of the study.
- Subjects must have read, understood, and signed an institutional review board
(IRB)-approved Informed Consent Form (ICF).
- Subjects must be able and willing to comply with protocol requirements.
Exclusion Criteria:
- Subject with any systemic conditions that could compromise wound healing and preclude
periodontal surgery (ie, bleeding disorder, cancer, except localized basal cell or
squamous cell cancer of the skin with no metastasis; human immunodeficiency virus; or
bone metabolic diseases [ie, osteoporosis or Paget's disease]).
- Subject who is currently receiving, anticipates receiving or has received within 30
days prior to Day 0: inhaled or systemic corticosteroids (ie, oral, IV),
immunosuppressive agents or radiation therapy, and/or chemotherapy, which could
compromise wound healing and preclude periodontal surgery.
- Subject who has had oral/periodontal surgery within 30 days prior to Day 0 or
anticipates having oral/periodontal surgery within 30 days after Day 0.
- Subject with acute mucosal infection, including suppuration or induration in the area
of intended surgery.
- Subject, who in the opinion of the Principal Investigator, will require a sinus lift
procedure to place dental implants in the surgical area.
- Subject without at least 1 tooth adjacent to the area to be treated.
- Subject has a history of alcohol or substance abuse within the previous 12 months of
Screening that could interfere with study compliance or protocol requirements.
- Subject who has used any tobacco product within 6 months of Screening.
- Subject with known hypersensitivity to porcine or bovine collagen, gentamicin or
surfactants.
- Subject who has received an investigational drug, device, or biological/bioactive
treatment within 30 days prior to Day 0 (medical or dental).
- Subject who was previously treated with Gintuit, or any other cell therapy at the
target treatment site or immediately adjacent teeth.
- Female subject that is lactating.
- Subject, who in the opinion of the Principal Investigator, for any reason other than
those listed above, will not be able to complete the study per protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety Study of Gintuit™ in Subjects Requiring Socket Grafting | NCT01929954 | Contradiction |
183 | 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:
- Ages 18-65
- History of hypogonadism
- In good health based on medical history, physical examination and clinical laboratory
tests
- Screening morning serum testosterone ≤ 297 ng/dL
- One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or
reduced sexual functioning of non-vasculogenic or neurogenic nature)
- Body mass index (BMI) between 18 and 31
Exclusion Criteria:
- Prostate cancer
- Palpable prostatic mass(es)
- Generalized skin irritation or significant skin disease
- Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
(DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride,
ketoconazole)
- Clinically significant anemia or renal dysfunction
- Hyperparathyroidism or uncontrolled diabetes
- Serum PSA Levels; ≥ 4ng/mL
- History of cardiovascular disease
- Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human
growth hormone (hGH), (within previous 12 months)
- Use of testosterone products (within eight months for parenteral products, or six
weeks for other preparations)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Efficacy, Pharmacokinetics and Safety of Testosterone | NCT01370369 | Entailment |
4,132 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Candidate patients will have evidence of an acute lower respiratory tract infection
(pneumonia or acute exacerbation of chronic bronchitis) as defined as follows:
o NEW onset within past 28 days
- At least one respiratory symptom: cough, sputum production, dyspnea, tachypnea,
pleuritic chest pain, wheezing
PLUS: At least one :
- auscultation abnormality suggestive of pneumonia (rales, ronchi, egophony)
- OR a new consolidation on chest radiology consistent with pneumonia
- OR at least one sign of systemic infection: fever >38.1 or WBC >10,000 or <4,000 AND
provider initiating empiric antibiotics
Exclusion Criteria:
- - Age <18
- Microbiologically documented infections caused by organisms for which a prolonged
duration is standard of care (i.e. Pseudomonas, Acinetobacter, Listeria, Legionella,
Pneumocystis, M. tuberculosis, Non-tuberculous mycobacterium (NTM) infection, S.
aureus pneumonia or cavitary pneumonia)
- Severe infections due to viruses and parasites with a risk of bacterial translocation
(hemorrhagic fever, malaria)
- Infectious conditions requiring prolonged therapy: endocarditis, brain abscess, deep
abscess
- Antibiotics already started 24 hours prior to initial PCT value
- Chronic localized infections (i.e. chronic osteomyelitis, mediastinitis, brain
abscess)
- Severely immunocompromised patients (HIV with CD4<200, neutropenic with absolute
neutrophil count (ANC) <500, patients on immunosuppressive therapy after solid organ
transplantation or those with autoimmune disease (corticosteroids allowed but no more
than 20 mg/day (prednisone equivalent) for 14 days). Cystic fibrosis
- Active IV drug abuse
- Pregnant patients
- Patients lacking capacity to consent
- Patients admitted for burn injuries
- Patients within 30 days of major intra-thoracic or intra-abdominal surgery
- Patients receiving antibiotics for a non-respiratory infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Procalcitonin for Stewardship in Respiratory Infections A Stewardship Project | NCT03109106 | Contradiction |
1,372 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical
examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide
the classification of rotator cuff tears defined and reassessed at the time of surgery
(Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full
thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 =
full thickness defect of three tendons).
Exclusion Criteria:
- Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
- Inability of the surgeon to repair the tear with remaining defect no greater than 10mm
in diameter,
- Inability of the surgeon to repair the tear with less than 1cm of medialization,
- Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion,
Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
- Active joint or systemic infection,
- Significant muscle paralysis of the shoulder girdle,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for
one year following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand
the English language
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.
| An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS | NCT00182299 | Contradiction |
3,551 | 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 or secondary adrenal insufficiency requiring glucocorticoid
substitution therapy
Exclusion Criteria:
- adrenocortical carcinoma
- long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other
reasons than adrenal insufficiency
- 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.
| Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency | NCT01184209 | Entailment |
1,955 | 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:
- All out-patients > 19 years old presenting for capsule endoscopy
Exclusion Criteria:
- Patients on narcotics
- Patients on motility enhancing and/or slowing drugs should stop these at least 5 days
prior to the procedure or be excluded from the study.
- Patients, who have proven or suspected obstruction of the bowel.
- Patients, who have had prior small bowel and/or gastric surgery.
- Patients with an ileostomy.
- Patients who have a known and/or have a history of swallowing disorder
- Patients with diabetes and/or hypo-/hyper- thyroidism
- Patients in whom the capsule become impacted at a stricture (these patients will be
taken out of the study and given the necessary medical/surgical treatment).
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.
| The Effect of Chewing Gum on Small Bowel Transit Time | NCT01241825 | Entailment |
4,864 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Age over 18 years
- Under investigation for hypercortisolism
- Able and willing to make informed consent
Exclusion Criteria:
- Use of systemic or local glucocorticoids
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.
| Does Serum-DXM Increase Diagnostic Accuracy of the Overnight DXM Suppression Test in the Work-up of Cushing's Syndrome? | NCT01504555 | Entailment |
2,561 | 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:
- Cases with severe insect sting allergy reactions
Exclusion Criteria:
- Without other severe systemic diseases
- Not pregnant or lactation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Causative Insects in Severe Insect Sting Allergy | NCT02764242 | Entailment |
4,243 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
-azoospermic patients
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Obtaining Undifferentiated Cells From Testis Biopsy | NCT01375062 | Entailment |
5,533 | 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:
- Healthy volunteer or
- Patient with a suspected diagnosis of GCA but found not to have GCA
- Recent diagnosis of GCA within 1 month or
- Suspected flare of GCA within one month
- Ability to provide written informed consent
Exclusion Criteria:
- Unable to provide written informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Giant Cell Arteritis: Improving Use of Ultrasound Evaluation | NCT02523625 | Entailment |
3,200 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Diagnosis of primary Sjögren's syndrome (pSS)
- ESSDAI score ≥ 6 at screening visit
Exclusion Criteria:
- Secondary Sjögren's syndrome
Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome | NCT02775916 | Entailment |
1,233 | 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:
- • All adult patients aged between18- 70 years presenting with pleural effusion in
association with a malignant disease.
- Patients with documented malignant pleural effusion ( i.e positive pleural fluid
for malignant cells on pleural fluid cytology and/or positive pleural biopsy for
malignant tissue).
- Reaccumulation of an effusion after drainage or patients presenting with symptoms
related to pleural fluid re-accumulation such as dyspnea, cough and chest pain.
- Patient with full lung re-expansion after thoracostomy tube insertion and
drainage of effusion.
Exclusion Criteria:
- • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline
- Failure to achieve full lung re-expansion following drainage of the effusion
within 48hrs
- Locoregional radiotherapy to the effusion side.
- Loculated pleural effusion
- Refusal to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination | NCT04039126 | Entailment |
3,335 | 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. Women and men aged 18-60 years.
2. For women, having a BMI between 18.5 and 35 kg/m2 (both included); for men having a
BMI between 18.5 and 25 kg/m2 (both included).
3. Healthy as determined from the self-reported medical history or when a clinical
condition exists, when this is considered to be irrelevant for the study by the study
medical doctor.
4. Not taking any medication that may affect sight, gastro-intestinal function or
appetite. Volunteers taking medication for clinical conditions that may affect the
above functions will be eligible if they report no side effects and the dose has been
stable for at least 3 months prior to commencement of the study.
5. Consuming breakfast and lunch regularly (at least 5 days per week).
6. Liking of the study foods defined by a score of >40 mm of the Liking VAS
questionnaire, for each compulsory meal component.
7. Able to consume food without the need for prescription glasses (contact lenses are
allowed).
8. Able to understand and be willing to sign the informed consent form and to follow all
the study procedures and requirements.
Exclusion Criteria:
1. Deficient nutrition or hydration status at the time of recruitment.
2. Abnormal gastro-intestinal function or structure such as malformation, angiodysplasia,
active peptic ulcer, and chronic inflammatory or malabsorptive diseases, even if at
the time of recruitment the volunteer is not taking medication for such conditions
(e.g. anti-inflammatory drugs).
3. History of gastro-intestinal surgery with permanent sequels (i.e. gastroduodenostomy).
4. History of liver disease.
5. History of cancer or receiving treatment for cancer.
6. Diabetes mellitus.
7. Food allergy, food restriction or avoidance of any of the study foods (e.g.
vegetarian).
8. History of mental illness, or being under active treatment for mental illness (e.g.
psychiatric disorder), whenever their condition affects their ability to comprehend or
follow the requirements of the study in full, or when their condition affects
short-term memory (e.g. Alzheimer disease).
9. Presence of an eating disorder defined as a score >19 on the Eating Attitudes Test
(EAT-26).
10. Diagnosed or suspected epilepsy or photosensitive epilepsy (e.g. experiencing an
"aura" or odd sensations while watching images or patterns on a computer screen).
11. Wearing a pacemaker or other medical electronic device.
12. Currently dieting to lose weight.
13. Smoking > 7 cigarettes per week.
14. Consuming >14 units of alcohol intake per week in women, or >21 units per week in men.
15. Performing >9 h of intense physical activity per week.
16. Pregnancy or lactation.
17. Having received formal portion size education as part of a university degree (e.g.
Dietetics, Human Nutrition, Psychology if relevant).
18. Being familiar with the nature of the covert measures involved in the study (i.e.
measure of eating speed and bite size).
19. Volunteers for which insufficient collaboration may be foreseen, or whom the
investigator has grounds to believe that they may experience difficulty in following
the study procedures.
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 | Effect of Tableware Visual Cues on Portion Control and Eating Rate | NCT03610776 | Contradiction |
2,607 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Age between 1 and 6 year-old
- ASA class 1 and 2
- Pediatric Inguinal hernia patients who are scheduled for elective laparoscopic
inguinal hernia repair
Exclusion Criteria:
- Allergy to local anesthetics or contraindication to use of lidocaine
- Current active upper respiratory infection or history of upper respiratory infection
within 2 weeks
- Severe cardiovascular disease
- Renal failure
- Liver failure
- Neurologic and psychologic disease
- Chronic treatment with analgesics
- Previous history of laparoscopic operation
- Parents' refusal
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 6 Years | The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children | NCT02007330 | Contradiction |
2,970 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Possible, probable (clinically or laboratory) or definite ALS according to the revised
version of the El Escorial World Federation of Neurology criteria
- Disease duration more than 6 months and less than 3 years (inclusive). Disease onset
defined as date of first muscle weakness, excluding fasciculations and cramps
- Vital capacity more than 50% of normal (slow vital capacity; best of three
measurements)
- Age: ≥ 18 years
- Continuously treated with 100 mg riluzole for at least four weeks
- Capable of thoroughly understanding all information given and giving full informed
consent according to GCP
- Women of childbearing age must be non-lactating and surgically sterile or using a
highly effective method of birth control and have a negative pregnancy test.
