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3,815 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients ≥40 and ≤ 80years of age
- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene
radiographic entry criteria
- Stable osteoarthritis during 3 months
- Score of 100mm pain VAS ≤ 80mm at screening
- Score of 100mm pain VAS ≥ 50mm at baseline
- Written consent form voluntarily
Exclusion Criteria:
- Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
- History of surgery or arthroscopy of the study joint within 6 months
- Trauma of study joint within 12 months
- Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
- Medication of intra-articular injection within 3 months
- Diagnosed with psychical disorder, and taking medication
- History of upper gastrointestinal ulceration within 6 months
- History of upper gastrointestinal bleeding within 12 months
- Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
- History of hypersensitivity to LAYLA, JOINS, or NSAIDs
- Participation in another clinical trials within 4 weeks
- Medication of constantly (more than 1 week) narcotic analgesics within 3 months
- Not consent about using effectual contraception method during trial
- Pregnant or lactating woman
- Investigator's judgment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients | NCT01768468 | Entailment |
5,746 | 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:
- histological diagnosis of OLP on the basis of WHO criteria (Meji and van der Waal
2003).
- presence of painful and atrophic-erosive oral lesions, unresponsive to topical
corticosteroid therapy
- ability to complete the present clinical trial.
Exclusion Criteria:
- Presence of histological signs of dysplasia
- use of lichenoid reaction inducing drugs
- Therapy for OLP in the 2 months prior to the study;
- Patients suffering from any disease that may present with features similar to OLP
(graft versus host disease or lupus erythematosus)
- Pregnant or lactating females
- Patients with uncontrolled diabetes or hypertension, positive HCV Ab or HBs Ag.
- Smokers
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 62 Years | Management of Pain in Oral Lichen Planus | NCT03572959 | Contradiction |
2,236 | 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. Age 18 and over.
2. Ability to attend follow up visits or at least converse on phone or complete email
follow up forms.
3. Competent to understand the study protocol and provide voluntary informed consent.
4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid,
Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis
Elbow), Chronic Kidney Disease (may be on dialysis), Back/Neck Pain, Erectile
Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy,
Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post
myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart
Failure.
Exclusion Criteria:
1. Active Cancer
2. Pregnancy, Lactating
3. Severe Clotting disorder
4. Myocardial Infarction less than six months ago.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | NCT03899298 | Entailment |
4,750 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Between 18-65 years
- Diagnosis of vertigo according to the clinical examination performed by an
Otorhinolaryngologist, Vestibular Evoked Myogenic Potentials (VEMP), Video Head
Impulse Test (VHIT)
- Patients with Unilateral Peripheral Hypofunction
- After giving detailed information about the research, agreeing to participate in the
study.
Exclusion Criteria:
- Severe hearing / vision impairment-loss
- Patients with neurological, orthopedic, circulatory system problems that may cause
vertigo, dizziness and balance disorders
- Having severe hypertension / diabetes
- Previous participation in a vestibular rehabilitation program
- Being healthy
- Patients using drugs that may affect the treatment negatively
- Refusing to participate in a clinical trial
- Patients who cannot adapt to the training program
- Patients who discontinued their treatment
- Patients with different diagnoses that may disrupt the treatment during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Effect of Proprioseptive Vestibular Rehabilitation in Patients With Peripheral Vestibular Hypofunction | NCT04687371 | Entailment |
6,148 | 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. Patients hospitalized to the National Medical and Surgical Center named after
N.I.Pirogov of the Ministry of Health of Russia (NMSC) with suspected or confirmed
COVID-19 or community-acquired pneumonia.
2. Age 18 years and older.
3. Permanent residency in Russia.
Exclusion Criteria:
1. Permanent residency outside of Russia.
2. The patient's refusal to participate in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia | NCT04522076 | Contradiction |
5,153 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and
treatment change is indicated (not responses to bisphosphonates, for bad tolerability
or for the potential risk of side effects in a long term treatment with
bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening
visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening
visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry
(DXA) scan
- At least 2 lumbar vertebrae must be evaluable by DXA
- Al least one hip must be evaluable by DXA (for secondary objectives)
Exclusion Criteria:
- Any disorder that compromises the ability of the subject to give written informed
consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental
treatment)
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic
steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH
derivates within 1 year.
- Hyper or hypothyroidism, current hyper or hypoparathyroidism
- History of Venous Thromboembolism Event (VTE)
- Significantly impaired renal function as determined by estimated Glomerular Filtration
Rate less 35 mL/min
- Hyper or hypocalcemia
- Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
- Any condition that could result in impaired calcium metabolism or metabolic bone
disease that could interfere with interpretation findings
Female
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women | NCT02090400 | Contradiction |
4,875 | 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 14 or older
- Active or treated Cushing's (due to pituitary, ectopic, or adrenal tumor)
- The diagnosis of CS will be made by the PI, based on the below Endocrine Society
guidelines, the patient's clinical presentation, and the PI's judgment.
° Diagnostic criteria for pituitary CD are according to the Endocrine Society
guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or
elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic
dexamethasone suppression testing for CD (morning cortisol > 5 ug/dL after 1 mg
overnight of classic 2-day low dose test) and a pituitary lesion on MRI. If patient
does not have any of these results, pathology of ACTH tumor may confirm presence of
disease.
- For pituitary patients, if the patient demonstrates non-classic testing or no
pituitary lesion is seen on MRI then petrosal sinus sampling or positive surgical
pathology will be used to confirm pituitary source of Cushing's. Clinical or
biochemical remission after surgery will also confirm pituitary source.
- Ectopic Cushing's will be confirmed by petrosal sinus sampling and appropriate imaging
tests, or positive surgical pathology.
- Adrenal Cushing's will be confirmed by a suppressed plasma ACTH value and
identification of an adrenal lesion on CT or MRI, or positive surgical pathology.
- In lieu of MRI, surgical, or laboratory reports, physician's assessment note including
mention of results will also be used as source for eligibility purposes.
Exclusion Criteria:
- Patients with a diagnosis of iatrogenic Cushing's.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
| Collecting Information About Treatment Results for Patients With Cushing's Syndrome | NCT03364803 | Entailment |
6,727 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Participant is male between 18 and 75 years old at the time of screening.
2. Established severe hemophilia A (plasma Factor VIII (FVIII) activity <1%) or B (plasma
Factor IX (FIX) activity ≤2%).
3. Provision of signed informed consent form (ICF).
4. Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
1. Bleeding disorder(s) other than hemophilia A or B.
2. Personal laboratory evidence of having developed inhibitors to FVIII or FIX protein at
any time (≥0.6 Bethesda Units [BU] on any single test).
3. Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy,
immunoglobulin therapy, or monoclonal antibody therapy.
4. Received systemic antiviral and/or interferon therapy within 30 days of blood draw,
with the exception of treatment for human immunodeficiency virus (HIV).
5. Currently receiving ribavirin and/or interferon based therapy for active hepatitis C
virus (HCV).
6. Received immunoglobulin therapy or plasma infusion within 120 days of the blood draw.
7. Has a known immune deficiency other than HIV.
8. Has lymphocyte or plasma cell malignancies.
9. Participant is a family member or employee of the investigator.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia | NCT03185897 | Contradiction |
71 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Men with documented total testosterone levels < 11.30 nmol/l
2. Able to come to the study centre (Community-dwelling or institutionalized)
3. Age 65+ years
4. At a higher risk for falling
5. Body mass index > 18.0 and < 35.0 kg/m2
6. Understands German in reading and writing plus able to read, understand, and complete
questionnaires and tests.
7. Willingness to limit additional vitamin D3 intake to a maximum of 800 IU per day
8. Willingness to limit calcium supplement intake to 500 mg/day
9. Willingness to stop active vitamin D metabolites
10. Willingness to forgo any additional use/application of testosterone products for the
duration of the trial.
11. Participant understands the study procedures, alternative treatments available and
risks involved with the study and voluntarily agrees to participate by giving a
written informed consent.
12. Participant meets the routine clinical laboratory safety screening tests performed at
screening visit.
13. Participant is able and willing to perform all study tests, attend all required office
visits, and provide blood and urine samples.
14. Participant is able to apply the testosterone/placebo gel and is able to drink the
vitamin D/placebo solution.
15. Participant is mentally competent (judicious) defined by having score > 24 on the
Folstein's mini mental state examination (MMSE) at the screening visit.
Exclusion Criteria:
1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product
2. Treatment with vitamin K-antagonists, insulin, adrenocorticotropic hormone (ACTH),
corticosteroid (>5mg/d)
3. Elevated (≥ 4.0 ng/ml) prostate-specific antigen levels (at screening) and/or palpable
signs of prostate cancer
4. Palpable signs of breast-cancer
5. Haemoglobin ≤ 100 g/l
6. Haematocrit ≥ 0.50 L/L
7. Liver function values (alanine aminotransferase, aspartate aminotransferase,
Gamma-glutamyl transferase, alkaline phosphatase) more than 3 times the upper limit of
normal.
8. Consumption of >800 IU vitamin D on any day in the 6 months prior to enrolment.
Provision: a person can be enrolled as soon as the mean intake in the last 6 months
and since the last dose is ≤ 800 IU.
9. Elevated serum calcium ≥ 2.60 mmol/l (adjusted for albumin )
10. Estimated (Cockcroft and Gault formula ) creatinine clearance ≤ 30 ml/min
11. Severe visual or hearing impairment
12. History of cancer < 5 years prior to signing informed consent, except for adequately
treated basal cell or squamous cell skin cancer
13. Myocardial infarction in the last 3 months, unstable angina pectoris and/or exertional
dyspnoea >=NYHA III
14. Treatment worthy but untreated sleep apnoea or chronic (obstructive) pulmonary
disease, epilepsy
15. Significant end-stage disease, i.e. genitourinary, cardiovascular, hepatic, renal,
endocrine, hematologic, psychiatric, or pulmonary disease, which, in the opinion of
the investigator, may pose a high risk to the patient or impair the patient's ability
to complete the trial or confound the results
16. Uncontrolled hypertension (blood pressure mm Hg ≥ 180 systolic or ≥ 110 diastolic)
17. Alcohol abuse or alcoholic disease
18. Participation in another interventional research trial within the last 6 months prior
to screening
19. Severe gait impairment, e.g. due to Parkinson's disease or hemiplegia
20. Previous enrolment into the current study
21. Enrolment of the investigator, his/her family members, employees and other dependent
persons
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors | NCT02419105 | Contradiction |
3,517 | 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:
- Diagnosis of chronic adrenal insufficiency
- Written informed consent/assent in compliance with applicable country-specific and
local regulations
Exclusion Criteria:
- Participation in an interventional clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI) | NCT01661387 | Contradiction |
6,756 | 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:
- Patients diagnosed with hemophilia A
- Patients over 18 years
- Patients under prophylactic treatment with rFVIIIFc concentrates.
Exclusion Criteria:
- Patients with neurological or cognitive disorders preventing the understanding of the
various measuring instruments
- Patients who are scheduled for major orthopedic surgery (total arthroplasty)
- Not signed the Informed Consent Document
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Extended Half-Life (EHL) Clotting Factor for Improving the Musculoskeletal Health of Patients With Hemophilia | NCT03914209 | Entailment |
2,534 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Children ages 2 months though 6 years.
- Participants must carry a diagnosis of atopic dermatitis according to the Hanifin and
Rajka criteria.
- New patients or consultations at an OHSU clinic.
- English-speaking families will be included in this study
Exclusion Criteria:
- Subjects who have been on systemic therapies for treatment of their atopic dermatitis
(prednisone or cyclosporine)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Months old.
Subject must be at most 6 Years | Group Eczema Education Visits:Impact on Patient and Family Quality of Life | NCT01143012 | Entailment |
4,394 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Men or women aged 18 - 60 yrs old in generally good health.
2. Healthy oral cavity with no pre-existing oral diseases including cancer,
periodontitis, or mucositis.
3. No chewing or swallowing disorders.
4. No known clotting disorders.
5. Willingness to follow the investigator instructions and requirements of the protocol.
6. Ability to give consent.
7. Proficiency with the English language (both written and verbal)
Exclusion Criteria:
1. Pre-existing oral diseases including oral cancer, periodontitis, or mucositis.
2. Chewing or swallowing disorder.
3. Iron deficiency or anemia. The level of deficiency needed for exclusion will be at the
discretion of the CRC physician associated with the study.
4. Pregnant, lactating, or planning to become pregnant during the study.
5. Phenylketonuric
6. Medical, social, or economic circumstance which is likely to prevent adherence to the
protocol.
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 | Vitamin Gum Pharmacokinetics | NCT03230396 | Entailment |
1,331 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria for Clusters
- marginalized communities based on CARE Nepal formula
- communities prioritized by Nepal Government
- no concurrent non-governmental organization (NGO) programming
- no concurrent CARE programming
Inclusion Criteria for Boys and Girls (invited to participate in the intervention, survey,
in-depth interviews, focus group discussions)
- unmarried
- age 12 -under 17
- living in study community
- no plans to migrate in subsequent 24 months
Inclusion Criteria for Mothers and Fathers of Selected Boys and Girls (invited to
intervention and focus group discussions)
- male and female parental figures of an adolescent who has been recruited to
participate in the intervention and associated measurement
Exclusion Criteria for Mothers and Fathers of Selected Boys and Girls:
- none
Inclusion Criteria for Community Adults:
- at least 25 years of age
- living in one of the study Communities
- no plans to migrate during the next two years
Exclusion Criteria for Community Adults:
- none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 16 Years | Preventing Early Child Marriage in Nepal | NCT04015856 | Contradiction |
3,412 | 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: age between 18 and 35 years and auditory threshold less than or equal
to 20 dBHL, between 0.5 and 8 kHz, with inter-ear frequency difference less than or equal
to 10 dB.
Exclusion criteria were: exposure to occupational or leisure noise; otological surgery;
more than three ear infections within the last year; use of ototoxic medication; buzzing in
the ear, vertigo, dizziness or other cochlear-vestibular symptoms ; presence of systemic
alterations that could contribute to cochlear-vestibular pathologies, such as diabetes,
hypertension, dyslipidemias and/or hormonal alterations.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Steady State Vestibular Evoked Myogenic Potentials | NCT01260077 | Contradiction |
6,672 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Participant has a documented diagnosis of hemophilia A
2. Participant has documented clotting factor levels of 5% or less
3. Participant is on a prescribed regimen of continuous prophylaxis. Continuous
prophylaxis is defined by the World Federation of Hemophilia as "… the intent of
treating for 52 weeks a year and receiving a minimum of an a priori defined frequency
of infusions for at least 45 weeks (85%) of the year under consideration"
4. Participant is willing and able to comply with the requirements of the protocol
5. Participant is proficient in the English language to allow for use of the Standardized
Goal Attainment Scaling menu for Hemophilia (GAS-Hem) tool.
