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3,745 | 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:
- all new patient present to AHNH clinic referred for osteoarthritis for considering
joint replacement
- Present with knee pain (unilateral or bilateral) contributed by osteoarthritis
Exclusion Criteria:
- mentally unsound
- dialectic speaker that difficult to communicate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Psychological Strengths and Burden Among Osteoarthritis Patient | NCT03899272 | Contradiction |
6,321 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Adults, aged 40 - 90 years (inclusive)
2. Acute onset (within 96 hours of the Baseline visit) of two or more COVID-19 symptoms
self-rated as moderate-to-severe, including fever, myalgia, fatigue, chest tightness,
chills, cough, diarrhea, gastrointestinal distress, headache, sore throat, congestion,
or runny nose, ageusia, anosmia, nausea, tingling or numbness in the extremities, or
shortness of breath.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by positive PCR in a sample
collected ≤ 96 hours prior to the Baseline visit.
4. PGI-Severity and CGI-Severity assessments of 'Mild', 'Moderate, or 'Severe' at the
Screening visit (e.g., cannot be 'Normal').
5. Participant (or legally authorized representatives) provides informed consent prior to
the initiation of any study procedures.
6. Participant is willing and able to follow all study procedures and assessments
according to the study protocol.
7. Participant is able to consume 60 ml of fluid orally twice daily.
8. Women of childbearing potential must agree to either abstinence or use at least one
primary form of contraception, not including hormonal contraception from the time of
screening through the end of study.
Exclusion Criteria:
1. Unable or unwilling to take ZnAg liquid solution or matching placebo as directed.
2. Hospitalized prior to Baseline for COVID-19 management.
3. Need for hospitalization and/or ventilatory support at Baseline.
4. The emergence of any disease during study, other than COVID-19 that could better
explain the participants' signs and symptoms.
5. Severe disease: respiratory distress, or requiring supplemental oxygen, or SpO2 ≤ 93%
on room air, or tachypnea (respiratory rate ≥ 30 breaths/min) at Baseline.
6. History or presence of serious or acute heart disease such as uncontrolled cardiac
dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or
uncontrolled congestive heart failure (NYHA class 3 or 4).
7. Legal incapacity or limited legal capacity.
8. Women of childbearing potential who do not agree to use either abstinence or at least
one primary form of contraception, not including hormonal contraception from the time
of screening through the end of the study.
9. Pregnant or breastfeeding.
10. Participation in another clinical study with an investigational product within the
prior 12 months (per Resolution 251/1997).
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 90 Years | Study of ZnAg Liquid Solution to Treat COVID-19 Symptomatic Participants | NCT04610138 | Entailment |
4,149 | 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:
- idiopathic oligozoospermia (spermatozoid number <2x10^6/mL) - 10 patients
- cryptozoospermia/azoospermia - 10 patients
Exclusion Criteria:
- age before 18 or after 60 years old
- heart insufficiency. stroke (during 1 year)
- anemia
- blood disease
- pelvis bone trauma
- chronic diseases in decompensation stage
- skin diseases
- tuberculosis
- hyperprolactinaemia
- hyper or hypothyreosis
- obstructive zoospermia
- sperm stimulating hormone therapy
- Men with previous surgery in testis
- Men with infectious genital diseases and anatomical abnormalities of the genital tract
- Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV
- Chromosomal aberration (e.g. Y microdeletion, trisomy….)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility | NCT03762967 | Contradiction |
2,330 | 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. Are an ambulant male aged ≥6 years at randomisation with DMD characteristic clinical
symptoms or signs (e.g., proximal muscle weakness, Gowers' maneuver, elevated serum
creatinine kinase level) already present at screening;
2. Have DMD diagnosis confirmed by genetic testing;
3. Are able to give informed assent and/or consent in writing signed by the subject
and/or parent/legal guardian (according to local regulations);
4. Are able to complete 2 Four Stairs Climb test (4SC) screening assessments; the results
of these tests must be within ±1 second of each other;
5. Have the mean of 2 screening 4SC assessments ≤8 seconds;
6. Have time to rise from floor between ≥3 and <10 seconds at screening
7. Have manual muscle testing (MMT) of quadriceps at screening Grade ≥- 3;
8. Have used systemic corticosteroids for a minimum of 6 months immediately prior to the
start of study treatment, with no significant change in corticosteroids type or dosage
or dosing regimen (excluding changes related to body weight change) for a minimum of 6
months immediately prior to start of study treatment and a reasonable expectation that
dosage and dosing regimen will not change significantly for the duration of the study.
9. Subjects must be willing to use adequate contraception.
Exclusion Criteria:
1. Have exposure to another investigational drug within 3 months prior to the start of
study treatment;
2. Have exposure to idebenone within 3 months prior to the start of study treatment;
3. Have exposure to any dystrophin restoration product (e.g., Ataluren, Exon skipping)
within 6 months prior to the start of study treatment;
4. Use of any pharmacologic treatment, other than corticosteroids, that might have had an
effect on muscle strength or function within 3 months prior to the start of study
treatment (e.g., growth hormone); Vitamin D, calcium, and any other supplements will
be allowed as long as their intake has been stable for 3 months prior to the start of
study treatment; Testosterone will also be allowed if it is used as a replacement
therapy for the treatment of delayed puberty, and testosterone dose and regimen have
been stable for at least 6 months and circulating testosterone levels are within the
normal ranges for the subject's age;
5. Have surgery that might have an effect on muscle strength or function within 3 months
before study entry or planned surgery at any time during the study;
6. Loss of ≥30 degrees of plantar flexion from the normal range of movement at the ankle
joint due to contracture (i.e. fixed loss of more than 10 degrees of plantar flexion
from plantigrade, assuming normal range of dorsiflexion of 20 degrees;
7. Change in contracture treatment such as serial casting, contracture control devices,
night splints, stretching exercises (passive, active, self) within 3 months prior to
enrollment, or expected need for such intervention during the study;
8. Have presence of other clinically significant disease, which, in the Investigator's
opinion, could adversely affect the safety of the subject, making it unlikely that the
course of treatment or follow-up would be completed, or could impair the assessment of
study results;
9. Have a diagnosis of other uncontrolled neurological diseases or presence of relevant
uncontrolled somatic disorders that are not related to DMD;
10. Have platelets count at screening < Lower Limit of Normal (LLN);
11. Have symptomatic cardiomyopathy or heart failure (New York Heart Association Class III
or IV) or left ventricular ejection fraction <50% at screening;
12. Have a current or history of liver disease or impairment;
13. Have inadequate renal function, as defined by serum Cystatin C >2 x the upper limit of
normal (ULN);
14. Have Triglycerides > 300 mg/dL (3.42 mmol/L) in fasting condition at screening visit;
15. Have a baseline QTcF >450 msec, or history of additional risk factors for torsades de
pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome);
16. Have a psychiatric illness/social situations rendering the potential subject unable to
understand and comply with the muscle function tests and/or with the study protocol
procedures;
17. Have any known allergic reaction to givinostat or any of its excipients.
18. Have any hypersensitivity to the components of study medication;
19. Have a sorbitol intolerance or sorbitol malabsorption, or have the hereditary form of
fructose intolerance.
20. Have contraindications to MRI or MRS (e.g., claustrophobia, metal implants, or seizure
disorder).
At the discretion of the Investigator, subjects not meeting inclusion/exclusion criteria
may be re-screened twice with an interval of at least 3 months between assessments.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 17 Years | Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy | NCT02851797 | Entailment |
6,457 | 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:
- Signed and dated informed consent prior to any study-mandated procedure
- Clinically diagnosed rosacea defined by a score of ≥6 and ≤15 out of a maximum score
of 30 for the primary and secondary features of the RSGS
- Female subjects of childbearing potential must be using appropriate birth control
Main exclusion Criteria:
- Pregnancy or lactation
- Women with the following menopausal symptoms within the last two years prior to
screening: excessive sweating, flushing, mood changes
- Ocular manifestations of rosacea
- Peripheral location(s) of rosacea
- Phymatous changes
- Severe facial skin dryness or xerosis
- Keratoconjunctivitis sicca
- Flushing due to conditions other than rosacea
- Any other abnormal facial skin conditions, e.g., eczema, perioral dermatitis, broken
and bleeding skin on area of application
- Malignancy within the past 2 years with the exception of in situ removal of basal cell
carcinoma
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 | Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic) | NCT01666509 | Entailment |
912 | 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:
- male or female subjects 18 years or older
- documented diagnoses of hypertension and of hypercholesterolemia or current therapy
for these conditions
- uncontrolled hypertension (SBP >140 mmHg or DBP >90 mmHg) or cholesterol levels above
their threshold based on their global atherosclerotic risk profile (based on ATP III
assessment)
- ability to give written informed consent
Exclusion Criteria:
- ischemic heart disease, atrial fibrillation, chronic kidney disease and significant
liver disease
- currently prescribed 3 or more drugs to control blood pressure
- currently prescribed 2 or more drugs to control hypercholesterolemia
- participating in other hypertension/hypercholesterolemia studies
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.
| STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia) | NCT00637078 | Entailment |
6,508 | 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:
- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or
pustules
Exclusion Criteria:
- Mild or severe rosacea
- Rosacea with marked ocular manifestations
- Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation
of the study course
- Wash out period required for patients treated prior to study with topical retinoids,
oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical
imidazole, laser surgery for telangiectasia
- History of hypersensitivity to propylene glycol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily | NCT00417937 | Entailment |
6,940 | 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:
Exploratory Cognitively Healthy Subjects
- ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
- Mini-mental state examination (MMSE) ≥ 29
- No significant history of cognitive impairment
Exploratory MCI Subjects
- ≥ 50 years of age
- MMSE ≥ 24
- Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA)
working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
Exploratory AD Subjects
- ≥ 50 years of age
- MMSE > 10
- Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines
for AD
- Have a study partner that can report on subject's activities of daily living
Confirmatory Subjects
- ≥ 50 years of age
- MMSE ≥ 20 and ≤ 27
- Cognitively impaired subjects with either MCI or dementia with a suspected
neurodegenerative cause
- Have a study partner that can report on subject's activities of daily living
Exclusion Criteria:
- Current clinically significant psychiatric disease
- Evidence of structural brain abnormalities
- History of moderate or severe traumatic brain injury
- Current clinically significant cardiovascular disease or ECG abnormalities, or
additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease,
pulmonary, renal or hepatic impairment, or cancer
- History of alcohol or substance abuse or dependence
- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity or not using reliable methods of contraception
- Have received or participated in a trial with investigational medications in the past
30 days
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within
7 days prior to the study imaging session.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects | NCT02016560 | Entailment |
275 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- patients undergoing in vitro fertilization
Exclusion Criteria:
- risk of ovarian hyperstimulation syndrome
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial | NCT00854373 | Contradiction |
5,971 | 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:
- Patient over 19 years old
- Patient with typical GERD symptom (heartburn or acid reflux more than once a week)
Exclusion Criteria:
- Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
- Patient with active gastric/duodenal ulcer
- Patient who received esophagus, stomach or duodenum surgery
- Patient with hypersensitivity to esomezol®
- Patient with no achieved agreement on the study from the guardian or patient himself.
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.
Subject must be at most 80 Years | Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease | NCT03436914 | Entailment |
4,759 | 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:
- Age-matched (18-100)
- Healthy normal controls with no known hearing loss
- Patients with clinically assessed hearing loss
Exclusion Criteria:
- Complete hearing loss/deafness
- Cognitive decline or dysfunction, dementia
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 100 Years | Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe) | NCT03429777 | Entailment |
1,353 | 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:
- Eligible patients are infants under 4 years of age with genetic disorders undergoing
developmental surveillance in the NICU GraDS program.
Exclusion Criteria:
- Children 4 years of age or older will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 4 Years | Application of a Systematic Developmental Assessment to a Novel Population: Infants With Rare Genetic Disorders | NCT03967743 | Entailment |
6,914 | 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:
- > in one family 2 cases of Alzheimer disease with age of onset under 65
Exclusion Criteria:
- other cases of young onset dementia
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 | Genetics of Mendelian Forms of Young Onset Alzheimer Disease | NCT01622894 | Entailment |
6,515 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Severe Hemophilia Cohort:Patients from 0 up to 30 months of age with diagnosis of
severe hemophilia A or B defined as a factor VIII:C/IX:C of <1% undergoing prophylaxis
regimen with any factor VIII or IX concentrate and without evidence (clinical or by
history) of target joint disease.
- Mild/moderate Hemophilia Cohort:Patients from 0 up to 30 months of age with diagnosis
of mild hemophilia A or B defined as a factor VIII:C/IX:C of 5-50% and those with
diagnosis of moderate hemophilia A or B defined a s a factor VIII:C/IX:C of 1-5%
without evidence (clinical or by history) of target joint disease and no history of
spontaneous joint bleeds.
Exclusion Criteria:
- Patients with concomitant Hepatitis B, Hepatitis C and HIV viral infections (because
of a recognized arthritogen effect).
- Present or prior history of anti FVIII or IX inhibitors.
- Known inflammatory joint disease.
