id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
39 | 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:
- Total testosterone level <240 ng/dL
- Serum LH and FSH levels within normal limits
Exclusion Criteria:
- Elevated prolactin
- Evidence of Benign Prostatic Hypertrophy
- History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or
any other malignancy
- Clinically significant endocrine/metabolic or cardiovascular disease
- Significant polycythemia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism | NCT00290134 | Contradiction |
4,274 | 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:
- Patients who can perform lung function tests and who can produce sputum (> 5 years of
age)
- (Fe)males between 6-64 years
Exclusion Criteria:
- Patients on the waiting lists for lung transplant.
- Pregnancy or breast feeding
- Patients can not take part in another 'inhalation'trial for Cystic Fibrosis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 64 Years | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function | NCT00996424 | Entailment |
2,520 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Healthy, female or male infants/children, aged 6 months through 7 years.
2. In generally good health (physical, mental, and social well-being, not merely the
absence of disease/infirmity), according to parent/legal guardian report.
3. Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).
4. Having mild to moderate eczema involving 3% to 20% of body surface area, and with EASI
score in the range of 1.1 to 20.0, further stratified into the following subgroups:
- Approximately 60% of subjects with clinically determined EASI score of 1.1-7.0
(mild)
- Approximately 40% of subjects with clinically determined EASI score of 7.1 to
20.0 (moderate)
5. Having a parent/legal guardian at least 18 years of age who regularly bathes the child
and otherwise cares for the child, and who presents proof of guardianship (eg,
insurance card, certificate of residence, or copy of officially issued family
registration) at the baseline visit.
6. Having a parent/legal guardian willing to provide written informed consent and who can
read, speak, write, and understand English.
7. Whose parent/legal guardian is willing to sign a photography release.
8. Willing, and having a parent/legal guardian who is willing, to cooperate and
participate by following study requirements (including those outlined in section 7.3)
for the duration of the study and to report any changes in health status or
medications, AE symptoms, or reactions immediately.
9. Willing to bring in currently used moisturizer and cleanser to visit 1 for
documentation by clinic staff.
Exclusion Criteria:
1. Diagnosed with known allergies to skin care products or ingredient(s) in the test
product.
2. History of skin cancer within the past 5 years.
3. Individuals who have clinically active bacterial, fungal, or viral skin infections or
those who have a history of recurrent cutaneous infections, according to subject
self-report.
4. Individuals whose use of topical corticosteroids or systemic medications for their
eczema has not been stable for at least 6 weeks prior to study start. This includes
medicines such as hydrocortisone, clobetasol, betamethasone, halobetasol, fluocinide,
diflorasone, mometasone, halcinonide, desoximetasone, pimecrolimus, tacrolimus,
crisabarole, and fluticasone.
5. Having a health condition and/or pre-existing or dormant dermatologic disease on the
body (eg, psoriasis, rosacea, acne [severe acne, acne conglobata, nodules, or cysts],
seborrheic dermatitis, severe excoriations.) that the Investigator or designee deems
inappropriate for participation or could interfere with the outcome of the study.
6. Who have observable suntan, scars, nevi, excessive hair, tattoos, or other dermal
conditions on the body that might influence the test results in the opinion of the
Investigator or designee.
7. Having a history of immunosuppression/immune deficiency disorders (including HIV
infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), had an
organ transplant (heart, kidney, etc), or currently using oral or systemic
immunosuppressive medications and biologics that are not used for the treatment of
eczema (eg, azathioprine, belimumab, Cimzia, Cosentyx, cyclophosphamide, cyclosporine,
Enbrel, Humira, Imuran, Kineret, mycophenolate mofetil, methotrexate, Orencia,
Remicade, Rituxan, Siliq, Simponi, Stelara, Taltz) and/or undergoing radiation or
chemotherapy as determined by study documentation.
8. Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or
hypothyroidism that is not controlled by diet or medication; experiencing asthma
flares or having multiple health conditions.
9. Having started a long-term medication within the last 2 months.
10. With any planned surgeries and/or invasive medical procedures during the course of the
study. Non-invasive planned surgeries will be reviewed for their impact on the study
outcome and acceptability by the Investigator or designee.
11. Who are currently participating in any other clinical trial at Stephens, another
research facility, or doctor's office
12. Who have participated in any clinical trial or experimental treatment involving the
test area within 4 weeks prior to inclusion into the study at Stephens, at another
research facility or doctor's office.
13. Infants/children with a history of or exhibiting signs and symptoms of any systemic
disease that may interfere with study evaluations (eg, urinary tract infections,
significant bowel or urinary congenital malformation).
14. Infant/child who has had a recent change in her/his dietary intake or who has had
severe diaper rash within 1 week prior to baseline.
15. Individuals who have received PUVA therapy for atopic dermatitis within 4 weeks prior
to inclusion in the study.
16. Individuals who have received phototherapy within 2 weeks prior to inclusion in the
study.
17. Individuals who have changed the type of moisturizer or cleanser used within the last
6 weeks prior to inclusion in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 7 Years | A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer | NCT03719742 | Entailment |
1,970 | 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. The patient has histologically or cytologically confirmed gastric carcinoma, including
gastric adenocarcinoma or GEJ adenocarcinoma. (Patients with adenocarcinoma of the
distal esophagus are eligible if the primary tumor involves the GEJ.)
2. The patient has metastatic disease or locally recurrent, unresectable disease.
3. The patient has measureable or evaluable disease as determined by standard computed
tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable,
nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas
of known disease, or peritoneal nodules that are too small to be considered measurable
by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) (48).
4. The patient has experienced disease progression during treatment or within 4 months
after the last dose of first-line therapy for metastatic disease.
- Acceptable prior chemotherapy regimens for this protocol are combination
chemotherapy regimens that include platinum and/or fluoropyrimidine components
(acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin;
acceptable prior fluoropyrimidine agents are 5-FU, capecitabine, or S-1).
Regimens including a third agent, such as an anthracycline or a taxane, are
acceptable provided a fluoropyrimidine and/or a platinum were used.
- Recurrence during or within 6 months of completion of adjuvant chemotherapy
(capecitabine, 5-FU, or TS-1) will be considered as first-line chemotherapy.
5. The patient's disease is not amenable to potentially curative resection.
6. The patient is ≥18 years of age.
7. The patient has resolution to Grade ≤1 (or to Grade ≤2 in the case of neuropathy) by
the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-
CTCAE), Version 4.03, of all clinically significant toxic effects of prior
chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of
alopecia).
8. The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS)
score of 0 or 1.
9. The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL
(25.65 µmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0
times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver
metastases).
10. The patient does not have:
- cirrhosis at a level of Child-Pugh B (or worse) or
- cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is
defined as ascites from cirrhosis requiring diuretics or paracentesis.
11. The patient has adequate renal function as defined by a serum creatinine ≤1.5 times
the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute
(that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to
calculate creatinine clearance must be performed).
12. The patient's urinary protein is ≤1+ on dipstick or routine urinalysis (UA; if urine
dipstick or routine analysis is ≥2+, a 24-hour urine collection for protein must
demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol).
13. The patient has adequate hematologic function, as evidenced by an absolute neutrophil
count (ANC) ≥1000/µL, hemoglobin ≥9 g/dL (5.58 mmol/L), and platelets ≥100,000/µL.
14. The patient must have adequate coagulation function as defined by international
normalized ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) ≤5 seconds above
the ULN (unless receiving anticoagulation therapy). Patients on full-dose
anticoagulation must be on a stable dose (minimum duration 14 days) of oral
anticoagulant or low molecular weight heparin. If receiving warfarin, the patient must
have an INR ≤3.0 and no active bleeding (that is, no bleeding within 14 days prior to
first dose of protocol therapy) or pathological condition present that carries a high
risk of bleeding (for example, tumor involving major vessels or known varices).
Patients on anticoagulation therapy with unresected primary tumors or local tumor
recurrence following resection are not eligible.
15. If the patient has received prior anthracycline therapy as part of his or her
first-line regimen, the patient is able to engage in ordinary physical activity
without significant fatigue or dyspnea (equivalent to New York Heart Association Class
I function) (49).
16. Because the teratogenicity of ramucirumab is not known, the patient, if sexually
active, must be postmenopausal, surgically sterile, or using effective contraception
(hormonal or barrier methods).
17. Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to enrollment.
18. The patient is able to provide informed written consent.
19. Feasible biopsy site
Exclusion Criteria:
1. The patient has documented and/or symptomatic brain or leptomeningeal metastases.
2. The patient has experienced any Grade 3 to 4 GI bleeding within 3 months prior to
enrollment.
3. The patient has experienced any arterial thromboembolic events, including but not
limited to myocardial infarction, transient ischemic attack, cerebrovascular accident,
or unstable angina, within 6 months prior to enrollment.
4. The patient has an ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia,
uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled
medical disorders in the opinion of the treating physician.
5. The patient has ongoing or active psychiatric illness or social situation that would
limit compliance with treatment.
6. The patient has uncontrolled or poorly controlled hypertension (>160 mmHg systolic or
>100 mmHg diastolic for >4 weeks) despite standard medical management.
7. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days
prior to enrollment.
8. The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted
therapy for gastric cancer within 2 weeks prior to enrollment.
9. The patient has received any investigational therapy within 30 days prior to
enrollment.
10. The patient has undergone major surgery within 28 days prior to enrollment, or
subcutaneous venous access device placement within 7 days prior to enrollment.
11. The patient has received prior therapy with an agent that directly inhibits VEGF
(including bevacizumab), or VEGF Receptor 2 activity, or any antiangiogenic agent.
12. The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal
anti- inflammatory drugs (NSAIDs; including ibuprofen, naproxen, and others),
dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose
325 mg/day) is permitted.
13. The patient has elective or planned major surgery to be performed during the course of
the clinical trial.
14. The patient has a known allergy to any of the treatment components.
15. The patient is pregnant or breastfeeding.
16. The patient is known to be positive for infection with the human immunodeficiency
virus (HIV).
17. The patient has known alcohol or drug dependency.
18. The patient has a concurrent active malignancy other than adequately treated
nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm.