Exclusion Criteria:
1. Participants with an active Factor VIII (FVIII) inhibitory antibody (≥ 0.4 Bethesda
units (BU) using the Nijmegen modification of the Bethesda assay or ≥ 0.6 BU using the
Bethesda assay) at any time prior to screening
2. Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease)
3. Participant has participated in a clinical study involving a medicinal product or
device within 30 days prior to enrollment or is scheduled to participate in a clinical
study involving a medical product or device during the course of this study
4. Participant is a family member or employee of the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 65 Years | GAS-Hem Feasibility Study | NCT02674997 | Contradiction |
3,990 | 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:
- Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on
fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing
within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic
criteria for knee OA
- 45-85 years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding
enrollment
- Report that knee pain negatively affects quality of life
- Willing not to use any cream, gel, or topical solution during the administration of
treatment other than the approved ultrasound 1% diclofenac gel provided to the subject
at the initiation of the study
- Deemed appropriate by their physician or by the study site physician to participate
Exclusion Criteria:
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make
participation in the study unacceptable, including, but not limited to, the subject's
ability to understand and follow instructions.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the
affected knee in the past 6 months
- Are non-ambulatory
- Participated in a clinical trial for an investigational drug and/or agent within 30
days prior to screening
- Modify their medications during the course of the study (medications and doses must
remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis | NCT04391842 | Entailment |
3,732 | 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:
- Evidence of a personally signed and dated informed consent document indicating that
the participant has been informed of all pertinent aspects of the study before any
assessment is performed.
- Male and female participants who, at the time of screening, are ≥ 50 years of age.
- Participant has a diagnosis of OA of the knee requiring arthroplasty and is scheduled
for single knee arthroplasty, with radiographic evidence within last 6 months
confirming Kellgren Lawrence grade of 2 or more.
- Participant is in general good physical health and deemed fit for surgery, as judged
by the investigator and no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, respiratory rate and temperature measurement, 12 lead ECG or clinical
laboratory tests.
- Body Mass Index (BMI) of 17.5 to less than 40 kg/m2; and a total body weight >50 kg
(110 lbs).
- Participants who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Female participants of childbearing potential and at risk for pregnancy must agree to
use a highly effective method of contraception throughout the study and for at least
21 days after the last dose of assigned treatment. Female participants who are not of
childbearing potential must meet following requirements: Female participants who are
of childbearing potential and are sexually active and at risk for pregnancy must agree
to use a highly effective method of contraception consistently and correctly for the
duration of the active study period (onwards from screening) and for at least 21 days
after the last dose of investigational product. The investigator or his or her
designee, in consultation with the participant, will confirm that the participant has
selected an appropriate method of contraception for the individual participant from
the permitted list of contraception methods (see below) and instruct the participant
in its consistent and correct use. Participants need to affirm that they meet the
criteria for the correct use of at least 1 of the selected methods of contraception.
The investigator or his or her designee will discuss with the participant the need to
use highly effective contraception consistently and correctly according to the
schedule of activities and document such conversation in the participant's chart. In
addition, the investigator or his or her designee will instruct the participant to
call immediately if the selected contraception method is discontinued or if pregnancy
is known or suspected in the participant. Highly effective methods of contraception
are those that, alone or in combination, result in a failure rate of less than 1% per
year when used consistently and correctly (i.e., perfect use) and include the
following a)Established use of oral, inserted, injected, transdermal, or implanted
hormonal methods of contraception is allowed provided the participant plans to remain
on the same treatment throughout the entire study and has been using that hormonal
contraceptive for an adequate period of time to ensure effectiveness as deemed
appropriate by the investigator, b) Correctly placed copper-containing intrauterine
device (IUD), c) Male condom or female condom used with a spermicide (i.e., foam, gel,
film, cream, or suppository), d) Male sterilization with absence of sperm in the
post-vasectomy ejaculate e) Bilateral tubal ligation / bilateral salpingectomy or
bilateral tubal occlusive procedure (provided that occlusion has been confirmed in
accordance with the device's label), f)Female who meets the criteria for
non-childbearing potential as described below. Female participants of non-childbearing
potential must meet at least one of the following criteria: 1) Achieved postmenopausal
status, defined as follows: cessation of regular menses for at least 12 consecutive
months with no alternative pathological or physiological cause; status may be
confirmed by a serum follicle-stimulating hormone (FSH) level confirming the
post-menopausal state, 2) Have undergone a documented hysterectomy and/or bilateral
oophorectomy, 3) Have medically confirmed ovarian failure.
All other female participants (including females with tubal ligations) will be considered
to be of childbearing potential.
Exclusion Criteria:
- Participants who are investigational site staff members directly involved in the
conduct of the study and their family members, site staff members otherwise supervised
by the investigator, or participants who are GSK employees directly involved in the
conduct of the study.
- Participation in other studies involving investigational drug(s) within one month
prior to study entry and/or during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
- Pregnant female participants.
- Breastfeeding female participants.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients.
- Participants in whom attacks of asthma, angioedema, urticaria, or acute rhinitis are
precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
(NSAIDs).
- Participants whose skin around the knee is broken, diseased or has skin wounds or open
injuries.
- Unwilling or unable to comply with the following lifestyle guidelines described in the
protocol or investigator instructions: a) Meals and Dietary Restrictions: No specific
meal or dietary restriction is required for the study. Participants will follow the
perioperative guidance with respect to meals and dietary restrictions as provided by
the surgical center. Participants must abstain from all food and drink (except water)
at least 4 hours prior to any safety laboratory evaluations, b)Alcohol, Caffeine and
Tobacco: participants will follow the perioperative guidance with respect to alcohol
and caffeine intake and use of tobacco- or nicotine containing products as provided by
the surgical center, c) Activity: participants will follow the perioperative guidance
with respect to activity as provided by the surgical center, d) Contraception: Female
participants who are of childbearing potential and are sexually active and at risk for
pregnancy must agree to use a highly effective method of contraception consistently
and correctly for the duration of the active study period (onwards from screening) and
for at least 21 days after the last dose of investigational product. The investigator
or his or her designee, in consultation with the participant, will confirm that the
participant has selected an appropriate method of contraception for the individual
participant from the permitted list of contraception methods (see below) and instruct
the participant in its consistent and correct use. Participants need to affirm that
they meet the criteria for the correct use of at least 1 of the selected methods of
contraception. The investigator or his or her designee will discuss with the
participant the need to use highly effective contraception consistently and correctly
according to the schedule of activities and document such conversation in the
participant's chart. In addition, the investigator or his or her designee will
instruct the participant to call immediately if the selected contraception method is
discontinued or if pregnancy is known or suspected in the participant.
Highly effective methods of contraception are those that, alone or in combination, result
in a failure rate of less than 1% per year when used consistently and correctly (i.e.,
perfect use) and include the following: 1) Established use of oral, inserted, injected,
transdermal, or implanted hormonal methods of contraception is allowed provided the
participant plans to remain on the same treatment throughout the entire study and has been
using that hormonal contraceptive for an adequate period of time to ensure effectiveness as
deemed appropriate by the investigator, 2) Correctly placed copper-containing intrauterine
device (IUD), 3) Male condom or female condom used with a spermicide (i.e., foam, gel,
film, cream, or suppository), 4) Male sterilization with absence of sperm in the
post-vasectomy ejaculate, 5) Bilateral tubal ligation / bilateral salpingectomy or
bilateral tubal occlusive procedure (provided that occlusion has been confirmed in
accordance with the device's label), 6)Female who meets the criteria for non-childbearing
potential as described below. Female participants of non-childbearing potential must meet
at least one of the following criteria: a) Achieved postmenopausal status, defined as
follows: cessation of regular menses for at least 12 consecutive months with no alternative
pathological or physiological cause; status may be confirmed by a serum
follicle-stimulating hormone (FSH) level confirming the post-menopausal state, b) Have
undergone a documented hysterectomy and/or bilateral oophorectomy, c) Have medically
confirmed ovarian failure.
All other female participants (including females with tubal ligations) will be considered
to be of childbearing potential e) Screen Failures: Screen failures are defined as
participants who consent to participate in the clinical study but are not subsequently
randomized. In order to ensure transparent reporting of screen failure participants, a
minimal set of screen failure information will include screening number, date of screening,
demography (gender, year of birth, age), screen failure details (e.g., withdrawal of
consent), eligibility criteria, and any serious adverse events. Screening failures will be
replaced in the recruitment schedule until the required number of participants are
randomized. Individuals who do not meet the criteria for participation in this study
(screen failure) may not be re-screened, f) Sponsor's Qualified Medical Personnel: The
contact information for the sponsor's appropriately qualified medical personnel for the
study is documented in the study contact list located in the supporting study
documentation. The contact number can be used by investigational staff if they are seeking
advice on medical questions or problems; however, it should be used only in the event that
the established communication pathways between the investigational site and the study team
are not available. It is therefore intended to augment, but not replace, the established
communication pathways between the investigational site and the study team for advice on
medical questions or problems that may arise during the study. The contact number is not
intended for use by the participant directly, and if a participant calls that number, he or
she will be directed back to the investigational site. To facilitate access to
appropriately qualified medical personnel on study-related medical questions or problems,
participants are provided with a contact card. The contact card contains, at a minimum,
protocol identifiers, participant study numbers, contact information for the
investigational site, and contact details in the event that the investigational site staff
cannot be reached to provide advice on a medical question or problem identified from the
participant's healthcare professional other than the investigator.
- Use of prescription or nonprescription drugs (unless deemed necessary by
investigator), NSAIDs, COX-2 inhibitors and dietary supplements within 7 days or 5
half-lives (whichever is longer) prior to the first dose of study treatment and during
the study. Specifically if, during the washout period or the treatment period, the
participant is unwilling to avoid the use of any topical or systemic analgesic or
anti-inflammatory treatments other than the study medication, the rescue medication,
and if needed codeine or tramadol.
- Use of one or more of the following treatments prior to the screening visit or between
screening and baseline visit: a) any topical NSAID treatment between screening and
baseline visit, b) any intra-articular or peri-articular procedures or injections in
either knee within the previous 3 months, c) any systemic treatment with
corticosteroids within the previous 6 weeks (topical treatments with corticosteroids
not related to either knee are permitted up to screening visit), d) any
chondroprotectant or disease-modifying OA drugs, such as glucosamine or chondroitin
sulfate, unless dose was stable over the previous month and will be maintained
throughout the study, e) any systemic anti-inflammatory or analgesic drugs at
screening if 5 times their elimination halftime exceeds 7 days (i.e., if half-life >
33.6 hrs), f) anticoagulants such as warfarin or heparin in the preceding week or
antiaggregants within the previous month other than aspirin at stable low doses
started at least one month before randomization and kept at a constant dose throughout
the study or anticoagulant therapy for surgery, g) any other investigational drugs
within the previous month or 5 half lives preceding the first dose of investigational
product (whichever is longer).
- A positive urine drug screen during Screening (Day -7).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
(150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor)
within 6 months of Screening.
- Participants who have previously been enrolled 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 50 Years old.
| A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty | NCT03497039 | Contradiction |
2,448 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Stable medical condition defined as no hospitalization or emergency room visit in the
previous 3 months
- No evidence of active pulmonary or systemic infection
- No other active inflammatory disease,
- No active malignancy.
- Normal serum ionized calcium level
Exclusion Criteria:
- Hospitalization or emergency room visit in the previous 3 months
- Evidence of active pulmonary or systemic infection
- Evidence of active other inflammatory disease
- Evidence of active malignancy
- Elevated serum ionized calcium level
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.
| Vitamin D Homeostasis in Sarcoidosis | NCT03621553 | Entailment |
4,916 | 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. Signed informed consent form indicating that the subject has been informed of the
procedures to be followed, the experimental nature of the therapy, alternatives,
potential benefits, side effects, risks, and discomforts.
2. Men or non-pregnant, non-breastfeeding women 18 to 75 years-of-age who are able to
read and understand English.
3. Diagnosis of definite or probable essential tremor (ET) as defined by the Tremor
Investigational Group with involvement of the hands and arms without present causes of
enhanced physiologic tremor (Deuschl et al.,1998).
4. Diagnosis of ET before the age of 65.
5. Tremor severity score of at least 2 in at least one upper extremity on at least one of
the three maneuvers on the TETRAS scale.
6. Total TETRAS performance score of at least 15.
7. One concomitant anti-tremor medication (other than primidone) is allowed. Note:
Primidone is NOT an allowed anti-tremor medication. If on primidone, subjects are
allowed to extend their screening period by 2 weeks (for a total of 6 weeks) and
discontinue primidone under the supervision of the investigator.
8. Subjects with reproductive capability including all males and women of child-bearing
potential (WOCBP) must agree to practice continuous abstinence or adequate
contraception methods (appropriate double barrier method or oral, patch, implant, or
injectable contraception) from as soon as feasible during screening period until at
least 30 days after the last dose.
9. Approval by the sponsor medical personnel as to final suitability for the study.
Exclusion Criteria:
1. Exposure to tremorigenic drugs or drug withdrawal states within the 30 days prior to
the first planned dose of study drug.
2. Direct or indirect trauma to the nervous system within 3 months preceding the onset of
tremor
3. History or clinical evidence of psychogenic tremor origin
4. Known history of other medical or neurological conditions that may cause or explain
subject's tremor, including, but not limited to: a. Parkinson's disease b. dystonia c.
cerebellar disease, other than essential tremor d. Traumatic Brain Injury e. alcohol
abuse or withdrawal f. mercury poisoning g. hyperthyroidism h. pheochromocytoma i.
head trauma or cerebrovascular disease within 3 months prior to the onset of essential
tremor j. multiple sclerosis k. polyneuropathy l. family history of Fragile X syndrome
5. Prior MR-guided Focused Ultrasound or surgical intervention (e.g., deep brain
stimulation, ablative thalamotomy or gamma knife thalamotomy).
6. Botulinum toxin injection in the 6 months prior to screening.
7. Currently using more than one anti-tremor medication.
8. Experiencing clinical benefit from and/or is not willing to discontinue primidone
9. Use of medication(s) in the past month that might produce tremor or interfere with the
evaluation of tremor, such as, but not limited to: CNS-stimulants, lithium,
amiodarone, metoclopramide, theophylline, and valproate
10. Inability to refrain from use of medication/substance(s) that might produce tremor or
interfere with the evaluation of tremor on study visit days, such as but not limited
to stimulant decongestants, beta-agonist bronchodilators, caffeine, alcohol and
tobacco, based on Investigator assessment at baseline.
11. Positive urine drug screen.
12. Regular use of more than two units of alcohol per day.
13. Sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep
performance. Stable use at a consistent dose is allowed as long as tremor persists
against the background of regular medication use. Use on the evening prior to a study
visit is prohibited.
14. Use of prescription or non-prescription drugs or other products (i.e. grapefruit
juice) known to be strong inhibitors or inducers of CYP3A4 which cannot be
discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study,
including primidone.