Acceptable methods of birth control with a low failure rate i.e. less than 1% per
year) when used consistently and correct are such as implants, injectables, combined
oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods
(condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomized
partner
Exclusion Criteria:
- Previous participation in another clinical study within the preceding 12 weeks
- Tracheostomy or assisted ventilation of any type during the preceding three months
- Gastrostomy
- Any medical condition known to have an association with motor neuron dysfunction which
might confound or obscure the diagnosis of ALS
- Presence of any concomitant life-threatening disease or impairment likely to interfere
with functional assessment
- Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine,
phenylpropanolamine, and ephedrine.
- Patients on analgesics with serotoninergic properties such as meperidine, tramadol,
methadone and propoxyphene.
- Patients on serotonin reuptake inhibitors (SSRIs). This includes fluoxetine or
fluvoxamine.
- Patients on dextromethorphan, St. John's wort, cyclobenzaprine or other MAO inhibitors
(selective or non-selective)
- Patients taking Antidepressants
- Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater
than 3 times the upper limit of the normal range)
- Renal insufficiency (serum creatinine more than 2.26 mg/dL)
- Evidence of major psychiatric disorder or clinically evident dementia precluding
evaluation of symptoms
- Known hypersensitivity to any component of the study drug
- Liable to be not cooperative or comply with the trial requirements (as assessed by the
investigator), or unable to be reached in the case of emergency
- Female with childbearing potential, if no adequate contraceptive measures are used
- Pregnancy or breast-feeding females
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis | NCT01879241 | Entailment |
6,778 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male; 12-65 years of age
- Subjects with severe hemophilia A
- Previously treated with factor VIII for a minimum of 150 exposure days
Exclusion Criteria:
- Inhibitors to FVIII (current evidence or history)
- Any other inherited or acquired bleeding disorder in addition to Hemophilia A
- Platelet count < 100,000/mm3
- Creatinine > 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine
aminotransferase) > 5x upper limit of normal
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A | NCT01580293 | Entailment |
4,212 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male or Female between 55 and 80 years of age
- 30 year pack-history of smoking and are either current smokers or who quit during the
past 15 years.
- Individuals who are members of the World Trade Center General Responder Cohort or
Subjects who meet the United States Preventive Services Task Forces guidelines for
lung cancer screening
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 80 Years | The Liver in the World Trade Center Health Program General Responder Cohort and Controls | NCT03858920 | Contradiction |
3,333 | 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. They are 55 years old or above, with no gender restriction. They are permanent
residents of Da-jie town and Jiu-zhi Township in Da-ming County.
2. Patients who meet one of the following:
A. Hypertension project group:
Primary hypertension was definitely diagnosed, systolic blood pressure ≥ 140
millimeter of mercury, diastolic blood pressure ≥ 90 millimeter of mercury, or both
after drug treatment.
B.Type 2 Diabetes project group:
Patients with type 2 diabetes mellitus (non insulin dependent diabetes mellitus) who
were diagnosed as type 2 diabetes mellitus (NIDDM) and had HbA1c ≥ 7.0% after drug
treatment before enrollment.
C.Hyperlipidemia project group:
Those who were diagnosed as hyperlipidemia and were treated with or without medication
before enrollment.
3. Patients who can provide real and reliable information related to drug treatment and
efficacy evaluation
Exclusion Criteria:
1. Respondents who are not willing to fill in the true and reliable information form for
any reason.
2. Patients with infectious diseases or serious life-threatening diseases such as
malignant tumors.
3. Patients with severe liver and kidney function damage, affecting the choice of
treatment drugs.
4. Patients with incomplete data related to study evaluation such as any of following:
A.The clinical data did not include systolic blood pressure, diastolic blood pressure,
heart rate, glycosylated hemoglobin, fasting blood glucose, total cholesterol, low-density
lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride core efficacy
evaluation indicators.
B.The data related to adverse reactions required by clinical research can not be collected,
including but not limited to the related drugs with adverse reactions, adverse reaction
performance, time correlation, whether to stop suspicious drugs, and whether to stimulate
adverse reactions by re-medication.
C.The information of medication compliance score and quality of life score could not be
provided for any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 120 Years | A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias | NCT04660630 | Contradiction |
5,418 | 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:
- Working at Covid 19 Pandemic Hospital
- Being at between 18 and 47 years old
- Having menstruation
Exclusion Criteria:
- Oral contraceptive users
- Pregnants
- Having malignancy
- Having primary amenorrhea
- Being at menopause
- Lactation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 47 Years | Menstrual Cycle Characteristics of Healthcare Professionals | NCT04413058 | Entailment |
5,146 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Women aged 50 and older
- Lumbar spine BMD (L1 to L4) T score between 0 and -2.0
- At least 3 years postmenopausal
Exclusion Criteria:
- Prior low trauma hip or vertebral fracture
- Total hip or femoral neck T score of <-2.0
- Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease)
- Treatment within six months of study entry with androgen, calcitonin, estrogen,
progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone
or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants
- Alendronate or risedronate use for at least four weeks, within the last three years
- Current treatment with nitrates
- Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the
baseline screening examination
- Abnormal electrocardiogram (ECG) at the baseline screening examination
- history of myocardial infarction, angina, valvular or congenital heart disease
- Disabling conditions that may interfere with follow-up visits
- Inability to give informed consent
- Migraine headaches
- Hypersensitivity to nitrates
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis | NCT00252421 | Contradiction |
541 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Subject must be 18 to 50 years of age inclusive, at the time of signing the informed
consent.
- Subjects who are healthy as determined by the investigator or medically qualified
designee based on a medical evaluation including medical history, physical
examination, laboratory tests, and cardiac monitoring (history and ECG).
- Body weight >=45.0 kilograms (kg) (99 pounds [lbs]) and body mass index (BMI) within
the range 18.5 to 31.0 kilograms per meter square (kg/m^2) (inclusive).
- Contraceptive use should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies.
- Female subjects will be included.
- Subject must not be pregnant or breastfeeding.
- Subject is a woman of childbearing potential (WOCBP) with intact ovarian function, as
determined by medical history. Subjects must use Portia for the duration of the run-in
and treatment periods.
- WOCBP must have been on an acceptable form of contraceptive for at least 28 days prior
to start of study intervention. Acceptable forms of contraception prior to study
intervention include the following: Intrauterine device or intrauterine system;
Combined estrogen and progestogen oral contraceptive; Contraceptive vaginal ring;
Percutaneous contraceptive patches (if used, the patch must be removed during study
participation); Bilateral tubal occlusion; Male partner sterilization with
documentation of azoospermia prior to the female subject's entry into the study, and
this male is the sole partner for that subject. The documentation on male sterility
can come from the site personnel's review of subject's medical records, medical
examination and/or semen analysis, or medical history interview provided by her or her
partner.; Sexual abstinence.
- Subjects who have been on a stable regimen of an oral contraceptive for at least 3
consecutive months must be without evidence of breakthrough bleeding or spotting.
- Subjects who have been taking oral contraceptives should continue their current
regimen until check-in to the clinic for the run-in period. Subjects not currently
taking an oral contraceptive are eligible, provided all other eligibility criteria are
met.
- Subjects may proceed to the treatment period provided the toxicity profile during the
run-in period with Portia is acceptable in the opinion of the investigator.
- Subjects must agree to use an additional method of contraception from the following
list of contraceptive methods for the run-in period, treatment period, and for 28 days
after the last dose of study intervention: Non hormonal Intrauterine device; Bilateral
tubal occlusion; Male partner sterilization with documentation of azoospermia prior to
the female subject's entry into the study, and this male is the sole partner for that
subject. The documentation on male sterility can come from the site personnel's review
of subject's medical records, medical examination and/or semen analysis, or medical
history interview provided by her or her partner.; Sexual abstinence. For the 28 days
after study exit, women may resume oral contraceptives but double barrier methods (a
combination of male condom with either cervical cap, diaphragm, or sponge with
spermicide) must be used in addition.
- Women of childbearing potential must have a negative highly sensitive serum pregnancy
test on Day -4 and Day -1.
- Additional requirements for pregnancy testing during and after study intervention as
outlined in protocol.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form and protocol.
Exclusion Criteria:
- History of jaundice associated with taking oral contraceptives or with pregnancy.
- History of clinically significant irregular bleeding while taking oral contraceptives.
- History of past deep venous thrombosis, pulmonary embolism, stroke, transient ischemic
attack, phlebitis, or migraine headaches with prolonged aura.
- History of cerebrovascular or coronary artery disease.
- History of retinal vascular lesions.
- History of carcinoma of the breast, endometrium, or other known estrogen-dependent
neoplasia.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or
motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic
and/or renal function, that could interfere with the absorption, metabolism, and/or
excretion of the study drugs or render the subject unable to take oral study
intervention.
- Any history of significant underlying psychiatric disorder, including, but not limited
to, schizophrenia, bipolar disorder with or without psychotic symptoms, other
psychotic disorders, or schizotypal (personality) disorder.
- Any history of major depressive disorder with or without suicidal features, or anxiety
disorders that required medical intervention (pharmacologic or not) such as
hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient
treatment. Subjects with other conditions such as adjustment disorder or dysthymia
that have required shorter term medical therapy (<6 months) without inpatient
treatment and are currently well-controlled clinically or resolved may be considered
for entry after discussion and agreement with the ViiV Healthcare/GlaxoSmithKline
(GSK) Medical Monitor.
- Any pre-existing physical or other psychiatric condition (including alcohol or drug
abuse), which, in the opinion of the investigator (with or without psychiatric
evaluation), could interfere with the subject's ability to comply with the dosing
schedule and protocol evaluations or which might compromise the safety of the subject.
- Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3
months, or cardiac disease or a family or personal history of long QT syndrome.
- Presence of hepatitis B surface antigen at Screening or within 3 months prior to
starting study intervention.
- Positive hepatitis C antibody test result at Screening or within 3 months prior to
starting study intervention AND positive on reflex to hepatitis C ribonucleic acid
(RNA).
- Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
- ALT >1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a
single screening period to determine eligibility.
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin
is fractionated and direct bilirubin <35%).
- Any acute laboratory abnormality at Screening which, in the opinion of the
investigator, should preclude participation in the study of an investigational
compound.
- Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine
phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides,
etc), and ALT (described above), will exclude a subject from the study unless the
investigator can provide a compelling explanation for the laboratory result(s) and has
the assent of the sponsor. A single repeat of any laboratory abnormality is allowed
within a single screening period to determine eligibility.
- A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine
(indicating active current smoking) at Screening or before the first dose of study
intervention.
- Unable to refrain from the use of prescription or nonprescription drugs including
vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or
14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is
longer) prior to the first dose of study intervention and for the duration of the
study (acetaminophen/paracetamol at doses of <=2 grams/day and hydrocortisone cream 1%
are permitted for use any time during the study).
- Treatment with any vaccine within 30 days prior to receiving study intervention.
- Unwillingness to abstain from excessive consumption of any food or drink containing
grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their
fruit juices within 7 days prior to the first dose of study intervention(s) until the
end of the study.
- Participation in another concurrent clinical study or prior clinical study (with the
exception of imaging trials) prior to the first dosing day in the current study: 30
days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Where participation in the study would result in donation of blood or blood products
in excess of 500 milliliters (mL) within 56 days.
- Any positive (abnormal) response confirmed by the investigator on a screening
clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale
(C-SSRS).
- Any significant arrhythmia or ECG finding (e.g., symptomatic bradycardia,
non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular
tachycardia, second-degree atrioventricular block Mobitz Type II, or third-degree
atrioventricular block) which, in the opinion of the investigator or ViiV
Healthcare/GSK Medical Monitor, will interfere with the safety for the individual
subject.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility
determination): heart rate-<50 or >100 beats per minute and QTcF->450 milliseconds.
- History of regular alcohol consumption within 6 months of the study defined as: an
average weekly intake of >14 units. One unit is equivalent to 8 g of alcohol: a
half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL)
measure of spirits.
- Unable to refrain from tobacco- or nicotine-containing within 3 months prior to
Screening.
- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or medical
monitor, contraindicates their participation.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive | NCT03984825 | Contradiction |
1,623 | 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:
Both phases (includes focus groups- Phase 1)
- Black (race)
- Heterosexual
- Currently enrolled in high school
Pilot Test (Phase 2)
- Ability to participate in web-based videogame
- Willing to sit for at least 60 minutes (to play the game)
- No HIV testing in the last 12 months
- Ability to provide assent or parental/guardian consent
Exclusion Criteria:
- Failure to meet inclusion criteria
Female
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
Subject must be at most 18 Years | A Digital Intervention for HIV Prevention in Black Adolescent Girls | NCT04108988 | Contradiction |
2,170 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Subjects who are at least 18 years of age but younger than or equal to 99 years of
age.
2. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria
for gouty arthritis.
3. Subjects with one palpable tophus detectable by one of the three clinical parameters
described.
-
Exclusion Criteria:
1. Subjects who are not eligible for urate lowering treatment or show a hypersensitivity
to these drugs or class of compounds.
2. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic,
renal or endocrine dysfunction who in the opinion of the principal investigator are
unfit for participation in a clinical trial.
3. Subjects for which the clinical and laboratory assessment would provide undue
discomfort and / or are contraindicated.
-
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.
| Elastography as Gouty Arthropathy Outcome (EGO) | NCT02471261 | Contradiction |
1,073 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
1. Index patients:
- Age ≤18 years
- written informed consent of parents/legal guardians
- diagnosis of primary cardiomypathy:
- DCM: left ventricular (LV) systolic dysfunction and dilatation greater than two
standard deviations (SD) above the mean of a normal population
- HCM: LV hypertrophy and septal wall thickness above two SD
- RCM: diastolic dysfunction and concordant atrial enlargement
- LVNC: separation of the myocardium into a compacted (C) and a non- compacted (NC)
layer with an NC/C ratio >2 in echocardiography and/or >2.3 in CMR
- ARVC: according to the revised Task Force Criteria
2. First-degree family members (parents and siblings):
- Age ≥3 years
- written informed consent of parents/legal guardians and siblings ≥18 years
Exclusion Criteria:
- unwillingness to give consent
- myocardial inflammation / myocarditis
- systemic disease with cardiac involvement (secondary cardiomyopathy)
- structural congenital heart disease
No condition on gender to be admitted to the trial.
Subject must be at most 18 Years | Risk Stratification in Children and Adolescents With Primary Cardiomyopathy | NCT03572569 | Contradiction |
3,156 | 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:
1. Adult females and males between the ages of 18 -75, seeking treatments for Dry Eye
Disease Due to Meibomian Gland Dysfunction
2. Tear breakup time (TBUT) ≤10 s;
3. Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower
eyelids for each eye as assessed by a clinician not involved in the study procedure
4. Subjective symptom score (using the Standard Patient Evaluation of Eye Dryness [SPEED]
questionnaire) ≥10;
5. At least one meibomian gland opening with a visible plugging over the eyelid margin
6. No ocular pathology requiring treatment other than eye lubricant and conventional
eyelid hygiene within the last month and during the study
7. The subjects should understand the information provided about the investigative nature
of the treatment, possible benefits, and side effects, and sign the Informed Consent
Form
8. The subjects should be willing to comply with the study procedure and schedule,
including follow up visits.
9. Agreement/ability to abstain from dry eye/MGD medications or any device treatments for
the time between the treatment visit and the final study visit. Ocular lubricants are
allowed if no changes are made during the study.
Exclusion Criteria:
1. Evidence of co-existing ocular conditions potentially posing an increased risk of
procedure-related injury, (e.g., active ocular infection or inflammation in either
eye)
2. History of ocular trauma or surgery including intraocular, oculoplastic, corneal or
refractive surgery within 1 year
3. Ocular surface abnormality potentially compromising corneal integrity in either eye;
eyelid abnormalities affecting lid function in either eye
4. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome,
vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis,
leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
5. Unwillingness to abstain from systemic medications known to cause dryness for the
study duration.
6. Individuals who have either changed the dosing of systemic or non-dry eye/MGD
ophthalmic medication within the past 30 days prior to screening
7. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere
in the body
8. Permanent metal implant in the treatment area
9. Any surgery in the treatment area in the last 3 months
10. Current or history of skin cancer, or current condition of any other type of cancer,
or pre-malignant moles
11. Pregnancy and nursing or females of childbearing potential and not utilizing adequate
birth control measures
12. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use
of immunosuppressive medications
13. Patients with a history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic regimen.
14. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction,
polycystic ovary, and hormonal virilization
15. Any active condition in the treatment area, such as but not limited to open sores,
psoriasis, eczema, vitiligo, herpes, and rash.
16. History of skin disorders, keloids, abnormal wound healing, as well as very dry and
fragile skin
17. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
18. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
19. Participation in another study within 30 days prior to screening.
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction | NCT04120584 | Contradiction |
5,587 | 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. Male and female participants with the age of ≥18 and ≤ 60 years of age.
2. BMI of ≥25 - ≤ 35 kg/m2
3. Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA:
Men: > 102 cm (40 inches), Women: >89 cm (35 inches)
4. Triglycerides >150 mg/dL
5. Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
6. Fasting blood glucose ≥ 100 mg/ dl
7. Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL
8. Ready to give voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the trial:
1. Current smoker.
2. Inability to walk independently.
3. Presence of unstable, acutely symptomatic, or life-limiting illness.
4. Neurological conditions causing functional or cognitive impairments
5. Unwillingness or inability to be randomized to one of three intervention groups.
6. Bilateral hip replacements.
7. Exposure to any non-registered drug product within 3 months prior to the screening
visit.
8. Unable/unwillingness to complete study specific diaries (digital/paper-based).
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 | To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals | NCT03973086 | Contradiction |
854 | 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:
- Patients with osteoarthrosis of the PIP joints.
- Patients with sufficient bone quality for implantation of a non-cemented prosthesis.
This is estimated by the surgeon preoperatively.
- Informed written patient consent.
- Patients must read and understand Danish.
Exclusion Criteria:
- Patients with neuromuscular or vascular diseases in the affected upper extremity.
- Patients who, preoperatively, are found to have unsuitable bone quality for
un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
- Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs)
postoperatively including cox-2 inhibitors.
- Patients with previously diagnosed osteoporosis.
- Women who are pregnant or are at risk of getting pregnant during the time of
investigation.
- Patients with rheumatoid arthritis.
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.
| An RSA and DEXA Study on Migration of Proximal Interphalangeal (PIP) Joint Prostheses of the Hand | NCT00175188 | Entailment |
479 | 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:
- Unexplained infertility (UI)
Exclusion Criteria:
- body mass index (BMI) ≥35 kg/m2,
- Follicle Stimulating Hormone >10 International Unit /Litter in early follicular phase,
- diagnosed cause of infertility, menstrual cycle irregularity,
- ovarian cysts,
- sever cervical stenosis,
- former IUI,
- ongoing pregnancy and
- renal or hepatic diseases were all the exclusion criteria.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 37 Years | Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility | NCT03461601 | Contradiction |
5,378 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
1. Participant has a documented diagnosis of severe von Willebrand disease (VWD)
(baseline Von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) less than (<)
20 International Units/Deciliter [IU/dL]) with a history of requiring substitution
therapy with von Willebrand factor concentrate to control bleeding
1. Type 1 (VWF:RCo <20 IU/dL) or,
2. Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype),
Type 2M or,
3. Type 3 (Von Willebrand factor antigen (VWF:Ag) less than or equal to [< or =] 3
IU/dL).
2. Diagnosis is confirmed by genetic testing and multimer analysis, documented in patient
history or at screening.
3. For on-demand patient group, participant currently receiving on-demand treatment for
whom prophylactic treatment is recommended by the investigator.
4. For Plasma derived von Willebrand factor (pdVWF) product switch patient group,
participant has been receiving prophylactic treatment of pdVWF products for no less
than 12 months prior to screening.
5. For on-demand patient group, participant has greater than or equal to (>or=) 3
documented spontaneous bleeds (not including menorrhagia) requiring von Willebrand
factor (VWF) treatment during the past 12 months.
6. Availability of records to reliably evaluate type, frequency and treatment of bleeding
episodes during at least 12 months preceding enrollment. Up to 24 months retrospective
data should be collected if available. Availability of dosing and factor consumption
during 12 months (up to 24 months) of treatment prior to enrollment is required for
pdVWF switch participants and is desired (but not a requirement) for on-demand
participants.
7. Participant is > or = 18 years old at the time of screening and has a body mass index
> or = 15 but <40 kilogram per meter square (kg/m^2).
8. If female of childbearing potential, participant presents with a negative blood/urine
pregnancy test at screening and agrees to employ adequate birth control measures for
the duration of the study.
9. Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
1. The participant has been diagnosed with Type 2N Von Willebrand disease (VWD), pseudo
VWD, or another hereditary or acquired coagulation disorder other than VWD (eg
qualitative and quantitative platelet disorders or prothrombin time [PT]/international
normalized ratio [INR] greater than [>]1.4).
2. The participant is currently receiving prophylactic treatment with more than 5
infusions per week.
3. The participant is currently receiving prophylactic treatment with a weekly dose
exceeding 240 IU/kg.
4. The participant has a history or presence of a VWF inhibitor at screening.
5. The participant has a history or presence of a Factor VIII (FVIII) inhibitor with a
titer ≥0.4 Bethesda units (BU) (by Nijmegen modified Bethesda assay) or > or = 0.6
Bethesda Unit (BU) (by Bethesda assay).
6. The participant has a known hypersensitivity to any of the components of the study
drugs, such as to mouse or hamster proteins.
7. The participant has a medical history of immunological disorders, excluding seasonal
allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
8. The participant has a medical history of a thromboembolic event.
9. The participant is human immunodeficiency virus (HIV) positive with an absolute Helper
T cell (CD4) count <200/ cubic millimeter (mm^3).
10. The participant has been diagnosed with significant liver disease per investigator's
medical assessment of the participant's current condition or medical history or as
evidenced by any of the following: serum alanine aminotransferase (ALT) greater than 5
times the upper limit of normal; hypoalbuminemia; portal vein hypertension (e.g.,
presence of otherwise unexplained splenomegaly, history of esophageal varices).
11. The participant has been diagnosed with renal disease, with a serum creatinine (CR)
level > or = 2.5 milligram per deciliter (mg/dL).
12. The participant has a platelet count <100,000/ milliliter (mL) at screening.
13. The participant has been treated with an immunomodulatory drug, excluding topical
treatment (e.g., ointments, nasal sprays), within 30 days prior to signing the
informed consent.
14. The participant is pregnant or lactating at the time of enrollment.
15. Patient has cervical or uterine conditions causing menorrhagia or metrorrhagia
(including infection, dysplasia).
16. The participant has participated in another clinical study involving another
Investigational product (IP) or investigational device within 30 days prior to
enrollment or is scheduled to participate in another clinical study involving an IP or
investigational device during the course of this study.
17. The participant has a progressive fatal disease and/or life expectancy of less than 15
months.
18. The participant is scheduled for a surgical intervention.
19. The participant is identified by the investigator as being unable or unwilling to
cooperate with study procedures.
20. The participant has a mental condition rendering him/her unable to understand the
nature, scope and possible consequences of the study and/or evidence of an
uncooperative attitude.
21. The participant is in prison or compulsory detention by regulatory and/or juridical
order.
22. The participant is member of the study team or in a dependent relationship with one of
the study team members which includes close relatives (i.e., children, partner/spouse,
siblings and parents) as well as employees.
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.
| rVWF IN PROPHYLAXIS | NCT02973087 | Entailment |
5,931 | 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. Patients with typical symptoms of heartburn sensation, or acid regurgitation,or both
for at least 6 months.The symptoms were moderate or severe and at least three days a
week in 7 days prior to the enrollment,which can complicate with Atypical and
extraesophageal symptoms .
2. Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with
grade A or B reflux esophagitis according to Los Angeles classification
Exclusion Criteria:
1. History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal
surgery.
2. History of the chest or abdominal radiotherapy.
3. History of grade C or D reflux esophagitis,other gastrointestinal diseases such as
Barrett's esophagus,zollinger-ellison syndrome, gastric or duodenal ulcer(excluding
ulcer scar),large (>5cm)hiatus hernia,malignant tumor,esophageal stricture,esophageal
and gastric Varices,hemorrhage or perforation of the digestive tract,mechanical
ileus,et al.
4. The presence of serious comorbidities (liver, gallbladder, pancreas,
spleen,kidney,heart,lung,blood system,endocrine,mental disease,autoimmunity and
metabolic disorders) and malignant tumor of other organs.
5. Diagnosis of endocrine,neurological and autoimmunity disorders that may seriously
affect motility(e.g. scleroderma or gastroparesis),and the primary esophageal motility
disorders(achalasia,esophagospasm or nutcracker oesophagus).
6. Pregnancy or lactation during the study and follow-up period.
7. Use of antisecretory drugs(PPIs or H2RA),eradication of H pylori,drugs influenced the
gastrointestinal motility,anticholinergics ,antipsychotics and so on within 4 weeks
before the study.
8. Contraindications to trimebutine maleate or rabeprazole.
9. Use of drugs have interaction with the study drugs （e.g. cisapride ,procainamide,
clopidogrel or ciclosporin),or drugs which may affect the results of the study(e.g.
antisecretory drugs(PPIs or H2RA),prokinetics,mucosal protective drugs or
anticholinergics),or drugs absorbed depending on the acidity of the gastric
fluid(e.g.ketoconazole or digoxin),or CYP3A4,CYP2C19 inhibitors during the study.
10. Patients inability or refuse to consent, unable to complete the questionnaire,and have
poor compliance to the treatment.