19. The patient has a known hypersensitivity to ramucirumab or any of the excipients.
20. The patient may not have received more than 1 prior therapy in the metastatic setting.
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.
| Ramucirumab/Paclitaxel as Second-line Treatment in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma With Integrative Genomic Analysis | NCT02628951 | Entailment |
4,334 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Male subjects in the range of age from 18 to 55 years.
2. Body weight within ± 15% of ideal weight as related to height and body frame according
to Life Insurance Corporation (LIC) Chart. (Appendix A)
3. Subjects with normal findings as determined by baseline history, physical examination
and vital signs (blood pressure, pulse rate, respiration rate and axillary
temperature).
4. Subjects with normal findings as determined by Haemogram with ESR,
Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and
Urinalysis, ECG, X-ray (X-ray if taken).
5. Willingness to follow the protocol requirement as evidenced by written, informed
consent.
6. Agreeing to, not using any medication prescription and over the counter medications
including vitamins and minerals for 14 days prior to study & during the course of the
study.
7. No history or presence of significant alcoholism or drug abuse in the past one year.
8. Non-smokers, ex smokers and moderate smokers will be included. "Moderate smokers are
defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who
completely stopped smoking for at least 3 months."
Exclusion Criteria:
1. Requiring medication for any ailment including enzyme-modifying drugs in the previous
28 days, before day 1 of dosing.
2. Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract, blood-forming organs etc.
3. History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary,
neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or
psychiatric diseases.
4. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.
5. History or presence of malignancy or other serious diseases.
6. Refusal to abstain from food for at least ten (10) hours prior to administration of
the study drug and for four (4) additional hours each, post dose during each study
period.
7. Any contraindication to blood sampling.
8. Refusal to abstain from water for at least one (1) hour prior to study drug
administration on dosing day of each study period and for at least two (2) additional
hours, post dosing except 240 mL administered during administration of the dose.
9. Use of xanthine-containing beverages or food and grapefruit or grapefruit products for
48 hours prior to each drug dose.
10. Blood donation 90 days prior to the commencement of the study.
11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
12. Subjects having contradiction or hypersensitivity to Tacrolimus or related group of
drugs or any excipients of the products.
13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period.
14. Found positive in Breath alcohol test done at the time of screening or on the day of
enrollment for each study period or for every ambulatory sample.
15. History or presence of problem in swallowing tablets or capsules.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition | NCT01080469 | Contradiction |
2,390 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- children with Duchenne muscular dystrophy (DMD). Diagnosis with DMD was established
according to DMD diagnostic criteria (Jennekens et al., 1991).
- children with juvenile dermatomyositis (JDM) according to Bohan and Peter diagnostic
criteria ( (Bohan and Peter, 1975).
Exclusion Criteria:
- Patients with age less than 2 years were excluded from the study due to inability to
perform manual muscle testing and functional scales.
- If no final diagnosis could be established.
- The presence of a concomitant illness that may result in peripheral neuropathy or
myopathy.
No condition on gender to be admitted to the trial.
Subject must be at least 2 Years old.
Subject must be at most 16 Years | Quantitative Muscle Ultrasound as a Marker of Progression in Children With Muscular Diseases | NCT03786913 | Entailment |
1,519 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- History of hypertension
- At least one blood pressure value that is greater than recommended in the year prior
to study entry
- An enrolled physician has provided care for managing the participant's blood pressure
for at least 1 year prior to study entry
- Access to the internet at home or at work
- Personal email account
- At least one blood pressure value greater than 140/90 mm Hg (130/90 mm HG for diabetes
patients) in the one year prior to study entry
Exclusion Criteria:
- Unable to speak and read English
- Pregnant or plans to become pregnant in the year following study entry
- Cognitively impaired
- Currently incarcerated
- Participating in another clinical research study
- Planning on moving out of the area in the year following study entry
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Individually Tailored Web-Based Program to Improve Blood Pressure Control | NCT00377208 | Entailment |
2,705 | 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 scheduled for elective laparoscopic abdominal surgeries (inguinal hernia
repair-missed IUCD extraction-appendectomy-ovarian vein ligation)
- Patient aged 18-60 years
- American Society of Anesthesiologists Physical Status I or II.
Exclusion Criteria:
- Patient refusal
- Body mass index (BMI) > 40 kilogram/square meter
- Contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic,
sever thrombocytopenia or infection at puncture site)
- Sepsis
- Chronic pain condition requiring the intake of opioids at home
- Any significant neurological, cardiovascular or respiratory disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Lateral Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Surgery | NCT04553991 | Entailment |
3,983 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2)
based on fixed-flexion x-ray radiological findings for osteophytes and joint space
narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic
criteria for knee OA
- 35-80 years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding
enrollment
- Report that knee pain negatively affects quality of life
- Willing not to use any cream, gel, or topical solution during the administration of
treatment other than the approved ultrasound gel provided to the subject at the
initiation of the study
- Deemed appropriate by their physician or by the study site physician to participate
Exclusion Criteria:
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make
participation in the study unacceptable, including, but not limited to, the subject's
ability to understand and follow instructions.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the
affected knee in the past 6 months
- Are non-ambulatory
- Participated in a clinical trial for an investigational drug and/or agent within 30
days prior to screening
- Modify their medications during the course of the study (medications and doses must
remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 Years | Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial | NCT02083861 | Entailment |
5,609 | 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
- Member of a Girl Scout troop with at least eight 5th grade girls
- Member of the Greater Minneapolis or St. Croix Valley Girl Scout organization
- Only troops with unanimous parental consent will be included in the trial
Female
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 11 Years | Program to Prevent Osteoporosis in Girls | NCT00063024 | Contradiction |
4,455 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion criteria
- Tendinopathy present in either lateral or medial elbow
- Pain by palpation at the lateral or medial epicondyle of the elbow
- Baseline elbow pain >3/10 during resisted wrist extension
- History of at least two periods of elbow pain lasting more than 10 days
- Symptoms lasting at least 3 months or longer
- Body Mass Index between 20 and 35.
- Commitment to comply with all study procedures
- The patient must give written informed consent
Exclusion Criteria:
- Presence of full tendon tear
- Body mass index> 35
- Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic
necrotizing vasculitis)
- Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
- Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9)
- Patients receiving immunosuppressive treatments
- Received local steroid injection within 3 months of randomization received
nonsteroidal antiinflammatory, opioids or oral corticosteroids within 15 days before
inclusion in the study
- Severe heart diseasePatients unable to comply with scheduled visits, for work or spend
long periods away from their habitual residence.
- Patients with active cancer or cancer diagnosed in the last five years.
- Analytical Diagnosis Hepatitis B, C or HIV infection.
- Pregnant or lactating.
- People who are taking a drug in clinical investigation or participated in any
investigational study clinic (with an authorized or not) within 30 days prior to
randomization.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | Platelet Rich Plasma (PRP) in Chronic Epicondylitis | NCT01945528 | Contradiction |
86 | 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:
- severely obese (BMI >= 35) male veterans with hypogonadotropic hypogonadism defined as
low total testosterone (lower than 300 ng/dl) between 35-65 years of age
- Luteinizing hormone (LH) lower than 9 U/L
- estradiol above 40 pmol/l
- normal Free T4 (FT4), Thyroid Stimulating Hormone (TSH), prolactin, cortisol,
Adrenocorticotropic hormone (ACTH), and Insulin-like growth factor-1 (IGF-1) levels.
- Subjects must be ambulatory, willing and able to provide written informed consent
Exclusion Criteria:
- clinical or biochemical evidence of pituitary or hypothalamic disease
- any ongoing illness that, in the opinion of the investigator, could prevent the
subject from completing study
- any med known to affect gonadal hormones, steroid hormone-binding globulin or bone
metabolism, e.g.,
- androgens
- estrogens
- glucocorticoids
- phenytoin
- bisphosphonates
- any medication known to interfere with anastrozole metabolism, e.g. tamoxifen or
estrogens
- diseases known to interfere with bone metabolism as
- osteoporosis
- hyperparathyroidism
- untreated hyperthyroidism
- osteomalacia
- chronic liver disease
- renal failure
- hypercortisolism
- malabsorption
- immobilization
- patients with a Total T score lower than -2.0 at Lumbar Spine or Left Femur.
- patients with symptomatic prostate disease, prostate carcinoma, or elevated serum
Prostate-specific antigen (PSA) >4 ng/ml or >3 for subjects with a family history of
prostate cancer among 1st degree relatives needs urologic evaluation before admission
into study
- hematocrit greater than 50%
- untreated severe obstructive sleep apnea
- severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS)
above 19
- documented heart failure
- cardiovascular disease
- liver disease
- excessive alcohol or substance abuse
- unstable weight (changes in weight more than ± 2 kg) during the last 3 months
- history of bariatric surgery
- subjects with elevated liver enzymes as alanine transaminase (ALT), aspartate
aminotransferase (AST), Alkaline phosphatase (ALP), and bilirubin at greater than
twice the upper limit of normal.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot) | NCT02959853 | Contradiction |
3,634 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB ≤ 0.30 IU/mL and/or FVIII:C ≤
0.40 IU/mL
- Treatment at a Hemophilia treatment center in the Netherlands
- All types of VWD
- All ages
Exclusion Criteria:
- Other known bleeding disorders present.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Von Willebrand Disease in the Netherlands | NCT03521583 | Entailment |
2,766 | 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. Age ≥ 18 year
2. Informed consent
3. a diagnosis of an inguinal hernia
4. ASA group ≤ 3
5. BMI ≤ 35
Exclusion Criteria:
1. Communication problems
2. No consent
3. Open procedure (not laparoscopic)
4. ASA-group 4
5. Use of Steroid or immunosuppressive tretament
6. Regular morphine use.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair | NCT01969006 | Entailment |
2,494 | 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:
- All residents aged over 40 in Namil area
Exclusion Criteria:
- Individuals registered but not actually living in this area
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Screening for Glaucoma in Namil Area, South Korea | NCT00727168 | Entailment |
1,752 | 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:
- outpatients
- chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation),
evaluated by standard questionnaire
- undergo upper digestive endoscopy
Exclusion Criteria:
- age less than 18 years old or more than 90 years old
- unable to complete upper endoscopy
- known diagnosis of gastroesophageal malignancy
- follow-up visit for known gastroesophageal lesion identified by previous upper
endoscopy
- failure to obtain informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms | NCT00730106 | Contradiction |
2,940 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Able to comprehend and willing to sign an Informed Consent Form (ICF)
2. Male or female 18 years of age or older
3. A diagnosis of familial or sporadic ALS (defined as meeting the possible,
laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
according to the World Federation of Neurology El Escorial criteria)
4. Upright Slow Vital Capacity (SVC) >50 % of predicted for age, height and sex
5. At least 4 of the 12 ALSFRS-R questions must be scored 2 or 3
6. Diminished but measurable maximum voluntary grip strength in at least one hand; i.e.,
between 10 and 50 pounds (females) and 10 and 70 pounds (males)
7. Able to swallow tablets without crushing
8. A caregiver (if one is needed) who can and will observe and report the patient's
status
9. Pre-study clinical laboratory findings within normal range or, if outside of the
normal range, deemed not clinically significant by the Investigator
10. Male patients must agree for the duration of the study and 10 weeks after the end of
the study to use a condom during sexual intercourse with female partners who are of
reproductive potential and to have female partners use an additional effective means
of contraception (e.g., diaphragm plus spermicide, or oral contraceptives) or the male
patient must agree to abstain from sexual intercourse during and for 10 weeks after
the end of the study
11. Female patients must be post-menopausal (≥ 1 year) or sterilized, or, if of
childbearing potential, not be breastfeeding, have a negative pregnancy test, have no
intention to become pregnant during the course of the study, and use contraceptive
drugs or devices as detailed in item 10 for the duration of the study and for 10 weeks
after the end of the study
12. Patients must be either on a stable dose of riluzole 50 mg twice daily for at least 30
days prior to screening or have not taken riluzole for at least 30 days prior to
screening and are willing not to begin riluzole use during the conduct of this study.