- Established target joint.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 30 Months | The Hemophilia Ultrasound Project | NCT02807753 | Contradiction |
5,846 | 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:
- patient is between 6 months and 18 years of age; AND
- patient has functional impairment classified by either gross motor functional
classification of 3, 4 or 5 OR impaired function in walking, crawling/standing,
rolling/sitting, arm use, hand use, ability to hold head up; AND
- patient has a gastrostomy; AND
- patient has intolerance of feedings or other complications attributed to GERD as
defined below; AND
- patient has a positive GERD diagnostic evaluation as define below:
- GERD diagnostic evaluation will include the following investigations;
- endoscopy and biopsy for visual assessment and histology of the esophageal
mucosa
- pH study and/or multichannel intraluminal impedance (MII) probe to detect
and quantify gastroesophageal reflux
- GER demonstrated by:
- Reflux Esophagitis: Endoscopic appearance of mucosal breaks in the distal
esophagus with or without pathologist diagnosis based on one or more biopsy
histologic features of: inflammatory cellular infiltrate, basal cell
hyperplasia, elongation of the vascular papillae AND no infectious
microorganisms and < 15 eosinophils per high power field; OR
- pH OR pH/multichannel intraluminal impedance(MII) probe evidence of
pathologic GER:
- pH probe: acid reflux index > 7 % OR
- pH/MII reflux symptom-associated acid or non-acid volume associated
reflux events;
- Upper GI will only be used to determine normal anatomy; AND
- patient has either medically refractory GERD or severe GERD as defined below:
- Medically refractory GERD - GERD that has not responded to 12 weeks of treatment
with a proton pump inhibitor (PPI) (and verified gastric pH > 4) and/or trial of
continuous intragastric feedings and has one of the following complications:
- Esophagitis: Endoscopic appearance of mucosal breaks in the distal esophagus
with or without pathologist diagnosis based on one or more biopsy histologic
features of: inflammatory cellular infiltrate, basal cell hyperplasia,
elongation of the vascular papillae
- Failure to thrive: diminishing weight percentile for age or weight for age
z-score sustained over 6 months.
- Pneumonia consistent with aspiration,
- Acute life threatening event,
- Severe GERD - at least one severe complication of GERD and patient cannot safely
tolerate a trial of medical management due to one of the following
life-threatening complications:
- aspiration pneumonia,
- acute life threatening event (ALTE),
- complete loss of airway protection (absent cough/gag) AND,
- Upper GI barium contrast study for anatomy; AND
- Barium pharyngeal swallow study or modified barium swallow study or Flexible
Endoscopic Evaluation of Swallowing (FEES) in past year; AND
- the parent or legal guardian speaks English or Spanish (the only two languages in
which the instruments are standardized)
Exclusion Criteria:
- Upper GI findings that would mandate a fundoplication including: hiatal hernia,
esophageal stricture, Barret's esophagus; OR
- Upper GI findings show uncorrected distal gastrointestinal obstruction including:
gastric outlet obstruction, duodenal obstruction, malrotation; OR
- Upper GI demonstrates structural foregut abnormalities that preclude a fundoplication
including: microgastria, short esophagus, high anesthetic risk; OR
- Diagnosis or history of congenital diaphragmatic hernia, esophageal atresia, chronic
intestinal pseudoobstruction; OR
- Endoscopy and biopsy demonstrates esophagitis from causes other than GER including:
eosinophilic esophagitis, candida esophagitis, viral esophagitis); OR
- Rapidly changing or indeterminate neurological including either a deteriorating
neurological condition such as rapid loss of developmental milestones or improving,
such as rapid recovery following severe neurological insult; OR
- Patient has unacceptable general anesthetic risk; OR
- A previous Nissen fundoplication; OR
- Feeds delivered by GJ/NJ at the time of enrollment occurring for greater than 3
months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 18 Years | Comparative Anti-Reflux Procedures in Neurologically Impaired Children | NCT01307982 | Contradiction |
6,195 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- age ≥ 18 years
- clinical suspicion of COVID-19 confirmed by RT-PCR
- CT scan at ER admission
- RT-PCR sampling
Exclusion Criteria:
- CT scan failure or loss of CT data
- RT-PCR initial results unavailable
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Prediction of Clinical Course in COVID19 Patients | NCT04377685 | Contradiction |
3,376 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Between 20 aged and 45 aged in healthy male and female
2. Body weight more than 55kg in male, 50kg in female
3. Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2)
4. If female, must include more than one among the items
1. The menopause (there is no natural menses for at least 2 years)
2. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or
other methods of infertility condition)
3. The male partner infertility before screening (Demonstrated azoospermia after
vasectomy)and if this man is the only partner of the female subject.
4. you are using one of the following contraceptive measure for 3 months before
screening, and Necessarily you agree that used continuously contraceptive measure
during the clinical trial and for 1 month after the final dosing investigational
product.(But, should not use a device of contraception or oral contraceptive drug
that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium
drug interactions during the clinical trials)
- Abstinence.
- Physical interrupt method (such as a condom, contraceptive diaphoretic or
cervical cap)
5. In case of women of childbearing age, the serum β-hCG pregnancy test is negative,
and urine β-hCG test is negative before taking the investigational product.
5. If men has sexual life with women of childbearing age, Necessarily he agrees that use
condoms during clinical trials and do not sperm donation during clinical trials and
until one month after the final dosage of investigational products
6. Those who fully understand about this clinical trial after enough hearing, and then
decided to join the clinical trials by themselves and to comply with the precautions
written consent.
Exclusion Criteria:
1. Have clinically significant disease that hepatobiliary system(severe hepatic
impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune
system, respiratory system, endocrine system,hemato-oncology disease, cardiovascular
system (heart failure, etc.).or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can affect drug absorption (Crohn,
ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
3. Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction
in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin
calcium) or additives
4. An impossible one who participates in clinical trial including screening tests(medical
history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test
result) within 28 days before the beginning of study treatment.
5. Defined by the following laboratory parameters:
- AST, ALT> 1.25*upper limit of normal range
- Total bilirubin > 1.5* upper limit of normal range
- CPK > 1.5* upper limit of normal range
- eGFR(using by MDRD method) < 60 mL/min/1.73m2
6. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after
5minuts break.
7. Drug abuse or have a history of drug abuse showed a positive for the Triage TOX drug
on urine.
8. Pregnant or lactating women.
9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or
smoker(cigarette>10cigarettes /day)
10. Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before
the beginning of study treatment but investigator determine that the taking drug
affect this study or could affect the safety of the subjects.
11. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates
etc.) within 30 days.
12. Taking foods containing grapefruit within 7 days before the beginning of study
treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days
before the beginning of study treatment)
13. Subject who treated with any investigational drugs within 60days before the beginning
of study treatment (However, biologicals applies for 90 days, but can be based on a
more extended period of time by considering the half-life.
14. Previously donate whole blood within 60 days or component blood within 30days.
15. An impossible one who participants in clinical trial by investigator's decision
including laboratory test result or another reason.
16. Positive for Hepatitis B, Hepatitis C, HIV
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin. | NCT01842256 | Contradiction |
2,777 | 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:
- between 18 and 80 years old on the day of study enrollment
- able and willing to sign the consent form and comply with all study visits and
procedures
- able to undergo elective laparoscopic hiatal hernia repair
- free of cognitive or speech impairment
- documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension
- commit to non-smoking for at least 4 weeks prior to procedure
Exclusion Criteria:
- previous operation of the esophagus or stomach
- sensitivity to porcine material
- pregnant or plan to be pregnant within next 2 years
- immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be
experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as
determined by the Investigator
- require emergent operation for acute gastric volvulus or strangulation
- American Society of Anesthesiology (ASA) class 4 or greater
- BMI ≥40
- life expectancy of less than 2 years at the time of enrollment
- associated gastrointestinal disease that requires extensive medical or surgical
intervention that might interfere with the quality of life assessment (e.g. Crohn's
disease)
- any condition in the opinion of the Investigator that would preclude the use of the
study device, or preclude the subject from completing the follow-up requirements
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Miromatrix Biological Mesh for Hiatal Hernia Repair | NCT02436681 | Entailment |
3,557 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Cohort 1a (typical EM and intention to treat):
Inclusion
1. Documented new onset Lyme disease EM rash (single or multiple) with photographic
evidence provided to Oxford Immunotec.
2. Patient must be able to provide blood sample at the initial visit (prior to treatment
initiation) and subsequent samples according to the schedule.
3. Patients 5 years of age or older, with a minimum weight of 40 pounds.
4. Patient able to read English and to give consent to study participation.
5. If patient is younger than 18 years of age a legally authorized representative must
provide consent.
Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
Inclusion
1. Patients with suspected Lyme disease, based on physician's examination, where the
physician has the intention to treat for Lyme disease (i.e. patients who following
initial examination were prescribed treatment for Lyme disease).
2. Documented new onset of Lyme disease symptoms without a typical EM rash or with no
rash. If a rash is present, photographic evidence must be provided.
3. Patient must be able to provide blood sample at the initial visit (prior to treatment
initiation) and subsequent samples according to the schedule.
4. Patients 5 years of age or older, with a minimum weight of 40 pounds.
5. Patient able to read English and to give consent to study participation.
6. If patient is younger than 18 years of age a legally authorized representative must
provide consent.
Cohort 2 (Healthy subjects):
Inclusion
1. Subjects 5 years of age or older, with a minimum weight of 40 pounds.
2. Subjects never diagnosed with any tick borne disease including Lyme disease
3. Subjects able to read English and to give consent to study participation.
4. If subject is younger than 18 years of age a legally authorized representative must
provide consent.
Exclusion Criteria:
- Exclusion Cohort 1a (typical EM and intention to treat):
1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study
enrolment.
2. Patients receiving treatment for any tick borne disease (including Lyme disease)
prior to enrolment.
3. Patients who received a Lyme vaccination.
4. Patients with anemia defined as a serum hemoglobin <10gm/dL.
5. Patients who are participating in, or plan to participate in, any investigational
drug study.
6. Patients who are considered unsuitable for the study by the Investigator.
Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior
to enrolment.
3. Patients who received a Lyme vaccination.
4. Patients with anemia defined as a serum hemoglobin <10gm/dL.
5. Patients who are participating in, or plan to participate in, any investigational drug
study.
6. Patients who are considered unsuitable for the study by the Investigator.
Cohort 2 (Healthy subjects):
Exclusion
1. Subjects with a history of tick bite
2. Subjects with past or current tick borne disease diagnosis
3. Subjects at risk for tick borne diseases including Lyme disease
4. Subjects residing in endemic regions for tick borne diseases: Connecticut, Delaware,
Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York,
Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.
5. Subjects who have ever visited non-urban areas of endemic regions for tick borne
diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New
Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and
Wisconsin.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
| Lyme Test Indication Combinations (LyTIC) Study | NCT03201042 | Contradiction |
5,222 | 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. | Primary Inclusion Criteria:
- The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip
(femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral
density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral,
sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have
an additional risk factor such as age 65 or greater or a strong maternal history of
osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as
determined by BMD criteria, are also study candidates.
- The patient is in good general health as determined by medical history and physical
examination and is without evidence of clinically significant abnormality in the
opinion of the Investigator.
Primary Exclusion Criteria:
- History of bone disorders (e.g., Paget's disease) other than postmenopausal
osteoporosis.
- Prior treatment with approved or as yet unapproved bone-acting investigational agents.
- History of carcinoma, nephrolithiasis or urolithiasis within the past five years or
osteosarcoma at any time.
- History of radiotherapy (radiation therapy).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis | NCT00542425 | Entailment |
3,414 | 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:
- Agreed for informed consent
- Age between 40-70 years old
- Type 2 diabetes mellitus
- Combined hyperlipidemia
- Serum triglyceride level between 200-500(mg/dl)
- No sudden change of glucose lowering therapies during trial, anticipated
Exclusion Criteria:
- Hypersensitivity to OMACOR(Omega-3 fatty acid)
- Alcoholics
- Pregnancy
- Proliferative diabetic retinopathy
- Patients already taking fibrates
- Enrolled in other clinical trials during the recent 3 months
- Severe ischemic heart disease, liver disease, neurological disease
- AST/ALT level 2 folds above the normal reference level
- Psychiatric disorder not adequately controlled
- Serum creatinine over 2.0 (mg/dl)
- Previous pancreatic surgery
- Patients who can not maintain regular diet
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 Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients | NCT00758927 | Entailment |
2,228 | 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:
- Screening Inclusion Criteria The subjects must meet all the following criteria to be
eligible for articipation in this study.
1. Subjects who are aged ≥19 and <70 years at the time of providing written informed
consent
2. Subjects who are diagnosed with gout according to American College of
Rheumatology (1977) criteria for the classification of acute arthritis of primary
gout.
3. Subjects who have the ability and willingness to actively conduct TLC recommended
in this study
4. Subjects who provided written informed consent to voluntarily participate in the
study
- Randomization Inclusion Criterion. Subjects who meet the screening inclusion criteria
will be randomly assigned to the following criteria.
1. sUA ≥ 7.0 mg/dL at Visit 2
Exclusion Criteria:
1. Subjects who have medical history or comorbidity as follow; (1) Active malignancy
or history of malignancy within the past 5 years at the time of screening (2)
Urolithiasis (3) Clinically important allergic disease (anaphylactic shock, etc.)