11. patients participated in other clinical trial 3 months before the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole | NCT02986685 | Contradiction |
2,963 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Age between 18 and 75 years
- Signed informed consent prior to the initiation of any study-specific procedures
- Familial or sporadic ALS/MND, defined as clinically possible, probable, or definite as
per the El Escorial criteria
- Relative TRICALS risk score between -6.0 to -2.0 (75% of patients with ALS/MND)
- Metabolic index ≥110%, at the screening visit.
- The use of riluzole will be permitted during the study. Individuals taking riluzole
must be on a stable dose for at least 30 days prior to the baseline visit, or stopped
taking riluzole at least 30 days prior to the baseline visit.
- Ability to swallow tablets
- Able to lie with torso elevated at a 35° angle for 30 minutes without respiratory
support
- Able to give informed consent (as judged by the investigator) and able to comply with
all study visits and all study procedures
- Females must not be able to become pregnant (e.g. post-menopausal, surgically sterile
or using highly effective birth control methods) for the duration of the study. Highly
effective methods of birth control are those with a failure rate of < 1% per year when
employed consistently and correctly, e.g. Combined (oestrogen and progestogen
containing) hormonal contraception associated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system ( IUS)
- vasectomised partner
- Females of child-bearing potential must have a negative serum pregnancy test at
screening and baseline and be non-lactating
Exclusion Criteria:
- Unable to provide informed consent
- History of, or current diagnosis of diabetes or medical condition that impacts whole
body energy expenditure (e.g. Hashimoto's, heart disease)
- Parkinson's disease or parkinsonism, tremor, restless-leg syndrome
- Safety Laboratory Criteria at screening related to significant kidney disease:
- Creatinine clearance < 50 mL / min (Cockcroft-Gault) based on Cystatin C
- Tracheostomy or non-invasive ventilation (NIV) use > 22 hours per day
- Inability to swallow tablets
- Contraindication therapy:
- Allergy for one of the product's active pharmaceutical ingredients (APIs) or
excipients.
- Antihypertensive treatment [Trimetazidine may cause hypotension]
- Evidence of malignant disease
- Significant neuromuscular disease other than ALS/MND
- Ongoing disease that may cause neuropathy
- Pregnancy or breastfeeding
- Females actively seeking to become pregnant who are not using an adequate form of
contraceptive as detailed in the Inclusion criteria.
- Deprivation of freedom by administrative or court order
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS) | NCT04788745 | Entailment |
789 | 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:
- primary osteoarthritis in the distal interphalangeal joint
- require surgical treatment
- patient aged 18 years and over
- signed written informed consent
Exclusion Criteria:
- posttraumatic osteoarthritis
- rheumatoid disease
- pregnant woman
- any disease process that would preclude accurate evaluation (e.g. neuromuscular,
psychiatric or metabolic disorder)
- legal incompetence
- no knowledge of German
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.
| Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint | NCT01740999 | Entailment |
4,879 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Cases
- Healthy Volunteers
- Men and women> 18 years
- No known chronic treatment or pathology
- Absence of tobacco or alcohol
- Normal bone mineral density for age (Z-score> -2 and T-score> -2.5) and markers
of bone remodeling in normal values for age and menopausal status (osteocalcin,
CTX)
- Free 24-hour urinary cortisol (CLU / 24 h) normal Cushing matching by menopausal
status, age group, BMI, sex
2. Postmenopausal women
- Menopause confirmed by hormonal assays
- Amenorrhea for more than one year
- Free 24-hour urinary cortisol (CLU / 24 h) normal
- Osteoporosis confirmed at DXA (T score ≤ -2.5 DS) Post menopausal women matching
according to BMI, T-DXA score (T score ≤ -2.5 DS)
3. Cushing's syndrome
- Endogenous hypercorticism, whatever the cause (dependent or independent ACTH)
- Active or controlled for less than 5 years
Exclusion Criteria:
1. Diseases with bone resonance:
- Disease that can affect phosphocalcium metabolism or promote bone loss: endocrine
diseases (hyperparathyroidism, hyperthyroidism); Osteomalacia, malabsorptive
intestinal or inflammatory or chronic liver diseases, chronic inflammatory
rheumatism.
- Heavy comorbidities: heart failure or chronic respiratory insufficiency, known
severe renal insufficiency.
2. Treatments:
- Anti-osteoporotic treatments (bisphosphonates, raloxifene, denosumab)
- Teriparatide; Lithium, thiazide diuretic, treatment with levothyrox suppressive
dose, hormone replacement therapy of menopause, anticonvulsants, corticotherapy
in progress or in the previous 5 years, anti-aromatases, anti-androgenic
3. Other:
- Minors, pregnant women
- Patients unable to express their will (sub-tutelage, curators, dementia).
- Lack of social security
- Lack of follow-up
- Excessive consumption of alcohol
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Cushing's Osteoporosis Specificities | NCT03162068 | Entailment |
2,852 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- ALS and controls(lumbar puncture at our department)
Exclusion Criteria:
- <18 years
- Other CNS 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.
Subject must be at most 100 Years | sCD163 in ALS Patients | NCT02325375 | Entailment |
2,618 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Male athlete (performing sports ≥ 1x/week) with sports-related groin pain ≥ 4 weeks
- Age: 18 - 40 years
Exclusion Criteria:
- Prior assessment/treatment of one of the two examiners for the same complaint (<6
months)
- Prior surgery in the hip- and groin area
- Clinical signs of prostatitis or urinary tract infections
- More than 7 days between the two examiners assessment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Inter-examiner Reproducibility of Clinical Examination Tests for Athletes With Longstanding Groin Pain | NCT03842826 | Contradiction |
4,288 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
Part 1
- Male; healthy according to complete medical history, including the physical
examination, vital signs (blood pressure, pulse rate), 12 lead ECG, clinical
laboratory tests.
- Age: 18-45 years (inclusive) at the first screening visit
- Non-smoker for at least the past 6 months and with a pack year history of equal to or
less than 5 years.
- Subjects who are sexually active and have not been surgically sterilized must agree to
use two reliable and acceptable methods of contraception simultaneously when having
sexual intercourse with women of childbearing potential (one method used by the
subject and one method used by the partner) during the study and for 90 days after
receiving the investigational medicinal product and not to act as sperm donor for 90
days after dosing. [Acceptable methods of contraception include for example: (a)
condoms (male or female) with or without a spermicidal agent, (b) diaphragm or
cervical cap with spermicide, (c) intrauterine device, (d) hormone-based
contraception.
Part 2:
- Age: >18 years at the first screening visit
- Refractory chronic cough for at least one year:
- that has been shown to be unresponsive to at least 8 weeks of targeted treatment
for identified underlying triggers including reflux disease, asthma and
post-nasal drip or unexplained cough, and
- for which no objective evidence of an underlying trigger can be determined after
investigation.
- Score of >40 mm on the Cough Severity visual analogue scale (VAS) at screening.
- For male patients:
Male patients who are sexually active and have not been surgically sterilized must agree to
use two reliable and acceptable methods of contraception simultaneously (one method used by
the study patient and one method used by the partner) during the study and for 90 days
after receiving the investigational medicinal product and not to act as sperm donor for 90
days after dosing. [Acceptable methods of contraception include for example: (a) condoms
(male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with
spermicide, (c) intrauterine device, (d) hormone-based contraception.
--For female patients: Confirmed post-menopausal woman (defined as exhibiting spontaneous
amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea
for 6 months before screening with documented serum follicle-stimulating hormone (FSH)
levels > 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at
least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy
with or without hysterectomy (documented by medical report verification) or Woman of
childbearing potential that agrees to use two reliable and acceptable methods of
contraception simultaneously (one method used by the study patient and one method used by
the partner) during the study and for at least 10 days after the last dose. Acceptable
methods of contraception include for example: (a)condoms (male or female) with or without a
spermicidal agent (b)diaphragm or cervical cap with spermicide (c) intrauterine device
(d)hormone-based contraception.
Exclusion Criteria:
Part 1
- Relevant diseases potentially interfering with the study's aims (e.g.respiratory
diseases) within the four weeks before screening or between screening and
randomization
- Any febrile illness within the four weeks before screening or between screening and
randomization
- Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his/her
ability to taste, as revealed by the taste disturbance questionnaire during screening
and the pre dose procedures
- Use of any over-the-counter cough mixture within the 24 hours before screening
Part 2:
- FEV1 or FVC of less than 60% of predicted normal, at screening
- History of upper or lower respiratory tract infection or recent significant change in
pulmonary status within the 4 weeks before baseline visit
- Current smoking habit or history of smoking within the 6 months before the screening
visit.
- History of smoking (at any time) for more than 20 pack-years in total (20 cigarettes
per pack)
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.
| Repeat Doses of BAY 1817080 in Healthy Males & Proof of Concept in Chronic Cough Patients | NCT03310645 | Entailment |
2,715 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion criteria;
- Age > 18 years
- BMI (body mass index) 20-35
- ASA (American Association of Anesthesiologists Classification system for physical
status) I-III.
- Scheduled for elective laparoscopic inguinal hernia operation
Exclusion criteria:
- Allergy to latex, local anesthesia or opioids
- Chronic pain with daily opiate use
- Patients with severe renal and/or hepatic disease
- Local infection at the site of injection
- Systemic infection
- AV block 2-3
- Inability to understand written or spoken Norwegian
- Inability to cooperate
- Dementia
- Known abuse of alcohol or medication
- Coagulation disorder
- Pregnancy Previously operated with same side operation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Effectiveness of a Transmuscular Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair | NCT03023462 | Entailment |
6,480 | 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:
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria:
- Greater than 3 inflammatory lesions on the face
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or
Sjogren's syndrome.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea | NCT02131636 | Entailment |
665 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- homozygous for C282Y
- currently treated with phlebotomy as maintenance therapy for at least 6 month
- ferritin level between 30-50 micog/L
- age 18 years an older
- weight more than 50 kg
- signed informed consent
- willingness to fill out additional questionnaires at three points in time
Exclusion Criteria:
- chelating therapy
- forced dietary regime
- aged below 18 years
- excessive overweight ( BMI more than 35)
- pregnancy
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 | Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients | NCT01398644 | Contradiction |
2,933 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
Main inclusion criteria:
1. Familial or sporadic ALS
2. Patient diagnosed with probable of definite ALS
3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior
to screening
Exclusion Criteria:
1. Patient who underwent tracheostomy and/or gastrostomy
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.
| Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | NCT02588677 | Entailment |
1,080 | 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. | - Children and adolescents (less than or equal to 21 years) with HCM who had been
evaluated in the Cardiology Branch, National Heart Lung and Blood Institute between
1977 and 2002. HCM was diagnosed by echocardiographic demonstration of a hypertrophied
non-dilated left ventricle (LV) in the absence of another cause of LV hypertrophy. All
patients participated in protocols approved by the NHLBI Institutional Review Board,
and provided informed written consent to participate. The patients participated in the
following protocols: 98-H-0102, 77-H-0082, 99-H-0150, 01-H-0007, 96-H-0144, 94-H-0001,
84-H-0232, 98-H-0100, and 99-H-0065.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Identification of Risk Factors for Arrhythmia in Children and Adolescents With Hypertrophic Cardiomyopathy | NCT00753233 | Contradiction |
1,750 | 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:
- Men and women 18 years and older
- Diagnosis of FD with either PDS or EPS as measured by Rome III Criteria
- Patients describing inadequate relief of dyspepsia symptoms
- Endoscopy performed in the last 3 years and negative for an organic cause for
dyspeptic symptoms
- H pylori negative by non-invasive testing or biopsy. Patients with a history of
successfully eradicated H pylori will be included if follow-up testing by stool
antigen, urea breath testing, or biopsy is negative
- Celiac disease excluded by serologies or biopsy
Exclusion Criteria:
- Patients with IBS predominant symptoms that are not well controlled
- Patients with a diagnosis of GERD who have uncontrolled heartburn
- History of esophagitis, ulcer disease, or other organic upper GI disease, including a
diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper GI
tract
- History of surgery involving the esophagus, stomach, or duodenum
- Known lactose intolerance, unless symptoms persist on a lactose free diet
- Known fructose intolerance unless symptoms persist on a fructose free diet
- Patients undergoing active titration of any medications
- Pregnant or breastfeeding women
- Prisoners
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. | NCT02863822 | Contradiction |
452 | 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:
- Fresh IVF/ICSI cycle
- Antagonist down-regulation
- Signed informed consent
Exclusion Criteria:
- Other known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting
the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial
tuberculosis)
- Oocyte donation acceptors
- Frozen egg transfers
- Embryos planned to undergo preimplantation genetic diagnosis (PGD)
- BMI >35 or <18
- Women already recruited for another trial on medically assisted procreation during the
same cycle
- Women who have previously enrolled in the trial
- Those unable to comprehend the investigational nature of the proposed study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | REFRESH: Receptivity Enhancement by Follicular-phase Renewal After Endometrial ScratcHing | NCT02061228 | Contradiction |
893 | 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:
- patients age 50 or older who present with symptomatic primary osteoarthritis of the
knee
- daily pain for the previous 3 months
- analgesics usage at least once a week
- less than 30 minutes of morning stiffness
- WOMAC score of ≤ 75 in the target knee
- Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2
Exclusion Criteria:
- evidence of secondary knee osteoarthritis
- severe osteoarthritis (Joint space width - JSW < 2 mm)
- prior intra articular injections within the previous one year prior to inclusion
- patients with clinically significant systemic disease
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.
| Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis | NCT03089762 | Entailment |
5,094 | 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:
- Generally healthy, community-dwelling ambulatory post-menopausal women.