Exclusion Criteria:
1. Any use of non-invasive positive pressure ventilation (NIPPV, e.g. continuous positive
airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for any portion of
the day, or mechanical ventilation via tracheostomy, or on any form of oxygen
supplementation
2. Patients with a diaphragm pacing system (DPS) at study entry or who anticipate DPS
placement during the course of the study
3. Body Mass Index (BMI) of 19.0 kg/m2 or lower
4. Unwilling to discontinue tizanidine and theophylline-containing medications during
study participation
5. Serum chloride < 100 mmol/L
6. Neurological impairment due to a condition other than ALS, including history of
transient ischemic attack (TIA) within the past year
7. Presence at screening of any medically significant cardiac, pulmonary,
gastrointestinal (GI), musculoskeletal, or psychiatric illness that might interfere
with the patient's ability to comply with study procedures or that might confound the
interpretation of clinical safety or efficacy data
8. Has taken any investigational study drug within 30 days or 5 half-lives of the prior
agent, whichever is greater, prior to dosing
9. Previously received CK-2017357 in any previous clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS) | NCT01709149 | Entailment |
3,533 | 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:
- Healthy male and female subjects aged 18-68 years, non-smokers or regular smokers of
greater than 6 cigarettes a day, BMI 16-29
- Male and female Cushing's syndrome aged 18-68 years with biochemically confirmed based
on cortisol and ACTH measurements, dexamethasone suppression test and 1 of the
following positive investigations (24 hour urine cortisol, salivary/serum cortisol
profile). Visible tumour in the pituitary and/or one of the following positive tests
pointing to pituitary source for ACTH overproduction (bilateral petrosal sinus
sampling, corticotropin releasing hormone test, high dose dexamethasone suppression
test) or adrenal tumour considered fit for surgery. No contraceptives for 6 weeks
prior to sampling (females only). Patients on medical therapy e.g. metyrapone for
Cushings to have a 2 week washout off treatment prior to sampling
- Male and female aged 18 -68 years with biochemically confirmed adrenal insufficiency
based on basal cortisol and ACTH measurements and/or Synacthen test +/- adrenal
antibodies, and on oral hydrocortisone or cortisone acetate glucocorticoid replacement
therapy
- Female aged 18-68 years with biochemically confirmed salt-wasting or simple virilising
CAH based on 17OHP, cortisol, androgen, renin and ACTH measurements; disease causing
mutation in CYP21A2 and/or synacthen testing.
- Male and female subjects aged 18 -68 years with biochemical confirmation of PHA based
on a valid pathological aldosterone/renin ratio and non-suppressible aldosterone
levels on one of the currently used confirmatory tests (saline/oral fludrocortisone
test). Unilateral only - diagnostic CT and/or adrenal vein sampling
- Male and female subjects aged 18-68 years with biochemically confirmed GHD (arginine
growth hormone releasing hormone test, insulin tolerance test, known pituitary disease
with confirmed pan hypopituitarism)
- Male and female aged 18-68 years with biochemically confirmed acromegaly (oral glucose
tolerance test or GH day curve and diagnostic insulin growth factor 1 levels) with
radiological evidence of a pituitary adenoma.
Exclusion Criteria:
- Healthy controls undergoing or planning pregnancy or lactating women. Presence of any
unstable pathological condition in past 3 months. On any regular prescribed
medications (except contraception). Prior or current history of an endocrine disorder.
Known allergy to Lignocaine, plasters. Current or past steroid therapies (oral,
inhaled, parenteral or topical) or other interfering medication in last 3 months.
Regular alcohol intake great then 26units of alcohol per week.Taking of any
investigational drug within the past two months. Abuse of illicit drugs. Occasional
smokers of cigarettes not able to abstain for sampling period or smoking less than 6
cigarettes a day. Needle phobia. Interfering diet/over the counter herbal remedies in
last 14 days.
- Cushing syndrome: Undergoing or planning pregnancy (females only). Known allergy to
Lignocaine. Adrenal cancer (post-operative histology diagnosis),cyclic Cushings,
squamous cell lung carcinoma, bronchial carcinoid and occult ectopic Cushings.
Concurrent use of steroid therapy for any other medical condition (oral, inhaled,
parenteral or topical)
- Adrenal insufficiency: Undergoing or planning pregnancy, known allergy to Lignocaine,
use of other steroid medications other than their standard glucocorticoid and
fludrocortisone replacement, other interfering medication or diet within 2 weeks of
sampling.
- CAH: Males, females undergoing or planning pregnancy, known allergy to Lignocaine, use
of other steroid medications other than their standard glucocorticoid and
fludrocortisone replacement or other interfering medication or diet within 2 weeks of
sampling
- Primary hyperaldosteronism: Undergoing or planning pregnancy (females only), known
allergy to Lidocaine, known adrenal failure and/or on steroid therapy (oral, inhaled,
parenteral or topical), concurrent use of interfering medication ( i.e. specific
interfering antihypertensive medication) or diet within 2-4 weeks of ultradian
sampling
- GHD: Undergoing or planning pregnancy (females only) or known allergy to Lignocaine
- Acromegaly: Undergoing or planning pregnancy (females only), known allergy to
Lignocaine treatment with somatostatin analogues and other interfering medication
(e.g. oestrogens)
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 68 Years | Dynamic Hormone Diagnostics in Endocrine Disease | NCT02934399 | Entailment |
2,878 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including
laboratory supported probable, probable, or definite ALS;
2. Subjects who have never taken riluzole tablets, OR Subjects who previously took
riluzole tablets but discontinued at least 1 month prior to the screening visit.
Subjects must not have had ALT or AST > 5 x ULN while taking riluzole tablets, or any
other clinically significant tolerability issues (e.g., hypersensitivity reactions) in
the judgement of the investigator;
3. Subjects determined by the investigator to be medically stable;
4. Subjects determined by the investigator to be willing and physically able to complete
the study as designed, with or without caregiver assistance.
Exclusion Criteria:
1. Target Disease Exceptions
2. Medical History Exceptions
1. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
2. Subject is known to have any other acute or chronic liver disease that is
clinically significant in the investigator's judgment;
3. Subject has a history of a clinically significant medical condition that would
interfere with the subject's ability to comply with study instructions, would
place the subject at increased risk, or might confound the interpretation of the
study results in the investigator's judgment;
4. Any other sound medical, psychiatric and/or social reason in the investigator's
judgment;
3. Physical and Laboratory Test Findings
1. Positive urine pregnancy test in WOCBP at screening;
2. Subject has evidence of organ dysfunction or any clinically significant deviation
from normal in physical examination, vital signs, or other determinations beyond
what is consistent with the target population, in the investigator's judgment;
3. Subject has liver function testing abnormalities (ALT, AST , or total bilirubin)
that are > 1 x ULN;
4. Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or
protocol procedures.
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.
| Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS | NCT03520517 | Entailment |
999 | 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:
- 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 | Entailment |
1,792 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients undergoing the first upper gastrointestinal endoscopy.
Exclusion Criteria:
- The patients had previously performed endoscopy and any esophageal, gastric or
duodenal surgery.
- The patients couldn't complete the questionnaire survey under the guidance of
physicians at the appointment of the upper gastrointestinal endoscopy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Correlation of Endoscopic Findings and Symptoms in Patients Undergoing the First Upper Gastrointestinal Endoscopy | NCT03736824 | Contradiction |
5,509 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- patients with a first episode of biopsy and/or scintigraphy proven giant cell
arteritis
- patients with a previous diagnosis of giant cell arteritis, in whom a yearly computed
tomography of the aorta is available can opt to participate in this study
- informed consent form has to be signed by all patients
Exclusion Criteria:
- patients already treated with steroids before performance of PET-scintigraphy
- earlier episodes of giant cell arteritis, without documentation of the aortic diameter
at that moment
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.
| Prospective Follow-up Study of the Aortic Diameter in Patients With Giant Cell Arteritis | NCT01588483 | Entailment |
434 | 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:
- Age > 35 years
- Day 3 serum FSH level > 10m IU/ml
- Number of antral follicles measuring 4-8mm during the early phase < 6
- Small ovarian volume
- AMH < 1
- Prior poor ovarian response to COH (oocytes < 5)
Exclusion Criteria:
- Polycystic ovarian syndrome patients
- Patients with Endometriosis
- Normal responders to ovulation induction
- Patients having ovarian cyst
- Patients receiving ovulation induction in the preceding cycle
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 42 Years | Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation | NCT02342197 | Contradiction |
1,780 | 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. Aged 18 years and older;
2. Presence of dyspeptic symptoms according with Rome IV criteria (Discomfort was
characterized by the presence of one or more symptoms that included bothersome
postprandial fullness, bothersome early satiation, bothersome epigastric pain,
bothersome epigastric burning, Symptoms had to be present for at least 3 months within
the preceding 6 months);
3. From March 2018 to January 2019, patient went to the Gastroenterology clinics of the
second affiliated hospital of xi'an jiaotong university, Xijing Hospital, Tangdu
Hospital, Xi'an No.3 Hospital, and received gastroscopy;
4. Upper abdominal ultrasonography, blood routine examination, liver function test were
conducted within six months.