15. Concurrent illnesses that would be a contraindication to trial participation,
including, but not limited to: a. Severe arterial thromboembolic events (myocardial
infarction, unstable angina pectoris, stroke) less than 6 months before screening b.
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled
blood pressure c. Clinically significant ECG d. Known infection with HIV, hepatitis B,
or hepatitis C, unless curative therapy completed for hepatitis C with negative PCR
for HCV RNA e. Significant hepatic (AST/ALT > 2X upper limit of normal) or renal
disease (creatinine clearance <39 mL/min) f. Significant psychiatric history including
mood disorders and alcohol or substance abuse within the last year g. A current C-SSRS
score of 4 or 5 at screening or history of suicide attempt at any time during the past
year h. Clinically significant impaired balance or is considered at increased risk for
falls i. Symptomatic orthostatic hypotension.
16. Treatment with an investigational agent within 30 days prior to the first dose of
CX-8998 or planning to receive an investigational agent during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Phase 2 RCT Study of CX-8998 for Essential Tremor | NCT03101241 | Entailment |
5,442 | 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:
- Males and Females age 18-65 inclusive at screening.
- Subject has to agree to practice abstinence or medically accepted contraception and
not to participate in sperm donation or in vitro fertilization.
- Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg.
- Subject must be healthy as determined by the investigator on the basis of screening
evaluations.
- Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined
by history. Must be able to abstain from smoking during the in-clinic stay.
Exclusion Criteria:
- Presence of clinically significant illness within 21 days prior to dosing, viral or
bacterial infection, or documented drug allergies that may affect subject's safety
during the study.
- Laboratory or clinical evidence suggestive of disease.
- Clinically significant or predisposing disorder that may interfere with the
absorption, distribution, metabolism and/or excretion of drugs.
- History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history
of alcohol use that may interfere with the ability to comply.
- Pregnant, lactating, or positive pregnancy test.
- Clinically significant electrocardiogram abnormalities.
- History of positive test for hepatitis B or C, or HIV.
- Positive findings of urine narcotic screen.
- History of drug allergy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects. | NCT00663481 | Entailment |
6,495 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Subjects 18 years of age and older.
2. Clinical diagnosis of papulopustular facial rosacea.
3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus
pustules).
4. Willing and able to understand and sign informed consent.
5. Able to complete study and comply with study procedures.
Exclusion Criteria:
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
or severe acne requiring systemic treatment.
2. History or presence of regional enteritis or inflammatory bowel disease (e.g.,
ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of
antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
3. Use of topical rosacea treatments in the past 2 weeks.
4. Use of systemic antibiotics in the past 4 weeks.
5. Use of systemic retinoids within the past 3 months.
6. Use of laser or light based rosacea treatments within the past 2 months.
7. Concomitant use of medications that are reported to exacerbate rosacea, such as
topical and systemic steroids as these may impact assessments.
8. Current drug or alcohol abuse.
9. Other dermatologic conditions that require the use of interfering topical or systemic
therapy or that might interfere with study assessments such as, but not limited to,
atopic dermatitis, perioral dermatitis or acne vulgaris.
10. Clinically significant abnormal findings or conditions (other than rosacea), which
might, in the opinion of the Investigator, interfere with study evaluations or pose a
risk to subject safety during the study.
11. Subjects who are pregnant or planning a pregnancy.
12. Use of any investigational therapy within the past 4 weeks.
13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea | NCT00823901 | Entailment |
254 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Maternal age ranges from 20-38 years.
2. Basal FSH < 10 mIU/ml.
3. BMI < 35 kg/m2.
4. Estradiol level > 1000 at the day of HCG administration.
5. Estradiol level < 4000 at the day of HCG administration.
Exclusion Criteria:
1. Presence of Endometriosis.
2. Presence of Hydrosalpinx.
3. Presence of vaginal infection.
4. Presence of galactorrhea.
5. Presence of hormonal disorders.
6. Severe male factor infertility:
Sperm Count < one million. Marked malformation
7. history of recurrent abortion.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 38 Years | Does Flushing the Uterine Cavity With Follicular Fluid After Ovum Pick-up Improve Implantation Rates in ICSI Cycles? | NCT01563822 | Contradiction |
162 | 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:
- Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week
(may wash out from previous oral, topical or buccal testosterone therapy)
Exclusion Criteria:
- Significant intercurrent disease of any type, in particular liver, kidney,
uncontrolled or poorly controlled heart disease, or psychiatric illness
- Recent history of stroke, not including transient ischemic attack
- Untreated, sever obstructive sleep apnea.
- Hematocrit <35% or >48
- Serum transaminases >2 times upper limit of normal, serum bilirubin > 2.0 mg/dL and
serum creatinine > 2.0 mgk/dL
- BMI > or equal to 36
- Stable doses of lipid-lowering medication for less than 3 months
- Stable doses of oral medication for diabetes for less than 2 months
- Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or
equal to 19 points.
- History of breast cancer
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
supplements that may increase serum testosterone within previous 4 weeks
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
- History of abuse of alcohol or any drug substance within the previous 2 years
- Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or
long-acting opioid analgesics
- Receipt of any drug as part of a research study within 30 days of initial dose
administration in this study.
- Blood donation within the 12 week period before the initial study dose.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men | NCT01403116 | Entailment |
1,048 | 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:
- Age : 18 to 40 years
- Size : 160 à 180
- Weight : BMI between 18 and 24
- Medical history :
- No history of cardiovascular disease
- No chronic treatment
- No syncopal events (>2 by year)
- Physical examination
- Normal cardio-pulmonary ausculation
- Normal (DBP [60 - 90] SBP [100 - 140]
- Normal heart rate (between 50 and 80 at rest)
- Complementary examination
- Normal Electrocardiogram
- Presence of temporal acoustic window
- Capable to understand the objectives and constraints of this study
- Covered by health social insurance
- Have signed the informed consent
Exclusion Criteria:
- Pregnant woman (beta HCG by urinary test) or breastfeeding
- Refusing to sign the informed consent
- Don't understand the objectives of this study
- Minors or majors protect by the law
- Don't Benefit of social insurance
- Participation at the time of study enrolment during the present trial period in
another clinical trial investigating.
- Having reached or surpassed the annual amount of compensation allowed by clinical
trials
- Receipt of any chronic and regular treatment
- Presence of sign cardiovascular diseases during the questioning
- Presence of sign cardiovascular diseases during the examination
- Presence of sign syncopals events ATCD diseases during the questioning (>2 by
year)
- Absence of temporal acoustic window with the Transcranial Doppler
- Respiratory disorder, asthma
- Any troubles preventing the realization of physical activity
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | CARDIOSPACE Evaluation in Healthy Volunteers | NCT02704247 | Contradiction |
1,314 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- patients with the Schnitzler syndrome according to criteria established by Lipsker D
et al. Medicine (Baltimore) 2001;80:37-44
Exclusion Criteria:
- children and pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Schnitzler Syndrome: Clinical Study, Physiopathological and Search for Genetic Factors | NCT00933296 | Contradiction |
430 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- healthy females without sterility factors
Exclusion Criteria:
- job-related exposition to pollutants
- low responder
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Analysis of Toxins in Follicle Fluid | NCT01385605 | Contradiction |
2,453 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Diagnosis of sarcoidosis
- Signed informed consent
Exclusion Criteria:
- Inability or unwillingness to adhere to the study
- Inability to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort | NCT04388566 | Entailment |
5,316 | 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. Women within ages of 18 to 45 years old with good health and regular menstrual cycles
with last menstrual cycle occurred within 5 weeks of enrolment; subjects can be
rescreened after completion of menstrual cycle
2. Women who use sanitary pads as their only menstrual hygiene product.
3. Women who agree to use only the study menstrual hygiene device and not sanitary pads
or other menstrual hygiene products for menstruation during the night time of study
duration.
4. Women who are able to understand instructions for correct use of study menstrual
hygiene product (i.e. the investigational device).
5. Literate women who can complete the study questionnaire on their own in a language of
their choice which are English, Malay and Chinese; and attending all study visits.
Exclusion Criteria:
1. Known history of vaginal or uterine infection(s), and/or urinary tract infections;
these subjects can be rescreened after 14 days after successful treatment.
2. Ongoing or past history of sexually transmitted disease, pelvic inflammatory disease,
and/or injuries to the pelvis requiring surgical intervention and/or pelvic floor
physiotherapy.
3. Female subject who is pregnant (established by urinary pregnancy test).
4. Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.
5. Staff who work directly under the investigators and/or employed directly by the device
manufacturers, sponsor and study team.
6. Moving outside Sibu area during study period and have difficulty to return for Visit
2.
7. Female subjects who have menopause (absence of menstruation for more than 6 months in
female) or any other circumstances that cause secondary amenorrhea (absence of
menstruation for more than 6 months in a normal female of reproductive age that is not
due to pregnancy) such as side effect from hormonal contraceptive.
8. Use any medications or preparation applied topically to the perineum or intravaginally
to the genitalia but subjects can be rescreened 14 days after the recovery if the
application is for acute illness.
9. Use of any medications which known to influence menstruation or study results for any
reasons within 14 days, 30 days before Visit 1 and during the intended study duration.
10. Subject participating in another clinical study involving menstrual hygiene device.
11. Acute disease at the time of enrolment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. Fever is defined as axillary /
tympanic / rectal temperature ≥ 38°C. Subjects can be rescreened 14 days after the
recovery;
12. Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other
malignant neoplasms affecting the bone marrow or lymphatic systems;
13. Presence of a clinically significant disorder involving the cardiovascular,
respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine,
or nervous system(s) or psychiatric disease or other conditions that may interfere
with the health conditions (such as in case the women subject become pregnant), or
would place the subjects at increased risk, as determined by the investigator(s).
Significant is defined as any disease/condition that, in the opinion of the researcher,
would put the subject's safety at risk through study participation, or which would confound
the interpretation of the study results if the disease/condition exacerbated during the
study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Proof Of Concept Menstrual Hygiene Product-Wondaleaf® | NCT02857972 | Contradiction |
4,232 | 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:
- Type of subject: Outpatient
- Informed Consent: A signed and dated written informed consent prior to study
participation.
- Participants 40 years of age or older at Visit 1.
- Gender: Male or female participants. A female is eligible to enter and participate in
the study if she is of: Non-child bearing potential (i.e., physiologically incapable
of becoming pregnant, including any female who is post-menopausal or surgically
sterile). Surgically sterile females are defined as those with a documented
hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females
are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical
profile, e.g., age appropriate, > 45 years, in the absence of hormone replacement
therapy.OR Child bearing potential, has a negative pregnancy test at screening, and
agrees to one of the following acceptable contraceptive methods used consistently and
correctly (i.e., in accordance with the approved product label and the instructions of
the physician for the duration of the study screening to follow-up contact):
Abstinence, Oral Contraceptive, either combined or progestogen alone, Injectable
progestogen, Implants of levonorgestrel, Estrogenic vaginal ring, Percutaneous
contraceptive patches, Intrauterine device (IUD) or intrauterine system (IUS) that
meets the Standard Operating Procedure (SOP) effectiveness criteria as stated in the
product label, Male partner sterilization (vasectomy with documentation of
azoospermia) prior to the female subject's entry into the study, and this male is the
sole partner for that subject. For this definition, "documented" refers to the outcome
of the investigator's/designee's medical examination of the subject or review of the
subject's medical history for study eligibility, as obtained via a verbal interview
with the subject or from the subject' s medical records. Double barrier method: condom
and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal
agent (foam/gel/film/cream/suppository)
- Diagnosis: An established clinical history of COPD in accordance with the definition
by the American Thoracic Society/European Respiratory Society.
- Smoking History: Current or former cigarette smokers with a history of cigarette
smoking of >=10 pack-years. Former smokers are defined as those who have stopped
smoking for at least 6 months prior to Visit 1.
- Severity of Disease: A pre and post-albuterol/salbutamol Forced Expiratory Volume in
One Second/ Forced Vital Capacity (FEV1/ FVC) ratio of <0.70 and a pre and
post-albuterol/salbutamol FEV1 of <=70% predicted normal value at Visit 1, calculated
using Quanjer reference equations.
- Dyspnoea: A score of >= 2 on the Modified Medical Research Council Dyspnoea Scale
(mMRC) at Visit 1.
- QT interval corrected (QTc) Criteria: QTc <450 milliseconds (msec) or QTc <480 msec
for patients with bundle branch block The QTc is the QT interval corrected for heart
rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or
another method, machine or manual overread. For subject eligibility and withdrawal,
QTcF will be used. For purposes of data analysis, QTcF will be used as primary. The
QTc should be based on single or averaged QTc values of triplicate Electrocardiogram
(ECGs) obtained over a brief recording period.
- French participants: In France, a subject will be eligible for inclusion in this study
only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant
during the study.
- Asthma: A current diagnosis of asthma.
- Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung
infections (such as tuberculosis), and lung cancer are absolute exclusionary
conditions. A subject who, in the opinion of the investigator, has any other
significant respiratory conditions in addition to COPD should be excluded. Examples
may include clinically significant bronchiectasis, pulmonary hypertension,
sarcoidosis, or interstitial lung disease. Allergy rhinitis is not exclusionary.
- Other Diseases/Abnormalities: Participants with historical or current evidence of
clinically significant cardiovascular, neurological, psychiatric, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
hematological abnormalities that are uncontrolled and/or a previous history of cancer
in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has
been resected for cure is not exclusionary). Significant is defined as any disease
that, in the opinion of the investigator, would put the safety of the subject at risk
through participation, or which would affect the efficacy or safety analysis if the
disease/condition exacerbated during the study.
- Contraindications: A history of allergy or hypersensitivity to any
anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or
magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic
hypertrophy or bladder neck obstruction that, in the opinion of the study physician,
contraindicates study participation or use of an inhaled anticholinergic or beta 2
agonist.
- Hospitalisation: Hospitalisation for COPD or pneumonia within 12 weeks prior to Visit
1.
- Lung Resection: Participants with lung volume reduction surgery within the 12 months
prior to Screening (Visit 1).
- 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at
Visit 1. Specific ECG findings that preclude subject eligibility will be listed in
protocol The study investigator will determine the medical significance of any ECG
abnormalities not listed.
- Screening labs: Significantly abnormal finding from clinical chemistry or haematology
tests at Visit 1 as determined by the study investigator.
- Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour
period required prior to spirometry testing at each study visit.