(4) Lesch-Nyhan syndrome (5) Hereditary problems such as galactose intolerance,
Lapp lactase deficiency or glucose-galactose malabsorption (6) Ischemic heart
diseases or congestive heart failure (7) Organ transplantation (recipient or
scheduled to receipt)
2. Subjects who have comorbidity or abnormality of lab results as follows; (1)
Uncontrolled diabetes mellitus with drug therapy
- HbA1c ≥ 9% or
- Fasting plasma glucose (FPG) ≥160 mg/dL (2) Uncontrolled hypertension with
treatment
- Systolic blood pressure (SBP) ≥180 mmHg or
- Diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia with
treatment
- Total cholesterol ≥ 250 mg/dL (at least 8 hours of fasting) (4) Aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 X upper limit
of normal (ULN) or Total bilirubin ≥ 1.5 X ULN (5) eGFR* < 60 mL/min/1.73m2
* eGFR (MDRD equation) GFR(ml/min/1.73m2) = 186 × (SCr)-1.154 × (age)-0.203
× (0.742 if female) × (1.210 if African American) (6) Uncontrolled thyroid
function with treatment (thyroid-stimulating hormone (TSH) ≥ 1.5 X UNL
3. Subjects who are judged by the investigator to have a clinical cardiovascular
disease that may affect the study based on the 12-lead ECG obtained at screening
or those suspected to be at such risk
4. Patients who have received or plan to receive any XOI or uricosuric agents within
3 weeks prior to study treatment
5. Patients who have received or plan to receive diuretics or any medication action
on human Uric Acid Transporter 1(hURAT1) such as indomethacin, pyrazinamide,
fenofibrate, atorvastatin, amlodipine, losartan, captopril, enalapril,
salicylates etc. within 2 weeks prior to study treatment However, those who have
been on stable doses as below are allowed to participate in the study, if the
administration method and dosage remain the same during the study period (1)
Diuretics (thiazide only or thiazide-based combination, etc.) and
antihypertensive agents (losartan etc.) used for the treatment of hypertension
(2) Fenofibrate or lipid lowering drugs (atorvastatin) used for hyperlipidemia
(3) Salicylates (aspirin)
6. Patients who have been administered or plan to administer Mercaptopurine,
Azathioprine, Theophyline within 1 week or within more than 5 times of its
half-life prior to the Visit 1
7. HIV Ag/Ab, HBs Ag or HCV Ab positive at screening
8. Subjects who have known hypersensitivity or allergy to IPs (URC102 or febuxostat)
or any components in their formulations
9. Subjects who have childbearing or nursing
10. Subjects who agree to use methods of birth control* during the study period and
for up to 7 days after the final administration of the IP
* Methods of birth control: ① intrauterine device or birth control implant, ②
dual protection (condom with spermicide and contraceptive diaphragm or
contraceptive sponge or cervical cap ③ surgical sterilization (vasectomy or tubal
ligation or etc.)
11. Subjects who have been administered any other IP or investigational device by
participating in other studieswithin 4 weeks or within more than 5 times of its
halflife prior to the Visit 1
12. Subjects who have a history of drug or alcohol abuse within 5 years prior to the
Visit 1
13. Subjects who have any other reason that may affect the study or those who are
judged by the investigator to be ineligible for participation 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 19 Years old.
Subject must be at most 69 Years | Study of of URC102 to Assess the Efficacy and Safety in Gout Patients | NCT04804111 | Entailment |
5,348 | 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:
- Adult or child patient ≥ 2 years
- Having a hemorrhagic score ISTH > 3 for men, > 5 for women and > 2 for children.
- With no abnormal coagulation (defined by normal TP and TCK or activity ≥ 50% of FII,
FV, FVII, FX, FVIII, FIX, FXI)
- no deficiency of Willebrand factor (defined by a cofactor activity with Ristoctin
(VWF: RCo < 50%))
- no a known major thrombocytopenia/thrombopathy linked to a deficiency of one of the
major platelet receptors
- Information of the patient and/or his legal representative present
Exclusion Criteria:
- Inability or refusal of compliance with research requirements
- Thrombocytopenia < 100 G/L
- Treatments interfering with platelet functions within 10 days prior to inclusion
- Malignant hemopathy
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.
| Anomalies of Dense Platelet Granules | NCT04095715 | Contradiction |
5,703 | 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:
- Patients with suspected or diagnosed genetic and/or metabolic conditions of all ages
are eligible for this protocol.
- In addition, children with unexplained developmental delay, deafness, dysmorphism,
congenital malformations, acidosis, failure to thrive, feeding problems, short
stature, birth defects, and other syndromes of sporadic or unknown etiology will
qualify for this protocol.
- The actual selection of patients most appropriate for research and clinical training
needs will be made by protocol investigators.
EXCLUSION CRITERIA:
- Patients that their care requires resources not available at the NIH Clinical Center
will not be eligible for the in-patient part of this study.
- There are no exclusions for the out-patient or DNA collection part of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Studies of Children With Metabolic and Other Genetic Disorders | NCT00025870 | Entailment |
4,674 | 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:
- Working at Covid 19 Pandemic Hospital
- Being at between 18 and 47 years old
- Having menstruation
Exclusion Criteria:
- Oral contraceptive users
- Pregnants
- Having malignancy
- Having primary amenorrhea
- Being at menopause
- Lactation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 47 Years | Menstrual Cycle Characteristics of Healthcare Professionals | NCT04413058 | Entailment |
366 | 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:
- Women ≥ 18 to ≤ 40 years of age, with one or more years infertility history, desirous
of conceiving, regularly ovulating (defined as 9 or more menses per year), at
initiation of participation.
- BMI ≥ 30 kg/m2 obtained at screening visit.
- Normal uterine cavity and at least one open fallopian tube confirmed by
hysterosalpingography (HSG), sonohysterography (SHG), or laparoscopy/hysteroscopy in
the last three years preceding enrollment into the study. An uncomplicated
intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course
resulting in live birth within the last three years will also serve as sufficient
evidence of a patent tube and normal uterine cavity as long as the subject did not
have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or
tubal disease or other disorder leading to an increased suspicion for intrauterine
abnormality or tubal occlusion.
- Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH ≤ 10 IU/L
with Estradiol ≤ 70 pg/mL OR AMH ≥ 1 ng/mL within one year prior to study initiation.
- Normal or corrected thyroid function within one year of study initiation.
- Normal or corrected prolactin level within one year of study initiation.
- In general good health, not taking any medications which could interfere with the
study (e.g., FSH, insulin sensitizers).
- Ability to have inseminations following hCG administration
- Male partner with total motile sperm in the ejaculate of at least 5 million sperm,
within one year of study initiation
- Able to comply with intercourse instructions and collection of semen for insemination
- Anyone enrolled and randomized to the RMN FIT PLESE study
Exclusion Criteria:
- Currently pregnant or successful pregnancies within 12 months of initiating
participation. Clinical intrauterine miscarriages prior to initiating participation,
within ASRM guidelines: subjects over 35 must wait six months, while subjects under 35
must wait 12 months. No exclusion for biochemical pregnancies.
- Undiagnosed abnormal uterine bleeding.
- Suspicious ovarian mass.
- Subjects on oral contraceptives, depo-progestins, or hormonal implants (including
Implanon). A two month washout period will be required prior to screening for patients
on these agents. Longer washouts may be necessary for certain depot contraceptive
forms or implants, especially when the implants are still in place. A one-month
washout will be required for patients who have taken oral cyclic progestins.
- Known 21-hydroxylase deficiency or other enzyme defect causing congenital adrenal
hyperplasia.
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
- Known significant anemia (Hemoglobin <10 g/dL).
- History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
- Known heart disease (New York Heart Association Class II or higher).
- Known liver disease (defined as AST or ALT >2 times normal, or total bilirubin >2.5
mg/dL).
- Known renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
- History of, or suspected cervical carcinoma, endometrial carcinoma or breast
carcinoma.
- History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks
at one time).
- Known Cushing's disease.
- Known or suspected adrenal or ovarian androgen secreting tumors.
- Allergy, known hypersensitivity or contraindication to the treatment medications used
in this study including clomiphene citrate (previous change in vision).
- Couples with previous sterilization procedures (e.g. vasectomy, tubal ligation)
whether or not it has been reversed.
- Subjects with untreated poorly controlled hypertension defined as a systolic blood
pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at
least 60 minutes apart.
- Subjects who have undergone a bariatric surgery procedure in the past or are in a
period of acute weight loss (defined as a weight loss of greater than 5 kgs in the
last 6 months).
- Known moderate or severe endometriosis
- Anovulation or oligo-ovulation including hypothalamic amenorrhea, polycystic ovary
syndrome, etc.
- Donated semen.
- Couples in which either partner is legally married to someone else.
- Medical conditions that are contraindications to pregnancy.
- Presence of severe, untreated psychiatric illness (major depression, substance abuse,
eating disorder, etc.) that would, in the opinion of the site investigator, interfere
with the patient's ability to successfully complete the study.
- Currently participating in a lifestyle intervention program (such as Weight Watchers,
Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.
- History of Gout.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Fetal Effects of Pre-Pregnancy Lifestyle Interventions in Unexplained Infertility Patients | NCT02541487 | Contradiction |
2,368 | 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. | Dystrophinopathy Participant Inclusion Criteria:
- Site confirmed genetic diagnosis of a dystrophinopathy
- Aged 6 years and older
- Able to transfer to testing table
- Able to walk 10 meters without an assistive device
Dystrophinopathy Participant Exclusion Criteria:
- Investigator assessment of inability to comply with protocol assessments
- Participants who have attention deficient disorder or other cognitive conditions that
may limit attention span to perform protocol assessments
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Clinical Evaluator Outcomes Reliability Study | NCT02146586 | Entailment |
1,785 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- All healthy patients without cholecystitis
Exclusion Criteria:
- Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports. | NCT04208568 | Contradiction |
1,836 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Age from over 18 to under 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0
resection surgicall results.
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
6. American Society of Anesthesiology (ASA) class I to III
7. Written informed consent
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
14. Forced expiratory volume in 1 second (FEV1)<50% of the 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 | Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer | NCT04795063 | Entailment |
5,304 | 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:
- vertebral compression fracture on spine radiograph (minimum 15% height loss)
- level of fracture at Th5 or lower; back pain for 6 weeks or less
- focal tenderness at fracture level on physical examination
- bone oedema of vertebral fracture on MRI
- decreased bone density (T scores ≤-1)
Exclusion Criteria:
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography exam
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 | Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures | NCT03360383 | Entailment |
1,676 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Physical examination and vital signs normal, or is considered abnormal, but clinically
insignificant by researcher.
- In the case of individuals with chronic stable dose drug treatment and during the last
3 previous months at baseline, the investigator will assess their possible inclusion.
Exclusion Criteria:
- BMI less than 25 or higher than 40 kg/m2
- Pregnant women
- Breastfeeding period. If artificial feeding until 6 months after birth.
- Type 1 diabetes
- Severe kidney diseases
- Severe digestive system diseases
- Electrolyte disorders (disorders of sodium, potassium, calcium, chlorine, phosphorus,
magnesium)
- Acute cardiovascular diseases
- Cancer
- Anemia
- Eating disorders
- Recent prescription drug treatment (without stable doses scheduled)
- Drug therapy that can influence weight loss as corticosteroids.
- Some type of cognitive impairment and / psychic
- Subjects in which poor collaboration or, in the investigator's opinion, have
difficulty following the procedures of the study is foreseen
- Lack of commitment (at the discretion of the investigator) with the intervention,
suspected non-compliance, or real difficulties to follow the development of the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit) | NCT02737267 | Entailment |
6,646 | 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:
- completed growth and development
- periodontally and dentally healthy conditions
- missing single molar tooth without free-end edentulism
- bone-level standard diameter of a specific implant from one manufacturer
- complication free healing period for osseointegration following straightforward
surgical implant placement
- natural dentition or fixed restoration in dental arch
- signing of informed consent form
Exclusion Criteria:
- absolute systemic contraindications for implant surgery (e.g. bone cancer, radiation
therapy)
- relative systemic contraindications for implant surgery (e.g. diabetes, steroid
therapy)
- risk factors (e.g. smoking, limited mouth opening)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Cementation Techniques for Single-tooth Implant Crowns | NCT03581565 | Contradiction |
4,630 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- women with adenomyosis
- at early- to mid-secretory phases
Exclusion Criteria:
- postmenopausal
- malignancy
Female
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 50 Years | Evaluation of Endometrial Stromal Cell Apoptosis in Adenomyosis | NCT00172588 | Entailment |
3,448 | 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 18-70y
- Be diagnosed with obesity, hyperlipemia or hyperglycemia
- Fully understood and voluntarily signed the informed consent
Exclusion Criteria:
- Secondary hyperlipidemia or hyperglycemia
- Multiple organ failure
- Allergic or intolerant to dietary fiber(dietary supplement)
- Have gastrointestinal diseases
- Have a history of abdominal diseases
- Experienced intra-abdominal surgery
- Pregnant and 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.