Exclusion criteria:
1. History of esophagitis or ulcer disease or other organic upper gastrointestinal
disease, pancreaticobiliary disease, metabolic disease(abnormal thyroid function,
diabetes );
2. Were pregnant, might become pregnant, or were lactating;
3. Major abdominal surgery;
4. Severe neurological disorder, psychological diseases; or with severe hepatic, renal or
respiratory dysfunction;
5. Known or suspected liver dysfunction, including NASH, HBV or HCV-related hepatitis;
6. History of gastroscope within 1 year;
(6) Current antidepressant, steroids or NSAID use; (7) Patients who had only reflux-related
symptoms or who had predominantly reflux-related symptoms; (8) Not willing to participate
in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Predictive Value of Alarm Symptoms in Patients With Dyspepsia Based on Roman IV | NCT03479528 | Contradiction |
3,501 | 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:
- Established autoimmune adrenal failure for >1yr age 16 to 65
Exclusion Criteria:
- Significant cardio-respiratory, chronic renal or non-autoimmune liver disease;
malignancy
- Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic
ulcer disease
- Pregnancy, breast feeding or plan for pregnancy within 9 months
- Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy
etc.)
- Known hypersensitivity or allergy to Synacthen
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 66 Years | Revival of Stem Cells in Addison's Study | NCT01371526 | Contradiction |
864 | 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:
- Joint pain related to daily activities;
- No morning joint stiffness greater than 30 minutes;
- Age between 30 and 95 years.
Exclusion Criteria:
- History of previous knee surgery.
- History of fracture in the knee region.
- History of any secondary OA associated with any cystic arthropathy.
- Any treatment for the knee with methotrexate.
- History of hemorrhagic disorders.
- History of any infiltration of the knee during the previous 6 months (eg
corticosteroids and hyaluronic acid).
- Morbid obesity.
- History of severe psychiatric disorders.
- History of skin cancer.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 95 Years | Effects of Sand Treatment on Osteoarthritis | NCT03943303 | Entailment |
157 | 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, ages 18 to 65 Serum total testosterone less than or equal to 250 ng/dL Naive to
androgen replacement therapy Subject must be on stable doses of thyroid or adrenal
replacement hormones for at least 14 days prior to enrollment
Exclusion Criteria:
Significant intercurrent disease of any type, in particular, liver, kidney or heart
disease, uncontrolled diabetes mellitus or psychiatric illness. Patients with treated
hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering
mediation for at least three months. For non-insulin dependent diabetic subjects, HbA1c>9%.
Abnormal prostate digital rectal examination, elevated PSA (serum PSA >4ng/mL), AUA Sympton
Score greater than or equal to 15 points, and a history or prostate cancer.
Serum transaminases >2X upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
History of severe or multiple allergies, severe adverse drug reaction or leucopenia. Known
hypersensitivity to lidocaine or all surgical dressings.
History of abnormal bleeding tendencies. Oral, topical, or buccal T therapy within the
previous week, or intramuscular T injection within the previous 4 week.
Use of dietary supplements that may increase serum T, such as androstenedione or DHEA,
within the previous 4 weeks.
Know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile
acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol.
Smokers who are unable to refrain from smoking during confinement periods. History of, or
current evidence of, abuse of alcohol or any drug substance. Poor compliers or those
unlikely to attend. Receipt of any drug as part of a research study within 30 days of
inital dose administration in this study.
Blood donation (usually 550 mL) within the 12-week period before the initial study dose.
Hematocrit less than 35%. Known clinical polycythemia or hematocrit greater than 50%.
Current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers,
or barbiturates.
History of sleep apnea.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men | NCT02697188 | Entailment |
4,481 | 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. A eumenorrheic healthy woman with a regular menstrual cycle for three months,
predictable, and a period between 24-38 days that lasts less than 8 days.
2. No hormonal contraceptives have been used in the past six months.
3. No history of smoking, drinking or drug abuse.
Exclusion Criteria:
1. Women with systemic diseases, cardiovascular diseases, liver diseases, kidney
diseases, diabetes or thyroid diseases.
2. Taking any medicine due to chronic disease
3. Women with mental illness
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire | NCT04452227 | Contradiction |
6,701 | 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:
- 40-70 years old
- having type 2 diabetes
- BMI 20-35 kg/m2
- having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous physical
activity < 150 minutes per week)
- willingness to undergo randomization
- being in the possession of personally owned smart phone
Exclusion Criteria:
- not being able to walk for 15 minutes for any (medical) reason
- currently engaged in an (medical) exercise program
- plan to move out of the study area in the next 12 months
- (digital) illiteracy or being unable to read Dutch
- a history of any cardiovascular event (including stroke) three months prior to
possible inclusion
- a history of signs or symptoms of ischemic heart disease and(or) heart failure three
months prior to possible inclusion
- a history or signs or symptoms of peripheral arterial disease three months prior to
possible inclusion
- a history or signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers
three months prior to possible inclusion
- a history of sign or symptoms of severe diabetic retinopathy three months prior to
possible inclusion
- a history or sign or symptoms of severe osteoarthritis or severe joint complaints
three months prior to possible inclusion
- a history or signs or symptoms of COPD (eligible are those participants with a COPD
Gold classification ≤ I)
- uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
- uncontrolled hypertension (i.e., systolic / diastolic blood pressure ≥ 180 / 95 mmHg)
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 | Light Intensity Physical Activity Trial | NCT03415880 | Contradiction |
6,995 | 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:
- Aged 70 years or older.
- Family history of parent, brother, or sister who has, or had, serious age-related
memory loss, senility, dementia, or Alzheimer's disease.
- Study partner available to provide information on the cognitive status of the
participant and to assist with monitoring of trial medications, if needed.
- Sufficient fluency in written and spoken English to participate in study visits and
neuropsychological testing.
- Willingness to limit use of the following for the duration of the study: vitamin E (at
doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor
antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic
doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
- Ability and intention to participate in regular study visits, in the opinion of the
study physician.
- Provision of informed consent.
Exclusion Criteria:
- History of peptic ulcer disease with bleeding or obstruction.
- Clinically significant liver or kidney disease.
- History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other
NSAIDs.
- Use of anti-coagulant medication.
- Cognitive impairment or dementia.
- Current alcohol abuse or dependence
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 70 Years old.
| Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) | NCT00007189 | Entailment |
680 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Hemochromatosis--Genetic Prevalence and Penetrance | NCT00006312 | Entailment |
2,718 | 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:
- Inguinal hernia,
- femoral hernia
Exclusion Criteria:
- pregnancy,
- not able to understand patient information
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate | NCT02457728 | Entailment |
4,705 | 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:
- indication for hysterectomy for benign disease or prophylactic surgery due to
hereditary cancer
- size of uterus and vagina allows for retrieval by the vaginal route
- maximum uterine size equivalent to 16 weeks of pregnancy
- informed consent
Exclusion Criteria:
- malignant disease
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopic surgery
- women with pacemaker or other implants where electrosurgery is to be avoided
- immunoincompetent women
- simultaneous need for prolapse surgery
- women with known defects of the hemostasis
- allergies towards metronidazole and doxycycline
- inability to understand patient information
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
| Minimally Invasive Benign Hysterectomy | NCT01865929 | Entailment |
4,246 | 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:
- infertile men with previously abnormal semen analyses.
- Control group: fertile adult males
Exclusion Criteria:
- Proxceed use within 3 months of the start of study.
- Vitamin E supplements with > 45 IU daily
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Vitamin E and Male Infertility | NCT00178516 | Entailment |
2,201 | 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:
- Hyperuricemic or gout patients
- Serum urate level:
>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension,
diabetes or metabolic syndrome, or >= 9.0mg/dL
Exclusion Criteria:
- Gouty arthritis within two weeks before start of study treatment
- Secondary hyperuricemia
- HbA1c: >= 8.4%
- Uric acid-overproduction type in the classification of hyperuricemia
- History of, clinically significant cardiac, hematologic and hepatic disease
- Kidney calculi or clinically significant urinary calculi
- eGFR: < 30mL/min/1.73m^2
- Systolic blood pressure: >= 180 mmHg
- Diastolic blood pressure: >= 110 mmHg
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.
| Study of FYU-981 in Hyperuricemia With or Without Gout | NCT03006445 | Contradiction |
6,475 | 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:
- Participants must be over the age of 18 years old.
- Participants must have a current diagnosis of moderate-to-severe
erythematotelangiectatic or papulopustular rosacea or free of rosacea to serve as
control.
- Participants must have the ability to understand and communicate with the
investigator.
- Participants must be willing and comply with the requirements of the protocol.
- Participants must provide written informed consent
Exclusion Criteria:
- Subjects unable to provide informed consent.
- Subjects with significant medical history or concurrent illness that the investigator
feels are not safe for study participation.
- Recently treated (4 weeks for topical antibiotics/steroids/other anti- inflammatory
medications on the face, 8 weeks for systemic antibiotics/steroids/other
immunosuppressive agents) or current (skin) diseases that would affect clinical
evaluation and skin sampling.
- Subjects with a history of facial surgeries and cosmetic procedures (i.e. laser
therapy, resurfacing, dermal fillers, and deep chemical peels) within 6 months.
- Subjects with facial features (i.e. significant hair growth) that would affect
clinical evaluation and skin sampling.
- Participants with a history of chronic gastrointestinal disease, diabetes mellitus,
cardiac disease or immunodeficiency disease.
- Intake of proton pump inhibitors, H2 receptor antagonists, laxatives, or antidiarrheal
medication, NSAIDs, or antacids within 2 weeks prior to enrollment.
- Participants with a history of major surgery of the GI tract (5 years).
- Participants with a known hypersensitivity to tetracyclines or doxycycline or topical
ivermectin
- Subjects unwilling to avoid facial washing for 24 hours prior to sampling and to come
to sampling visit without make-up.