- Medications prior to Screening: Use of the following medications according to the
following defined time intervals prior to Visit 1: Depot corticosteroids (12 weeks);
Oral or parenteral corticosteroids (6 weeks); Antibiotics (for lower respiratory tract
infection) (6 weeks); Cytochrome P450 3A4 strong inhibitors ( 6 weeks); Long Acting
Beta-Agonist (LABA)/ inhaled corticosteroids (ICS) combination products (e.g.
fluticasone/salmeterol, mometasone, furoate/formoterol fumarate,
budesonide/formoterol, fumarate), If LABA/ICS therapy is discontinued completely (30
days); If discontinuing LABA therapy and switching to ICS monotherapy (48 hours for
salmeterol or formoterol, 14 days for Olodaterol, Indacaterol or, Vilanterol); Use of
ICS at a dose >1000 mcg/day of fluticasone propionate or equivalent (30 days);
Initiation or discontinuation of ICS use (30 days); Inhaled long acting beta2-agonists
(LABA): Salmeterol, Formoterol (48 hours), Olodaterol, Indacaterol and Vilanterol (14
days); Long acting muscarinic antagonists (LAMA) (Tiotropium, Aclidinium,
Glycopyrronium, Umeclidinium) (7 days); LABA/LAMA combination products (Whichever mono
component has the longest washout); Roflumilast (14 days); Oral beta-agonists-
Long-acting (48 hours), Short-acting(12 hours); Theophyllines (48 hours); Oral
leukotriene inhibitors (zafirlukast, montelukast, zileuton) (48 hours); Inhaled sodium
cromoglycate or nedocromil sodium (24 hours); Inhaled short acting beta2-agonists (4
hours); Inhaled short-acting anticholinergic (short acting muscarinic antagonist
[SAMA]) products eg ipratropium (4 hours); Inhaled short-acting
anticholinergic/short-acting beta2-agonist combination products (SAMA/Short Acting
beta2-agonists [SABA]) (4 hours); Any other investigational medication (30 days or
within 5 drug half-lives)
- Oxygen: Use of Long Term Oxygen Therapy (LTOT).This is defined as oxygen therapy
prescribed for greater than 12 hours per day. As needed oxygen use (i.e. <=12 hours
per day) is not exclusionary.
- Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use)
of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
- Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary
rehabilitation program within 12 weeks prior to Visit 1. Participants who are in the
maintenance phase of a pulmonary rehabilitation program are not excluded.
- Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2
years prior to Visit 1.
- Affiliation with Investigator Site: Is an investigator, sub-investigator, study
coordinator, employee of a participating investigator or study site, or immediate
family member of the aforementioned that is involved in this study.
- Inability to read: In the opinion of the investigator, any subject who is unable to
read and/or would not be able to complete a questionnaire.
- Participants who are pre-screen or screen failures cannot be re-screened.
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.
| Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium | NCT02257385 | Contradiction |
2,994 | 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:
The population studied is composed of children:
- from 8 to 12 years old
- seen for any reason for consultation in general practice
- Schooled in an ordinary environment since the Preparatory Course in France
- Francophone parents
- One of whose parents has signed the consent
- Consent of the child
- Social Insured
Exclusion Criteria:
The background and living conditions that may promote secondary learning disabilities, for
example:
- Child with a known intellectual disability (Wisc)
- Child in IME (Institut Médico Educatif)
- Child followed in SESSAD (Specialised education service at home)
- Child not knowing how to answer the questions asked
- Child with a known etiology causing learning disabilities (epilepsy, autism spectrum
disorder, hearing impairment, visual impairment (deafness, blindness, low vision))
- Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)
- Child under the care of a psychiatrist,
- Child followed by the CMP (Centre médico-psychologique)
- Child living in an institution,
- Adopted child
- A child whose mother has experienced known depression during the child's early
childhood (0-18 months) because it causes attachment disorders, which can impact the
child's development, including learning
- Child of a family that has lived through more than two family recompositions
- Child known to be a victim of abuse.
- Out of school child.
To determine the presence of an HV-Labile
- Child with a known visual correction greater than + or- 2 diopters
- Known amblyopic child
- Known strabic child
- Child with no known binocular vision.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 12 Years | Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). | NCT04122820 | Contradiction |
5,501 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of
Rheumatology (ACR) criteria for the diagnosis of GCA:
1. At least 50 years of age at disease onset
2. New onset or new type of localized pain in the head
3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation unrelated to arteriosclerosis of cervical arteries)
4. ESR of greater than 40 mm in the first hour by the Westergren method
5. Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells
Exclusion Criteria:
- Unable to give informed consent and sign the consent form
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.
| Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis | NCT00315497 | Entailment |
3,768 | 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:
- Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence
x-ray grade equal to, or greater than, 2.
- Patients must be experiencing some benefit from their current stable dose regimen of
oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either
100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
- Pain level and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue all non-study pain medications for osteoarthritis except rescue
medication (acetaminophen) and not use prohibited pain medications throughout the
duration of the study except as permitted per protocol.
- Willing and able to comply with lifestyle guidelines, scheduled visits, treatment
plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Pregnant women.
- BMI greater than 39.
- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy or other moderate to sever pain that may confound assessments or
self-evaluation of the pain associated with OA.
- Signs and symptoms of clinically significant cardiac disease with 6 months prior to
screening.
- Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with
residual deficits that would preclude completion of required study activities.
- History, diagnosis, signs or symptoms of clinically significant neurological and/or
psychiatric disease/disorder.
- At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%,
ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7
mg/dL (men) or 1.5 mg/dL (women).
- Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
within 30 days prior to screening.
- Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip | NCT00809354 | Entailment |
2,738 | 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:
1. Man ≥18 years
2. Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal
preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or
laparoscopic umbilical herniorrhaphy to be performed according to standard surgical
technique under general anesthesia.
3. Willing to use opioid rescue analgesia.
Exclusion Criteria:
1. Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
2. Scheduled for bilateral inguinal herniorrhaphy.
3. Undergone a prior herniorrhaphy at the location scheduled for repair.
4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy | NCT01224145 | Entailment |
4,926 | 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:
- individuals with essential tremor who are at least 6 months status-post thalamic
stimulator placement
- maintained a consistent chronic or intermittent stimulation schedule for at least 4
consecutive weeks prior to study enrollment
- no changes in stimulation parameters for at least 2 consecutive months prior to study
enrollment
Exclusion Criteria:
- patients with clinically significant dementia (i.e., a score less than 24 out of 30 on
the Mini Mental Status Exam14)
- women who are not post-menopausal
- patients with other significant neurological or psychiatric disease other than
essential tremor
- patients treated with pallidotomy or thalamotomy
- patients with significant psychiatric disturbance as determined by Diagnostic and
Statistical Manual-IV criteria which would make informed consent/cooperation
problematic
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 80 Years | Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor | NCT01334814 | Entailment |
3,218 | 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. Healthy sexually active women who have ever used an FC and using condoms (male or
female) as their current method of contraception.
2. Be 18 to 40 years at enrolment (inclusive).
3. Have a negative urine pregnancy test at enrolment visit.
4. Is HIV negative
5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using
hormonal contraception.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for
a period of 6 months.
10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary
method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and
details of condom use and any condom failures.
13. Be willing to state that, to her best knowledge, her sexual partner:
- Has not had a vasectomy or been previously diagnosed as infertile.
- Is HIV negative
- Has no known history of allergy or sensitivity to natural rubber latex,
water-based or silicone lubricants
- Does not want her to become pregnant in the next 7 months
14. Agree to have fingerprint identity check
15. Be willing to give written informed consent to participate in the trial.
16. Intend to stay in the area for the next 6-7 months
17. Be willing to be randomized
Exclusion Criteria:
1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone
lubricants
2. Have evidence of sexually transmitted infections on syndromic assessment and / or
vaginal examination
3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
4. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
6. Be in a monogamous relationship of less than 4 months with their partner.
7. Have any contraindications to pregnancy (medical condition) or regularly use
medications that are unsafe to use in pregnancy
8. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
9. HIV positive.
10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or
Nur-Isterate in the last 4 months prior to enrolment
16. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
17. Have taken an investigational drug or used an investigational device within the past
30 days.
18. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom | NCT04233632 | Entailment |
6,973 | 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:
- AD patients: clinical dementia rating between 0.5 and 2 free and cued recall test
(Grober and Buschke) cued-recall < 18/48 and total recall < 40/48
- atypical AD : i visual-spatial disorder and respect of episodic memory progressive
evolution, Balint syndrome ii progressive language disorder constituted of logopenic
aphasia respect of episodic memory
- controls: age over 30 MMSE over or equal to 27 normal neuropsychiatric state for age
and education level
Exclusion Criteria:
- for every patients : psychiatric disorders age under18 absence of social security
counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Influence of Age on Amyloid Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease | NCT01095744 | Entailment |
1,860 | 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:
- Age from 18 to 75 years
- Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring
cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee
on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs
are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
- Enlarged or bulky regional lymph node envelop important vessels
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of predicted values
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy | NCT02930278 | Entailment |
1,947 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients with high-risk GAC defined as: Diffuse cancer (signet ring cells predominant)
or clinical stage: cTany + cN2-3 or cT3-T4 + cNany or GAC patients with preoperative
positive peritoneal cytology submitted to laparoscopic gastrectomy (+/- neoadjuvant
treatment).
- Age 18 or above
- Written informed consent
- Women must be postmenopausal or use adequate contraception with a negative pregnancy
test at inclusion.
Exclusion Criteria:
- Previous allergic reaction to cisplatin, doxorubicin or other platinum containing
compounds.
- Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as NYHA class 3-4.
- Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
- Inadequate haematological function defined as absolute neutrophil count (ANC) ≤ 1.5 x
10^9/l and platelets ≤ 100 x 10^9/l.
- Any other condition or therapy, which in the investigator's opinion may pose a risk to
the patient or interfere with the study objectives.
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.
| Adjuvant PIPAC in Gastric Cancer Patients | NCT04047004 | Entailment |
2,250 | 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:
- Gout patients
Exclusion Criteria:
- Pregnant women
- Chronic renal failure
- Patients with Allopurinal hypersensitivity
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
| The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients | NCT03601260 | Entailment |
4,117 | 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:
- aged 18-30
- healthy civilians volunteers
- with no background illnesses
- with history of combat unit service in the IDF.
- fit to perform 10 Km moderate march while carrying load.
Exclusion Criteria:
- The existence or suspicion of existing cardiac or respiratory disease.
- Hypertension.
- Diabetes.
- Any muscles or skeleton condition.
- Any hormonal disease or any other chronic illness that may inhibit participation in
the experiment.
- Infectious disease 3 days prior to the experiment.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment | NCT02644213 | Contradiction |
5,975 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients complaining about heartburn or acid regurgitation, the typical GERD symptoms,
more than once a week
- After a full explanation about the observational study, patients who fully understand
it and sign a written consent form
Exclusion Criteria:
- Patients who took rabeprazole sodium within the last four weeks
- Patients who are hypersensitive to the active ingredient of rabeprazole sodium or
benzimidazole
- Patient with other digestive tract diseases other than GERD (gastrointestinal cancer,
liver disease, pancreatic disease, peptic ulcer, inflammatory digestive tract diseases
[in case of ulcer, however, scars from healed ulcer may be included])
- Patients with other severe accompanying diseases including renal impairment,
cerebrovascular disease, cardiovascular disease and severe respiratory disease
- Patients who must constantly take Proton Pump Inhibitors other than rabeprazole sodium
during study period
- Pregnant or lactating women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea | NCT01018160 | Entailment |
2,886 | 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:
- Definite diagnosis of ALS
Exclusion Criteria:
- No prior participation in R(+)PPX clinical studies
No condition on gender to be admitted to the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day | NCT00596115 | Entailment |
1,469 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Participants with clinic blood pressure more than or equal to 130/80 mm Hg who are not
taking medication
- Participants with controlled blood pressure defined as < 130/80 using
anti-hypertensive medication for a minimum of six weeks.
- Participants live in Banshgram Union only
Exclusion Criteria:
- Aged > 75 years of age
- Pregnant women
- People who have advanced CVDs or are any serious condition that restricts their
participation in the study
- Participants will be withdrawn from the study if they are unwilling to continue their
participation and withdraw their consent, or any women participants who become
pregnant during the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 75 Years | Lowering Blood Pressure by Changing Lifestyle | NCT04505150 | Entailment |
5,951 | 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:
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg
twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of
14 days, where zero = none, one = mild, two = moderate, three = severe.
Exclusion Criteria:
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms,
gastric or duodenal ulcers, or any other significant gastric or esophageal pathology
judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily
for a period of > 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh
Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics
of esomeprazole and/or lansoprazole.
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 Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD) | NCT00637845 | Contradiction |
437 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. age between 21-40 years old
2. basal FSH hormone level less than 10 mIU/mL
3. the first cycle of IVF treatment with standard long protocol
4. both ovarian present and normal uterus.
Exclusion Criteria:
1. PGD cycles
2. Gametes donation cycles
3. Anyone that does not meet the inclusion criteria
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 40 Years | The Effect of Vitamin D on in Vitro Fertilization Outcome | NCT02361827 | Contradiction |
503 | 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
To enroll into the clinical trial, potential subjects must:
1. Be healthy women, who are sexually active, at risk for pregnancy and desiring
contraception.
2. Be within the age range of 18 through 40 years inclusive at enrollment.
3. Have a negative urine pregnancy test at the admission visit.
4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not
using hormonal contraception.
5. Have one menses after switching from oral contraceptives to using the Woman's Condom.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Be willing to engage in at least four acts of heterosexual vaginal intercourse per
month for a period of 6 months.
10. Be willing to only use the study product as the primary method of contraception over
the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a diary to record coital information, product use information,
information about the use of other vaginal products, and any symptoms, which occurred
in her or her partner over the course of study participation.
13. Be willing to state that, to her best knowledge, her sexual partner(s):
1. Has not had a vasectomy or been previously diagnosed as infertile.
2. Has not been previously diagnosed or suspected of HIV unless he has subsequently
had a negative HIV test.
3. Has not been known to have engaged in homosexual intercourse in the past 5 years
unless he has had negative HIV test results since then.
4. Has not shared injection drug needles in the past unless he has had a negative
HIV test at least 6 weeks since last use.
5. Has no known history of allergy or sensitivity to polyurethane (condom pouch),
polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
14. Agree not to participate in any other clinical trials during the course of this study.
15. Be willing to give written informed consent to participate in the trial.
Exclusion Criteria
To enroll into the clinical trial, potential subjects must not:
1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl
alcohol (capsule), or other water-based lubricants such as Astroglide.
2. Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis,
or if needed by a urine culture or wet mount (see Schedule of Assessments for
definitions), unless treated and proof of cure is documented by a negative test result
performed at least 2 weeks post-treatment.
3. Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and
her partner(s) complete treatment and proof of cure is documented for the subject only
by a negative test result performed at least 3 weeks post-treatment.
4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
5. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
7. Be in a monogamous relationship of less than 4 months with their partner.
8. Have any contraindications to pregnancy (medical condition) or regularly use category
D or X or exclusionary medications listed in Appendix F.
9. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
10. Have known or suspected to have an HIV infection.
11. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
12. Be lactating or breastfeeding.
13. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
14. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
16. Have received a Depo-Provera® injection in the 9 months prior to enrollment (this
exclusionary time period can be shortened to 6 months if the subject has also had 2
spontaneous menstrual cycles [requires minimum of 3 menses] that meet criteria for
normal menstrual cycles).