Subject must be at most 70 Years | Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases | NCT04690075 | Entailment |
17 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male patients 18-75 years
- Treatment with opioid for >3 months, daily dose >50-100 mg
- Total testosterone < 12 mmol/L
- Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below
normal laboratory values
- Normal prolactin levels
Exclusion Criteria:
- Hematocrit> 54% at screening
- Prostate Specific Antigen (PSA) > 3 ng/ml
- Severe organic and mental disease
- current or present cancer diagnosis
- Previous venous thrombotic embolism and cerebrovascular disease
- Uncontrolled hypertension
- Epilepsy or migraine not adequately controlled by therapy
- Severe benign prostate hypertrophy with symptom score >19
- Sleep apnea
- Alcohol or drug abuse
- Implantation of sustained action sex hormone in the last 12 months
- Use of oral, buccal or transdermal testosterone in the last two weeks
- Treatment with glucocorticoids > 5 mg/day or 5 alfa reductase inhibitors
- Hypersensitivity to Nebido
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease | NCT02433730 | Contradiction |
3,147 | 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:
- Be at least 18 years of age;
- Provide written informed consent;
- Have a subject reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms;
- Ocular Discomfort;
- Schirmer's Test score;
- Have corneal fluorescein staining ;
- Have lissamine green conjunctival Staining;
- Have a conjunctival redness;
Exclusion Criteria:
- Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;
- Have any clinically significant slit lamp findings at Visit 1;
- Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
1;
- Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
over the study period;
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be a woman of childbearing potential who is not using an acceptable means of birth
control;
- Have a known allergy and/or sensitivity to the study drug or its components;
- Have a condition or be in a situation which the investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study;
- Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1;
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.
| Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome | NCT04206020 | Contradiction |
2,919 | 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. | - Any volunteer of any age from birth to old age who is deemed medically fit to
participate and is willing to provide their informed consent will be included in the
study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 1 Month old.
| Human Movement Database | NCT00001252 | Entailment |
5,345 | 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:
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous
combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding
enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Exclusion Criteria:
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Benign or malignant liver tumor that developed during the use of oral contraceptives
or other estrogen-containing products
- Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting
triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.
- Diabetes mellitus
- Migraine or increased sensitivity of headaches during previous estrogen or oral
contraceptive study
- Depression requiring hospitalization or associated with suicidal ideation
- Chronic renal disease
- Known hypersensitivity to estrogens and/or progestogens
- Neuro-ocular disorders
- Cholestatic jaundice
- Pregnancy while taking oral contraceptives
- Persistent non compliance with taking medication
- Serious adverse experiences with oral contraceptive use
- Malabsorption due to illness or surgery
- Use of any experimental drug or device within the last 90 days before study drug
administration
- Any anticonvulsant medications
- Any use of rifampin within 3 months of enrollment
- Any use of lipid lowering agents
- Impaired liver function or disease
- Known or suspected pregnancy
- Hypertension whether treated or untreated
- Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or
greater that is untreated within the last year
- The use of an intrauterine device (IUD) or injectable or implantable estrogen,
progestogens, or androgens during the six month period before enrollment; or oral
contraceptive or sex hormone use within three cycles before enrollment.
- Breast feeding
- Known or suspected alcoholism or drug abuse
- Smoking
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function | NCT00128726 | Contradiction |
6,831 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Severe haemophilia A (FVIII < 1 IU/dl)
- Currently on prophylactic therapy
- The same prophylaxis regimen in the last six months
- Age: 2 (with a body weight ≥12.5 kg ) - 45 years
- Adequate venous access
- Haemophilia patient's diary or equivalent regularly completed
- Ability of patient or family (for minors) to give informed consent
- Subject with health insurance
Exclusion Criteria:
- Age <2 and >45 years
- Haemophilia A with documented inhibitor in the last 12 months
- Clinically symptomatic liver disease (historical evidence documented in patient's
medical file)
- Platelet count < 100x109/l
- Poor venous access
- Presence of a documented target joint
- Subject under legal protection measure.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 45 Years | TGA (Thrombin Generation Assay) and Prophylaxis in Haemophilia | NCT02781766 | Entailment |
3,854 | 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 who are ≥ 45 years old
- Symptomatic knee OA defined as symptoms of knee pain and/or decreased range of motion
(ROM)
- Classified radiographically as having Grade 2 or 3 Knee OA
- Failure of 3-months conservative management (NSAIDs and Physical therapy)
Exclusion Criteria:
- Patients < 45 years old
- Pregnant or breastfeeding women
- Cancer patients
- Rheumatoid arthritis patients
- Patients having any autoimmune disease affecting the joint
- Patients who have had hyaluronic acid injection <1 year ago
- Patients who have undergone lower extremity surgery or trauma on the same side
- Hypersensitivity to methylprednisolone (Depo-Medrol®)or any of its components,
lidocaine/xylocaine or any of its components, and any of the ingredients of Lipogems®
injection kit
- Patients with acute systemic or local infection
- Patients on anticoagulants (warfarin, coumadin, heparin, Xeralto, or Plavix)
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.
| Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study) | NCT04230902 | Entailment |
1,159 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Patients hospitalized or seen in consultation with pleural effusion diagnosed
clinically or radiologically whatever be its initial management.
Exclusion Criteria:
- Patient with a neoplasia
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.
| Thoracic Ultrasound in the Treatment of Pleural Effusion | NCT02505763 | Contradiction |
4,503 | 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:
- At least one year of primary dysmenorrhea (physician-confirmed).
- Written informed consent (also from parents/legal guardians of underage girls).
- Menarche at least one year ago.
Exclusion Criteria:
- Secondary dysmenorrhea.
- Participation in another study.
- Mental retardation.
- Addiction.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 46 Years | Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea) | NCT03712800 | Contradiction |
4,091 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- following a diagnostic of chronic sleep disorders responsible to hypersomnolence with
a score at the Epworth scale better than 10/24
- can be treated or not for chronic sleep disorder.
- speak and understand french
- should have a social security system
- should not have infectious or inflammatory pathology
Exclusion Criteria:
- be private of liberty
- live in medical institution
- be a major protected by law
- not have social security system
- refuse to participate in protocol
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.
| Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence | NCT03998020 | Entailment |
1,079 | 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:
- Subject is ≥ 18 years of age
- Subject is indicated for implantation or replacement of a dual chamber permanent
pacemaker where no lead extraction is necessary.
- Subject has stable regimen of 2 or more maximally tolerated anti-hypertension
medications, which is anticipated to be able to be maintained without changes for 3
months.
- Subject has office systolic blood pressure measurements > 140 mmHg on two separate
days within a one week period prior to enrollment, and the average of these two
measurements is ≥150 mmHg
Exclusion Criteria:
- Subject has known secondary cause of HTN
- Subject has a history of atrial fibrillation
- Subject has ejection fraction <50%
- Subject has symptoms of heart failure of NYHA Class II or more
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or
interventricular septal thickness ≥15 mm
- Subject is on dialysis
- Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
- Subject has prior neurological events (stroke or TIA) or carotid artery disease
- Subject has known autonomic dysfunction
- Subject has a history of clinically significant tachyarrhythmia
- Subject has had previous active device-based treatment for hypertension
- Subject has an existing implant, other than a pacemaker that needs replacing
- Subject with average Systolic BP >190 mmHg
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 Performance Study of the Moderato System | NCT02282033 | Contradiction |
60 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
Men with late-onset hypogonadism who are either on testosterone treatment or naïve of
treatment:
- have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e.
with a positive score on the Androgen Deficiency in the Aging Male (ADAM)
Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).
- morning total T levels of <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/l) on two separate days
prior to randomization (after appropriate wash-out, if applicable).
- calculated free T <=0.074 ng/mL.
- at least 50 and at most 75 years of age.
- BMI of at least 18 kg/m^2 or at most 32 kg/m^2
Inclusion Criteria for Normogonadal Men:
- morning total T levels <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/L).
- calculated free T <=0.074 ng/mL.
- at least 50 and at most 75 years of age.
- BMI of at least 18 kg/m^2 or at most 32 kg/m^2
Exclusion Criteria:
- History or current diagnosis of prostate cancer or any clinically significant finding
on prostate examination
- Severe obstructive symptoms of benign prostate hypertrophy
- Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening
- History or current diagnosis of carcinoma of the breast
- Known chronic polycythemia and/or hematocrit greater than 50% at screening
- Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level
>=50 ng/mL)
- Hematological or biochemical values at screening outside the reference ranges
considered as clinically significant in the opinion of the investigator
- clinically significant abnormal physical finding prior to randomization
- sensitive to trial medication or its components
- History or presence of hepatic or renal disorder considered as clinically relevant in
the opinion of the investigator.
Exclusion Criteria for Normogonadal Men:
- Presence or previous diagnosis of androgen deficiency.
- Previous or present use of testosterone preparations
- Use of medication within the 12 weeks prior to the visit that may interfere with the
objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g.,
gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid
- Any other disease that in the opinion of the investigator might compromise or confound
the subject's symptomatology (e.g., presence of clinically significant depression or
other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular
and cerebrovascular diseases, etc.)
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years | A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815) | NCT00254553 | Contradiction |
5,452 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Females 18-45 years of age
- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
normal VWF multimers
- Menorrhagia refractory to estrogens, hormones, hemostatic agents
- Willingness to have blood drawn
Exclusion Criteria:
- 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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia | NCT00524342 | Entailment |
3,092 | 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:
- Molecularly confirmed diagnosis of Fragile X Syndrome
- Molecularly confirmed diagnosis of Williams-Beuren Syndrome
- Autism features
- Score > or = 4 in Clinical Global Impression (Guy et al., 1976)
Exclusion Criteria:
- Parent yet enrolled in a parent training during first evaluation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 7 Years | Cooperative Parent Mediated Therapy in Children With Fragile X Syndrome and Williams Syndrome | NCT04610424 | Entailment |
540 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Indication and wish for IVF/ICSI treatment
- Womens age 20-39 years (both inclusive)
- Regular menstrual cycle within normal range
- Body Mass Index: 18-30 kg/m2 (both inclusive)
- Negative pregnancy test before treatment
- A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy
Exclusion Criteria:
- serious systemic disease
- Presence of polycystic ovarian syndrome (PCOS)
- Earlier poor response with less than 4 mature follicles
- Earlier participation in the investigation
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial | NCT00286364 | Contradiction |
3,191 | 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:
- 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 | Entailment |
3,250 | 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:
- Capacity to give informed consent
- Self-reported literacy
- Best corrected visual acuity at distance 20/40 in each eye
- Signed Institutional Review Board (IRB) approved consent agreeing to terms of the
study
- Additional inclusion criteria for the dry eye group (both SS- and non-SS) will
include a previous diagnosis of dry eye made by an eye care specialist.
- Differentiation of SS-related versus non-SS dry eye will be made according to the
2016 revised SS classification criteria.
The classification criteria are based on the weighted sum of the below 5 items:
• SS laboratory findings
- Anti-Sjogren's Antibody A (SSA) antibody positivity
- Focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2
each scoring=3
• SS clinical findings
- Abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4) in one eye
- Schirmer test ≤ 5 mm/5 min (without anesthesia) in one eye
- Unstimulated salivary flow rate ≤ 0.1 mL/min
each scoring=1
Individuals who have a total score ≥ 4 for the items above, meet the criteria for primary
SS. In other words, for final classification, an individual should have at least one
laboratory and one clinical finding.
Additional inclusion criteria for control subjects will include no previous history of dry
eye diagnosis, and no known history of autoimmune disease, verified using a review of
systems and past medical history form.
Exclusion Criteria:
- Age less than 18 years
- Known diagnoses of: Hepatitis C infection, HIV infection, Sarcoidosis, Amyloidosis,
Graft Versus Host Disease (GVHD), Cicatrizing conjunctivitis (ie. from trachoma,
Stevens-Johnsons Syndrome (SJS), pemphigoid, drug induced pseudo-pemphigoid, or
chemical burns, other severe ocular surface diseases such as atopic
keratoconjunctivitis
- Physical or mental issues, illiteracy, language problems which might possibly
interfere with reading ability or other condition that would preclude successful
participation in this study
- Contact lens wear within 10 days of enrollment
- Any intraocular surgery (including cataract surgery) within the last 3 months
- Any minor ocular surgery including tear duct cauterization or plugs, within the last
30 days
- Any history of corneal surgery or cosmetic lid surgery in the past 12 months
- Best corrected vision worse than 20/40
- Pregnant or nursing
- Artificial tear use within 24 hours of study visit
- History of taking or current use of topical prescription eye drops (including,
cyclosporine and steroids as well as any glaucoma eye drops).
- Patients who are willing to discontinue their treatment for at least a period of
30 days can be placed on a "wash-out period" as per the discretion of the
investigator and patient safety, and be eligible at the end of this period, given
all other criteria have been met. Otherwise, patients on these medications will
be excluded.
- Any person treated with glaucoma drops in the past (more than 30 days ago) or who
had glaucoma surgery (more than 12 months ago) can be included.