- Able and willing to sign informed consent.
- Age 60 to 89.
- Have osteoporosis defined as follows:
- BMD T-score of the lumbar spine, femur neck, total proximal femur or .3 radius of -2.5
to -4.0; note: the lumbar spine must include two vertebrae that are evaluable by DXA
in the opinion of the investigator.
OR
- BMD T-score of the lumbar spine, femur neck, total proximal femur or .3 radius of -1.5
or lower and either an atraumatic (in the opinion of the investigator) nonvertebral
fracture; [note: nonvertebral fracture sites include the wrist, hip, pelvis, ribs,
humerus, clavicle, femur, tibia and fibula] or a minimum of two mild or one moderate
or severe atraumatic vertebral fractures (defined using the Genant visual
semi-quantitative scale).
- Baseline serum 25(OH)D concentration > 20 ng/ml and < 60 ng/ml.
- Able and willing to receive daily subcutaneous injections using a Forteo® pen.
Exclusion Criteria:
- History of exposure to external beam or implant radiation therapy involving the
skeleton.
- Paget's disease or unexplained elevations of alkaline phosphatase.
- Any history of venous thrombosis including deep vein thrombosis, pulmonary embolism,
retinal vein thrombosis and superficial phlebitis.
- Documented atherosclerotic vascular disease, including but not limited to prior
myocardial infarction, angina, atrial fibrillation, stroke and TIA.
- Marked hypertriglyceridemia (>500 mg/dl).
- History of prior treatment with estrogen resulting in hypertriglyceridemia (> 500
mg/dl).
- Serum calcium, alkaline phosphatase, PTH or TSH outside the normal reference range.
- History of nephrolithiasis or urolithiasis within 10 years prior to enrollment; those
with a history of nephro- or urolithiasis must have an appropriate radiology study
(e.g., IVP or KUB) within six months documenting absence of stones.
- Baseline 24-hour urine calcium > 250 mg.
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis.
- History of any form of cancer except adequately treated squamous cell or basal cell
skin carcinoma.
- Use of active vitamin D analogs or high dose vitamin D (≥50,000 IU weekly) in the last
year.
- Active or suspected diseases (within 1 year prior to enrollment) that affect bone
metabolism, e.g., renal osteodystrophy, hyperthyroidism, osteomalacia,
hyperparathyroidism.
- Known allergy, hypersensitivity, contraindication or intolerance to teriparatide or
raloxifene.
- History of vaginal bleeding within the past year.
- Renal failure or substantial hepatic impairment. Note "renal failure" is defined as a
calculated creatinine clearance (using the Cockroft-Gault formula) of ≤ 35 ml/minute.
- Severe disease, e.g., cardiac, hepatic, pulmonary, etc., which may limit ability to
complete this study. Specifically, significantly impaired hepatic function (ALT or GGT
3x the upper limit of normal.
- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel
disease, gastric bypass, etc.
- Use of anion exchange resins (e.g., cholestyramine) in the past month.
- Current use of warfarin (coumadin).
- Current use of highly protein-bound drugs including diazepam, diazoxide and lidocaine.
- Current use of digoxin.
- Any prior use of bisphosphonates, denosumab, strontium, fluoride, teriparatide or
parathyroid hormone.
- Prior use of estrogen, raloxifene, calcitonin or testosterone will be allowed if
discontinued more than six months previously. Low dose intra-vaginal estrogens (0.3 mg
or less of conjugated equine estrogen or equivalent) may be continued throughout the
study.
- Treatment with glucocorticoids in doses ≥ 5 mg prednisone daily for > 30 days in the
prior year.
- Treatment with other drugs known to affect bone metabolism, e.g., anticonvulsants
except benzodiazepines or gabapentin, within the prior year. Note: oral calcium
supplementation, vitamin D supplementation or diuretic use that has been stable for
six months are allowed).
- Treatment within the last 30 days with any drug that has not received regulatory
approval.
- Metal in spine precluding spine QCT.
- Any condition that may interfere with evaluation of at least two lumbar vertebrae
determined on VFA performed at time of screening. Examples include confluent aortic
calcification, severe osteoarthritis, spinal fusion and lumbar spine fractures.
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 89 Years | Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window? | NCT01166958 | Contradiction |
2,104 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- any patient referred to the Interstitial Lund Disease clinic who is undergoing
evaluation and or treatment for a new diagnosis of ILD. This can include patients
referred for presumed pulmonary fibrosis/interstitial pneumonitis (IPF, UIP, NSIP),
sarcoidosis, hypersensitivity pneumonitis, cryptogenic organising pneumonia,
drug-induced, or other idiopathic ILDs.
Exclusion Criteria:
- pregnancy
- inability to follow study requirements
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.
| Idiopathic Pulmonary Fibrosis Registry for Future Studies | NCT00815711 | Entailment |
3,944 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Voluntary signature of the IRB approved Informed Consent
2. Unilateral or bilateral osteoarthritic male or female ages 35-85
3. Pain, swelling, and/or functional disability in the affected knee consistent with
osteoarthritis in the knee joint
4. Physical examination consistent with osteoarthritis in one knee joint
5. Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging
of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect,
bone marrow lesion, meniscus tear, synovial thickening, etc…)
6. Is independent, ambulatory, and can comply with all post-operative evaluations and
visits
Exclusion Criteria:
1. Knee injections of any type within 3 months prior to the study.
2. Knee surgery within 6 months prior to the study.
3. Inflammatory or auto-immune based joint diseases or other lower extremity pathology
(e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis,
polymyalgia, polymyositis, gout pseudogout)
4. Quinolone or Statin induced myopathy/tendinopathy
5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
6. Contraindications for MRI
7. Condition represents a worker's compensation case
8. Currently involved in a health-related litigation procedure
9. Is pregnant
10. Bleeding disorders
11. Currently taking anticoagulant or immunosuppressive medication
12. Allergy or intolerance to study medication
13. Use of chronic opioid
14. Documented history of drug abuse within six months of treatment
15. Any other condition, that in the opinion of the investigator, that would preclude the
patient from enrollment
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 85 Years | Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment | NCT02848027 | Entailment |
2,663 | 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:
- Informed consent
- Age 18 years or older
- Diagnosis of reducible incisional hernias up to 200 cm²
- Medically fit for general anesthesia
- Comprehension and use of French language
- Installed in the geographical region without foreseeable move for two years
Exclusion Criteria:
- Incarcerated hernia
- Ongoing chronic pain syndrome, other than hernia origin
- Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop
platelet antiaggregation therapy 10 days before surgery
- American Society of Anesthesiology Class 4 and 5 patients
- Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
- Mentally ill patients
- Presence of local or systemic infection
- Life expectancy < 2 years
- Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
- Morbid obesity (BMI over 40)
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 | Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair | NCT00625053 | Entailment |
5,082 | 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:
- Members of the Henry Ford Health System
Exclusion Criteria:
- Individuals who are not members of the Henry Ford Health System
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 89 Years | Osteoporosis Disease Management Demonstration Project (0000-037) | NCT00139425 | Contradiction |
4,311 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Severe male factor infertility, Average response to COH,
Exclusion Criteria:
- Poor responders,
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility? | NCT02992665 | Entailment |
2,259 | 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:
- Body weight ≥7.5 kilograms (kg)
- No clinically significant abnormality based upon laboratory assessments during the
screening period, in the opinion of the Investigator; good general health, as
determined during the screening period by medical history and physical examination
(including vital sign measurements).
- Diagnosis of duchenne muscular dystrophy (DMD) based on an elevated serum creatine
kinase and genotypic evidence of dystrophinopathy.
- Documentation of the presence of a nonsense mutation of the dystrophin gene.
- Verification that a blood sample was drawn for sequencing of the dystrophin gene.
Exclusion Criteria:
- Participation in any drug investigation or received an investigational drug within
three months prior to the Screening Visit or who anticipate participating in any other
drug or device clinical investigation or receiving any other investigational drug
within the duration of this study.
- Expectation of a major surgical procedure during the study period.
- Known hypersensitivity to any of the ingredients or excipients of the study drug
(polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25C, crospovidone
XL10, hydroxyethyl cellulose, vanilla, colloidal silica, or magnesium stearate).
- Prior and concomitant use of corticosteroids.
- Ongoing use of the following drugs:
1. Systemic aminoglycoside therapy and/or intravenous (IV) vancomycin.
2. Coumarin-based anticoagulants (for example, warfarin), phenytoin, tolbutamide, or
paclitaxel.
3. Inducers of UGT1A9 (for example, rifampicin), or substrates of OAT1 or OAT3 (for
example, ciprofloxacin, adefovir, oseltamivir, aciclovir, captopril, furosemide,
bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 2 Years | A Study to Evaluate the Safety and Pharmacokinetics of Ataluren in Participants From ≥6 Months to <2 Years of Age With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) | NCT04336826 | Contradiction |
897 | 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:
- Able and willing to give informed consent and comply with the study protocol.
- Symptomatic OA of the knee greater than 3 months, as defined by the American College
of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the
Knee. If symptoms are bilateral, then the knee identified as more symptomatic will
serve as the index knee.
- Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while
walking on a flat surface (corresponding to question 1 of the visual analog format of
the WOMAC).
- Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren
and Lawrence (K-L) grading scale.
- Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or
the presence of medial bone cyst, sclerosis, or osteophyte.
- Able to walk at least 10 minutes without a break.
- Age of 40 years or older
Exclusion Criteria:
- Unwillingness to wear study shoes for at least 6 hours/day for 6 days of the week
- Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
- Presence of clinical OA of the ankle or hip or ankle/hip pain>10 mm (WOMAC).
- Predominant lateral compartment OA, defined as narrowing of the lateral joint space in
excess of the narrowing of the medial joint space in either knee.
- Concurrent systemic inflammatory arthropathy
- Prior knee or hip arthroplasty, or surgical arthroscopy within the previous 3 months.
- Intrinsic foot disease: hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar
fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated
particular footwear.
- Intra-articular knee injection: steroids within 6 wks, hyaluronan derivatives within 4
mos.
- Body mass index greater than 38.
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.
| Using Pressure Detecting Insoles to Reduce Knee Loading | NCT02955225 | Entailment |
2,645 | 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 laparoscopic TEP and TAPP repairs that have been registered in the SHR from
January 1, 2005 until December 31, 2017.
Exclusion Criteria:
- Open repairs.
- Hernioplasties that were converted from laparoscopic to open surgery.
- Age < 15 years.
- Patients not having a 10-digit state-assigned Patient Identification Number.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
| Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery | NCT03755219 | Entailment |
300 | 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:
The inclusion criteria for RIF group were:
•unexplained repeated implantation failure (RIF) which is defined as the absence of a
gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo
transfers with high quality embryos or after the transfer of ≥10 embryos in multiple
transfers.
The inclusion criteria for control group were:
- age <35 years;
- regular menstrual cycles of 24-35 days;
- baseline follicle- stimulating hormone (FSH) < 9.0 IU/L;
- endometrial thickness ≥8.0 mm on the day of hCG administration.
Exclusion Criteria:
- uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus);
- intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated
hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm
and/or endometrial pressure)
- history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal
malformation).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Personal FET in RIF Patients According to Histological Dating of Endometrial of Natural/ Hormone Replacement Cycle | NCT03312309 | Contradiction |
2,385 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Subject Inclusion Criteria
1. Age: 5 - 11 years old
2. Ambulant
3. Diagnosis of DMD confirmed by at least one the following:
- Positive X-linked family history for typical Duchenne muscular dystrophy in older
male relatives (onset by age 5 yr., wheelchair-bound by age 12 yr.) OR
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical Duchenne dystrophy OR
- Gene deletion test positive (missing one or more exons) in the central rod domain
(exons 25-60) of dystrophin, where reading frame can be predicted as
'out-of-frame', and clinical picture consistent with typical Duchenne dystrophy.
4. On Glucocorticosteroids: Children must be on a steady dose of prednisone or
deflazacort, on any schedule (Daily, alternate days, 10 days on, 10 days off or twice
a week), for the last 6 months before starting the clinical trial. Dose of steroid or
schedule cannot be altered during the study.