17. Have an abnormal Pap test based on the following criteria:
- Pap test in the past 15 months with ASC-US unless:
- less than 21 years of age;
- a repeat Pap test at least 6 months later was normal;
- reflex HPV testing was performed and was negative for high-risk HPV; or
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with LSIL unless:
- less than 21 years of age;
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL
unless colposcopy and/or treatment was performed and follow-up at least 6 months
after the colposcopy and/or treatment showed no evidence of disease;
- Pap test in the past 15 months with malignant cells.
18. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
19. Have taken an investigational drug or used an investigational device within the past
30 days.
20. Have previously participated in or completed this study.
21. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study. For example, if the subject is found to have Condyloma
Accuminata, the investigator can decide whether to exclude the subject or not,
depending on its location and if use of the condom may be painful for the subject.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom | NCT01223313 | Contradiction |
6,203 | 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 diagnosed with COVID-19, non COVID-19, and suspected COVID-19 infection,
based on the results of anamnesis, physical examination, laboratory, X-rays and rapid
tests.
- Able to produce samples for RT-PCR examination.
- Agree to participate (sign informed consent). For children, informed consent are
obtained from the parents. For adolescent patients, accent consent is asked.
- Patients who do not need oxygen therapy supplementation in the form of mask-type or
ventilator. Patients who use oxygen supplementation with nasal cannula are still
included as study participants.
Exclusion Criteria:
- Unable to breath deeply due to difficulty breathing due to complications of COVID-19
or other diseases
- The quality of the breath do not meet the standard interpretation of the instrument
sensor curve (breath sampel is declared invalid).
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.
| Genosvid Diagnostic Test for Early Detection of COVID-19 | NCT04558372 | Contradiction |
2,050 | 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. | For the study on lung tissue, eligible subjects were IPF patients undergoing lung
transplant surgery and from organ donors who died from non-pulmonary causes. For the study
in clinic, subjects were IPF patients who had no other pulmonary disease other than IPF and
the diagnosis of IPF was confirmed by lung biopsy or by clinical and chest CT findings. The
control group consisted of subjects without respiratory symptoms or pulmonary diseases who
were the household partner or spouse of an enrolled IPF subject and accompanied the IPF
patient to outpatient clinic visits.
Exclusion Criteria:
- Failure of the patient to provide informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Herpesvirus in Idiopathic Pulmonary Fibrosis | NCT00228670 | Contradiction |
5,611 | 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:
- Males and females volunteers, able to read and write.
- Subject with 25 ≤ Body Mass Index ≤ 35 kg/m².
- Subject with a good physical condition based on the subject's interview and the
clinical exam performed by the Investigator.
- Subject with stable body weight (< 5% variation) within the last 3 months prior to
screening (based on interview).
- Written informed consent provided prior to screening, after receiving and
understanding the subject information.
- Subject willing to lose weight.
- Subject accepting to follow diet and lifestyle instructions throughout the study.
- Subject willing to take study capsules three times a day for 3 months and 1 week and
undergo other study-related procedures.
- Registered with the French Social Security, in agreement with the French law on
biomedical experimentation.
Exclusion Criteria:
- Smoker or former smoker having stopped within 2 months prior to screening visit.
- Subject with a history of alcohol or drug abuse.
- Subject with physical activity more than 3 hours per week.
- Subject with any sensitivity or allergy to any of the products used within this
clinical trial.
- Subject with history of eating disorder (anorexia nervosa, bulimia nervosa).
- Subject having used weight reduction treatments or products during the last 3 months
prior to screening visit.
- Subject with significant gastrointestinal disease (e.g. coeliac disease,
pancreatitis), signs of intestinal obstruction or medical history of constipation.
- Intake of chronic medication which could interfere with study parameters (weight,
appetite, satiety, lipid blood levels, glycemia, gastrointestinal function), having an
effect on digestion or absorption of nutrients, excepted oestroprogestative or
progestative contraception started at least three months before the screening visit.
- Female subject planning a pregnancy, pregnant or breastfeeding.
- Female subject without efficient contraceptive method.
- Subject with history of bariatric surgery.
- Subject with known systemic disease such as cancer, human immunodeficiency virus (HIV)
seropositivity.
- Subject with type 1 or type 2 diabetes mellitus.
- Subject with history of significant medical or surgical event requiring
hospitalization during the 3 months prior the screening visit.
- Subject having, had or scheduling to have an exam that uses barium, a radioisotope
injection, or oral or intravenous contrast material within 2 weeks prior screening
visit and during the study.
- Participation to any other clinical trial simultaneously and/or within 1 month prior
the screening visit.
- Subject who has donated blood or blood products within the previous month prior to
screening or who plans to donate blood or blood products at any time during the trial
and in the 3 months following the end of the study.
- Subject judged unlikely to comply with study product intake (screening compliance <
80%) and with diet and lifestyle instructions.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers | NCT02246699 | Contradiction |
968 | 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:
- Documented Osteoarthritis of the hip or knee
- Chronic pain for more than 3 months treated with daily analgesic for the last month
- Moderate to severe OA pain of the target joint, which cannot be adequately treated
with non-steroidal anti-inflamatory drugs or paracetamol
- Moderate to severe pain by means of a mean weekly score of >= 5 in the Brief Pain
Invetory item 5 'pain on average'
Exclusion Criteria:
- Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use
of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4
weeks before the screening visit is acceptable, however, treatment must be stopped at
screening visit)
- Diagnosis of major depression
- Treatment for epilepsy
- Corticosteroid injection within the last 3 months
- Major surgery in the 3 months before the start of the study
- Women who are pregnant or breast-feeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee | NCT00980798 | Entailment |
1,377 | 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 18 years of age
- Weight of at least 12 kg and capable of swallowing a capsule
- Able to refrain from use of medications known to treat or associated with constipation
symptoms
- Stable fiber therapy or ADHD therapy if using such medications
- Patient/Caregiver able to complete daily diary
- Patient able to use recommended rectal and/or oral rescue medications if needed
Exclusion Criteria:
- Constipation is associated with some medical, anatomic, physical, organic, or other
condition
- Hirschsprung's Disease or Nonretentive Fecal Incontinence
- Untreated fecal impactions or impactions requiring digital manipulation
- Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator
discretion
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or
unexplained weight loss
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric
disorder, other systemic disease, or abnormal laboratory tests at the investigator
discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse
during the clinical study
- Sexually active males and females must utilize acceptable birth control methods
- Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 17 Years | Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation | NCT00452335 | Contradiction |
3,418 | 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:
- has functional ventilation tube or a chronic perforation in at least one ear;
- history of Eustachian tube dysfunction and/or otitis media with effusion;
- history of middle-ear effusion at least once;
- otherwise healthy except for possible gastro-esophageal reflux disease (GERD),
allergies, sinusitis;
- BMI of less than 35;
- no history of difficult intubation;
- no known family history of malignant hyperthermia.
Exclusion Criteria:
- history of adverse reaction to any study-related medication and a suitable alternative
is not available;
- current or past history of cancer;
- current or past history of vestibular pathology or cranial base surgery;
- craniofacial dysmorphology (examples: down syndrome, cleft palate);
- pregnancy or "at risk" and not using contraception;
- patulous Eustachian tube;
- non-patent nasal cavity;
- adenoids that block the Eustachian tube orifice;
- blood pressure greater than 140/90;
- had experimental drug or procedure in the previous 3 months;
- allergic to eggs, egg products, soy, or soy products;
- previously underwent balloon dilation of the Eustachian tube.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction | NCT02114762 | Entailment |
1,033 | 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:
- Clinically and radiographically diagnosed with OA in both knees, according to the
criteria set by the American College of Rheumatology
- Knee OA grade II or III, according to the criteria by Kellgren and Lawrence
- Moderate to very severe pain, according to the Western Ontario and McMaster
Universities (WOMAC) pain subscale) (score between 10 and 20)
- Using stable doses of analgesics and NSAIDs during the intervention;
- Do not perform physical therapy or other complementary therapies with laying on of
hands different from those proposed in the current study;
- Being able to travel to the rehabilitation site;
- Being able to read, understand and speak Portuguese;
- Preserved cognition
Exclusion Criteria:
- Having made use of oral or intra-articular corticosteroids for at least 3 months
before the intervention;
- Having made use of intra-articular hyaluronate for at least three months before the
intervention;
- Having full or partial prosthetic hips and/or knees;
- Presenting neurological diseases or other rheumatic diseases;
- Presenting medical contraindications to perform light to moderate physical activity;
- Being absent for two consecutive or three non-consecutive times.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| The Effect of "Laying on of Hands" in Older Women With Knee Osteoarthritis | NCT02917356 | Entailment |
3,703 | 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. Informed consent form for participation in the study;
2. KOA (based on ACR, 1987)
3. Age between 30-60 years old
4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic
dose)
5. Dyspeptic symptoms (according to SODA questionnaire)
6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS
7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against
stable antihypertensive therapy.
Exclusion Criteria:
1. Contraindications to amtolmetin guacil (according to patient information leaflet)
2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
3. Signs of renal or hepatic failure;
4. Pregnancy, lactation or planning for pregnancy.
5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT,
AST.
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 | Amtolmetin Gaucil in Knee Osteoarthritis | NCT02865161 | Contradiction |
3,879 | 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:
- Minimum 20% length shorting
- NPRS more than 3
- Gender include male and female
- Age 40-65
- Pain more than 3 months.
- Patients with mild to moderate knee OA (primary and secondary) grade 1and 2 Kellgren
and Lawrence classification system based on plain x-rays taken in supine lying
position. They should satisfy the American College of Rheumatology Criteria for
clinical classification of knee OA.
Hamstring shortness screening criteria: following tests should be positive for participants
to enroll in this study
- Active knee extension test
- 90-90 test
- Sit and reach test
Exclusion Criteria:
- Co morbidities (i.e. Systematic diseases)
- Patient on long-term Medications i.e. corticosteroid
- Patient with Spinal Surgery
- Recent trauma
- Hamstring contracture.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Mobilization Effect on Hamstring Length | NCT04574700 | Entailment |
5,042 | 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:
- Men and women age 18 years or older
- Diagnosis of essential tremor as confirmed from clinical history and examination by a
neurologist or neurosurgeon
- Tremor following prior first line therapy with either propranolol or primidone
- Must be able to undergo MRI of brain and CT of head for treatment planning
- Postural or intention tremor severity score of greater than or equal to 2 in one
hand/arm as measured by the CRST rating scale
Exclusion Criteria:
- Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral
deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or
ultrasound ablation of an ipsilateral thalamic target
- Prior whole brain radiation therapy
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gamma Knife Radiosurgery for Treatment of Essential Tremor | NCT02255929 | Entailment |
2,838 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable,
possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar
palsy
Exclusion Criteria:
Patients with other neurological diagnoses than mentioned in the inclusion 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 100 Years | Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis | NCT03536962 | Entailment |
4,010 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Symptomatic knee OA
Exclusion Criteria:
- Younger than 45 years of age or older than 85 years of age
- Prosthetic knee replacement or other clinically significant surgery to the arthritic
knee
- Uncontrolled hypertension (>150/95)
- Heart disease including heart failure
- Peripheral neuropathy in which pain testing was contraindicated
- Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus
erythematosus, gout, and fibromyalgia
- Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of
sensory or motor function, or uncontrolled seizures
- Significantly greater pain in body sites other than in the knee
- Daily opioid use
- Hospitalization within the preceding year for psychiatric illness
- Currently pregnant or nursing/breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Study of Pain Catastrophizing-2 (SPAC-2) | NCT04805190 | Entailment |
1,751 | 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:
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on
Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs
are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy,
previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
- History of other malignant disease within past five years
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of predicted values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy | NCT02902575 | Contradiction |
2,270 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Subject's parent(s) or legal guardian(s) has (have) provided written informed consent
and Health Insurance Portability and Accountability Act (HIPAA) authorization, where
applicable, prior to any study-related procedures; participants will be asked to give
written or verbal assent according to local requirements
2. Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis
of DMD as defined as:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical DMD, OR
- Identifiable mutation within the DMD gene (deletion/duplication of one or more
exons), where reading frame can be predicted as 'out-of-frame,' and clinical
picture consistent with typical DMD, OR
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication, other) that is expected to preclude production of the dystrophin
protein (i.e., nonsense mutation, deletion/duplication leading to a downstream
stop codon), with a clinical picture consistent with typical DMD;
3. Subject is ≥ 4 years and <7 years of age at time of enrollment in the study;
4. Subject weighs >13.0 kg and ≤ 39.9 kg at the Screening Visit;
5. Subject is able to walk independently without assistive devices;
6. Subject is able to complete the Time to Stand Test (TTSTAND) without assistance in <10
seconds, as assessed at the Screening Visit;
7. Clinical laboratory test results are within the normal range at the Screening Visit,
or if abnormal, are not clinically significant, in the opinion of the Investigator.
[Notes: Serum gamma glutamyl transferase (GGT), creatinine, and total bilirubin all
must be ≤ upper limit of the normal range at the Screening Visit. An abnormal vitamin
D level that is considered clinically significant will not exclude a subject from
randomization];
8. Subject has evidence of chicken pox immunity as determined by:
- Presence of IgG antibodies to varicella, as documented by a positive test result
from the local laboratory from blood collected during the Screening Period, OR
- Documentation, provided at the Screening Visit, that the subject has had 2 doses
of varicella vaccine, with or without serologic evidence of immunity; the second
of the 2 immunizations must have been given at least 14 days prior to
randomization.
9. Subject is able to swallow tablets, as confirmed by successful test swallowing of
placebo tablets during the Screening Period; and
10. Subject and parent(s)/guardian(s) are willing and able to comply with scheduled
visits, study drug administration plan, and study procedures.