- Additional exclusion criteria for control subjects will include previous
history of dry eye diagnosis, or history of any known autoimmune,
inflammatory or rheumatologic disease including but not limited to Sjögren's
syndrome, rheumatoid arthritis, Lupus, mixed connective tissue disease,
scleroderma. Also the above exclusion criteria apply to control subjects.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye | NCT04493658 | Entailment |
1,005 | 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: 40-85
- Hand OA according to the ACR criteria (with recent X-rays of the hands - less than 6
months )
- Symptomatic hand OA lasting more than 3 months (DIP or PIP) despite analgesics and
NSAIDs
- OA affecting more than three finger joints (DIP or PIP) (Kellgren and Lawrence equal
or more than 2)
- Pain intensity superior to 40 (VAS 0-100 mm) in the last 24 hours
- Not breastfeeding throughout the study and for 150 days after the last infusion
- Negative pregnancy test or effective contraception for women of childbearing age
throughout the study and for 150 days after the last infusion or postmenopausal or
surgically sterile
- Written informed consent
- Affiliated to health system
Exclusion Criteria:
- Patients having already been treated with an anti-TNF alpha within 6 months
- Patients having already been treated with an Interleukin-6-Receptor Inhibitor
- Hand OA secondary to inflammatory rheumatism
- Existence of painful syndrome of upper limbs likely to interfere with the monitoring
of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint
disorders of the elbow or shoulder)
- Inflammatory rheumatism
- Psoriasis
- Contraindications to Interleukin-6-Receptor Inhibitor
- Contraindications to acetaminophen
- Anticoagulant (oral) or treatment with heparin at a curative dose
- Surgery scheduled within 6 months following recruitment
- Local injection of a corticosteroid in a symptomatic finger joint during the previous
month
- Local injection of hyaluronic acid in a symptomatic finger joint during the prior 6
months
- Treatment with a slow-acting anti-osteoarthritis agent initiated within the previous 3
months
- Treatment with methotrexate, hydrochloroquine, sulfasalazine, colchicine within the
last month
- History of symptomatics sigmoiditis or intestinal ulceration
- Oral corticosteroid within 3 days for hydrocortisone or cortisone, within 8 days for
prednisone, prednisolone, methylprednisolone or triamcinolone, and within 12 days for
betamethasone or dexamethasone
- Psychiatric illness
- Antidepressants initiated or modified within previous month
- Non-controlled diabetes "mellitus"
- Known viral hepatitis B or C, HIV infection
- Current infectious (active or latent tuberculosis)
- Excessive drinking
- Participation in another search
- Lidocain plasters on digital joint within two months
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 | Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis | NCT02477059 | Entailment |
5,447 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women with menorrhagia
- 18-49 years of age
- Regularly occurring menstrual periods
Exclusion Criteria:
- History or presence of clinically significant disease or abnormalities that may
confound the study
- History of bilateral oophorectomy or hysterectomy
- Hormone therapy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Efficacy and Safety Study of XP12B in Women With Menorrhagia | NCT00386308 | Entailment |
3,365 | 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:
- Patient older than 18 years and younger than 81 years and
- Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical
examination, history, audiology, speech interpretation tests and tinnitus evaluation
and
- Seen in the clinic within the first 14 days after the onset of symptoms. and
- Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive
frequencies.
- Excellent English Speaking and Comprehension
Exclusion Criteria:
- Children
- Prisoners
- Pregnant women
- Patients who have experienced similar prior events of SSNHL
- Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis,
fungal infections,
- Autoimmune inner ear disease
- Middle ear inflammation or effusion
- Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc.
- Head Trauma, lead poisoning
- Genetic disorders affecting hearing
- Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis,
and stroke-like episodes), stroke, Cogan's syndrome
- Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous
meningitis, intravascular lymphomatosis, others)
- Sarcoidosis
- Hyperviscosity syndrome
- Diabetes
- Use of statins within the last 12 months
- Allergy, hypersensitivity or intolerance to any components of the study medication
- Prior tinnitus
- Prior otologic surgery other than ventilation tubes
- History of drug abuse or alcoholism within the prior 2 years
- Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants,
hypnotics or anxiolytics
- Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers,
multiple sclerosis
- Oral steroid treatment within the preceding 30 days
- Heart disease or TIAs
- Chronic kidney failure
- HIV, Hepatitis B or C
- Active shingles
- Skull, facial or temporal bone anomalies
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 | Oral Statins and Protection From Hearing Loss | NCT04826237 | Contradiction |
2,396 | 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. diagnosis of DMD confirmed by muscle biopsy or DNA analysis
2. age 7-15y
3. ambulatory
4. no clinical evidence of heart failure
Exclusion Criteria:
1. hypertension, diabetes, or heart failure by standard clinical criteria
2. elevated BNP level (>100 pg/ml)
3. LVEF < 50%
4. non-ambulatory
5. cardiac rhythm disorder, specifically: rhythm other than sinus, SVT, atrial
fibrillation, ventricular tachycardia
6. continuous ventilatory support
7. liver disease
8. renal impairment
9. contraindications to sildenafil (use of nitrates, alpha-blockers, CYP3A inhibitors,
amlodipine, or other PDE5A inhibitors)
Male
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 15 Years | PDE Inhibitors in DMD Study (Acute Dosing Study) | NCT01580501 | Entailment |
4,089 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
1. Has a diagnosis of narcolepsy type 1 (NT1) (Parts A-C) or NT2 (Part D) by
polysomnography (PSG)/ multiple sleep latency test (MSLT) performed within the past 10
years meeting the minimal acceptable criteria for the proper performance of the
PSG/MSLT as outlined by the International Classification of Sleep Disorders, 3rd
edition criteria.
2. The participant's Epworth Sleepiness Scale (ESS) score must be greater than or equal
to (>=) 10 at Day -1.
3. Must be willing to discontinue all medications used for the treatment of NT1/NT2.
4. The human leukocyte antigen (HLA) genotype: Part A: should test positive for human
leukocyte antigen (HLADQB1)* 06:02 (PARTs A-C)- (positive results for either
homozygous or heterozygous alleles will be considered "positive" and acceptable).
However, if the HLA test is negative (i.e. negative for the heterozygous allele) and
the PI feels strongly that the participant has narcolepsy with cataplexy (NT1) then a
discussion should be initiated between the PI and the sponsor or designee about the
advisability of doing a spinal tap to determine the participant's cerebrospinal fluid
(CSF) orexin-1 (OX-1) level. If the CSF result shows the orexin 1 (OX-1) concentration
is either less than or equal to<110 pg/mL, or less than one-third of mean values
obtained in normal participants with the same standardized assay, then the diagnosis
of NT1 is established allowing the participant to be enrolled and randomized, If the
CSF OX-1 concentration is >110 pg/mL then the participant will not be allowed to
continue in the study .
5. For Parts A, B, and C, during the screening period, participant, must have >=4 partial
or complete episodes of cataplexy/week (WCR), and >=4 partial or complete episodes of
cataplexy/week during the screening period when off of anticataplexy medications,
averaged over 2 weeks (14 consecutive days) minimum. WCR recording taken during
following period will be considered for study eligibility: after the participant has
stopped taking anticataplexy medications for at least 7 days (minimum 7-day washout)
and study Day -2.
Exclusion Criteria:
1. Has a risk of suicide according to endorsement of Item 4 or 5 of the
screening/baseline visit Columbia suicide severity rating scale (C-SSRS) or has made a
suicide attempt in the previous 12 months.
2. Is an excessive (>600 mg/day) caffeine user 1 week before to the study screening.
3. Has a history of cancer (except carcinoma in situ that has been resolved without
further treatment or basal cell skin cancer); past or current epilepsy, seizure; a
lifetime history of major psychiatric disorder other than depression or anxiety; a
clinically significant history of head injury or head trauma; a history of cerebral
ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous
malformation; known coronary artery disease, a history of myocardial infarction,
angina, cardiac rhythm abnormality, or heart failure; or current or recent (within 6
months) gastrointestinal disease expected to influence the absorption of drugs. Any
history of Roux-en-Y gastric bypass is considered exclusionary and any other surgical
intervention that may influence the absorption of drugs should be discussed and
approved by the sponsor or designee before enrolling the participants.
4. Has a medical disorder, other than narcolepsy, associated with EDS. This includes
clinically significant moderate to severe obstructive sleep apnea and/or with or
without treatment with mandibular advanced device hypoglossal nerve stimulation and/or
positive airway pressure (PAP) therapy) and/or restless legs syndrome (RLS)/periodic
limb movement disorder that has a significant impact on daytime sleepiness. This is
evidenced by a clinical history of sleep apnea syndrome (loud snoring with observed
respiratory pauses in the absence of nPSG) and/or RLS causing historical sleep
onset/maintenance insomnia with resultant insufficient sleep. Or any as evaluated
during the clinical interview at screening. pPast PSG data demonstrating any of the
following sleep disturbances: apnea Hypopnea Index ≥15 or apnea index ≥10, an oxygen
saturation of <80 for >10 seconds, periodic leg movement arousal index of ≥15/h) or as
evaluated on interview at the time of screening. Asshould be considered exclusionary
unless, based on a clinical evaluation by the investigator, a meaningful change in
clinical status has occurred that would impact the results. Because nPSG data is
obtained on Day -2, subjects may fail screening if criteria are not meet on the Day -2
nPSG.
5. Has a usual bedtime later than 2400 (12:00 AM, midnight) or an occupation requiring
nighttime shift work or variable shift work within the past 6 months or travel within
more than 3 time zones, within 14 days before Study Day -2.
6. Has a nicotine dependence that is likely to have an effect on sleep (e.g., a
participant who routinely awakens at night to smoke) and/or an unwillingness to
discontinue all smoking and nicotine use during the confinement portions of the study.
Participants undergoing optional CSF collection.
7. Has a local infection at the puncture site.
8. Has developed signs of lumbar radiculopathy, including lower extremity pain and
paresthesia.
9. Has any known focal neurological deficit that might suggest an increase in
intracranial pressure.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy | NCT04096560 | Entailment |
6,739 | 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:
- Age ≥ 20 years
- Willingness to sign informed consent and to participate in the study
- Plaque index according to Silness and Loe of < 35% [26]
- Presence of a mandibular first molar that has to be extracted
- Sufficient vertical interocclusal space for the placement of an implant crown (7 mm)
- Presence of an opposing natural or artificial tooth
- Ridge height sufficient for the placement of a ≥ 10 mm-long implant
- Sufficient ridge width for the placement of a 4.1mm diameter implant
Exclusion Criteria:
- Any physical or mental disorder that would interfere with the ability to perform
adequate oral hygiene or the capability of providing written informed consent and
compliance to the protocol
- Any disorder that would interfere with wound healing or represent a contraindication
for implant surgery such as, but not limited to, uncontrolled diabetes or conditions
resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of
antibiotics or antiresorptive medication such as bisphosphonates
- Pregnancy or lactation
- Intention to become pregnant between inclusion and implant loading
- Heavy smoking habit with ≥ 10 cig/d
- Severe bruxism or clenching habits, present oro-facial pain
- Insufficient ridge width/height for the study implant
- Defect of any alveolar wall (secondary exclusion criterion at tooth extraction)
- ISQ < 70 (secondary exclusion criterion for Group A at implant placement, for Group B
at loading visit)
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.
| Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later. | NCT04319042 | Contradiction |
6,206 | 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:
- Signed informed consent by participant, or for pediatric participants, signed informed
consent by parent/legal guardian and, where appropriate, signed assent by participant
- At least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough)
and
- One of the following criteria:
- Fever (≥ 38 °C by any method: oral, axillary, etc.) on examination or
participant-reported fever (≥ 38° C) or feverishness in the past 24 hours
- One or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain)
- Consenting to provide aspirate or naso-pharyngeal swab
Exclusion Criteria
- The onset of illness is more than 48 hours after hospitalization.
- Participants previously included in this study within the last 30 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Characterization of Influenza-like Illness in Mexico | NCT01418287 | Contradiction |
1,513 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
1. age 21 years or older
2. a clinical diagnosis of hypertension with uncontrolled BP in the previous three
months, currently taking or about to take anti-hypertensive medications
3. received high school or above level of education
4. active user of smart phone (Android or Apple) and mobile Apps
5. the average of three BP measurements during the screening visit at the CHC is ≥ 140/90
mm Hg, or ≥ 130/80 mm Hg if the patient has diabetes or renal diseases;
6. being able to give informed consent.
Exclusion Criteria:
- acute coronary syndrome
- heart failure
- cardiac arrhythmia
- stroke within the past three months
- renal failure
- cancer
- dementia, severe or acute psychiatric illness, pregnancy or intention to be pregnant
in the next 18 months, and hospitalization within 3 months.
- additional exclusion criteria include participation in another clinical trial, arm
- circumference >32 centimeters that may affect the accuracy of BP measurement due to
cuff size limit of the tele-monitor's, and unwillingness to comply with the 12 month
intervention duration.
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.
| Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China | NCT02919033 | Entailment |
6,392 | 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:
Innate Infection Cohort>
- PCR positives: persons who were symptomatic for COVID-19 and have tested positive for
COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test
- PCR negatives: persons who have never had COVID-19 and who have tested negative for
COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test
- persons 2+ years old
Vaccination Cohort>
- persons 7- 60 days post second dose of EUA COVID-19 vaccine
- persons 18+ years old
Exclusion criteria:
Innate Infection Cohort>
- PCR positives: persons with a COVID-19 positive test result >45 days old
- PCR negatives: persons with any prior COVID-19 positive result
- persons who have received COVID-19 vaccine
- persons <2 years old
Vaccination Cohort>
- persons symptomatic or previously infected with COVID-19 prior to vaccination
- persons <18 years old
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
| NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons | NCT04799392 | Entailment |
6,694 | 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. severe hemophilia A (FVIII<1%) with high responding inhibitors (peak levels >5 BU)
2. male, any age;
3. any inhibitor level at study enrollment;
4. ability and willingness to participate to the study;
5. previous ITI course of at least 9 months with a VWF-free FVIII concentrate at any
dosage, such as recombinant FVIII and/or monoclonally purified FVIII.
Exclusion Criteria:
1. concomitant systemic treatment with immunosuppressive drugs;
2. concomitant experimental treatment;
3. previous history of myocardial infarction and/or cerebral stroke
Male
No healthy subjects accepted to join the trial.
| Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) | NCT01051076 | Contradiction |
2,344 | 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:
- Literate mothers with physical disabilities or healthy children between the ages of 4
and 16, without any known functional and psychological problems
- Literate mothers aged 4-16 years with healthy children, without any known functional
and psychological problems
- Signed informed consent form
Exclusion Criteria:
- Mothers of 20 healthy children will be included. with the children who have multiple
disabilities
- Mothers of 20 healthy children will be included. with the children who have severe /
moderate mental impairment
- Mothers of 20 healthy children will be included. with the children who have Down's
syndrome or autism
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 24 Years old.