- Subjects with known allergy to lidocaine and epinephrine.
- Subjects with known bleeding disorders.
- Subjects with a history of keloids or excessive scarring.
- Pregnant subjects. Self-reporting will be used to determine whether a patient is
pregnant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Analysis of the Microbiome in Rosacea | NCT04108897 | Entailment |
5,913 | 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:
Case group:
- Patients diagnosed as gastroesophageal reflux disease within 6 months had endoscopy
within 6 months and presented with reflux symptoms in the past 4 weeks.
- Patients with RDQ questionnaire score of no less than 12 points.
- Patients who met the requirements and signed the informed consent.
- Collection and processing of samples should comply with the requirements of laboratory
operation rules and product specifications.
Healthy group:
- Healthy subjects without any symptoms of gastroesophageal reflux, extra-esophageal
reflux and laryngopharyngeal reflux.
- Healthy subjects with RDQ questionnaire score of 0.
- Healthy subjects with RSI questionnaire score of no more than 9 points and heartburn
symptom score of 0.
- Healthy subjects who met the requirements and signed the informed consent.
- Collection and processing of samples should comply with the requirements of laboratory
operation rules and product specifications.
Exclusion Criteria:
- Patients with functional heartburn.
- Patients who took gastric motor drugs within 7 days after entering the study.
- Patients with esophageal spasm and achalasia, eosinophilic esophagitis, dysphagia,
esophageal or gastric cancer, and patients who received esophagus and stomach surgery
- Patients with serious hypohepatia or renal insufficiency
- Pregnant women
- Patients whose saliva samples were not appropriate for detection
- Samples not meeting the collection and processing requirements.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD | NCT02456779 | Contradiction |
5,733 | 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:
- Meets the International Study Group criteria for Behcet's Disease
- Presents with at least one active lesions accessible to measurement, the largest of
which is to be designated as the index ulcer
- Index oral ulcer to be assessed should be in the easily accessible areas of the oral
mucosa, and the oral ulcer first began within 48 hrs prior to enrollment
- Adult (>18 years) male or a non-pregnant, non-lactating female
- Has signed an Ethics Committee (EC) approved subject consent form
- Has completed all screening procedures satisfactorily, is deemed to be an acceptable
subject and is otherwise eligible for entry into the study
- Is willing and able to comply with the protocol
- Is being treated with colchicine
Exclusion Criteria:
- Has a severe, acute, or chronic systemic disease other than Behcet's Disease such as
congestive heart failure, hepatic failure, renal failure, systemic lupus
erythematosus, Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia,
diabetes, AIDS, or any other condition that is severely compromising the immune system
- Has received pentoxifylline in any form over the previous 60 days prior to enrollment
- Has experienced recent cerebral and/or retinal hemorrhage or in patients who have
previously exhibited intolerance to pentoxifylline or methylxanthines such as
caffeine, theophylline, and theobromine
- Has concomitant administration of strong CYP1A2 inhibitors (including e.g.
ciprofloxacin or fluvoxamine) and other drugs that may increase the exposure to
pentoxifylline
- Is receiving immune suppressing or modulating therapy (e.g., apremilast) or topical
corticosteroids within 2 weeks prior to enrollment
- Is not being treated with colchicine
- Is under active treatment for dental conditions, such that multiple dental office
visits would be required during the study period, or presents with oral conditions
which are not thought to be related to Behcet's Disease and in the judgment of a
qualified dentist, will require treatment during the study period
- Is suffering from any medical condition other than Behcet's Disease known to cause
oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid,
Systemic Lupus Erythematous, Crohn's disease, Reiter's syndrome, or AIDS. Has an
eating disorder and/or psychiatric illness requiring treatment. Has a history of, or
is currently exhibiting, any disease or condition, which, in the opinion of the
principal investigator, would place the subject at increased risk during study
therapy. Has any abnormality in hematological or biochemical variable, which, in the
opinion of the principal investigator, would place the subject at increased risk
during study therapy
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.
| Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers | NCT03888846 | Contradiction |
2,556 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in
the pulmonary disease ward (PL and EU).
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in
the pulmonary disease ward or treated in an outpatient clinic (US).
- Informed consent of parents or caregivers, according to local regulations.
Exclusion Criteria:
- Skin/soft tissue disease or local infection at the site of pulmonary auscultation or
any other contraindication for the pulmonary auscultation.
- Any concurrent disease or condition that, in the opinion of the investigator, would
make the patient unsuitable for participation in the project.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 18 Years | Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds | NCT04208360 | Contradiction |
1,619 | 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:
- She is 18 or older
- She is currently court supervision at Bronx Community Solutions or a drug treatment
court or she is currently on probation.
- She reports using any illicit drug or drinking 4 or more alcoholic drinks in a 6-hour
period in the past 90 days or she has been in alcohol or drug treatment in the past 6
months OR if she report attending any drug or alcohol treatment in the past 6 months.
- She reports having had an ongoing intimate, dating or sexual relationship with a male
or female partner that lasted 3 or more months in the past year.
- She lives within a 90-minute commute of 125th and Broadway
Exclusion Criteria:
- Ability to speak and understand English is not sufficient to participate in
assessments or intervention sessions.
- Inability to complete informed consent process due to a psychiatric or cognitive
impairment.
- The participant is unwilling or unable to commit to completing all the activities in
the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Women Initiating New Goals of Safety | NCT01788579 | Contradiction |
2,165 | 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:
- Male or female age 20 to 80 years, inclusive
- Meets at least 6 of the 12 American College of Rheumatology preliminary criteria
(1977) for the classification of acute arthritis of primary gout, OR have proven
tophus or documented monosodium urate (MSU) crystals in the joint fluid
- Serum uric acid ≥7.5 mg/dL at screening
- Experienced ≥2 gouty arthritis flares within one year prior to screening
Exclusion Criteria:
- Occurrence of a gouty arthritis flare ongoing at screening or during the screening
period through baseline
- Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4
weeks prior to screening
- Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to
screening
- Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases
with arthritis, or any condition requiring chronic daily use of pain medication
- History of allergy to any components of study medication, including diacerein
- Allergy, contraindication, or intolerance to febuxostat
- Contraindication or allergy to NSAIDs
- Severe renal impairment
- Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor
necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | A Proof-of-Concept Study of AC-201 to Prevent Gout Flares | NCT01712204 | Contradiction |
6,067 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients 18 to 75 years old
- GERD documented by :
- Typical reflux symptoms (heartburn, regurgitations) completely responsive to PPI
therapy
- And/or erosive esophagitis or Barrett's esophagus at endoscopy
- And/or positive pH 24h monitoring (acid exposure time > 5% or positive symptom
association indices)
- Possibility of easily positioned transnasal catheter
- Patients covered by social security
- Subjects must provide written, free and informed consent
Exclusion Criteria:
- Pregnant or lactating women
- History of digestive or thoracic surgery (except appendicectomy)
- Patients unable to stop PPI therapy for 7 days
- Subjects unable to provide written consent, including adult under guardianship and
emergency situation
- Simultaneous participation in another study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD | NCT01844440 | Entailment |
5,134 | 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:
- Low bone mineral density as determined at the time of screening [as defined by bone
mineral density (BMD) T-scores of the lumbar spine (L1-L4), or total evaluable
vertebrae (if fewer than L1-L4); or femoral neck between -1.0 and -2.5, exclusive]
- 25-hydroxyvitamin D ≥ 20 ng/mL
- Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 800 IU (but ≤ 1,000 IU)
vitamin D daily upon enrollment
Exclusion Criteria:
- Osteoporosis, as defined by BMD T-scores of the lumbar spine (L1-L4) or total
evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ 2.5
- History of vertebral fracture, or fragility fracture (a fracture resulting from no or
minor trauma; ie, fall from standing height or less) of the wrist, humerus, hip, or
pelvis after age 50
- Diagnosed with any condition that will affect bone metabolism
- Diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder
- History of spinal stenosis
- History of facial nerve paralysis
Exclusion Criteria for Cohort 7 Sub-study (Transition to Alendronate):
- Contraindicated or intolerant of alendronate therapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 75 Years | An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density | NCT01101048 | Contradiction |
595 | 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:
- Positive urinary pregnancy test performed 18 days after oocyte retrieval in a fresh
treatment cycle or 13-16 days after embryo transfer in a frozen embryo replacement
cycle depending on the stage of embryo development at the time of transfer
Exclusion Criteria:
- Negative urinary pregnancy test performed 18 days after oocyte retrieval in a fresh
treatment cycle or 13-16 days after embryo transfer in a frozen embryo replacement
cycle depending on the stage of embryo development at the time of transfer
- No evidence of an intrauterine fluid collection during the index test
- Evidence of a yolk sac and/or fetal pole during the index test
- Final diagnosis not known
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Pregnancies of Uncertain Location or Viability Research | NCT02700789 | Entailment |
5,144 | 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:
- Body mass index (BMI) < 30
- Postmenopausal women with no evidence of osteoporosis by dual energy X-ray
absorptiometry (DEXA) scan (T ≥ -2 in the total hip and lumbar spine).
- Pre- or peri-menopausal women with osteopenia but no evidence of osteoporosis by DEXA
scan (-1.5 ≤ T ≤ -2 in the total hip and lumbar spine)
- No estrogens or corticosteroids
- No prior history of bisphosphonate medication
- Otherwise in good health with no significant illnesses which could affect bone
metabolism such as hypercortisolism, untreated hypothyroidism, treatment with statins
or other drugs affecting bone metabolism other than calcium and vitamin D3.
- No change in exercise regimen or calcium intake in the past 3 months.
- Subject must sign the Institutional Review Board-approved written informed consent
prior to the initiation of any study specific procedures or randomization. A subject
will be excluded for any condition that might compromise the ability to give truly
informed consent for participation in the study.
Exclusion Criteria:
- Males
- Premenopausal women with DEXA T scores ≥ -1.5 or ≤ -2.
- Postmenopausal women with DEXA T scores ≤ -2.
Female
Accepts Healthy Volunteers
| Effects of Naturally Silicon-Rich Water on Bone Metabolism in Women | NCT01067508 | Contradiction |
1,221 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Male or female, at least 18 years of age, inclusive.