Exclusion Criteria:
1. Subject has current or history of major renal or hepatic impairment, diabetes mellitus
or immunosuppression;
2. Subject has current or history of chronic systemic fungal or viral infections;
3. Subject has had an acute illness within 4 weeks prior to the first dose of study
medication;
4. Subject has used mineralocorticoid receptor agents, such as spironolactone,
eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium),
mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of study
medication;
5. Subject has a history of primary hyperaldosteronism;
6. Subject has evidence of symptomatic cardiomyopathy [Note: Asymptomatic cardiac
abnormality on investigation would not be exclusionary];
7. Subject is currently being treated or has received previous treatment with oral
glucocorticoids or other immunosuppressive agents [Notes: Past transient use of oral
glucocorticoids or other oral immunosuppressive agents for no longer than 1 month
cumulative, with last use at least 3 months prior to first dose of study medication,
will be considered for eligibility on a case-by-case basis, unless discontinued for
intolerance. Inhaled and/or topical glucocorticoids are permitted if last use is at
least 4 weeks prior to first dose of study medication or if administered at stable
dose beginning at least 4 weeks prior to first dose of study medication and
anticipated to be used at the stable dose regimen for the duration of the study];
8. Subject has an allergy or hypersensitivity to the study medication or to any of its
constituents;
9. Subject has used idebenone within 4 weeks prior to the first dose of study medication;
10. Subject has severe behavioral or cognitive problems that preclude participation in the
study, in the opinion of the Investigator;
11. Subject has previous or ongoing medical condition, medical history, physical findings
or laboratory abnormalities that could affect safety, make it unlikely that treatment
and follow-up will be correctly completed or impair the assessment of study results,
in the opinion of the Investigator;
12. Subject is taking (or has taken within 4 weeks prior to the first dose of study
medication) herbal remedies and supplements which can impact muscle strength and
function (e.g., Co-enzyme Q10, creatine, etc);
13. Subject is taking (or has taken within 3 months prior to the first dose of study
medication) any medication indicated for DMD, including Exondys51 and Translarna;
14. Subject has been administered a live attenuated vaccine within 14 days prior to the
first dose of study medication;
15. Subject is currently taking any other investigational drug or has taken any other
investigational drug within 3 months prior to the first dose of study medication;
16. Subject has a sibling who is currently enrolled in any vamorolone study or Expanded
Access Program, or who intends to enroll in any vamorolone study or Expanded Access
Program during the subject's participation in the VBP15-004 study; or
17. Subject has previously been enrolled in the study. Note: Any parameter/test may be
repeated at the Investigator's discretion during Screening to determine
reproducibility. In addition, subjects may be rescreened if ineligible due to a
transient condition which would prevent the subject from participating, such as an
upper respiratory tract infection or injury, or if ineligible due to negative
anti-varicella IgG antibody test result.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | NCT03439670 | Contradiction |
658 | 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 groups M and HSD at least one criteria of the metabolic syndrome definition
according to the International Diabetes Federation
- for group M only hepatic iron overload mesured by IRM (above 50 µmol/g)
hyperferritnemia between 450 and 1500 µg/l
- for group T only BMI < 25 kg/m² Waist size < 80 cm for women and <94 cm for men
Exclusion Criteria:
- persons under guardianship
- pregnancy
- active smoking
- current inflammatory or cancerous disease
- hereditary hemochromatosis
- use of anti-inflammatory, immunosuppressive or hypoglycaemic drugs
- hemolysis
- alcool consumption above 14 doses for women and 21 doses for men per week
- history of therapeutic phlebotomy
- inflammatory syndrome with CRP above 15 mg/l
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload) | NCT02066012 | Contradiction |
551 | 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:
- 16-40 years
o 16 and 17 year olds, where permissible by state regulations and local Institutional
Review Board (IRB) approval
- Sexually active, anticipating at least one act of vaginal intercourse per menstrual
cycle with a male partner and at risk for pregnancy
- seeking contraception, and willing to use the study IUD as the only contraception
method
- willing to be randomized to one of the two copper IUDs
- has an intact uterus and at least one ovary
- has a history of regular menstrual cycles; defined as occurring every 21-35 days when
not using hormones, and with a variation of typical cycle length of no more than 5
days
- able and willing to provide written informed consent
- agrees to follow all study requirements
- not currently pregnant or at risk for luteal phase pregnancy based on history of
unprotected intercourse
Exclusion Criteria:
- abnormal Pap requiring treatment after enrollment
- known human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS)
infection
- intending to become pregnant in the 37 months after enrollment
- known infertility
- history of allergy or sensitivity to copper
- previous tubal sterilization
- has received an injectable contraceptive in the last 9 months and has not resumed
regular menstrual cycles (as evidenced by 2 spontaneous menses)
- within 30 days of administration of mifepristone and/or misoprostol for medical
abortion or for miscarriage management
- within 30 days of first, second, or third trimester abortion or miscarriage (note:
potential abortion/miscarriage participants can be screened and return after 30 days
for randomization and IUD insertion)
- within 30 days of delivery (for parous population)
- breastfeeding or recently breastfeeding women unless two consecutive normal menstrual
periods have occurred after delivery and prior to enrollment.
- wants to use a copper IUD for emergency contraception
- has previously participated in the study
- participated in another clinical trial involving an investigational product within the
last 30 days (before screening) or planning to participate in another clinical trial
involving an intervention or treatment during this study
- not living in the catchment area of the study site or planning to move from the area
within the year (unless known to be moving to the catchment area of another study
site)
- known or suspected current alcohol or drug abuse
- planning to undergo major surgery during study participation
- current need for use of exogenous hormones or therapeutic anticoagulants (Note:
subjects who start a therapeutic anticoagulant after enrolment will be allowed to
continue in the study.)
- at high risk for sexually-transmitted infections or pelvic infection
- anticipated need for regular condom use (refer to Section 8.1).
- has any condition (social or medical) which in the opinion of the Investigator would
make study participation unsafe or complicate data interpretation
- Reported medical contraindications (Medical Eligibility Criteria category 3 or 4)14 to
copper IUDs, including:
- suspicious unexplained vaginal bleeding
- known cervical cancer
- known endometrial cancer
- known Wilson's disease
- Confirmed gestational trophoblastic disease with persistently elevated beta-hCG
levels or malignant disease, with evidence or suspicion of intrauterine disease
- anatomic abnormalities with distorted uterine cavity
- current pelvic inflammatory disease (PID)
- pelvic tuberculosis
- immediately post-septic abortion or puerperal sepsis
- current known purulent cervicitis or chlamydial infection or gonorrhea; Note: to
enroll, there must be no obvious signs of infection at the time of enrollment
based on pelvic exam. If lab results come back for positive infection after
enrollment, treatment should be provided but the IUD can be left in place.
- complicated solid organ transplantation
- systemic lupus erythematosus with severe thrombocytopenia
Female
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 40 Years | Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard | NCT03124160 | Contradiction |
4,982 | 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:
- All subjects will be age 40 or older,
- Be on stable medications for at least 30 days
- Montreal Cognitive Assessment (MOCA) of 26 or higher
- Scores within 1.5 standard deviations of age-matched norms for all neuropsychological
tests
- Parkinson's Plus Disorders (PD) will be defined using United Kingdom (UK) Brain Bank
Criteria.
- PD dementia (PDD) will be defined using the Movement Disorder Task Force 2007 criteria
and supported by scores less than 1.5 standard deviations of age-matched norms in at
least two domains.
- Probable Alzheimer's Disease (AD) will be defined using the National Institute on
Aging-Alzheimer Association 2011 guidelines.
- Parkinson's Plus Disorders (PD) with mild cognitive impairment (MCI) will be defined
by history, MOCA of 21 or higher, at least one score less than 1.5 standard deviations
of age-matched norms, and cannot meet diagnostic criteria for PDD.
- Essential tremor and Parkinson plus syndromes (multiple systems atrophy, corticobasal
degeneration, progressive supranuclear palsy) will be defined using previously
published research criteria.19-22
Exclusion Criteria
- Features suggestive of other causes of parkinsonism/Parkinson-plus syndromes;
- Features suggestive of other causes of dementia, including moderate to severe
cerebrovascular disease by history, or imaging or history of major head trauma;
- History of deep brain stimulation, ablation surgery, or other brain surgery;
- Evidence for depression based on the Hospital Anxiety Depression Scale (score > 11).
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.
| Defining Phenotypes of Movement Disorders :Parkinson's Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography. | NCT02132052 | Entailment |
889 | 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:
- Adult patient above 30 years old.
- Clinically diagnosed osteoarthritis before treatment.
- Patient with refractory active osteoarthritis (not responding to treatment).
- Ability to sleep in fixed position for about 25 minutes
- Ability to provide informed consent.
Exclusion Criteria:
- Patient with resolved osteoarthritis.
- patient with other disease in joints:
- Avascular necrosis
- Stress fracture
- Neuropathic pain
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 Years | The Role of Tc 99m MDP SPECT/CT in Osteoarthritis | NCT03290807 | Entailment |
989 | 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:
- Age between 40-70 years at screening
- Proven hand OA by clinical examination and/or ultrasound
1. Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement,
squaring and/or deformity of the thumb base and no clinical signs of inflammatory
arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP)
joints, and no soft tissue swelling of the wrist).
2. Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb
base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler
activity in two or less MCP joints and no synovitis with power Doppler activity
in the wrist).
- Capable of understanding and signing an informed consent form
- Provided a written informed consent to participate in the study
Exclusion Criteria:
- Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative
rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or
arthritis related to connective tissue disorders
- Diagnosis of psoriasis
- Erythrocyte sedimentation rate (ESR) > 40 mm/hour and/or C-reactive protein (CRP) >20
mg/L, without a known ongoing infection
- Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
- Ferritin >200 microgram/L for women and >300 microgram/L for men and s-iron/s-total
iron binding capacity (TIBC) above 50%
- Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe
infections, uncontrollable hypertension, severe cardiovascular disease or severe
respiratory disease)
- Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other
factors that make compliance to the study protocol difficult.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | The Nor-Hand Study | NCT03083548 | Entailment |
6,141 | 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:
- Inclusion Criteria:
- Age 18-80 years
- Confirmed Covid19 patient with positive RT PCR
- Exclusion Criteria:
- Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
- HIV positive/ AIDS patients
- Pregnancy
- Active malignancy within the last 5 years
- Not willing 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 80 Years | Study of Coagulation Profile and Role of Heparin Like Effect in Patients With COVID-19 | NCT04668404 | Contradiction |
4,681 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Female ASA I/II patients above age of 21 years old scheduled gynecological open
surgery for benign condition (fibroids, adenomyosis), who are willing and able to give
written informed consent for participation in this study.
Exclusion Criteria:
- Contraindications to the use of S+ ketamine, as listed in the product label e.g.
untreated or insufficiently treated thyroid hyperfunction, unstable angina pectoris or
myocardial infarction within the last 6 months, diseases of the central nervous
system, increased intraocular pressure and perforating ocular injuries, surgical
procedures in the upper respiratory tract;
- History of drug or alcohol abuse;
- Regular use of analgesics, or use of opioids within 12 hours of surgery;
- Chronic use of benzodiazepine or neuroleptics;
- Thyroid replacement hormone;
- History of ischaemic heart disease, hypertension, psychiatric disorder;
- BMI> 30kg/m2;
- Laparoscopic surgery converted to open surgery;
- Pregnant or breast feeding females.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Use of S+Ketamine During Target-Controlled Intravenous Anaesthesia After Abdominal Hysterectomy | NCT03231683 | Entailment |
4,673 | 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:
- Ability to understand and provide a written informed consent.
- Healthy adult females between 18 and 50 years of age. Included in this group are women
with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
- Normal menstrual cycle of 26-32 days
- Agree not to attempt to become pregnant
- Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid
alcohol consumption within 48 hours of each visit
- Ability to swallow gelatin capsules Ability to complete a daily subject diary
- Willing to discontinue hormonal contraceptives and consent to use of double barrier
contraceptive techniques over the course of the study.
- Has a negative pregnancy test at the Screening and Baseline visits An exception for
the pregnancy test requirement will be granted for subjects reporting surgical
sterilization in medical history
- A Body Mass Index (BMI) between 18 and 39 inclusive
- Is available for all treatment and follow-up visits
Exclusion Criteria:
- Subject is a post-menopausal woman, defined as either; six (6) months or more
(immediately prior to screening visit) without a menstrual period, or prior
hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant
during the 7 month study period
- Women with abnormal liver enzymes or liver disease.
- Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003,
ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
DHEA or hormonal products for at least 2 weeks prior to screening and during the
study.
- Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of
Depo-Provera® in the preceding 6 months.
- Women currently using narcotics
- Women currently taking cimetidine or spironolactone
- Clinically significant abnormal findings on screening examination or any condition
which in the opinion of the investigator would interfere with the participant's
ability to comply with the study instructions or endanger the participant if she took
part in the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Determination of the Lowest, Safe and Effective Dose of Proellex | NCT01187043 | Entailment |
1,493 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Known or suspected esophageal or gastroesophageal junction malignancy
- Known Barrett's metaplasia
- Clinical management of symptomatic gastroesophageal reflux disease (GERD)
- Achalasia
- Hiatal hernia
Exclusion Criteria:
- Elevated pre-operative bloodwork will not have the additional biopsies taken.
- Platelet count less than 150,000, partial thromboplastin time (PTT) of 50 or above,
and/or International Normalized Ratio (INR) of 1.8 or above will not have the
additional biopsies taken.
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.
| Esophageal Cancer Risk Registry | NCT00260585 | Entailment |
3,094 | 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:
- Places in the first 3 categories of the MacCAT flip chart
- Can provide informed consent using a standard practice
Exclusion Criteria:
- Not in the first 3 categories of the MacCAT flipchart
- Not able to provide informed consent without significant modifications to consent
procedures
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 40 Years | Decisional Capacity and Informed Consent in Fragile X Syndrome | NCT02465931 | Entailment |
24 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.
3. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from the time of signing
of informed consent throughout the duration of the study and for 12 weeks after the
last dose.
Exclusion Criteria:
1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality
that may impact the ability of the participant to participate or potentially confound
the study results. Participants will be excluded based on:
1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.
2. Is receiving dialysis treatment.
3. Has an American Urological Association (AUA)/ International Prostate Symptom
Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram
per milliliter (ng/mL) at Screening.
4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units
per liter (mIU/L) at Screening.
5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood
pressure >100 mm Hg (if out of range may be repeated once for eligibility
determination) at Screening.
6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.
7. Is receiving insulin therapy.
8. Has a hematocrit <30 percent (%) or >48% at Screening.
9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).
2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated
hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular
disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome,
systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or
prior pituitary surgery.
4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists,
antiandrogens, clomiphene, or other reproductive hormone-related agents within 6
months prior to Screening.
5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA],
androstendione, any other androgen, or recombinant human growth hormone) within 1 year
of Screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| A Randomized, Single-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Stimulatory Effects of TAK-448, a Kisspeptin Analog, Administered Intermittently in Middle-aged and Older Men With Low Testosterone | NCT02381288 | Contradiction |
4,653 | 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:
- Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure
symptoms)
Exclusion Criteria:
- Genital malignancy
- Uterine size more than 16 weeks
- Coagulation defects or concurrent anticoagulant therapy
- Pregnancy
- Compromised cardiopulmonary status
- Contraindications for general anesthesia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy | NCT02998658 | Entailment |
4,034 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Patients with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP
tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:
- Grade 0: no radiographic features of OA are present
- Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
- Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing
radiograph
- Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
- Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony
deformity
2. Patients who are between the ages of 18 - 85 years
3. Patient has signed informed consent
4. Patient has access to a smartphone or tablet (Android or iOS)
5. Subject must be ambulatory.
6. Subject must be willing to stop taking any pain medications 24 hours prior any
scheduled study visit.