Subject must be at most 70 Years | Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities | NCT04035967 | Entailment |
407 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- The inclusion criteria for RIF group were: unexplained repeated implantation failure
(RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks
after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after
the transfer of ≥10 embryos in multiple transfers.
The inclusion criteria for control group were: (1) age <35 years; (2) unregular menstrual
cycles of >37 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4)
endometrial thickness ≥7.0 mm on the day of hCG administration.
Exclusion Criteria:
- The exclusion criteria were: (1) uterine abnormalities (double uterus, bicornuate
uterus, unicornuate uterus); (2) intrauterine adhesions（moderate - severe）,
endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal
fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure) (3) history of
adverse pregnancy (including spontaneous abortion, stillbirth, and fetal
malformation).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Transcriptomic Profile of Endometrium in Different Histological Dating of Hormone Replacement Cycle | NCT03222882 | Contradiction |
2,712 | 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:
- > 18 years
- ASA Classification I, II, III
- scheduled for elective TEP inguinal hernia repair
Exclusion Criteria:
- ASA Classification IV or greater
- needing emergency surgery
- known history of narcotic dependence
- undergoing bilateral inguinal or combined umbilical hernia repair
- undergoing other procedures during same anesthetic
- undergoing recurrent inguinal hernia repair
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparison of Self-Fixating vs Non-Fixating Hernia Mesh | NCT02062775 | Entailment |
6,209 | 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. Written informed consent by the patient
2. Patient of either gender
3. Age equal to or greater than 18 years old
4. Fever onset less than 24 hours
5. Body temperature greater than or equal to 38.50C.
6. Infection of the upper respiratory tract or of the lower respiratory tract or acute
pyelonephritis or infection of the skin and soft tissues that can explain fever onset.
Exclusion Criteria:
1. Age below 18 years old
2. Denial for written consent
3. Intake of paracetamol for any reason either orally or intravenously or intramuscularly
the last 12 hours
4. Intake of any non-steroidal anti-inflammatory drug the last 8 hours
5. Intake of any steroidal anti-inflammatory drug the last 12 hours
6. History of liver cirrhosis
7. Serum creatinine greater than 3 mg/dl
8. Aspartate aminotransferase more than 3 times greater than the upper normal limit for
the hospital lab
9. Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol
10. Pregnancy or lactation
11. Active bleeding of the upper or the lower gastrointestinal tract
12. Thrombocytopenia defined as any absolute platelet count below 50000/mm3.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A New Formulation of Intravenous Paracetamol for Fever Management | NCT02283203 | Contradiction |
33 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Agrees to written as well as audio-visual informed consent.
2. Ability to understand the risks/benefits of the protocol
3. Male between 35-65 years of age.
4. Diagnosed with Symptomatic hypogonadism
Exclusion Criteria:
1. Uncooperative Subjects
2. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.
3. Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of
normal
4. elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L or1.2mg/dl)
5. Patients suffering from CAD
6. History of malignancy
7. History of hypersensitivity to any of the investigational drugs Receiving any other
testosterone booster therapy/medication/supplement within the last 2 months
8. History of coagulopathies
9. High alcohol intake (>2 standard drinks per day)
10. History of psychiatric disorder that may impair the ability of subjects to provide
written informed consent.
11. Any medical condition, where the investigator feels participation in the study could
be detrimental to the subjects overall well-being
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Asses the Efficacy of Furosap: A Testosterone Booster Supplement in Human Volunteers | NCT02748005 | Contradiction |
1,516 | 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:
- Men/Women, 40 or older, diagnosed with hip or knee osteoarthritis.
- Hypertensive Patient with treated and controlled essential hypertension.
- Must receive at least one antihypertensive treatment from the following drug classes:
Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blockers
(ARB) or Beta-Blocker (BB).
- Must be current chronic user of NSAIDS or acetaminophen.
- Must discontinue all analgesic therapy at Screening.
Exclusion Criteria:
- More than two different classes of antihypertensive drugs.
- Uncontrolled diabetes.
- Hepatic or renal impairment.
- A history of alcohol/drug abuse.
- Diagnosis of gastric or duodenal ulceration and/or history of significant
gastro-duodenal bleeding.
- History of congestive heart failure.
- Clinically relevant abnormal ECG.
- Current or history of a medical disease that could interfere with the study objectives
or put the patient's safety at risk.
- Current or expected use of anticoagulants.
- Participation within 30 days prior to pre-screening in another investigational study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension | NCT00662896 | Entailment |
3,539 | 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:
- Age > 18 years
- Written informed consent
- Chronic adrenal insufficiency (first diagnosis > 6months), stable hormone replacement
therapy with glucocorticoids (no dose-adjustment >50mg hydrocortisone within the last
8 weeks) and mineralocorticoids (only primary adrenal insufficiency)! Or healthy
control (no adrenal insufficiency, normal serum-electrolytes, normotensive blood
pressure, no medication with a known influence on the electrolyte balance)!
Exclusion Criteria:
- Pregnancy or breast-feeding
- Metal-implant (not MRI-compatible)
- Claustrophobia
- Chronic internistic disease (hypertension, heart failure, liver cirrhosis)
- Polydipsia (>4l/d)
- Long-term medication that can cause a hyponatraemia (for example diuretics)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency | NCT03505775 | Entailment |
1,689 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Is the individual a healthy, normal adult man or woman who volunteers to participate?
- Is s/he within 18 to 45 years of age, inclusive?
- Is his/her BMI between 19 and 30 inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
non-sterile male partner, or by the use one of the following methods: diaphragm +
spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or
has she been surgically sterile or post-menopausal at least six months prior to
entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and
role in the study?
- Has s/he provided written informed consent?
Exclusion Criteria:
- Does the individual have a history or allergy or hypersensitivity to desloratadine,
milk or eggs?
- Does s/he have clinically significant laboratory abnormalities that would interfere
with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune,
cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
ongoing infection, pancreatic, or renal disease that would interfere with the conduct
or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history (within the past year) or clinical evidence of
alcohol or drug abuse?
- Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C
screen, or a positive pregnancy test?
- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
beverages during periods beginning 48 hours prior to study drug administration and
ending when the last blood sample has been taken in each study period?
- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14
day period prior to study initiation, or any OTC drug during the 72 hour period
preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than
hormonal contraceptives, during the study?
- Has s/he donated or lost blood or participated in a clinical study which involved the
withdrawal of a large volume of blood (480 mL or more), during the six week period
preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation?
- Has s/he received an investigational drug during the 30 day period preceding study
initiated?
- Has s/he used any tobacco products in the 3 months preceding drug administration?
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition | NCT01506037 | Entailment |
206 | 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/exclusion criteria:
- Age 18 years and older,
- Confirmed diagnosis of HH with
- Low testosterone or estradiol,
- Low or low-normal gonadotropin levels,
- Thyroid stimulating hormone (TSH) and prolactin within the reference range,
- Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance
imaging (MRI),
- All other medical conditions stable and well controlled,
- No prescription medications known to affect reproductive endocrine function for at
least 2 months or for 5 half-lives of the drug (whichever is shorter) except for
medications used to treat the subject's reproductive condition,
- No history of a medication reaction requiring emergency medical care,
- No illicit drug use,
- No excessive alcohol consumption (<10 drinks/week),
- Normal blood pressure (BP), (systolic BP < 140 mm Hg, diastolic < 90 mm Hg),
- White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of
the upper limit of the reference range,
- Prolactin below 110% of the upper limit of the reference range,
- Hemoglobin
- Women: no less than 0.5 gm/dL below the lower limit of the reference range for
normal women,
- Men: on adequate testosterone replacement therapy: normal male reference range,
- Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine
transaminase (ALT) not elevated,
- For women,
- Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of
screening (additional urine pregnancy test will be conducted prior to drug
administration),
- Not breastfeeding and not pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism | NCT04648969 | Entailment |
4,754 | 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:
- Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
for the 2 months prior to the study lead-in period.
- Subject has experienced active vertigo during the lead-in period.
- Subject has documented asymmetric sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while
on-study.
- Subjects currently on a low-salt diet and/or diuretic at the time of screening agree
to continue this treatment throughout the study.
Exclusion Criteria:
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of previous endolymphatic sac surgery.
- Subject has a history of previous use of intratympanic (IT) gentamicin in the affected
ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of
closure.
- Subject has experienced an adverse reaction to IT injection of steroids.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a trial of OTO-104.
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 | OTO-104 for the Treatment of Meniere's Disease | NCT01412177 | Entailment |
2,079 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Idiopathic pulmonary fibrosis for >3 months <5 years
- High resolution CT scan of chest consistent with IPF within the previous 12 months
- FVC > 40% and < 90% predicted, TLC >40% <80%, DLCo >30% <90%
- Chronic Cough - cough >8 weeks
- Age >50
- Non-child bearing potential
Exclusion Criteria:
- Pregnant or lactating women
- Women of child bearing potential
- Known etiology of lung fibrosis other than IPF
- Significant respiratory toxin exposure
- Collagen Vascular Disease
- Use of narcotic anti-cough agent in last week
- significant peripheral vascular disease or neuropathy
- history of seizures
- poorly controlled diabetes
- allergy to thalidomide
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.
| Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide | NCT00600028 | Entailment |
4,277 | 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:
- Man or woman with cystic fibrosis whose diagnosis was documented on clinical history
and a test for detecting genetic or sweat test positive
- Patient who signed the informed consent (or parents for patients minors)
- Elderly aged 15 and over
- Patient affiliated with a social security
- Patient against non-cardiac indication of physical
- Patient in stable condition on a respirator with a higher FEV to 1000 ml
- In the case of insulin-dependent diabetes, it must be balanced
- Patient had been informed of the results of the medical examination
- Women of childbearing age have achieved a pregnancy test on urine negative.
Exclusion Criteria:
- Diabetic patient unbalanced known cardiac pathology
- Patient on transplant list
- Patient major protected
- Patient under guardianship or trusteeship
- Safeguard patient justice
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 65 Years | Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period | NCT00792194 | Entailment |
5,892 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male or female aged 20 years or more
- Documented history of reflux esophagitis verified by endoscopy in the past, including
the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment
- Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily,
for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week
in the past 7 days prior to Visit 1.
- Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by
the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort
sufficient to cause interference with normal activities) to severe symptoms (i.e.
incapacitating, with inability to perform normal activities) OR At least 4 days with
symptoms including mild ones (i.e. awareness of sign or symptom, but easily
tolerated).
- The subject needs to be able to understand and read the official languages of the
country.
Exclusion Criteria:
- Use of other PPIs and/or H2RA during rabeprazole treatment
- Previous use of esomeprazole 40 mg during the 12 weeks before enrolment
- Current or historical evidence of gastrointestinal pathology
- History, signs or symptoms of clinically significant or uncontrolled cardiovascular,
pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or
hepatic disease as judged by the investigator to interfere with the conduct of the
study, the interpretation of study results, subject compliance, or the health of the
subject during the study.
- Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or
pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy,
endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of
an ulcer are not exclusion criteria.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole | NCT01249651 | Contradiction |
6,357 | 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. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined
by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg,
oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.
2. WHO Clinical Progression Scale score > 0 and < 4.
3. Participant must be dosed with IMP no more than 7 days from self-reported onset of
COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as
the self-reported date of first reported sign/symptom.
4. One or more of the following signs/symptoms must be present within 24 hours prior to
Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with
activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction
or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or
smell.
5. Oxygenation saturation of ≥ 92% obtained at rest by study staff within 24 hours prior
to Day 1 (unless participant regularly receives chronic supplementary oxygen for an
underlying lung condition).
6. Participant agrees not to participate in another clinical trial for the treatment of
COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28
days after entry into the study (whichever is earliest).
7. Participant must be ≥ 18 years of age, provide informed consent and is able to comply
with study requirements/procedures.
Exclusion Criteria:
1. History or current hospitalization for COVID-19.
2. Need for hospitalization/immediate medical attention in a clinic/emergency room
service
3. Previous adverse reaction to any monoclonal antibodies or known allergy to components
of the IMP or placebo.
4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any
time prior to entry into this study.
5. Requirement or anticipated impending need for mechanical ventilation.
6. Any significant disease, disorder or finding that may increase risk to the participant
that might affect his/her ability to participate in this study.
7. Received convalescent COVID-19 plasma treatment any time prior to entry into this
study.
8. Pregnant or breastfeeding women.
9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or
expected receipt of IMP during the study follow-up period, or concurrent participation
in another interventional 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.
| Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults | NCT04723394 | Entailment |
384 | 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:
- Endometrial thickness < 7 mm under estrogen replacement therapy or repeated
implantation failure
- Age between 18 and 46 years
Exclusion Criteria:
- Age < 18 and > 46 years
- Pregnancy
- Bleeding diathesis
- Previous uterine surgery (miomectomy, cesarean section, etc...)