5. Evidence of muscle weakness by MRC score or clinical functional evaluation
6. Ability to provide reproducible repeat QMT bicep score within 10% of first assessment
score.
7. Ability to swallow tablets
Subject Exclusion Criteria
1. Failure to achieve one or more of the diagnostic inclusion criteria cited above.
2. Symptomatic DMD carrier
3. Previous (6 months or less) or current use of Coenzyme Q10 (for DMD or any other
disease)
4. Use of carnitine, other amino acids, creatine, glutamine, or any herbal medicines
within the last 3 months.
5. History of significant concomitant illness or significant impairment of renal or
hepatic function.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 11 Years | An Open-label Pilot Study of Coenzyme Q10 in Steroid-Treated Duchenne Muscular Dystrophy | NCT00033189 | Entailment |
2,931 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Have the ability to understand the requirements of the study, provide written informed
consent, understand and provide written authorization for the use and disclosure of
Protected Health Information (PHI) [per Health Insurance Portability and
Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.
2. Subjects with sporadic or familial ALS, meeting the definition of laboratory-supported
probable, probable or definite ALS according to the World Federation of Neurology El
Escorial Criteria (Appendix A). At the time of enrollment subjects should be within 24
months of symptom onset.
3. Age 18 years or older.
4. Females must have a negative serum pregnancy test and practice an acceptable method of
contraception or be of non-childbearing potential (post-menopausal for at least 2
years or surgically sterile [hysterectomy, oophorectomy or surgical sterilization]).
5. Geographic accessibility to the study center and the ability to travel to the clinic
for study visits.
6. Presence of a willing and able caregiver.
7. Medically able to undergo lumbar and/or cervical laminectomy or laminoplasty as
determined by the site Principal Investigator and neurosurgeon.
8. Medically able to tolerate the immunosuppression regimen consisting of basiliximab,
tacrolimus, mycophenolate mofetil, prednisone and methylprednisolone as determined by
the site PI.
9. Agrees to the visit schedule as outlined in the informed consent.
10. Not taking riluzole (Rilutek®) or on a stable dose for ≥ 30 days.
11. Vital capacity ≥ 60% of predicted normal for age, height and gender measured in the
seated position and ≥50% in supine position during the 7 days prior to surgery.
12. Ambulatory subjects with extremity weakness and/or spasticity due to ALS. Patients
undergoing lumbar surgery must have demonstrable weakness or spasticity in one or both
lower extremities. Patients undergoing cervical surgery must have demonstrable
weakness or spasticity in one or both upper extremities, with at least antigravity
strength. Subjects must have normal neck extensor and flexor strength.
Exclusion Criteria:
1. Etiology of paraplegia or weakness is due to causes other than ALS.
2. A positive result on the Panel Reactive Antibody (PRA) test, with the presence of
specific HLA antibodies matching the HLA DNA profile of the donor cells.
3. Any known immunodeficiency syndrome.
4. Receipt of any investigational drug, device or biologic within 30 days of surgery.
5. Any concomitant medical disease or condition limiting the safety to participate:
1. Coagulopathy
2. Active uncontrolled infection
3. Hypotension requiring vasopressor therapy
4. Previous spinal surgery that the neurosurgeon deems to be an obstacle to the
planned transplantation
5. Skin breakdown over the site of surgery
6. Malignancy (except for non-melanoma skin cancer)
7. Spinal stenosis severe enough to preclude surgery (as determined by the
neurosurgeon)
8. Pre-existing kyphosis by preoperative MRI or X-ray
9. Less than 5/5 grade in neck extension and strength test at the time of surgery.
6. Creatinine >1.5, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2x upper
limit of normal, hematocrit/hemoglobin < 30/10, total WBC < 4000, uncontrolled
hypertension (systolic > 180 or diastolic > 100) or uncontrolled diabetes (defined as
hemoglobin A1C >8), evidence of GI bleeding by hemoccult test, tuberculosis (TB test:
PPD), serologic evidence of current infection with a hepatitis virus or human
immunodeficiency virus (HIV).
7. Presence of any of the following conditions:
1. Current drug abuse or alcoholism
2. Unstable medical conditions
3. Unstable psychiatric illness including psychosis and untreated major depression
within 90 days of screening
8. Any condition or ALS disease phenotype that the site PI feels may interfere with
participation in the study or in the interpretation of study endpoints.
9. Any condition that the neurosurgeon feels may pose complications for the surgery.
10. Known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, prednisone
or methylprednisolone.
11. Inability to provide informed consent as determined by the site PI.
12. Inadequate family or caregiver support as determined by the site PI.
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.
| Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis | NCT01730716 | Entailment |
6,546 | 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:
- Able to provide informed consent and comply with requirements of the study
- Males ≥18 y.o. with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous
factor IX)
- Received ≥50 exposure days to factor IX products
- A minimum average of 4 bleeding events per year requiring episodic treatment of factor
IX infusions or prophylactic factor IX infusions
- No measurable factor IX inhibitor as assessed by the central laboratory and have no
prior history of inhibitors to factor IX protein
- Agree to use reliable barrier contraception until 3 consecutive samples are negative
for vector sequences
Exclusion Criteria:
- Evidence of active hepatitis B or C
- Currently on antiviral therapy for hepatitis B or C
- Have significant underlying liver disease
- Have serological evidence* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (* subjects who
are HIV+ and stable with CD4 count >200/mm3 and undetectable viral load are eligible
to enroll)
- Neutralizing antibodies reactive with AAV-Spark100 above and/or below a defined titre
- Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
with an investigational drug within the last 12 weeks
- Unable or unwilling to comply with study assessments
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Gene Therapy Study for Hemophilia B | NCT02484092 | Contradiction |
3,051 | 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. Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).
2. Male (who have more serious effects due to the X chromosome nature of the disorder)
3. Age 13-29 years.
4. Parent of adolescent must be willing to sign informed consent.
5. Intelligence Quotient (IQ) > 42.
Exclusion Criteria:
1. Cardiac risk factors.
2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or
atypical antipsychotics.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 29 Years | Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome | NCT01254045 | Entailment |
4,878 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Key Inclusion Criteria:
1. Male or female ≥18 years of age
2. Able to provide written informed consent prior to any study procedures being
performed; eligible subjects must be able to understand the informed consent form
prior to inclusion into the study.
3. Confirmed diagnosis of newly diagnosed, persistent or recurrent Cushing's disease (CD)
or endogenous CS of other etiology if subjects are not candidates for surgery or
radiotherapy within the 18 months after enrollment.
Previous medical records will be collected and used to support the diagnosis of CD or
endogenous CS of other etiology, including the following etiologies:
- Ectopic adrenocorticotropic hormone (ACTH) secretion, i.e. ACTH not of pituitary
origin
- Ectopic corticotropin-releasing hormone (CRH) secretion
- Adrenal-dependent CS (i.e. adrenal adenoma (NOT carcinoma), adrenal hyperplasia,
etc.)
- Etiology unknown.
4. Must have elevated mean 24 hour UFC levels ≥1.5X ULN based on the normative range of
the central lab assay and on a minimum of four measurements from adequately collected
urine.
5. In addition to elevated mean UFC, presence of abnormal values from one of the
following tests:
- Abnormal DST: Elevated 8 AM serum cortisol ≥1.8 micrograms/dL (50 nmol/L) after 1
mg dexamethasone orally at 11 PM the evening prior (if not conducted already in
the diagnostic workup of the subject within the previous 2 months before start of
Screening Phase; in that case previous test results and details of conduct will
need to be available by the Baseline Visit)
- Elevated late night salivary cortisol concentrations (at least two measurements)
>ULN
6. Previously irradiated subjects with CD or endogenous CS of other etiology will be
allowed as long as the radiation treatment occurred > 4 years ago and subjects have
not exhibited evidence for improvement in their underlying CD for 6 months prior to
the Screening visit. The total number of previously irradiated subjects enrolled in
this study will not exceed 10.
7. Subjects with CD or CS of other etiology who are not candidates for surgery, refuse
surgery, or in whom surgery will be delayed for at least 18 months following
enrollment. Subjects may be allowed to participate in the trial while awaiting
surgery, but must agree to complete this study prior to surgery.
8. Subjects on treatment for CD or endogenous CS of other etiology for whom treatment has
been inadequate or not well tolerated must agree to minimum washout periods prior to
the Baseline Visit as specified.
Key Exclusion Criteria
1. Subjects with Pseudo-Cushing's syndrome based on assessment of the Investigator.
2. Subjects with cyclic CS based on assessment of the Investigator
3. Subjects with a non-endogenous source of hypercortisolism such as exogenous source of
glucocorticoids or therapeutic use of ACTH.
4. Known inherited syndrome as the cause of hypercortisolism, including but not limited
to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex
5. Subjects with adrenal carcinoma
6. History of malignancy, other than thyroid, early stage prostate, squamous cell and
basal cell carcinoma, within 3 years prior to the Screening Phase.
7. Subjects with QTc interval of >470 msec during the Screening Phase.
8. Pre-existing hepatic disease; subjects with mild to moderate hepatic steatosis
consistent with fatty infiltration (non-alcoholic fatty liver disease [NAFLD] are
allowed).
9. History of documented or suspected drug-induced liver injury requiring drug
discontinuation of ketoconazole or any azole antifungals.
10. Subjects who receive any prohibited concomitant medication and cannot discontinue it
safely prior to the Baseline Visit.
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.
| Treatment for Endogenous Cushing's Syndrome | NCT01838551 | Entailment |
6,482 | 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. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA)
score rated 3 (moderate) or 4 (severe),
2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and
pustules) on the face.
Exclusion Criteria:
1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans,
isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
keratosis pilaris, seborrheic dermatitis, and acne,
2. The subject has rosacea with more than two nodules on the face.
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.
| Phase 3 Papulopustular Rosacea Study | NCT01494467 | Entailment |
5,889 | 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 between 18 - 80 years of age.
2. Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order
to have reached a stable weight loss plateau).
3. Subject has a history of heartburn, regurgitation or both for >6 month prompting
physician recommendation of continual daily use of PPI after sleeve gastrectomy.
4. Baseline off-PPI GERD-HRQL score ≥ 20 following 10-14 days off PPI
5. Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a
positive relationship between the occurrence of their primary symptom during the pH
impedance monitoring (symptom association probability ≥ 95% or a SI score ≥ 50%) is
present.
6. Subject who are on standard medical therapy for 6 months or longer and experience
discomfort or who are otherwise dissatisfied with GERD symptoms.
7. Subjects with a GERD condition that in the opinion of the PI justifies a minimally
invasive reversible procedure prior to attempting a more drastic procedure such as a
gastric bypass.
8. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry
of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 6%
of total time.
9. Subject has a resting LES end expiratory pressure ≥ 5mmHg on manometry performed
within 6 months of enrollment.
10. Subject has no esophagitis or esophagitis ≤ Grade C (LA classification) on upper
endoscopy within 6 months of enrollment.
11. Subject has esophageal body contraction amplitude > 30 mmHg for >30% of swallows and >
30% peristaltic contractions on manometry.
12. Subject has signed the informed consent form and is able to adhere to study visit
schedule.
Exclusion Criteria:
1. Subject has any non-GERD esophageal motility disorders.
2. Subject has evidence of obstruction or stricture in the gastric sleeve by a barium
swallow and endoscopy.
3. Subject has any significant multisystem diseases.
4. Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma,
dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST),
Sjogren's Syndrome, Sharp's Syndrome) requiring therapy in the preceding 2 years.
5. Subject has Barrett's epithelium (> M2; >C1) or any grade of dysplasia.
6. Subject has a hiatal hernia larger than 3 cm.
7. Subject has a body mass index (BMI) greater than 35 kg/m2.
8. Subject has Type 1 Diabetes Mellitus
9. Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c >9.5 in the
previous 6 months, or has T2DM for > 10 years.
10. Subject has a history of suspected or confirmed esophageal or gastric cancer.
11. Subject has esophageal or gastric varices.
12. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular
disease.
13. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
14. Subject requires chronic anticoagulant therapy.
15. Subject has dysphagia or esophageal peptic stricture, excluding Schatzki's ring.
16. Subject of child-bearing potential who is pregnant or intends to become pregnant
during the trial period.
17. Subject is currently enrolled in other potentially confounding research.
18. History of any malignancy in the last 2 years.
19. Subject has any condition that, at the discretion of the investigator, would preclude
participation in the trial.
20. Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to
enrollment.
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 | An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy | NCT02210975 | Contradiction |
3,402 | 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:
Inclusion criteria for enrolment at birth
- Written informed consent obtained from the parents or guardians of the subject.
- A male or female infant born after a normal gestation period (between 36 and 42
weeks).
- Born to a mother seronegative for HBsAg.