7. Subjects must be proficient in English.
8. Subject must be willing and able to sign an informed consent document.
9. Subjects must be willing and able to comply with all study procedures for the duration
of the clinical study.
Exclusion Criteria:
1. Subjects who have a body mass index > 40 at the time of consent. Exclusion of a
patient with BMI>40 is up to the discretion of the PI.
2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint
infection, Lyme disease, SLE, etc.).
3. Subjects who have had an injury or an acute traumatic injury to the index knee within
6 months of screening will be excluded.
4. Subject must NOT have had arthroscopy within 8 weeks of randomization.
5. Subjects who have had treatment of the target knee with intra-articular injections of
steroids within 8 weeks of screening.
6. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of
screening.
7. Subjects who have had a scheduled surgery on the target knee within the study period.
(Note- Patients who are scheduled to go under surgery within the next 6 months will be
excluded. Patients that are contemplating the surgery can be included.)
8. Subjects who have used electrotherapy or acupuncture for OA of the target knee within
4 weeks of screening
9. Subjects with significant and clinically evident mal-alignment of the target knee (>
10 degrees varus or valgus in the target knee).
10. Subjects with surgical metallic hardware in the target knee.
11. Subjects who have contraindications to MRI and X-rays, for example, implanted
electrical devices (cardiac pacemakers, deep brain stimulators).
12. Subjects with a current malignancy or who have received treatment for malignancy with
the last 5 years, with the exception of resected basal cell carcinoma and squamous
cell carcinoma of the skin.
13. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of
chronic substance abuse (> 5 years).
14. Subjects with skin breakdown or infection in the area where the study device will be
placed.
15. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart
failure, etc.) that have not been well-controlled for at least 3 months prior to
screening.
16. Subjects who have any ongoing litigation for worker's compensation.
17. Subjects with any condition, in the opinion of the Investigator that might interfere
with the evaluation of the study objectives.
18. Subjects who are pregnant.
19. Subject must not have participated in a clinical study within the past 12 weeks that
required the use of an investigational device, drug or biologic
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients | NCT03980964 | Entailment |
5,759 | 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:
1. Patients with Oral Lichen Planus, who are willing to participate in the study.
2. Patients who are physically healthy and well oriented in time, space and as a person.
3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus.
4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.
Exclusion Criteria:
1. Patients with Oral Lichen Planus, who are not willing to participate in the study.
2. Patients with any other mucosal disease or any other skin disease which may be
associated with oral lesions.
3. Patients with a known allergy or contraindication to study medications.
4. Patients with known history of systemic diseases, where steroids are contraindicated.
5. Pregnant women.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus | NCT03026478 | Contradiction |
1,190 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study v1.0 | NCT02524470 | Entailment |
5,933 | 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:
- Adults between 20 and 75 years old based on the date of written agreement
- Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA
Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid regurgitation within the last 7
days
Exclusion Criteria:
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory,
endocrine, hematologic, cardiovascular, urinary system disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3) | NCT03736369 | Contradiction |
115 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Men aged 18 to 65 years.
2. Have a diagnosis of primary or secondary hypogonadism with a:
- Single morning serum total testosterone concentration <250 ng/dL or
- Two (2) consecutive morning serum total testosterone concentrations <300 ng/dL
(determined at least 1 week apart during a 3 week screening period) Total serum
testosterone sampling must occur between 7 AM and 11 AM at screening
3. Have a body mass index (BMI) ≥22 kg/m2 and ≤35 kg/m2.
4. Have a hematocrit level ≤50% at screening
5. Use of reliable contraception for subjects who have sexual partners of childbearing
potential (women not of childbearing potential are defined as postmenopausal, ie,
amenorrhea ≥1 year or permanently sterile). Reliable methods of contraception are:
- Barrier type devices (eg, condom, female condom, diaphragm, contraceptive sponge)
only in combination with a spermicide.
- Intra-uterine devices.
- Oral, injectable, transdermal or implantable hormonal contraceptives.
6. Is able to understand and give written informed consent
Exclusion Criteria:
1. Severe concomitant illness, which in the opinion of the Investigator, may put the
subject at risk when participating in the trial or may influence the results of the
trial or affect the subjects' ability to take part in the trial.
2. Acute or chronic renal impairment [(Cr ≥ 1.5x ULN (upper limit of normal)].
3. Acute or chronic hepatic impairment will be excluded.
4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 × ULN
(upper limit of normal).
5. Clinically significant, abnormal, baseline laboratory result(s), which in the opinion
of the Investigator affect(s) the subject's suitability for the trial.
6. History of, or any existing, clinically significant cardiac disease (New York Heart
Association [NYHA] Class III and IV).
7. Clinically significant electrocardiogram (ECG) abnormalities such as QTcB or QTcF ≥450
msec; or QTc ≥480 msec in subjects with bundle branch block.
8. Prostate specific antigen (PSA) level >4 ng/mL.
9. An abnormality on digital rectal examination deemed to be suspicious or worrisome for
cancer, such as a nodule or asymmetric induration.
10. Severe symptomatic benign prostatic hyperplasia or International Prostate Symptom
Score (IPSS) >19 (at screening).
11. Sleep apnea which is untreated, or subjects with sleep apnea which is treated
(including c-PAP treatment) but in the opinion of the investigator has been clinically
unstable during the 3 months prior to screening.
12. Current eczema, psoriasis, sunburn, or any other clinically significant skin condition
at the application site.
13. Current abrasions at site of application.
14. Malignancy (or suspected malignancy) of any type except a basal cell carcinoma.
Subjects with a history of malignancy must have a disease free status ≥5 years prior
to starting study treatment. Subjects who have had prostate or breast cancer are not
permitted to participate in the study.
15. Known to be sensitive and/or has had an adverse skin reaction to testosterone hormone
replacement therapy or topical products containing alcohol.
16. Actively or potentially trying to start a family or requiring fertility treatment or
with a spouse/partner who is pregnant.
17. Participated in any experimental drug or device study within 30 days prior to starting
study treatment.
18. History of alcohol or substance abuse within the last year.
19. Taking opioids for any reason within 3 days of screening
20. Receiving the following medications:
- Androgen treatments.
- Androgen antagonists.
- Application of any lotions, ointments, or steroids to the application site.
- 5alpha-reductase inhibitors (eg, finasteride, dutasteride).
21. Any subjects receiving testosterone hormone replacement treatments must abide by the
indicated washout period prior to screening total serum testosterone measurement
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Time to Eugonadal Range, Time to Steady State and Drying Time | NCT01228071 | Contradiction |
866 | 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:
- Age greater than 30 years and less than 80 years
- Knee pain for at least 6 weeks
- Pain rate greater than or equal to 4/10 on a visual analog scale
- Morning stiffness less than 30 minutes
- Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the
knee
- Willing and able to consider all medical treatment options used to manage
osteoarthritis of the knee
- No contraindications to knee radiographs or MRI
- Willing to participate in a registry
- Able to understand and sign a consent
- Able to answer registry questions independently
Exclusion Criteria:
- Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE,
systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme
arthritis, reactive arthritis, viral arthritis
- pregnant or nursing
- unable to give informed consent
- contraindication to MRI such as indwelling paemaker or cochlear implant
- requirement of metal equipment (such as oxygen)
- known claustrophobia
- gadolinium allergy
- lack of fluency in English. Unfortunately, we do not have the financial resources to
offer full translation services
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | The Knee Usual Care Evaluation Study | NCT01905358 | Entailment |
3,887 | 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:
- Primary osteoarthritis of the knee, verified radiographically
- Moderate flare of pain in the knee after washout of stable therapy
- If female, non-pregnant
- Ability to swallow moderately-sized tablets
Exclusion Criteria:
- Secondary osteoarthritis of the knee
- Major knee surgery at any time, or minor knee surgery in previous year
- Severe uncontrolled heart, liver or kidney disease
- Ulcer or bleeding from the stomach
- Corticosteroid use
- Fibromyalgia
- Skin disorder of the knee
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis | NCT00108992 | Entailment |
3,058 | 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:
- Adult and adolescent patients, 14-50 years of age
- Diagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1)
full mutation and qualifying scores on the Aberrant Behavior Checklist (ABC) and CGI-S
- Patients must agree to either remain completely abstinent or to use two effective
contraceptive methods during and 3 weeks after the study
Exclusion Criteria:
- Previous treatment with another metabotropic glutamate (mGLU) receptor antagonist
within 18 months or with RO4917523
- Participation in a clinical trial involving an investigational (unapproved) drug
within 3 months or 5 times the half-life (whichever is longer) before start of this
study
- Any uncontrolled, unstable clinically significant psychiatric condition other than
fragile X syndrome
- History of suicidal behavior
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 50 Years | A Study of RO4917523 in Patients With Fragile X Syndrome | NCT01517698 | Entailment |
329 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study | NCT02521922 | Contradiction |
3,907 | 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:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
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 | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Entailment |
1,155 | 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 with recurrent pleural effusion of unknown origin after a first pleural tap
according to BTS guidelines.
2. Indication for thoracoscopy according to BTS guidelines.
3. Patients accept further investigation according to Danish and BTS guidelines.
4. Have received oral and written consent and agreed.
5. At the time of inclusion, above 18 years of age.
Exclusion Criteria:
1. Female patients: pregnancy or breastfeeding.
2. Lack of language comprehension.
3. Legally incompetent patients.
4. Life expectancy less than 3 month.
5. Contraindications to pleural tissue sampling.
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.
| Rational Approach to a Unilateral Pleural Effusion | NCT03272087 | Contradiction |
3,925 | 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. Grade 1 or Grade 2 Osteoarthritis knee as per Ahlbacks radiographic staging
2. Patients willing to give consent
Exclusion Criteria:
1. Osteoarthritis secondary to joint inflammatory diseases (eg- rheumatoid arthritis,
ankylosing spondylitis etc)
2. Patients with other diseases, affecting the knee joint like crystal arthropathy,
symptomatic chondrocalcinosis, acute synovitis, excessive joint effusion(>100ml),
cystic disease around the knee joint(eg-popliteal cyst)
3. Advanced stage of osteoarthritis
4. Bone marrow suppression
5. Co morbidities like pregnancy, cancer, immunosuppression,
6. Osteoarthritis secondary to trauma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee | NCT01985633 | Entailment |
5,165 | 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:
- Patient is an ambulatory female 45 years of age or older
- Postmenopausal women with diagnosis of osteoporosis
- Prescription of zoledronic acid or any OBP as per the current Canadian monograph
- Must provide informed consent
Exclusion Criteria:
- Any prior use of iv bisphosphonates within the last 2 years
- Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or
premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)
- Metabolic bone diseases such as primary or secondary hyperparathyroidism,
hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..
- Non-corrected hypocalcaemia at the time of zoledronic acid infusion
- Creatinine clearance < or = 30 ml/min
- Unwillingness or inability to comply with the study requirements
- Concurrent participation in a clinical trial of an investigational drug, or within the
last 30 days
Other protocol-defined inclusion/exclusion criteria may apply.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Intra-venous Zoledronic Acid Once Yearly | NCT00984893 | Contradiction |
2,257 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Subject is male ≥ 10 years and ≤ 17 years of age at the time of study drug
administration.
2. Subject has clinical diagnosis compatible with Duchenne's Muscular Dystrophy (DMD) and
evidence of mutational and dystrophin defects from muscle biopsy consistent with DMD
(out-of frame deletions, absent dystrophin).Eligible deletions are those that can be
rescued by the skipping of exon 51 [45-50; 47-50; 48-50; 49-50; 50; 52; 52-63].
3. Subject has had a muscle biopsy analysed, showing <5% revertant fibres present. Biopsy
may be collected at the time of DMD diagnosis or as part of protocol screening
procedures.
4. Subject is unable to ambulate or stand independently.
5. Subject has Stage 1 to 3 EDB muscle preservation determined by MRI.
6. Subject has a forced vital capacity ≥ 25% confirmed within 3 months from Day One.
7. Subject has mean oxygen saturation monitoring > 94% in overnight domiciliary overnight
sleep study within 3 months of Day One.
8. Subject has the ability to comply with all study evaluations and return for all study.
9. Subject and parent have psychiatric adjustments, adequately supportive psychosocial
circumstances and a full understanding of study aims process and likely outcomes.
Exclusion Criteria:
1. Subject has had external digitorum brevis (EDB) muscle removed.
2. Subject has Stage 4 EDB muscle preservation determined by MRI.
3. Subject has a left ventricular shortening fraction of < 25% and/or an ejection
fraction of < 35% by echocardiography at visit one or within three months of visit
one.
4. Subject has evidence of nocturnal hypoventilation (mean oxygen saturation at night of
≤ 94%) confirmed via overnight sleep study at Visit One (as screening procedure) or
within 3 months of Visit One by overnight sleep study.
5. Subject has severe respiratory insufficiency defined by the need for invasive or
non-invasive mechanical ventilation (does not include nocturnal ventilatory support).
6. Subject has severe cognitive dysfunction rendering them unable to understand and
collaborate with study protocol.
7. Subject has immune deficiency or autoimmune disease.
8. Subject has a known bleeding disorder or has received chronic anticoagulant treatment
within three months of study entry.
9. Subject has received pharmacologic treatment, apart from corticosteroids, that might
affect muscle strength or function within 8 weeks of study entry (viz.,anabolic
steroids, creatine protein supplementation, albuterol or other beta agonists).
10. Subject has had surgery within 3 months of study entry or planned for anytime during
study.
11. Subject has active significant illness at time of study entry.
12. Subject has is unable to undergo MRI testing (viz., has metal implants).
13. Subject or parent has active psychiatric disorder, has adverse psychosocial
circumstances, recent significant emotional loss, history of depressive or anxiety
disorders that might interfere with protocol completion or compliance.
14. Subject has any known allergies to products likely to be used in the study
(viz.,antiseptics, anaesthetics).
15. Subject has used any experimental treatments or has participated in any clinical trial
within 4 weeks of study entry.
16. Subject has used intranasal, inhaled or topical steroids for a condition other than
muscular dystrophy within 1 weeks of study entry.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 17 Years | Safety and Efficacy Study of Antisense Oligonucleotides in Duchenne Muscular Dystrophy | NCT00159250 | Contradiction |
3,387 | 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:
- bilaterally intact tympanic membranes
- flyer or diver with middle-ear symptoms
- flyer or diver without middle-ear symptoms (controls)
- generally good health
- no recent history of non-activity related otitis media
Exclusion Criteria:
- existing middle-ear disease
- allergic rhinitis symptoms or "cold" on day of testing
- syndrome predisposing to otitis media
- history of ossicular reconstruction
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 50 Years | Gas Supply, Demand and Middle Ear Gas Balance -- Fly/Dive Simulation | NCT01976429 | Contradiction |
1,252 | 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 with a symptomatic MPE*
2. Predicted survival of more than 6 months
3. Eastern Cooperative Oncology Group (ECOG) score = Peformance status defined as a
patient's level of functioning in terms of their ability to care for themselves, daily
activity, and physical ability (walking, working, etc. ECOG 0-1 (or ECOG greater than
or equal to 2 if it is felt that removal of pleural fluid would improve their status
to 0 or 1).