2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as
malignant, at least one of the following must be true:
1. There is histocytological confirmation of pleural malignancy
2. The effusion is an exudate (per Light's criteria) in the context of
histocytologically proven malignancy elsewhere, with no other clear cause for
fluid identified.
3. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that
responded to thoracentesis where the lung expanded and the dyspnea was improved.
4. Subject is willing and able to provide written informed consent.
5. Subject is willing and able to meet all study requirements, including follow-up visits
and receiving study-related telephone calls.
6. Subject has sufficient pleural fluid to allow safe insertion of an IPC.
7. Subject has negative pregnancy test if appropriate.
8. Subject or caregiver is able to perform home drainage of the pleural effusion (a
caregiver can be a friend, family member, or paid healthcare professional).
Exclusion Criteria:
1. Subject has significant trapped lung, or a proximal bronchial obstruction which is
likely to lead to trapped lung. For a subject to be eligible for this study, two
separate study center clinicians must agree that there is no significant trapped lung
on the same CXR using visual estimation (reference guide). The CXR used to make this
decision must have been performed ≤30 days preceding the consent form being signed,
and must have been performed preferably on the same day, but no more than 7 calendar
days after tunneled pleural catheter insertion. Significant trapped lung is deemed
present if any 1 of the following criteria is met:
1. A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and
pleural line) apical pneumothoraces.
2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung
parenchymal markings and there is no suggestion of pleural fluid.
3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid
AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung
(e.g., chest pain or cough).
2. Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern
Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a
performance status of 3 may be considered for the study if the removal of their fluid
would likely improve their performance score by 1 or more.
3. Subject is pregnant, planning to become pregnant, or is lactating.
4. Subject has a history of empyema.
5. Subject has a history of chylothorax.
6. Subject has an uncorrected coagulopathy.
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.
| Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion | NCT04792970 | Entailment |
1,182 | 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:
- Clinically confident diagnosis of malignant pleural effusion, defined as any of the
following:
1. Pleural effusion with histocytologically proven pleural malignancy OR
2. Pleural effusion in the context of histocytologically proven malignancy
elsewhere, without a clear alternative cause for fluid OR
3. Pleural effusion with typical features of malignancy with pleural involvement on
cross-sectional imaging (CT/MRI)
- Degree of breathlessness for which therapeutic pleural intervention would be offered
- Age >18 years
- Expected survival > 3 months
- Written Informed Consent
Exclusion Criteria:
- Females who are pregnant or lactating
- Clinical suspicion of non-expansile lung for which talc pleurodesis would not be
offered
- Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
- Previous ipsilateral failed talc pleurodesis
- Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
- Any contraindication to chest drain or IPC insertion, including:
Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC
tunnel site
- Any contraindication to MRI scanning, including:
Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign
body Previously documented reaction to Gadolinium-containing intravenous contrast agent
Significant renal impairment (eGFR<30 ml/min)
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.
| EDIT Management Feasibility Trial | NCT03319186 | Entailment |
6,435 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Signed Informed Consent that meets all criteria of current FDA regulations.
2. Healthy male or non-pregnant, non-lactating female greater than or equal to 8 years of
age with a clinical diagnosis of moderate to severe papulopustular rosacea, defined as
the presence of:
A total of 8 to 50 combined papules/pustules on the face, AND At least moderate
erythema, AND Telangiectasia
3. Patient has a baseline Investigator's Global Evaluation (IGE) score of 3 (moderate) or
4 (severe) for rosacea severity (See Appendix A).
4. Females of child bearing potential must not be pregnant or lactating at Screening (as
confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL
or equivalent units of human chorionic gonadotropin). Women of childbearing potential
must agree to the use of a reliable method of contraception (e.g., total abstinence,
IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral,
transdermal, injected or implanted non- or hormonal contraceptive), throughout the
study. If the female is using a hormonal contraceptive, the same product must be taken
for 3 months prior to Visit 1 and must agree not to replace with some other hormonal
contraceptives during the study. A sterile sexual partner is not considered an
adequate form of birth control.
All females will be considered to be of childbearing potential unless they: Are
post-menopausal, defined as women who have been amenorrheic for at least 12
consecutive months, without other known or suspected primary cause.
Have been sterilized surgically or who are otherwise proven sterile (i.e., total
hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks before
Screening. Tubal ligation will not be considered a surgically sterile method.
Female patients of childbearing potential are defined as Women without prior
hysterectomy of at least 4 weeks, or who have had any evidence of menses in the past
12 months.
Females who have been amenorrhea for more than or equal to 12 months, but the
amenorrhea is possibly due to other causes, including prior chemotherapy,
anti-estrogens, or ovarian suppression.
5. Free from any systemic or dermatologic disorder that, in the opinion of the
Investigator, will interfere with the study results or increase the risk of adverse
events.
6. Willing to minimize external factors that might trigger rosacea flare-ups (e.g.,
extreme temperatures, aggressive astringents, known offending foods such as spicy
foods and thermally hot foods and drinks, prolonged sun exposure, strong winds,
alcoholic beverages, and emotional stress) within 24 hours before the Screening visit.
7. Of any skin type or race, provided the skin pigmentation allows accurate evaluation of
papulopustular rosacea.
8. Willingness and capability to cooperate to the extent and degree required by the
protocol.
Exclusion Criteria:
1. Females who are pregnant, lactating or planning to become pregnant during the study
period.
2. Patient has mild facial rosacea (less than 8 inflammatory lesions on the face) or very
severe rosacea (more than 50 inflammatory lesions).
3. Patient has mild erythema.
4. Patient has a baseline IGE score of 0, 1 or 2.
5. Patient has a skin condition on the face that would interfere with the diagnosis or
assessment of rosacea (e.g., dermatitis, psoriasis, squamous cell carcinoma, eczema,
acneform eruptions caused by medications, steroid acne, steroid folliculitis,
bacterial folliculitis).
6. Patients with excessive facial hair, such as beards, sideburns, moustaches, etc., that
would interfere with diagnosis or assessment of rosacea.
7. Patients with tattoos or excessive facial scarring that, in the Investigator's
opinion, may interfere with the evaluation of the patient's rosacea.
8. Patients with active facial sunburn, peeling from sunburn, or patients that will be
exposed to excessive sunlight during the study.
9. Patient has significant history or current evidence of chronic infectious disease,
system disorder, organ disorder or other medical condition that in the Investigator's
opinion would place the study patient at undue risk by participation.
10. Any patient (male or female) who has started, or changed hormonal therapy within 3
months of the baseline visit (this includes hormonal contraceptives). Patients who
have been on stable hormone therapy for at least 3 months and whose therapy is
considered unlikely to be changed for the duration of the study will be eligible.
11. History of hypersensitivity or allergy to study drug, or other ingredients of the
formulation.
12. Use within 6 months prior to baseline of oral retinoids (e.g., Accutane) or
therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are
allowed).
13. Use for less than 3 months prior to baseline of estrogen- and/or progestin-containing
oral, injectable, implant, or transdermal contraceptives; use of such therapy must
remain constant throughout the study.
14. Use within 1 month prior to baseline of 1) topical retinoids to the face, 2) systemic
(e.g., oral or injectable) antibiotics known to have an impact on the severity of
facial rosacea (e.g., containing tetracycline and its derivatives, erythromycin and
its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic steroids, 4)
photodynamic therapy (including laser and other light therapies), or 6) cosmetic
procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the
face).
15. Use within 2 weeks prior to baseline of 1) topical corticosteroids, 2) topical
antibiotics, 3) topical anti-inflammatory agents or 4) topical medications for rosacea
(e.g., metronidazole, azelaic acid, sodium sulfacetamide, ivermectin) 5)
immunosuppressive drugs, 6) anticoagulant therapy.
16. Use of any other topical products applied to the target site.
17. Use of systemic corticosteroids. The use of inhaled corticosteroids up to less than
1mg per day is acceptable.
18. Use of antipruritics, including antihistamines, within 24 hours of study visits.
19. Patients who use make-up must have used the same brands/types for a minimum period of
14 days before study entry and must agree to not change brand or frequency of use
throughout the study.
20. Presence of carcinoid, pheochromocytoma, or other causes of systemic flushing.
21. Presence of acne conglobata, acne fulminans, secondary acne or severe acne requiring
systemic treatment.
22. Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.
23. Receipt of any drug as part of a research study within 30 days before dosing.
24. Employees of the research center or Investigator.
25. Patients who are illiterate
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.
| Clinical Endpoint Study of Ivermectin 1% Cream | NCT02840461 | Entailment |
2,622 | 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:
- Children aged 0-18 years
- Diagnosed with inguinal hernia or communicating hydrocele
- Due to undergo laparoscopic inguinal hernia repair
Exclusion Criteria:
- Previous abdominal surgery
- Comorbidities that will effect surgical time, time under anesthesia, intragastric
pressure and abdominal pressure
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 | Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway | NCT02696837 | Contradiction |
3,888 | 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:
Subjects eligible for enrollment in the study met all of the following criteria:
1. Subjects who are capable of giving written informed consent, which includes compliance
with the requirements and restrictions listed in the consent form.
2. Ambulatory nom pregnant females and males 40-<80 years of age.
3. Subjects who withdraw pain medication or nutritional supplements for symptom relief
for knee OA for a total of at least 15 days before screening.
4. Pain at or below 80 mm on a 100 mm VAS in the index knee.
5. A documented diagnosis of OA of the knee, or meeting American College of Rheumatology
(ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6
months prior to screening. If OA is presented in both knees the investigator will
identify which knee will be X-rayed for study entry, with preference for the knee with
more severe pain (<80mm VAS).
6. Has documented radiographic evidence of OA of the knee from the screening Visit
radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading
(11)
7. Subjects with baseline minimum joint space width in the medial and lateral
compartments of the index knee of > 1.5 mm and > 2.5 mm at Baseline respectively,
measured from radiographs using the MTP view.
Exclusion Criteria
Subjects with any of the following criteria must not be enrolled in the study:
1. Subjects with history of hypersensitivity to Plai.
2. Subjects with skin lesion at the index knee.
3. A history of lower extremity surgery within 6 months prior to screening.
4. Significant prior injury to the index knee within 12 months prior to screening
5. Disease of the spine or other lower extremity joints of sufficient degree to affect
the index knee.