- Platelet count < 105/μL
- Hemoglobin < 10 g/dL
- Presence of a tumor in the wound bed or metastatic disease
- Current diagnosis of cancer
- Other concomitant active infections
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 46 Years | Autologous Platelet-Rich Plasma (PRP) and Endometrial Thickness | NCT03067623 | Contradiction |
526 | 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 :
- 18-39 hyears old with regular menstrual cycles (25-35 days in length);
- Body Mass Index between 18-29 kg\m2
- Basal follicle-stimulating hormone levels within normal range (<30 mUI\mL)
- Absence of clinically relevant anomalies at transvaginal ultrasound examinatio
Exclusion Criteria:
- Patients affected by grade III or IV endometriosis according to American Society for
Reproductive Medicine (ASRM)
- History of Ovarian Hyperstimulation Stimulation (OHSS)
- History of poor response in previous IVF\ICSI cycle: ≤ 3 oocytes retrieved
- ≥ 3 prior consecutive IVF\ICSI cycle without a clinical pregnancy.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Cetrorelix and Ganirelix Flexible Protocol for (IVF) | NCT03477929 | Contradiction |
4,280 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male subjects aged 20~35.
- They accorded with diagnostic criteria of severe oligospermia or azoospermia.
- They had'nt been treated with drug which could improve sperm count and quality one
month before observation，otherwise,they should have a elution for 1 month before the
study.
Exclusion Criteria:
- Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma
hominis were detected in their semen.
- Subjects addicted to drug，tobacco，or alcohol.
- Subjects had heat,chemicals,radioactive material,or toxic contact history within a
year.
- Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic
drugs,or nonsteroidal anti-inflammatory drugs .
- Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe
primary disease,or mental disease.
- Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for
infertility .
- Subjects did not meet the inclusion criteria, did not according to the prescribed
medication, were unable to judge the efficacy ,had incomplete information, or affected
the efficacy or safety judgment.
- Subjects were IHH patients
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 35 Years | Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH | NCT02307994 | Entailment |
5,804 | 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:
- Consultation with a general practitioner for any motive during which, the general
practitioner deems necessary to obtain a dermatologic expertise for a skin lesion (for
diagnosis or treatment)
Exclusion Criteria:
- Emergency, assessed by the general practitioner (needs care or quick telephonic advice
in the next 24 hours)
- Patients for which diagnosis and/or treatment are known by the general practitioner
(the GP needs a dermatologic advice for a specific treatment (for example= laser,
instrumental treatment...))
- Patient cannot go the dermatologic consultation by himself (for example: dependant
patients...)
- Cognitive or psychiatric impairment (cannot give informed consent)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions | NCT02122432 | Entailment |
5,741 | 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:
Biopsy confirmed symptomatic erosive oral lichen planus. World Health Organization
histological criteria (21) in combination with compatible clinical picture will be used for
diagnosis. In questionable cases, direct immunofluorescence will be performed to exclude
other conditions.
No current treatment with hydroxychloroquine or other immunomodulatory agents. A one-month
washout period will be required prior to enrollment if patients are taking immunomodulatory
agents. Prior treatment with topical steroids will be allowed.
Age greater than 18 years old. Lichen planus is very rare in patients younger than 40 years
old and children are especially sensitive to the effects of hydroxychloroquine.
Patients of both sexes and all racial and ethnic groups will be eligible.
The presence of at least one ulcerated oral lesion with a surface area of at least 100 sq.
mm as measured bi-directionally.
EXCLUSION CRITERIA:
Unable to undergo oral biopsy for diagnosis
Lichen planus with no ulcerated oral lesions of greater than 100 sq. mm in area.
Treatment with hydroxychloroquine or other immunomodulatory agents within 1 month of the
randomization.
Hepatitis B or Hepatitis C infection
Significant abnormalities in hepatic status as measured by liver function tests (ALT, AST,
AP, bilirubin.) Mild asymptomatic elevations in liver enzymes (up to 20% above the
reference range) will not preclude enrollment in the trial.
Significant abnormalities in renal status as measured by kidney function tests (creatinine,
BUN).
Uncontrolled diabetes
Contraindications to hydroxychloroquine or clobetasol therapy (known hypersensitivity,
retinopathy from prior use, history of aplastic anemia or agranulocytosis).
Anemia (defined as a hemoglobin level more than 2 standard deviations below the mean
reference value for age).
Granulocytopenia (defined as an absolute neutrophil count (ANC) in adults as less than
1500/mm(3)).
Pregnancy or lactation. Pregnancy status will be assessed by questionnaire. Potentially
pregnant patients will be evaluated by plasma HCG test. Patients planning pregnancy will be
excluded. Sexually active females will be required to use contraception prior to enrollment
in the study. Every woman of childbearing age will have a pregnancy test.
Inability or unwillingness to give written informed consent.
Serious concurrent disease (e.g. myocardial infarction, severe heart failure, severe COPD)
requiring hospitalization or limiting life expectancy to less than 1 year.
Psoriasis
G6PD deficiency
Porphyria
Chronic use of non-steroidal anti-inflammatory agents or other agents to relieve pain.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus | NCT00102557 | Contradiction |
6,728 | 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:
Inclusion criteria for hemophilia A carriers:
- Females 18-60 years of age at time of enrollment
- Genetically verified or obligate hemophilia A carrier (mother of 2 boys with
hemophilia A, daughter of a father with hemophilia A or mother of a son and another
male relative with hemophilia A)
- To stratify patients by carriage of mutation type 10 hemophilia carriers of mild
mutations that are predicted to lead to reduced FVIII secretion, protein stability or
thrombin cleavage site interference and 10 hemophilia carriers of severe mutations
that lead to predicted negative cross reactive material will be selected. Predicted
FVIII function of the mutation will be verified by EAHAD (European Association for
Haemophilia and Allied Disorders) Coagulant Factor Variant Database at
www.eahad-db.org)
- Weight >40kg to ensure volumes of blood to be drawn are within accepted safe range
Inclusion criteria for non-hemophilia A carriers (Females with mild qualitative platelet
dysfunction):
- Females 18-60 years of age at time of enrollment
- Whole blood or platelet rich plasma lumiaggregometry consistent with reduced
aggregation to at least 1 agonist on at least one occasion (excluding evidence of
Glanzmanns Thrombasthenia or Bernard Soulier Syndrome) or determined by primary
hematologist as having a qualitative platelet disorder
- Age-matched by 10 years to carrier enrolled
- Weight >40kg to ensure volumes of blood to be drawn are within accepted safe range
Exclusion Criteria:
- Personal history of concomitant bleeding or clotting disorder
- Cardiac condition that requires the daily use of Aspirin or Clopidogrel
- Inability to comply with fluid restriction protocol for 24 hours following
Desmopressin (DDAVP)
- Personal history of a myocardial infarction, renal or hepatic insufficiency or
epilepsy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Characterization of Laboratory Response to DDAVP in Adult Hemophilia A Carriers | NCT02506023 | Contradiction |
5,279 | 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:
- Postmenopausal for at least 5 years
- No history of fragility fracture, unless participant is not willing to take marketed
osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
- Agrees not to use medications for osteoporosis except medications associated with the
study
- Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD
sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD
sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy
may have one or more areal BMD T-scores of < -3.5
Exclusion Criteria:
- Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie,
weight >250 lbs)
- Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3
months in the past 2 years, or lifetime use of more than 6 months
- Use of intravenous bisphosphonates, strontium, or growth hormone at any time
- Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within
6 months prior to Visit 1
- Use of pioglitazone or rosiglitazone at study screening
- Use of estrogen ± progestin, in any form other than vaginal or topical application,
for 6 months prior to Study Visit 1
- Prior total thyroidectomy
- Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome
(AIDS)-related illness
- History of malignant cancer within 5 years of study screening, except for certain skin
or cervical cancers
- History of Paget's disease and/or kidney stones
- An active user of any illicit drug
- History of or active alcohol abuse
- Participated in an investigational drug study within the past 30 days
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001) | NCT00960934 | Entailment |
5,701 | 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:
- Children 3.5-18 years old refered to the endocrine pediatric clinic due to short
stature or other growth abnormalities
Exclusion Criteria:
- Children with bone disease
- Children who within the last year took medications which might change bone metabolism
or mineralization
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 42 Months old.
Subject must be at most 18 Years | Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray | NCT03123003 | Entailment |
4,613 | 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:
1. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Entailment |
5,354 | 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:
- Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days)
and who are initiating an IUD
- Women who can provide bleeding information for 3 cycles off of any hormonal
contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days
- Women who are between 6 and 12 months postpartum (if they have had normal menses the
last 3 cycles)
Exclusion Criteria:
- Use of any hormonal contraceptive method in the previous 3 months
- Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days)
- Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days
based on self report of the last 3 cycles
- Contraindication to use of the ParaGard® T380A IUD
- Mucopurulent cervicitis at the time of IUD insertion
- Unable to speak, read, and write in English
- Currently pregnant
- Plans for or desire for pregnancy in the next 6 months
- Currently breastfeeding
- Women who are <6 months postpartum
- Participation in any clinical investigation utilizing an investigational drug or
medical device or requiring invasive gynecologic procedures within the 30 days prior
to enrollment
- Wilson's disease
- Known coagulopathy or bleeding disorder
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users | NCT02311478 | Contradiction |
3,074 | 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:
Individuals with selected psychiatric and neurologic disorders, including childhood onset
schizophrenia, atypical psychosis, mental retardation, bipolar affective disorder, and
ADHD.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Genetic Aspects of Neurologic and Psychiatric Disorders | NCT00001544 | Entailment |
2,649 | 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. Patient desires an elective surgical repair,
2. patient is able to give informed consent,
3. diagnosis of a midline ventral hernia with a fascial defect width on clinical
examination or CT scan of 3-10 cm in size,
4. body mass index <40kg/m2,
5. candidate for LVHR based upon surgeon assessment.
Exclusion Criteria:
1. acute or urgent presentation,
2. multiple defects defined as defects from two separate incisions,
3. patient has loss of domain assessed,
4. patient has a severe co-morbid condition likely to limit survival to <2 years,
5. contamination noted pre-operative or intra-operative,
6. patient is pregnant or intends to become pregnant during the study period.
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.
| Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial | NCT02363790 | Entailment |
1,254 | 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:
- Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural
biopsy.
- Recurrent and symptomatic malignant pleural effusion.
- Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.
- Karnofsky Performance Status >30
- Agreement to participate of the study by signing of the Informed Consent Term.
Exclusion Criteria:
- Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).
- Active pleural or systemic infection.
- Massive skin neoplastic infiltration.
- Inability of understanding the pain scale.
- Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).
- Refusal to participate of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion | NCT01125124 | Entailment |
4,758 | 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:
General Requirements:
- Ability to provide Informed Consent
- 18 years of age or older
- English language proficiency
- Willingness to participate in all scheduled procedures outlined in the study
investigational plan
- Willingness to use an approved cochlear implant signal processing strategy in an
everyday listening program during study
Ear to be Implanted:
- Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone
average for 500, 1000, 2000 and 4000 Hz
- CNC word recognition score ≤30% (tested in subject's everyday listening condition for
that ear)
- Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and
≤10 years in the ear to be implanted only
Contralateral (non-implanted) ear:
- Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone
average for 500, 1000, 2000 and 4000 Hz
- CNC word recognition score >30% (tested in subject's everyday listening condition for
that ear)
Exclusion Criteria:
- Previous experience with a cochlear implant
- Cochlear malformation or obstruction (i.e. ossification) that would preclude full
insertion of electrode array in the ear to be implanted
- Medical or psychological conditions that contraindicate surgery or impact the ability
to manage an implanted device or the study related procedures as determined by the
investigator
- Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or
the contralateral ear
- Active middle-ear disease/infection in the ear to be implanted
- Unrealistic expectations regarding potential benefits, risks and limitations inherent
to implant surgical procedures as determined by the investigator
- Unwillingness or inability of subject to comply with all investigational requirements
as determined by 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 18 Years old.
| Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss | NCT02811549 | Entailment |
5,337 | 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. Menstruating females 10-19 years of age
2. Non-smoker
3. Physician and patient have agreed to initiate Lysteda
4. Diagnosis of HMB based on the medical judgment of the principal or site investigator
5. Subjects must report menstrual periods occurring within 21-60 days from the start of
one period to the start of the next menstrual period
6. Negative pregnancy test
7. Informed consent obtained and signed
8. Informed assent obtained and signed
9. Understanding of study procedures
10. Ability to comply with study procedures for the entire length of the study
11. Subjects should be either sexually inactive (abstinent) or agree to use a barrier
method with spermicide in the event of sexual activity throughout the study period
Exclusion Criteria:
1. Active thromboembolic disease, history of thromboembolic disease (including retinal
vein or artery occlusion), known inherited thrombophilia, or family history of
thrombosis in a first degree relative
2. Subject has a severe medical or psychiatric illness that, in the opinion of the
Investigator, would affect subject safety or compliance
3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders
such as type 1 von Willebrand disease, mild platelet function defects such as platelet
storage pool or release defects, and patients with bleeding due to Ehlers Danlos
syndrome WILL be eligible to participate in the study.
4. Pregnancy within the past 6 months and/or breast-feeding
5. Use of hormonal contraception (estrogen and progestin) within 3 months of study entry,
or anticipated need to initiate estrogen-containing hormonal contraception during the
study period
6. Use of systemic steroids within 1 month of study entry
7. History of subarachnoid hemorrhage
8. History of Hepatitis B, C, or HIV
9. Baseline creatinine >20% above the upper limit of normal for age
10. Severe anemia (hemoglobin <8 g/dL)
11. Systolic blood pressure <85 or diastolic blood pressure <55
12. Heart rate <50 at time of screening
13. Use of intranasal DDAVP during menses will be permitted, but only if the patient has a
history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment,
so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use
of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study
period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical
procedures during the study period.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 19 Years | Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding | NCT01846507 | Contradiction |
2,491 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Male and female patients of any race who are at least 18 years of age and can
understand and provide verbal and written informed consent are eligible for this
study.