- MPE is defined as histologically/cytologically proven pleural malignancy or an
otherwise unexplained pleural effusion in the context of clinically proven cancer
elsewhere.
Exclusion Criteria:
1. Age <18yrs;
2. Unfit to undergo a surgical procedure (American Society of Anaesthesiologists Score
>/=4); 3. Pleural infection;
4. Chylothorax; 5. Pregnancy or lactation; 6. Uncorrectable bleeding diathesis; 7. Previous
ipsilateral lobectomy/pneumonectomy; 8. Inability to consent or comply with 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.
| AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion | NCT04322136 | Entailment |
2,819 | 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. Age 18-85
2. Male or Female
3. Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial
criteria
4. ALSFRS-R > 25
5. Must be willing to undergo longitudinal blood draws for biomarker analysis
6. Must have a caregiver
7. Availability and willingness to complete the study
8. Capable of providing informed consent and complying with trial procedures
9. If patients are taking riluzole and/or Radicava, they must be a on a stable dose for
at least thirty days prior to the baseline.
Exclusion Criteria:
1. Patients with FVC ≤ 60%
2. History of liver disease
3. Severe renal failure
4. History of intolerance to memantine
5. Onset of weakness for greater than 3 years
6. Any other co-morbid condition which would make completion of the trial unlikely
7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to
use birth control.
8. Taking any trial medications. Non-trial medications are not cause for exclusion.
9. Unwillingness to provide consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Therapy in Amyotrophic Lateral Sclerosis (TAME) | NCT02118727 | Entailment |
3,790 | 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. | Key Inclusion Criteria:
- Male or female 35 to 85 years of age (inclusive).
- Diagnosis of moderate to severe pain in the index knee due to OA.
- Pain in the non-index knee is less than pain in the index knee.
- Body mass index ≤40 kg/m².
- Experienced treatment failure with at least 2 prior categories of therapies.
- Able to understand and complete study-related forms and communicate with the
Investigator and/or site staff.
Key Exclusion Criteria:
- Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited
bleeding disorders or thrombocytopenia.
- History of or current condition of poorly controlled hypertension, QTc prolongation,
history of risk factors for Torsades de Pointes, or family history of long QT
syndrome; or is using concomitant medications that prolong the QT interval.
- Received index knee injections with corticosteroids within 30 days, or hyaluronic acid
within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
- Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone
OA, or knee pain attributable to disease other than OA.
- Instability or misalignment in the index knee.
- Concurrent use of opioids or indications other than knee pain.
- History within the past 2 years of substance abuse, including alcohol.
- Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin,
acetaminophen, tramadol, or radiographic contrast agents.
- Female participants who are pregnant, planning on becoming pregnant, or currently
breastfeeding.
- Any medical condition or comorbidities that, in the Investigator's opinion, could
adversely impact study participation or safety, conduct of the study, or interfere
with pain assessments.
- Sensory peripheral neuropathy that is of moderate severity or higher.
- Arterial or venous thrombi (including stroke), myocardial infarction, hospital
admission for unstable angina, cardiac angioplasty, or stenting within the past 12
months.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related
illness, acute or history of chronic hepatitis B or hepatitis C. Participants with
these viral infections who are receiving or have received antiviral treatment and have
a viral load that is undetectable are eligible.
- Concurrent medical or arthritic conditions that could interfere with the evaluation of
the index knee joint including chondromalacia patellae, metabolic diseases,
gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or
other inflammatory arthropathies affecting the knee joint.
- Undergone arthroscopic surgery of the index knee within 6 months of the injection day,
or open surgery to the index knee within 24 months of the injection day.
- Undergone replacement surgery of the index knee.
- Presence of surgical hardware or other foreign bodies in the index knee.
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 | A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee | NCT04044742 | Entailment |
1,241 | 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. Age greater than 18 years old
2. Pleural effusion (etiology fulfilling one of the following criteria):
- Malignant effusion confirmed by cytology or pleural biopsy
- Exudative effusion in the setting of known malignancy with no other identifiable
cause
- Malignant effusion due to tumors that are historically rapidly responsive to
systemic therapy (small cell lung cancer, hematological malignancies) will only
be included if refractory to standard chemotherapy
3. Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
4. Age greater than 18 years old
5. Pleural effusion (etiology fulfilling one of the following criteria):
- Demonstration of symptomatic improvement after therapeutic thoracentesis (removal
of ≤ 1.5 L of pleural fluid)
- Recurrent pleural effusion after therapeutic thoracentesis
Exclusion Criteria:
1. Projected life expectancy less than 30 days as predicted by Karnofsky Performance
Status score less than 30
2. Radiographic evidence of trapped lung - persistent lung collapse with failure of the
lung to reexpand following drainage of a pleural effusion
3. Radiographic evidence of loculated pleural fluid
4. Previous attempted pleurodesis on the affected side
5. Previous lobectomy or pneumonectomy on the affected side
6. Patient receiving intrapleural chemotherapy
7. Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on
lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
8. Parapneumonic effusion - pleural effusion associated with pneumonia
9. Empyema - infected pleural space as defined by purulent pleural fluid, positive gram
stain, or positive culture
10. Inability to adequately perform pleural drainage at home
11. Uncorrectable bleeding disorder
12. Skin infection at the site of intended catheter insertion
13. Pregnancy
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.
| Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter | NCT00978939 | Entailment |
5,138 | 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:
- presenting or not a history of chronic nonspecific back pain
Exclusion Criteria:
- History of back trauma or surgery
- Severe osteoarthritis
- Inflammatory arthritis
- Vascular conditions
- Contraindication to the use of spinal manipulation or spinal mobilization
- Pregnancy
- Scoliosis
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 | Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain | NCT02660801 | Contradiction |
5,456 | 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:
- Males and females 18 years of age and older
- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
normal VWF multimers
- A past bleeding history
- Responsive to DDAVP
- Scheduled elective major surgery or major dental surgery at MUH or PUH
- Willingness to have blood drawn
Exclusion Criteria:
- Presence of other bleeding disorders, acquired Von Willebrand disease, primary
thrombocytopenia
- Use of immunomodulatory or experimental drugs, or diuretics
- Pregnant or lactating women or those unwilling to use contraception during study
- Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
atrial flutter), hypertension, MI, stroke, or thrombosis
- Past allergic reaction to Neumega or DDAVP
- Surgery within the past 8 weeks
- Inability to comply with study protocol requirements
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing substantial quantities of FVIII and/or VWF within five days of study
- Past allergic reaction to Neumega or DDAVP
- Surgery within the past 8 weeks
- Inability to comply with study protocol requirements
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing substantial quantities of FVIII and/or VWF within five days of 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.
| IL-11 in Adults With Von Willebrand Disease Undergoing Surgery | NCT00524225 | Entailment |
5,445 | 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:
A. Normal Healthy Volunteers:
1. Normal healthy volunteers
2. 18 years of age or older
3. Either sex
4. Any ethnic background.
B. Patients with Glanzmann thrombasthenia or their relatives, inherited qualitative and/or
quantitative platelet disorders, inherited disorders of white blood cells, inherited
disorders of coagulation (including von Willebrand disease):
1. Adults and children
2. Either sex
3. Any ethnic background
Exclusion Criteria:
A. Normal Healthy Volunteers:
1. For studies of platelets that may be affected by anti-platelet therapy, ingestion of
aspirin or similar medication in the past week.
2. Having given blood in the last 8 weeks such that the current donation would exceed a
total of 250 ml for the 8 week period.
3. Having given blood in the past week such that this donation would result in more than
2 donations in one week.
B. Patients with Glanzmann thrombasthenia or their relatives, inherited qualitative and/or
quantitative platelet disorders, inherited disorders of white blood cells, inherited
disorders of coagulation (including von Willebrand disease).
1. For studies of platelets that may be affected by antiplatelet therapy, ingestion of
aspirin or similar medication in the past week
2. If the patient is known to have a hematocrit ≥25 (assay performed in past 3 months),
the same blood drawing criteria as in A, with the addition that for children less than
18 years of age, the maximum amount of blood allowed to be donated in an 8 week period
is the lesser of 50 ml or 3 ml/kg.
3. If the patient has a hematocrit <25 or if the hematocrit is unknown, the blood drawing
limit is the lesser of 20 ml or 1 ml/kg in any 8 week period.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| The Genetics and Functional Basis of Inherited Platelet, White Blood Cell, Red Blood Cell, and Blood Clotting Disorders. | NCT00230165 | Entailment |
171 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Adult Male over 19 years old and under 65 years old at screening.
2. Serum total testosterone level under 3.0 ng/mL at screening.
3. Subjects who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5 kg/m2 and a total body
weight ≥ 55 kg.
- Body Mass Index(BMI) = Weight(kg) / [Height(m)]2
4. Subjects without congenital/chronic diseases and without abnormal symptoms or
diagnosis based on a medical examination within the last 3 years, except for
hypogonadism.
5. Subjects who were deemed to be appropriate as study subjects in accordance with the
screening results (laboratory tests, vital signs, ECG etc.).
6. Subjects who voluntarily signed an informed consent form approved by the Institutional
Review Board(IRB) of each clinical study site and decided to participate in the study
after being fully informed of the study prior to participation, including the
objective, content of the clinical trial.
7. Subjects who consent to the use of reliable contraception during the clinical trial.
Subjects who have no plan of pregnancy and agree to not donate his sperm during the
study period and up until 180 days after the last administration of investigational
product.
8. Subjects with the ability and willingness to participate during the study period.
Exclusion Criteria:
1. Subjects with a medical evidence or a history (excluding a hypogonadism, dental
history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically
significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary,
cardiovascular, hepatic, psychiatric, neurologic or immune disease.
1-1. Subjects with a severe acute/chronic physical and mental conditions that can
increase risk or interfere with the interpretation of the results of test.
1-2. Subjects who have a androgen-dependent tumor(e.g., prostate cancer, male breast
cancer).
1-3. Subjects with hypercalcemia associated with malignant tumors.
1-4. Subjects with or with a history of liver tumors.
1-5. Subjects with bone metastasis of cancer.
1-6. Subjects being treated for an enlarged prostate.
1-7. Subjects who have severe alcohol and/or drug abuse history within a year from
screening.
1-8. Insulin-dependent diabetes mellitus or uncontrolled non-insulin- dependent
diabetes mellitus.
2. Subjects with the following laboratory test results at screening:
2-1. AST, ALT exceeding 2.5 times from the upper limit of normal.
2-2. Total bilirubin exceeding 2.5 times from the upper limit of normal.
2-3. Subjects had renal impairment(eGFR < 60 mL/min/1.73 m2)
2-4. Positive results of virus/bacterial test and/or urine drug test at screening.
2-5. Systolic blood pressure >150 mmHg or <90 mmHg and/or diastolic blood pressure >60
mmHg or >95 mmHg at sitting position.
3. History of regular alcohol consumption exceeding 210 g/week within 6 months prior to
screening (1 drink (250 mL) of beer (5%) = 10 g, 1 drink (50 mL) of hard liquor (20%)
= 8 g; 1 drink (125 mL of wine (12%) = 12 g).
4. Subjects who smoked more than 20 cigarettes per day within 6 months prior to
screening.
5. Subjects who had been administered investigational product(s) from other clinical
study or bioequivalence study within 180 days prior to the first dose of this
study(except when subject have not taken investigational product(s)).
6. Subjects who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of
drug-metabolizing enzymes within 30 days prior to the first dose of investigational
product(s).
7. Subjects who had taken any contraindication drug(s)(Drug influencing the level of
serum testosterone, modulating activity of testosterone and which have drug
interaction) within 28 days prior to the first dose of investigational product(s).
8. Subjects who use of oral anticoagulants (with the exception of low-dose aspirin)
within 28 days prior to the first dose of investigational product(s).
9. Subjects who use the testosterone pellet within 90 days prior to the first dose of
investigational product(s).
10. Subjects who use of any injectable testosterone preparations within 28 days prior to
the first dose of investigational product(s).
11. Subjects who use oral testosterone products within 7 days prior to the first dose of
investigational product(s).
12. Subjects who use of supplements (e.g., saw palmetto, phytoestrogen, androstenedione,
DHEA, niacin, fish oil etc.) prior to the first dose of investigational product(s).
13. Subjects who have hypersensitivity of investigational products and its components.
14. Subjects who donated whole blood within 60 days or blood components within 30 days
prior to the first dose of the investigational product(s).
15. Subjects who were deemed inappropriate to participate in the study by the
investigator.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 65 Years | A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-845 | NCT04673682 | Entailment |
5,934 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients who are offered anti-reflux surgical treatment with elevated DeMeester scores
or with low (less than 14.7) DeMeester scores, but with positive impedance scores
(positive symptom index associated with reflux episodes).
Exclusion Criteria:
- • Previous major upper gastrointestinal surgery (includes esophagus, stomach, and
duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major
upper GI surgery
- Presence of paraesophageal hernia (type II - type IV)
- Presence of large hiatal hernia >5cm
- Presence of peptic strictures
- History of severe esophageal motility disorders such as:
- achalasia
- diffuse esophageal spasms
- scleroderma
- poorly-controlled diabetes mellitus
- autonomic or peripheral neuropathy
- myopathy
- Pregnancy (As a standard operating procedure, women of child-bearing age will
undergo a urine pregnancy test the morning of surgery because anti-reflux surgery
is considered an elective case, where pregnancy is a relative contraindication.)
- BMI greater than 40
- Undergoes Collis gastroplasty during surgery
- Conversion to an open procedure
- Age less than 18 years old
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
| Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery | NCT01241149 | Contradiction |
1,298 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to
theoretically reach the adult height within the study period
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin | NCT01435629 | Contradiction |
3,243 | 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:
- A diagnosed (by the European League Against Rheumatism guidelines) primary or
secondary Syndrome of Sjögren
- Age: > 18 years and < 70 years
- A remaining salivary flow
Exclusion Criteria:
- A complete lack of measurable salivary flow, also after stimulation of the glands by
taste or chewing
- Acute sialadenitis
- Use of sialogogue medication (i.e. pilocarpine or cevimeline)
- Other severe illnesses or physical conditions that make a treatment under general
anesthesia impossible or highly riskful.
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 | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome | NCT02112019 | Entailment |
2,519 | 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:
- New clinical diagnosis of atopic dermatitis
- New patient to Columbia University Medical Center, Department of Dermatology
- Caregiver has mobile that can send/receive text messages
Exclusion Criteria:
- Age over 7 years
- Caregiver is not fluent English speaker
- Those patients in which a definitive diagnosis of atopic dermatitis cannot be made
- Any individual who declines participation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 6 Years | Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores | NCT02779426 | Entailment |
Subsets and Splits