6. Treatment with other drugs potentially affecting bone or cartilage metabolism as
described below:
- chronic systematic corticosteroids
- hyaluronan injection into the index knee with in the previous 6 months.
- Diacerin or Glucosamine treatment within the last 12 months.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels | NCT01836393 | Entailment |
2,461 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as
defined by the clinical presentation consistent with sarcoidosis, biopsy finding
granulomas, and no alternative for the cause of the granulomas, such as tuberculosis
2. Patients must have chronic cutaneous skin lesions with or without taking chronic
therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine,
hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in
which the dose has not been altered in the 2 months prior to starting the study.
3. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
Sarcoidosis Activity and Severity Index assessment score of at least 4. Diagnosis can
be made by either:
- Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with
no evidence of mycobacteria, fungus, or malignancy.
- A biopsy that does not show granulomas, but the patient has characteristic skin
lesions and history of clinical features suggesting sarcoidosis (previous biopsy
revealing noncaseating granuloma, bilateral hilar adenopathy, erythema nodosum,
uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on
gallium scan)
- Accepted clinical variants include, but are not necessarily limited to the
following:
- lupus pernio
- nodular
- subcutaneous
- annular
- angiolupoid
- plaque
- papular
- lichenoid
- psoriasiform
- For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined
as the presence of sarcoidal skin lesions with any of the following features:
- At least 5 easily visible facial lesions, or
- Disease which involves > 3% BSA, or
- Disease which confers functional impairment (e.g. nasal or visual field
obstruction), or
- Disease which confers significant symptoms of itching and/or pain.
4. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or is using one of the following methods of birth
control for the duration of the study and 90 days after study completion:
- condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- contraceptives (oral or parenteral) for three months prior to study drug
administration
- a vasectomized sole partner
- Females of childbearing potential must have a negative serum pregnancy test at
screening visit.
Exclusion Criteria:
1. No consent/inability to obtain consent.
2. Age less than 18 years of age.
3. Inability to obtain biopsy or draw blood.
4. CPK, ALT or AST >5 times upper limit of normal (ULN)
5. Pregnancy or breast feeding.
6. Current use of medications metabolized by rifampin (See Appendix).
7. Allergy to macrolides, quinolones or rifamycins.
8. Visual Impairment as defined by differentiating colors.
9. Family or personal history of long QT syndromes.
10. Patients receiving another interventional investigational drug within the 30 days
prior to dosing
11. Use of any investigational medication within the past 28 days prior to study
enrollment.
12. Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.
13. Subject has a history of tuberculosis at anytime or close contact with a person with
active tuberculosis within the previous 6 months, or persistent or active infections
requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV
antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or
antifungals for purpose of treating infection, within 14 days of baseline.
14. Evidence of other active skin diseases or skin infections during screening that may
interfere with evaluation of sarcoidosis.
15. Subject has an active infection requiring systemic antibiotics at time of screening
16. Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to
individuals with tuberculosis.
17. Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the
absence of chronic indurated lesions, such as:
- Acute, "benign" sarcoid associated with erythema nodosum
- Acute iritis
- Ichthyosiform sarcoidosis
- Hypo- or hyperpigmented macular sarcoidosis
- Ulcerative sarcoidosis
- Erythroderma
- Alopecia
18. Patients otherwise unsuitable for participation in the opinion of the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Trial of Antimycobacterial Therapy in Sarcoidosis | NCT01074554 | Entailment |
4,347 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Healthy young adult males with myopia <-8D
Exclusion Criteria:
- Best corrected visual acuity <6/9
- Previous intraocular surgery
- Intraocular pressure >21mmHg
- Gonioscopic findings of angle closure
- Clinical evidence of pseudo-exfoliation, uveitis or pigment dispersion syndrome,
corneal or media opacities, retinal pathology or neurological diseases
- Family history in a first degree relative of glaucoma or other optic neuropathy.
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 35 Years | Optical Coherence Tomography Imaging of the Posterior Segment in High Myopia. | NCT00347451 | Entailment |
2,689 | 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:
- inguinal hernia
Exclusion Criteria:
- recurrent hernia
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 Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy | NCT03820570 | Entailment |
6,389 | 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:
- Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
- Any age
- Membership in the general social security system
- Inform consent signed by the patient or by legal representatives for minors
Exclusion Criteria:
- Refusal of the patient or one of the legal representatives
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Collection of Biological Samples With Clinical Characterization of Covid-19 Patients | NCT04363385 | Entailment |
2,176 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- 1. The subject has given his / her informed consent to participate in this study; the
Informed Consent Form has been signed both by the patient and the Investigator;
- 2. Established diagnosis of gout according to Gout Classification Criteria established
by the American College of Rheumatology (ACR) and European League against Rheumatism
(EULAR) in 2015;
- 3. Pain in at least one joint at the screening and immediately prior to initiation of
therapy with the study drugs, with intensity 50 mm to 100 mm according to the Visual
Analogue Scale (VAS);
- 4. Development of acute gout attack within 120 hours (5 days) prior to the
randomization date;
- 5. History of 1 or more acute gout attacks prior to the Screening Visit;
- 6.The patients receiving uric acid-lowering drugs should continue receiving these
drugs at a constant dose for at least 4 weeks prior to enrolment to the study and
throughout the entire study period; the patients not receiving uric acid-lowering
drugs may start receiving this treatment after the end of the study;
- 7. Body mass index ≤40 kg/m2;
- 8. QTcF interval ≤450 msec for male subjects and ≤470 msec for females on ECG at the
screening;
- 9. For women of child-bearing potential: negative result of the serum pregnancy test
performed at the screening;
- 10. The consent of a woman of child-bearing potential, as well as of a man who has
female partners of child-bearing potential, to abstain from sexual intercourses or to
use effective birth control methods throughout the entire study period and for 60 days
after RPH-104 administration (if RPH-104 is administered);
- 11. The patient is able to fulfil the requirements of the Study Protocol as judged by
the Investigator
Exclusion Criteria:
- 1. The patient received therapy with ibuprofen in a dose of up to 400 mg inclusive
within 4 hours or >400 mg within 8 hours prior to randomization.
- 2. The patient received therapy with diclofenac in a dose of up to 50 mg inclusive
within 8 hours or >50 mg within 24 hours prior to randomization.
- 3. The patient received any other non-steroidal anti-inflammatory drug (NSAID) within
24 hours prior to the randomization;
- 4.The patient received opioids within 48 hours prior to the randomization;
- 5. The patient received metamizole or metamizole-containing drugs within 12 hours
prior to the randomization;
- 6. The patient received any drug with analgesic activity (including paracetamol)
within 6 hours prior to the randomization;
- 7. The patient received a long-acting NSAID (half-life ≥24 hours) within 5 half-life
periods or 1 month prior to the randomization whichever is longer;
- 8. The patient received naproxen, meloxicam, nabumetone, celecoxib, etoricoxib or
extended-release indomethacin within 5 days prior to the randomization;
- 9 . The patient received corticosteroids (including their intra-articular
administration and inhalations) within 4 weeks prior to the randomization;
- 10. The patient received colchicine within 7 days prior to the randomization;
- 11. Intolerance or contraindications for NSAID use;
- 12. Contraindications for the use of Ortanol® capsules 20 mg;
- 13. Chronic heart failure functional class II-IV (classification of NYHA);
- 14. History of clinically significant ventricular arrhythmias or clinically
significant atrial tachy-arrhythmias or presence of these arrhythmias at the moment of
evaluation;
- 15. Unstable angina or stable exercise-induced angina of functional class III or IV;
- 16. Secondary gout, chemotherapy-induced gout, lead- or transplantation-induced gout;
- 17. Rheumatoid arthritis, confirmed or suspected infectious septic arthritis or any
other type of acute inflammatory arthritis;
- 18. Clinically significant renal impairment determined based on creatinine clearance
(estimated using the Cockcroft-Gault equation) <60 mL/min, or patients on
hemodialysis;
- 19. Blood coagulation disorders; history of gastrointestinal bleedings or perforation;
- 20. Pregnant or nursing women;
- 21. Scheduled surgical treatment or performed major surgical procedure (minor surgical
procedures, such as catheter placement are not considered non-inclusion criteria)
within 14 days prior to the first dose of the test drug;
- 22. Current or suspected HIV-infection, HBsAg, Hepatitis C Virus antibodies (HCVAb),
other acute or chronic bacterial, fungal or viral infections at the moment of
subject's enrolment to the study;
- 23. Presence of any risk factors for tuberculosis based on the results of assessment
using Tuberculosis Risk Assessment Questionnaire at the screening or confirmed
tuberculosis or any other infectious disease of the lungs or bronchi based on findings
of the chest X-ray exam in two views performed within 3 months prior to the screening
visit, or the need for using therapy with tuberculosis medications, such as isoniazid
in the course of the study;
- 24. Neutropenia, leukopenia, or thrombocytopenia determined based on the following
laboratory parameters assessed during the screening:
1. Absolute neutrophil count (ANC) <1.5 x 10^9/L;
2. White blood cell count <4.0 х 10^9/L
3. Platelet count <150 х 10^9/L;
- 25. Immunization with live vaccines within 3 months prior to the subject's enrolment
to the study or planned vaccination within 60 days after the expected date of the
first dose of the test drug;
- 26. History of allergic reactions to biologicals, Voltaren® (diclofenac) or Ortanol®
(omeprazole);
- 27. Contraindications for subcutaneous, intramuscular, intravenous or intra-articular
injections;
- 28. History of malignancy (except for patients with localized in situ basal cell
carcinoma of the skin or in situ cervical cancer, who can be enrolled to the study
immediately after the therapy for this disease), unless it is in remission for ≥5
years, as well as patients who are being examined for cancer or patients with
suspected malignancy;
- 29. A condition or disease, which, in the Investigator's opinion, could put the
patient's safety at risk or affect the test drug safety assessment;
- 30. Any other conditions and diseases, such as uncontrolled diabetes mellitus,
uncontrolled hypertension, congestive heart failure, exacerbation of peptic ulcer
disease, clinically significant liver diseases, kidney diseases, uncontrolled thyroid
dysfunction, unhealed wounds, ulcers or bone fractures, psychiatric disorders,
uncontrolled epilepsy, drug dependence, which could prevent the patient from complying
with the requirements of this Study Protocol.