Exclusion Criteria:
- Patients who have had intraocular surgery less than six months ago,
- Potential contraindication for visual field test that include anxiety disorder,
pregnancy, seizure disorder,cardiac pacemaker or another implantable device, severe
vertigo or balance issues.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues | NCT04714424 | Entailment |
2,623 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients ≥15 years of age, of either gender having Incomplete indirect inguinal hernia
with or without direct concurrent hernia as mentioned in operational definition.
Exclusion Criteria:
- Complete inguinal hernias.
- Patients having obstructed and/or strangulated inguinal hernia.
- Recurrent inguinal hernias.
- patients with ipsilateral synchronous inguinoscrotal pathologies e.g. hydrocele,
testicular malignancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty | NCT04079504 | Contradiction |
1,459 | 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:
- 55 years of age or older
- physician approval of medical stability
- aspiration or penetration of the laryngeal vestibule (score of 3 or higher on the
Penetration/Aspiration Scale) or post-swallow residue in the oropharynx as
instrumentally documented by a Speech-Language Pathologist (SLP) during a standard
videofluoroscopic oropharyngeal swallow study
- capacity to provide informed consent.
Exclusion Criteria:
- poorly controlled psychosis (3 or more related hospitalizations in one year
- refractory alcoholism (on AWD precautions)
- allergy to barium (used in radiographic swallowing assessment)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Development of Novel, Biophysically Designed Fluids for Swallowing Disorders | NCT03131869 | Entailment |
4,190 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria
1. Age 18-45 of both genders
2. Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy
3. Calculated 10 year risk of CVD by the Framingham risk score of <5%
Specific for Healthy Volunteers
4. No history of episodic wheezing, chest tightness or shortness of breath consistent
with asthma, or physician diagnoses asthma.
5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70
Specific for Allergic Asthmatic Volunteers
6. History of episodic wheezing, chest tightness, or shortness of breath consistent with
asthma, or physician diagnosed asthma.
7. A POST-bronchodilator increase in FEV1 of at least 12%, OR a clinical history of
asthma after the age of 6.
8. FEV1 of at least 75% of predicted without use of short acting bronchodilating
medications for 12 hours, consistent with lung function of persons with no more than
mild episodic or mild persistent asthma.
9. Mild persistent asthmatics must be well controlled (in accordance with NHLBI
guidelines) and willing to discontinue Singulair, inhaled corticosteroids or cromolyn
for a period of 2 weeks prior to study visits (except for use of cromolyn exclusively
prior to exercise)
10. Allergic sensitization to at least one of the following allergen preparations: (House
Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1,
Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive
immediate skin test response; or a clinical history consistent with seasonal or
perennial allergy symptoms.
11. Subjects must be willing to avoid caffeine for 12 hours prior to all visits. Allergy
skin testing are performed as part of IRB98-0799, which a subject must complete in
order to be considered for this protocol.
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study
participants:
1. Clinical contraindications:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic
renal disease, chronic thyroid disease, history of chronic
infections/immunodeficiency, history of tuberculosis.
2. Viral upper respiratory tract infection within 4 weeks of challenge.
3. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
4. Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or
< 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry
saturation reading less than 94%.
5. Unwillingness to use reliable contraception if sexually active (IUD, birth
control pills/patch, condoms).
6. Use of immunosuppressive or anticoagulant medications including routine use of
NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other
medications may be permitted if, in the opinion of the investigator, the
medication will not interfere with the study procedures or compromise safety and
if the dosage has been stable for 1 month
7. Orthopedic in juries or impediments that would preclude bicycle or treadmill
exercise.
8. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
9. Medications which may impact the results of the WSP exposure, interfere with any
other medications potentially used in the study (to include steroids, beta
antagonists, non-steroidal anti-inflammatory agents).
10. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal medications in
the 4 days prior to the screening visit the exposure session.
11. Symptomatic allergic rhinitis or current active allergies.
12. Cigarette smoking > 1 pack per month
Specific for Healthy Volunteers
13. Physician diagnosis of asthma.
Specific for Asthmatic Volunteers
14. Physician directed emergency treatment for an asthma exacerbation within the
preceding 3 months
15. Moderate or Severe asthma
16. Exacerbation of asthma more than 2x/week which would be characteristic of a
person of moderate or severe persistent asthma as outlined in the current NHLBI
guidelines for diagnosis and management of asthma.
17. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person of moderate or severe
persistent asthma as outlined in the current NHLBI guidelines for diagnosis and
management of asthma. (Not to include prophylactic use of albuterol prior to
exercise).
18. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not
during a clearly recognized viral induced asthma exacerbation) which would be
characteristic of a person of moderate or severe persistent asthma as outlined in
the current NHLBI guidelines for diagnosis and management of asthma
19. History of intubation for asthma
20. Use of systemic steroid therapy within the preceding 3 months for an asthma
exacerbation. All use of systemic steroids in the last year will be reviewed by a
study physician.
21. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or
Zafirlukast) except for use of cromolyn exclusively prior to exercise.
22. Use of daily theophylline within the past month
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility | NCT02767973 | Contradiction |
1,650 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 65 years of age the
time of signing the ICF.
2. Subject must understand and voluntarily sign an ICF prior to any study related
assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
4. Satisfactory medical assessment with no clinically significant or relevant
abnormalities as determined by medical history, physical examination, vital signs,
12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry,
coagulation, and urinalysis) that is reasonably likely to interfere with the subject's
participation in or ability to complete the study as assessed by the Investigator.
5. Female subjects NOT of childbearing potential must:
1. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper
documentation required) at least 6 months before screening, or be postmenopausal
(defined as 24 consecutive months without menses before screening, with a
follicle stimulating hormone [FSH] level of > 40 IU/L at screening).
6. Females of childbearing potential (FCBP) must have a negative pregnancy test at the
Screening and Baseline Visits. While receiving investigational product (IP) and for at
least 28 days after taking the last dose of IP, FCBP who engage in activity in which
conception is possible must use one of the approved contraceptive options described
below:
Option 1: Any one of the following highly effective methods: hormonal contraception
(oral, injection, implant, transdermal patch, vaginal ring); intrauterine device
(IUD); tubal ligation; or partner's vasectomy.
OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm
with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with
spermicide.
7. Male subjects must:
a. Practice true abstinence (which must be reviewed on a monthly basis and source
documented) or agree to use a barrier method of birth control (condoms not made out of
natural [animal] membrane [latex condoms are recommended]) during sexual contact with
a pregnant female or FCBP while participating in the study, during dose interruptions,
and for at least 28 days after the last dose of IP, even if he has undergone a
successful vasectomy.
8. Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
9. Subject has clinical laboratory safety test results that are within normal limits or
acceptable to the Investigator.
10. Subject vitals are as follows:
1. Tympanic body temperature: 35.0 - 37.5°C.
2. Supine blood pressure (BP) after at least 5 minutes supine rest:
i. Systolic BP: 90 - 140 mmHg ii. Diastolic BP: 40 - 90 mmHg c. Supine heart rate
(after at least 5 minutes of rest): 40 - 90 beats per minute d. Postural drop
(standing BP taken after no more than 1 minute standing) of ≤20 mmHG (systolic) or ≤10
mmHg (diastolic) associated with clinically relevant symptoms.
11. Subject has a normal or clinically acceptable 12 lead ECG at screening. In addition:
1. If male, subject has a QTcF value ≤ 430 msec at screening.
2. If female, subject has a QTcF value ≤ 450 msec at screening.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Subject has any significant and relevant medical condition (including but not limited
to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological,
pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or
other major disorders), laboratory abnormality, or psychiatric illness that would
prevent the subject from participating in the study.
2. Subject has any condition including the presence of laboratory abnormalities, which
places the subject at unacceptable risk if he/she were to participate in the study.
3. Subject has any condition that confounds the ability to interpret data from the study.
4. Subjects who have:
a. previously been exposed to GED 0301; or b. been exposed to an investigational drug
(new chemical entity) within 90 days preceding the first dose administration, or five
half-lives of that investigational drug, if known (whichever is longer).
5. Subject has used any prescription drugs or over-the-counter medication (including
multi-vitamins) in the 14 days prior to the planned admission day.
1. Subject has consumed herbal remedies or dietary supplements containing St. John's Wort,
in the three weeks before the planned admission day.
6. Subject has any surgical or medical conditions possibly affecting drug absorption,
distribution, metabolism, and excretion, eg, bariatric procedure. Appendectomy and
cholecystectomy are acceptable.
7. Subject donated blood or plasma within 8 weeks before the first dose administration to a
blood bank or blood donation center.
8. Subject has a history of drug abuse (as defined by the current version of the Diagnostic
and Statistical Manual [DSM]) within 2 years before the first dose administration, or
positive drug screening test reflecting consumption of illicit drugs.
9. Subject has a history or clinical evidence of substance and/or alcohol abuse within the
12 months before screening. Alcohol abuse is defined as regular weekly intake of more than
14 units (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx).
10. Subject is known to have serum hepatitis or known to be a carrier of hepatitis B
surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the
test for human immunodeficiency virus (HIV) antibodies at screening.
11. Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products
(self reported).
12. Subject is part of the clinical staff personnel or a family member of the clinical site
staff.
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 Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects | NCT02957474 | Entailment |
2,820 | 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:
- Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
- Vital capacity of at least 75% of predicted
- Onset of weakness within 3 years prior to enrollment
- If patients are on riluzole, they must be on a stable dose for at least 30 days prior
to baseline visit
- Women of childbearing potential must be surgically sterile or using an effective
method of birth control and have a negative pregnancy test
- Willing and able to give informed consent
Exclusion Criteria:
- Diagnosis of other neurodegenerative disease
- Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day
- Clinically significant history of any unstable medical condition in past 30 days
- History of renal
- History of liver disease
- Current pregnancy or lactation
- Use of lithium within thirty days of enrollment
- Significantly limited mental capacity
- History of recent drug or alcohol abuse
- Use of any investigational drug within 30 days prior to enrollment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) | NCT00790582 | Entailment |
4,540 | 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:
- Age between 18 and 35 years (inclusive), in good general health and requesting
contraception.
- Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity
without hormonal contraceptive use).
Exclusion Criteria:
- Known or suspected pregnancy or is lactating.
- History of ectopic pregnancies.
- Any genital infection (until successfully treated).
- Abnormal uterine bleeding of unknown origin.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study | NCT00528112 | Contradiction |
744 | 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:
- Female
- 40 years and older
- Subjects who are willing and able to comply with x-ray and MRI procedures
- Evidence of a personally signed and dated consent document
Additional inclusion for normal controls:
- Infrequent knee pain, aching, or stiffness during the past year or infrequent use of
medication for treatment of knee pain during the past year
- No evidence of OA on either knee (i.e. K-L grade = 0 diagnosed by knee radiography)
Additional inclusion for OA patients:
- Pain, aching, or stiffness on most days of a month during the past year; or use of
medication for treatment of knee pain on most days of a month during the past year
- Kellgren-Lawrence Grade 2 or 3 of the study knee obtained on a Standard knee
radiograph (with either the same or less severe OA, or no OA in the contralateral
knee)
Exclusion Criteria:
- Subject is unable to undergo MRI because of contraindication
- Women at risk of pregnancy
- Weight greater than 250 lbs
- History of surgery in the study knee
- History of other diseases involving the study knee joint including inflammatory joint
diseases, crystalline disease, and infection of the study knee
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA) | NCT00665548 | Contradiction |
1,656 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Must be a current primary care clinic patient
Exclusion Criteria:
- Inability to provide 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.
| A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings ("CDE-EHR-PC" Study), Phase 1 | NCT02974335 | Entailment |
1,698 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Be an active patient of one of the participating Planned Parenthood health centers
- Own a smartphone
- Be fluent in English
- Be 17 to 20 years of age
- Be biologically able to become pregnant (to the best of their knowledge)
- Score at least 10 on the PHQ-8
- Have had penile-vaginal sex in the past 3 months
- Have had penile-vaginal sex at least once a week, on average
- Report having done at least one of the following during the 3 months preceding
eligibility screening: 1) Not using a condom every time they have sexual intercourse;
2) Used condoms, a diaphragm, cervical cap, spermicide, sponge, fertility awareness,
or withdrawal as a primary form of birth control; 3) Had sexual intercourse with more
than one person; 4) Had sexual intercourse within 2 hours after using drugs and
alcohol; and/or 5) Been treated for an STI/STD
Exclusion Criteria:
- Trying to get pregnant or currently pregnant at the time of eligibility screening
- Have given birth during the 6 months preceding eligibility screening
- Married or engaged to be married at the time of eligibility screening
Female
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
Subject must be at most 20 Years | Evaluation of Momentary Affect Regulation - Safer Sex Intervention | NCT04798248 | Entailment |
3,461 | 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:
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Minimum 1 year hearing aid experience
- Moderate-Severe (N3-N5) hearing loss or Normal Hearing
Exclusion Criteria:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to
the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09 | NCT04578457 | Entailment |
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