- Free of obvious health problems as established by clinical examination before entering
into the study.
Inclusion criteria for administration of the combined vaccine regimen
- Between, and including, 6 and 8 weeks of age at the time of the first dose of the
three-dose course of vaccination.
- Free of obvious health problems as established by medical history and clinical
examination before entering into this phase of the study.
Inclusion criteria for administration of the booster dose
- Between, and including, 15 and 18 months of age at the time of the booster
vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- Completion of the three-dose primary vaccination course.
Exclusion Criteria:
Exclusion criteria for enrolment at birth
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- Major congenital defect(s).
Exclusion criteria for administration of the combined vaccine regimen
- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding the first dose of study vaccine, or planned use
during the study period.
- Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine except Bacille Calmette-Guérin
vaccine during the period starting from 30 days before each dose of vaccines and
ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae
type b disease.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or
Haemophilus influenzae type b disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.
Exclusion criteria for administration of the booster dose
- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding the booster dose of study vaccines, or planned use
during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months of vaccination.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B,
polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Acute disease at the time of enrolment.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the booster dose of study vaccine or planned administration during the study
period.
- Hypersensitivity reaction due to vaccine in primary course
- Encephalopathy within 7 days of previous vaccination with DTP vaccine
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Weeks old.
Subject must be at most 8 Weeks | Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine | NCT00880477 | Contradiction |
2,389 | 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:
- Young man ou woman (5 to 17 years old) with Duchenne Muscular Dystrophy (confirmed by
immunohistochimy on the muscular biopsy and/or mutation in the dystrophin confirmed by
molecular biology)
- Time more than 7 secondes to test of 10 m and/or distance less than 330 m to walk test
of 6 minutes. These values are recent markers to include children with a strong risk
of loss of walking ability in 2 years.
- Parental inform sign consent and / or child inform consent
Exclusion Criteria:
- Recent orthopaedic surgery of lower limbs (6 months)
- Other chronic disease associated, which have an impact on the walking
- Cognitive Deficiency or behavior disorders limiting the understanding of the study
- Children who can benefit ATU (translarna ® or other) during the study
- All MRI contradications : pacemaker or neurosensory stimulator or implantable
defibrillator, neurosurgical valves, cochlear implant or ferromagnetic implants near
nervous structures, brace, metallic prostheses, not cooperative or agitated patients,
patient claustrophobic, pregnant woman.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 17 Years | Biomechanical and Morphological Changes in Dystrophic Muscle | NCT02472990 | Entailment |
6,149 | 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 ≥50 years old OR primary healthcare professional (defined as having a job that has
had direct patient contact during the COVID-19 pandemic) and ≥18 years old
- No symptoms of COVID-19 (a fever of 100.0o F or greater, OR a new cough, OR new
shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing
(respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of
smell, OR new change or loss of taste sensation) in the past 7 days
- Have a negative Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening
- Have not had close contact with a person with a LABORATORY CONFIRMED case of COVID-19
without full PPE (Close contact is defined by CDC as: Being within approximately 6
feet of a COVID-19 patient for a total of 15 minutes or more over a 24 hour period) or
having direct contact with infectious secretions of a COVID-19 patient (e.g. being
coughed on)) in the last 14 days
- Mayo Clinic patient who has a patient online account set up or is willing to set up an
online account
- Must have a valid email address and internet service
Exclusion Criteria:
- History of positive or indeterminate COVID PCR test prior to screening or Elecsys
Anti-SARS-CoV-2 immunoassay antibody test positive or indeterminate at screening
- Active symptoms of COVID ((a fever of 100.0o F or greater, OR a new cough, OR new
shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing
(respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of
smell, OR new change or loss of taste sensation)) in past 7 days
- Known intolerance to multivitamins or zinc supplements from prior exposure
- Inability to complete follow-up questions or grant access to electronic health record
for surveillance
- Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in
past 14 days
- Current or former smoker less than 5 years ago
- Pregnant or breastfeeding
- Prisoner
- Any subject with known immunosuppressed state, including
1. A history of solid organ or bone marrow transplantation
2. Subjects currently receiving chemotherapy
3. Current rheumatologic or autoimmune illness requiring treatment with
glucocorticoids, antimetabolite agents (methotrexate, azathioprine,
mercaptopurine, fluorouracil, mycophenolate, leflunomide), IMIDs (lenalidomide,
thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine),
mTOR inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs
(including any drug given intravenously or subcutaneously) for the purpose of
immunosuppression
4. Subjects with HIV or primary immunodeficiency syndromes
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 | Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 | NCT04551339 | Contradiction |
1,379 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Less than 2 per week defecation
- Fecal incontinence
- Retentive behavior
- Pain at defecation and
- Hard stools
Exclusion Criteria:
- Medication use (calcium, antacid, diuretic and hematinic)
- Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental
delay neuropsychomotor, kidney disease and metabolic diseases)
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 18 Years | Physiotherapeutic Intervention in Children With Chronic Functional Constipation | NCT00906971 | Contradiction |
1,390 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
1. Age<14 years
2. Hirschsprung's disease diagnosed by biopsy
3. Surgical indication
Exclusion Criteria:
1. Age>14 years
2. Not Hirschsprung's disease
3. Surgical contraindication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 14 Years | Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial | NCT02234219 | Entailment |
4,523 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Healthy female volunteers
- Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion
- History of regular cyclic menstrual periods (with a cycle length between 25 and 35
days)
- Willingness to use barrier methods of contraception (condoms with spermicide,
diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during
the trial
Exclusion Criteria:
- Pregnancy, lactation (less than three menstrual cycles before Visit 1 following
delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)
- Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at
Visit 1 or a normal result has to be documented within the last 6 months before Visit
1)
- Laboratory values outside inclusion range at Screening - Any disease that may worsen
under hormonal treatment or might interfere with the conduct of the study or the
interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of
venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis,
pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including
prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could
increase the risk to suffer from any of the above mentioned disorders, e.g., a family
history indicating a hereditary predisposition. -- uncontrolled arterial hypertension
(repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood
pressure > 90 mmHg)
- Liver -- presence or history of liver tumor (benign or malignant) -- presence or
history of severe hepatic disease as long as liver function values have not returned
to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic
jaundice associated with pregnancy or previous COC use
- Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe
dyslipoproteinemia
- Other diseases: any known or suspected malignant or premalignant disease, uncontrolled
thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or
acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history
of hypertriglyceridemia-associated Pancreatitis, systemic lupus erythematodes,
pemphigoid gestationis during a previous pregnancy, Sydenham chorea, herpes
gestationis, otosclerosis-related hearing loss, history of migraine with focal
neurologic symptoms, epilepsy, current or history of clinically significant
depression, hereditary angioedema
- Additional sex steroids, other hormonal contraceptive methods (oral, transdermal)
during treatment (blister in use at randomization should be finished); intra-uterine
devices (IUD) with or without hormone release within 1 month prior to Visit 1,
implants within 1 month prior Visit 1, depot progestins within 6 months prior to Visit
1 - Surgical interventions scheduled in the study period
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Cycle Control and Safety of E2-DRSP | NCT00653614 | Contradiction |
1,561 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Age > 18 years
- Post-operative cardiac surgery patients on the ICU floors at the Cleveland Clinic Main
Campus
- Wrist size range ranging from 16 cm to 19 cm
Exclusion Criteria:
- Wrist size range smaller than 16 cm or larger than 19 cm
- Use of a radial artery graft for coronary artery bypass grafting
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 Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch | NCT03986281 | Contradiction |
4,870 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
1. Has a confirmed diagnosis of endogenous Cushing's syndrome.
2. Requires medical treatment of hypercortisolemia.
3. Meets at least one of the following criteria:
1. Has type 2 diabetes mellitus.
2. Has impaired glucose tolerance.
3. Has hypertension.
Exclusion Criteria:
1. Has non-endogenous source of hypercortisolemia
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has Stage ≥ 4 renal failure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Study to Evaluate CORT125134 in Participants With Cushing's Syndrome | NCT02804750 | Entailment |
4,103 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | INCLUSION CRITERIA
- Have signed & dated informed consent before beginning protocol procedures.
- Willing & able to complete entire trial as described in protocol.
- 16 years of age or older.
- Have a history and presenting symptoms of excessive daytime sleepiness.
- Have a history of cataplexy localizable to a specific muscle group(s) or part(s) of
body during which the patient is lucid (not experiencing an inadvertent nap or micro
sleep).
- Have valid PSG & MSLT scores (collected during an overnight test) within last five
years and a current diagnosis of narcolepsy according to the following criteria
established by the American Sleep Disorders Association: (1) Recurrent daytime naps or
lapses into sleep occur almost daily for at least 3 months; (2) Sudden bilateral loss
of postural muscle tone occurs in association with intense emotion (cataplexy); (3)
Polysomnography demonstrates one or more of the following: (a) Sleep latency less than
10 minutes; (b) REM sleep latency less than 20 minutes; (c) An MSLT that demonstrates
a mean sleep latency of less than 5 minutes; (d) Two or more sleep-onset REM periods
- Females who are surgically sterile, two years post-menopausal, or if of child-bearing
potential, using a medically accepted method of birth control and agree to continue
use of this method for the duration of the trial.
- In the opinion of the investigator, have adequate support for the duration of trial to
include transportation to and from trial site. In addition, if in the investigator's
assessment it is clinically indicated, the patient is willing to not operate a car or
heavy machinery for the duration of the trial or for as long as the investigator deems
clinically indicated.
EXCLUSION CRITERIA
- Received gamma-hydroxybutyrate in the last 30 days.
- Have taken any investigational therapy within 30-day period prior to initial screening
visit for this trial.
- Patients taking fluoxetine (Prozac).
- Have been diagnosed with sleep apnea syndrome, defined as an Apnea Index > 10 per hour
or an Apnea Hypopnea Index greater than 15 per hour, or have any other cause of
daytime sleepiness, and have any other disorder(s) that can be considered a primary
cause of excessive daytime sleepiness.
- Taking hypnotics, tranquilizers, antihistamines (except for non-sedating
antihistamines), benzodiazepines or clonidine at the start of the baseline period.
Patients taking anticonvulsants are not eligible to participate even if willing to
washout anticonvulsants for the trial.
- Experiencing unstable cardiovascular, endocrine, neoplastic (excluding localized basal
cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic,
neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which
would place the patient at risk during the trial or compromise objectives outlined in
the protocol.
- Have psychiatric disorders, major affective or psychotic disorders, or other problems
that, in the investigator's opinion, would preclude the patient's participation and
completion of this trial or compromise reliable representation of subjective symptoms.
- Have current or recent (within one year) history of a substance use disorder including
alcohol abuse as defined by DSM-IV.
- Serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or
SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin
(more than 1.5 times upper limit of normal), or pre-trial ECG results demonstrating
clinically significant arrhythmias, greater than a first degree AV block or a history
of myocardial infarction within last six months.
- Have an occupation that requires variable shift work or routine night shift.
- Have a clinically significant history of seizure disorder, a history of clinically
significant head trauma (i.e., concussion resulting in clinically significant loss of
consciousness) or past invasive intracranial surgery, and are taking anticonvulsant
medications.
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.
| Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients | NCT00049803 | Entailment |
3,311 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Age 3 to 60 years with albinism
Exclusion Criteria:
- Glaucoma or at increased risk of glaucoma
- History of dystonia
- History of melanoma
- Planning to undergo eye muscle surgery during study time frame
- Undergoing vision therapy
- Taking iron supplements or vitamins with iron
- Taking medication for ADHD
- Known liver or gastrointestinal disease
- Previous treatment with levodopa
- Psychological problems
- Ocular abnormalities other than those associated with albinism
- Pregnant, nursing or planning to become pregnant during study
- Known allergy to levodopa/carbidopa
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 60 Years | Trial of L-DOPA as a Treatment to Improve Vision in Albinism | NCT01176435 | Entailment |
5,618 | 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:
- Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and
<50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of
controlled hypertension and/or treated or untreated dyslipidemia. For patients
receiving antihypertensive and/or hypolipidemic medications, these should have been at
a stable dosage for at least 2 months before the start of the run-in period.
Controlled hypertension is defined as a diastolic blood pressure <100 mmHg and a
systolic blood pressure <160 mmHg, in the presence of antihypertensive drug treatment.
For patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C
greater than or equal to 3.4 mmol/L (130 mg/dL), HDL C <1 mmol/L (40 mg/dL) for men or
<1.3 mmol/L (50 mg/dL) for women, or triglycerides greater than or equal to 1.7 mmol/L
(150 mg/dL)
- A stable weight, i.e., increasing or decreasing not more than 5 kg in the 3 months
before the start of the run-in period
- Consumption of breakfast and dinner on a daily basis
- Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with
water, as judged by e.g., the patients's history of having no difficulty with
swallowing e.g., capsules or intact tablets
- Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening
- Women must be postmenopausal or surgically incapable of childbearing or if sexually
active, be practicing an effective method of birth control
Exclusion Criteria:
- History of obesity with a known cause (e.g., Cushing's disease)
- History of anorexia nervosa, bulimia, or binge-eating disorder
- An established diagnosis of diabetes mellitus or treatment with glucose lowering
prescription drugs at screening
- Prior exposure or known contraindication or hypersensitivity to R256918
- History of weight-reducing diet or receiving any drugs to treat obesity within the 3
months prior to screening
- Treatment with any investigational drug or device within 1 month before the start of
the run-in period
- History or evidence of liver or renal impairment
- History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology
- History of clinically significant gastro-intestinal disease
- History of major gastro-intestinal surgery other than appendectomy or uncomplicated
cholecystectomy
- Previous gastric restrictive surgery or other surgical procedures to induce weight
loss
- Liposuction within the last 3 months before screening
- Pregnant or nursing women, or women who plan to become pregnant during the study
- History of significant cardiovascular disease or hypertension
- Elevated levels of thyroid-stimulating hormone (TSH)
- A significant change in smoking habits within 3 months of the start of the run-in
period
- Malignancy or a history of a malignancy within 5 years before the start of the run-in
period, other than basal cell carcinomas of the skin or in situ cervical carcinoma
- History of seizures or significant central nervous system-related disorders
- History of significant psychiatric disorder, including, schizophrenia, or psychosis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients | NCT00622765 | Contradiction |
6,103 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Age >18 at the time of informed consent
2. Able to understand and provide informed consent in either English or Spanish
3. At high risk for COVID-19 disease progression by fulfilling at least ONE of the
following criteria at Screening:
1. Age ≥65 years
2. Has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g.
COPD, chronic persistent asthma, cystic fibrosis, chronic bronchitis)
3. Has a diagnosis of chronic heart disease
4. Has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or
insulin therapy
5. Has hypertension requiring at least one oral medication for treatment
6. Has a body mass index (BMI) of ≥33 kg/m2
7. Has an immunocompromising disease (e.g. HIV infection with CD4 count < 200
cells/mm3)
8. Is immunocompromised due to daily treatment with ≥20 mg of prednisone or
equivalent
9. Has received a solid organ transplant
10. Has any chronic condition that, in the opinion of the investigator, places the
patient at increased risk for progression of COVID-19
4. Documentation of positive diagnostic test for SARS-CoV-2 (confirmed by PCR assay or
other approved diagnostic test) performed with a sample from nares or saliva,
collected within 7 days of the Screening visit.
5. Is symptomatic for COVID-19 for no more than 7 days prior to the Screening visit
6. Has a WHO Clinical Progression Scale (WHOb 2020) score of either '2' or '3' at
Screening and Randomization
7. Has at least one of the following symptoms at the Screening visit that are new in
onset, or if present by history, has worsened during the 7 days prior to Screening:
· fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal
congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia
8. If female of child-bearing potential, must agree to use of 2 forms of contraception
from Screening to end of the study. Males must agree to use 2 forms of contraception
from screening to the end of the study if their partners are of childbearing
potential. Acceptable methods of birth control which must be used together are:
1. Oral or injectable contraceptive and condom, or
2. IUD and condom, or
3. Diaphragm with spermicide and condom.
9. Agrees to participate in all in-person visits and remote or home visits as required by
the protocol and to provide updated contact information, as necessary.
Exclusion Criteria:
1. Has a WHO Clinical Progression Scale (WHOb 2020) score of '4' or higher at Screening
or Enrollment
2. Previous hypersensitivity or allergic reactions to naltrexone
3. Women who are pregnant or lactating or expecting to become pregnant
4. Drugs of abuse screen positive for opiates
5. Patients with history of moderate to severe renal impairment (estimated creatinine
clearance < 50 mL/min) or hepatic impairment (Child-Pugh C)
6. Serum ALT or AST value > 3 times the ULN at Screening
7. Serum creatinine value > 2 times the ULN at Screening, or requires renal dialysis
8. Hematology results at Screening showing any one of the following: WBC <2000 cells/mm3
or platelet count <100,000 cells/mm3 or hemoglobin <8.5 Gm/dL
9. Currently receiving chronic daily opioid therapy
10. Use of tocilizumab or other immunomodulator therapy directed to treatment or
prevention of COVID-19
11. History of active substance abuse within the 2 years prior to Screening
12. Participation in another clinical trial investigating a treatment for COVID-19
13. Currently hospitalized or under immediate consideration for hospitalization (for any
medical reason) at the Screening visit
14. At Screening, has new onset of dyspnea (shortness of breath) or, if previously
diagnosed with a chronic lung condition, the severity of dyspnea has increased over
patient's historical baseline condition (increased dyspnea should be present
continually and not intermittent)
15. Measurement of oxygen saturation at Screening is < 94% on ambient room air
16. Shares a household with a patient currently enrolled in this protocol
17. Patients who refuse biomarker blood draws
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.
| Phase 2 Trial to Evaluate Safety and Efficacy of CYTO-205 in Mild COVID-19 | NCT04708327 | Contradiction |
6,056 | 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:
- 18 years of age
- Capable of giving informed consents.
- Cases of NERD will be recruited on the basis of presence of heartburn and/or
regurgitation using two validated GERD questionnaires in conjunction with an abnormal
esophageal pH result and absence of erosions at standard endoscopy.
- Control subjects will include patients referred for an upper endoscopy for evaluation
of non-reflux symptoms such as iron deficiency anemia, heme positive stools, screening
of esophageal varices amongst others. A negative esophageal pH result and absence of
erosions will be inclusion criteria for these patients.
Exclusion Criteria:
- Presence of macroscopic erosive esophagitis
- Pregnancy/lactation
- Chronic anticoagulation
- Patients with significant medical comorbidities (oxygen dependent chronic obstructive
pulmonary disease, NYHA class III or IV congestive heart failure, recent diagnosis of
cancer with a life-expectancy < 5 years)
- History of Barrett's esophagus
- Presence of columnar lined distal esophagus on endoscopy with intestinal metaplasia
- Presence of cancer or mass lesion in the esophagus or stomach
- Esophageal strictures
- Peptic ulcer disease and Helicobacter pylori infection
- Prior history of esophageal surgery
- Allergic to PPIs
- Patients on drugs known to cause pill-related esophagitis (e.g. potassium supplements)
- Patients with HIV or other immunocompromised conditions who may have infectious
esophagitis
- Eosinophilic esophagitis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study | NCT02081404 | Entailment |
3,110 | 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:
1. Age: 40-85 years, visual acuity better than logMAR of 1.0
2. Chief complaint should be dry eye
3. Symptoms:
3.1. SPEED score > 6
3.2. TCM score satisfies lung-kidney yin deficiency profile
4. Signs:
4.1. TBUT (<10s) or Schirmer's test (<10mm/5 mins) 4.2 Any corneal fluorescein staining
Exclusion Criteria:
1. Glaucoma or other ophthalmic disease, eg. Extraocular muscle palsies, ectropion,
entropion
2. Ocular allergies, eg. Allergic conjunctivitis, sinusitis, eczema, atopic
keratoconjuntivitis
3. Known of thyroid disorders (diagnosed by physician)
4. Trichiasis
5. Eye surgeries patients including LASIK (within 1 year)
6. Steven-Johnson syndrome
7. Sjogren's syndrome
8. Eye related trauma (within 1 year)
9. Contact lens wear (within 1 year)
10. Punctal occlusion
11. Systemic disease requiring regular medication (except hypertension and lipidemia)
12. Pregnancy or planning to be pregnant
13. Requirement for medications such as anti-microbial, inflammatory, creams (except
moisturizers or cosmetics), or steroidal therapies
14. Unable to do this clinical trial for any reason
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Randomised Research Comparing Acupuncture, Herbal Treatment and Artificial Tear Eye Drops in Dry Eye | NCT02219204 | Contradiction |
5,127 | 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:
- They were required to have reduced bone density but no evidence of osteoporosis or
osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar
spine).
- Perimenopausal women : aged 40-70
Exclusion Criteria:
- Women with a body mass index (BMI) >30 kg/m2 or who were being treated with estrogens,
corticosteroids, or bisphosphonates, or who had significant illness affecting bone
metabolism were excluded
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 70 Years | A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism | NCT01402115 | Contradiction |
5,387 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women 18 years or older
- And with a diagnosis of dysfunctional uterine bleeding without organic pathology
- And with at least one of the following symptoms: prolonged, frequent or excessive
bleeding.
Exclusion Criteria:
- The use of steroidal oral contraceptives, or any drug that could alter oral
contraception metabolism will be prohibited during the study.
- Women with a history of endometrial ablation or dilatation and curettage within 2
months prior to study start will be excluded.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding | NCT00307801 | Entailment |
5,593 | 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 (physicians):
- Consenting physicians from the Northwestern Memorial General Internal Medicine (NMFF
GIM) practice
Exclusion Criteria (physicians):
- Study investigators will be excluded from participation (Dr. David Baker, Dr. Joyce
Tang)
Inclusion Criteria (patients):
- Adults ages 18-65 seen at the NMFF GIM who are patients of consenting physicians
- Have at least one appointment at the NMFF GIM clinic between 9/1/09-2/28/10
- Body mass index (BMI) 27-29.9 at one or more visits between 9/1/09-2/28/10
Exclusion Criteria (patients):
- Patients without at least one recorded height measurement from any prior visit or
without weight information from a visit within the 6 month target window will be
excluded due to inability to calculate BMI.
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 | Electronic Tools to Assist With Identification of and Counseling for Overweight Patients | NCT00973661 | Contradiction |
4,383 | 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. | Eligible subjects must have one of the conditions listed below and be enrolled in-person at
one of the participating clinical centers.Contact the study coordinator at the location
nearest you for more information about participation.
- Marfan syndrome
- Turner syndrome
- Ehlers-Danlos syndrome
- Loeys-Dietz syndrome
- FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 genetic mutation
- Bicuspid aortic valve without known family history
- Bicuspid aortic valve with family history
- Bicuspid aortic valve with coarctation
- Familial Thoracic Aortic Aneurysm and DissectionsYes
- Shprintzen-Goldberg syndrome
- Other aneurysms and dissections of the thoracic aorta not due to trauma, <50yo
- Other congenital heart disease (e.g., Tetralogy of Fallot, coarctation)
Exclusion Criteria:
- Inability of the patient, parent or guardian to give consent.
- Unwillingness to provide a blood or buccal specimen.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions | NCT01322165 | Entailment |
6,174 | 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 presented by fever, myalgia or respiratory symptoms
- Close contact with a confirmed COVID-19 patient
Exclusion Criteria:
- pediatric patients
- patients refuse any of the following: MSCT chest, taking of nasopharyngeal swabs or
blood sample
- chest MSCT -Angiography was done for suspected vascular complications (e.g., pulmonary
embolism)
- severely dyspneic patients with motion artifact on MSCT images.
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.
| MSCT Chest in Suspected COVID-19 Patients | NCT04492865 | Contradiction |
4,940 | 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:
- A tremor syndrome of bilateral upper limb action tremor with at least 3 years'
duration
Exclusion Criteria:
- Patients who have decided not to receive DBS for control of their
medication-refractory essential tremor.
- Patients with secondary tremor (ie not Essential Tremor), such as side effects from
medications, secondary to another identified neurologic disease (eg multiple
sclerosis, -----Parkinson's disease, dystonia).
- Prior history of deep brain stimulation.
- Prior history of thalamotomy.
- A history or signs of dystonia, ataxia or parkinsonism.
- Task specific tremor.
- Orthostatic tremor.
- Patients with cardiac pacemakers, defibrillators, or neurostimulators.
- Patients who require MRI, ECT, rTMS, or diathermy.
- Subjects with other type of neurological disease or injury.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Directional Versus Nondirectional DBS for ET | NCT04828798 | Entailment |
6,301 | 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:
- Adult subjects (> 18 years old) with COVID 19 infection.The patients will be
classified on the basis of the severity of the disease.
Exclusion Criteria:
- -patients have symptoms of fever and /or respiratory with negative PCR for COVID-19.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Immunogenetics Predictors With COVID-19 | NCT04390269 | Entailment |
4,979 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for
definite or probable Essential Tremor.
2. Age: 18 years or over.
3. Willingness and ability to comply with the study requirements and give informed
consent.
Exclusion Criteria:
1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or
Stevens-Johnson syndrome.
2. Known alcohol or substance abuse in previous 12 months.
3. Positive pregnancy test.
4. Unwillingness to use adequate contraceptive methods if of childbearing potential.
5. Known allergy to sulfonamides.
6. Laboratory abnormalities prior to onset of 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.
| Zonisamide in the Treatment of Essential Tremor | NCT00616343 | Entailment |
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