- 31. The patient received biologicals or investigational medicinal products within 5
half-life periods of these drugs or 3 month prior to the randomization whichever is
longer;
- 32. Blood donation or blood loss of ≥400 mL within 8 weeks prior to the randomization.
- 33. The patient has already been randomized in this clinical 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, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack | NCT04067492 | Contradiction |
2,533 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Caucasian, Hispanic and African American children ages 6 months to 5 years with a
diagnosis of atopic dermatitis within the last 12 months will constitute the candidate
pool for enrollment into the study group. The diagnosis of atopic dermatitis will be
determined by the presence of at least 3 major diagnostic features (i.e., pruritis,
rash,relapsing-remitting presentation, family history or atopy) in addition to at
least 3 minor features (including but not limited to xerosis, elevated serum IgE,
ocular involvement, food allergy). Healthy Caucasian, Hispanic and African American
children within the same age range will comprise the pool for enrollment into the
control group.
Exclusion Criteria:
- Any child with atopic dermatitis who has a documented history of asthma or
bronchospasm or who is currently receiving treatment for either of these conditions
will be excluded. Any control subject who has asthma or positive family history of
allergy or atopic disease in a first-degree relative (biological mother, father or
siblings) will also be ineligible for enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 5 Years | Histamine Pharmacogenetics in Children With Atopic Dermatitis | NCT00277433 | Entailment |
5,978 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Adults ages 21-70 years old
- Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3
or more on a 7 day baseline symptom diary
- English language proficiency
- Willingness to be videotaped and connected to physiologic monitoring devices during
the visit
Exclusion Criteria:
- Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric
cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or
medical record review
- Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
- Pregnant women.
- Dementia or significant memory difficulties
- Severe, unstable psychiatric disease
- Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the
prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level
deemed likely to interfere with the study
- Failure to complete the baseline symptom diary for at least 6 of 7 days
- Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids,
H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on
a stable regimen)
- Allergy to adhesives
- 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 21 Years old.
Subject must be at most 70 Years | Correlates of GERD Symptom Severity | NCT03020550 | Entailment |
4,626 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study v1.0 | NCT02524470 | Entailment |
1,288 | 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:
- Patient is > 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either Malignant
Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma,
Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC).
- Patient's tumor has been pathologically reviewed by the central laboratory with
confirmed positive MSLN expression on > 50% of tumor cells that are 2+ and/or 3+ by
immunohistochemistry.
- Prior to gavo-cel infusion, patients must have received at least 1 systemic standard
of care therapy for metastatic or unresectable disease with more details provided in
the clinical protocol
- Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
- Patient has a left ventricular ejection fraction > 45% as measured by resting
echocardiogram, with no clinically significant pericardial effusion.
- Patient is fit for leukapheresis and has adequate venous access for the cell
collection.
- Patient must have adequate organ function as indicated by the laboratory values in the
clinical protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer | NCT03907852 | Entailment |
6,753 | 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:
- May be either male or female
- Age: 18 years or older
- Subjects with a single-rooted tooth (except mandibular incisors) indicated for
extraction
- Extractions socket walls should either be intact or have no more than one bony wall
(buccal or lingual) dehiscence extending no more than 50% of the total bony wall
height
- Must be in adequate physical and mental health to undergo routine dental treatment
including the surgical procedures associated tooth extraction and implant placement
- Subjects' treatment plan must include replacement of the tooth to be extracted with
dental implant supported fixed restoration
- Subjects must have read, understood and signed an informed consent form
Exclusion Criteria:
- Mandibular incisors
- Acute infection associated with the tooth to be extracted or with adjacent teeth
- History of significant heart, stomach, liver, kidney, blood, immune system disease, or
other organ impairment or systemic diseases that would prevent undergoing the proposed
treatment or may result in compromised healing (e.g. poorly controlled diabetes,
active heavy tobacco use [>10 cigs/day])
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as
osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone
metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or
chronic intake of glucocorticoids
- Pregnant women or nursing mothers
- Subjects that are unwilling or unable to sign the informed consent
- History of lack of compliance with dental visits
- Subjects unwilling to return for the required number of visits
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 95 Years | Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® | NCT03659617 | Entailment |
6,615 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients diagnosed with AHA based on a reduced FVIII activity (<50 %) and positive
FVIII inhibitor (>0.6 BU/ml) at screening (local laboratory)
- Signed informed consent form by the participant or a Person who is legally authorized
to sign on behalf of the participant before any study specific tests or procedures are
done
- Male or female patients aged 18 years or older at the time of informed consent
- Ability to understand and follow study-related instructions
- Current bleeds due to AHA at the time of screening
Exclusion Criteria:
- Congenital hemophilia A
- Treatment with aPCC within the last 48 h before first study treatment or planned
treatment with aPCC during the course of the study
- Treatment of AHA within the days before study enrollment with more than 100 mg
prednisolone (or equivalent) per day or prednisolone for more than 2 days or with
other immunosuppressive drugs (e.g. rituximab, cyclophosphamide). IST for other
concomitant disorders (e.g. autoimmune disorders) is not an exclusion criterion and
can be continued at the investigator's discrétion
- Therapy (current or planned during the emicizumab treatment period) with
immunospuppressive or immune modulating drugs that were not already given on a regular
basis before first diagnosis of AHA
- Positive lupus anticoagulant at the time of screening
- Severe uncontrolled infection at the time of screening
- Signs of active disseminated intravascular coagulation at the time of screening
- Current treatment for thromboembolic disease or signs of current thromboembolic
disease at time of screening
- Patients who are at high risk for TMA (e.g., have a previous medical or family history
of TMA), in the investigator's judgment
- Known severe congenital or acquired thrombophilia
- Life expectancy <3 months at the time of screening
- Other conditions that substantially increase risk of bleeding or thrombosis by the
discretion of the investigator
- Contraindications according to the local SmPC of emicizumab (see 16.1 Appendix I)
- Current treatment with emicizumab at time of screening
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection by the discretion of the
investigator
- Concurrent disease, treatment, or abnormality in clinical laboratory tests that could
interfere with the conduct of the study, may pose additional risk, or would, in the
opinion of the local investigator, preclude the patient's safe participation in and
completion of the study
- Addiction or other diseases that preclude the patient from appropriately assessing the
nature and scope as well as possible consequences of the clinical study by the
discretion of the investigator
- Pregnant or breast-feeding women
- Women of childbearing potential unless women who meet the following criteria:
1. Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum
FSH > 40 U/mL)
2. Postoperatively (six weeks after bilateral ovariectomy with or without
hysterectomy)
3. Regular and correct use of a contraceptive method with error rate <1% per year
such as implants, depot injections, oral contraceptives or intrauterine devices
4. Sexual abstinence
5. Vasectomy of the partner
- Men of sexual activity with women of childbearing potential who are not willing to use
an effective barrier method of contraception during and up to 3 months after the end
of therapy
- Subject is in custody by order of an authority or a court of law
- Receipt of an investigational drug concurrently or within 5 half-lives before
administration of the study drug
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.
| Emicizumab in Acquired Hemophilia A | NCT04188639 | Contradiction |
4,591 | 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 menstrual pain of more than 6 months of evolution.
- Women with pain equal to or greater than 4 on the visual analogue scale in more than
half of their one-year menstrual cycles.
Exclusion Criteria:
- Hormone treatment
- Contraindication to any of the treatments
- Participate in this period of no functional recovery program or physiotherapy
treatment.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effectiveness of Manual Therapy in Dysmenorrhea | NCT03593057 | Contradiction |
6,579 | 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 16 or over.
- Have documentation of physician-confirmed diagnosis of moderate or severe Hemophilia A
(severity defined as moderate = FVIII activity 1% to 5% and severe = FVIII activity
≤1%).
- Signed written informed consent provided by the patient or the patient's parents for
patients under the age of 18 (dependent of local regulations).
- Signed written assent is also required for patients under the age 18 years (dependent
on local regulations).
- Plan to receive at least half of their Hemophilia care at the registry site.
- Willing and able to enter data as per the data collection schedule.
- Currently receiving prophylactic or on demand treatment (including within last 6months
for on demand).
- Expected life expectancy of at least 2 years.
Exclusion Criteria:
- Patients with Hemophilia B
- Patients with von Willebrand disease (vWD)
- Patients with other rare bleeding disorders
- Unable to comply with the study protocol
Male
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment | NCT02396862 | Contradiction |
3,408 | 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
ETD participants:
- Bilaterally intact tympanic membranes
- aged 5 to 60; generally good health
- ability to understand and give informed consent
- history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear
fluids, or prior ETD diagnosis
- ability to perform maneuvers that will be done during the testing protocol.
Control participants
- Bilaterally intact tympanic membranes
- aged 5 to 60
- generally good health
- ability to understand and give informed consent
- no personal history of recurrent otitis media or other middle--ear disease
- ability to perform maneuvers that will be done during the testing protocol
- no difficulty equalizing middle--ear pressures in daily life.
EXCLUSION CRITERIA
ETD participants:
- Cold/allergic rhinitis (temporary) on presentation
- current dental problem or dental work within 7 days (temporary)
- history of ossicular reconstruction
- history of tympanoplasty
- syndromes predisposing to otitis media
- extant middle--ear disease
- inability to complete testing protocols
- tympanic membrane perforation
- abnormal tympanogram (type B tympanogram)
- BMI >40
- history of congenital heart disease
- prior radiation to head and neck
- uncontrolled respiratory disease
- any medical condition or use of medication for which the study physician feels study
procedures would not be in the subject's best interest.
- In adults, a positive urine pregnancy test (in females), blood pressure above 140/90,
glaucoma, and sensitivity to drugs used to prepare the nose for endoscopic examination
will also exclude potential participants.
Control participants:
- (in addition to above) significant middle--ear disease history
- evidence of middle ear pathology.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 60 Years | Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing | NCT03850197 | Contradiction |
4,746 | 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:
- Clinical diagnosis of peripheral vestibular dysfunction and no other neurological
deficit (confirmed where possible with vestibular function testing; canal paresis
>20%).
- One of the following subjective complaints indicating a failure of vestibular
compensation; disequilibrium, gait instability, vertigo/dizziness, motion sensitivity.
- Not taking medication for vertigo or willing to discontinue with permission from
consultant physician.
Exclusion Criteria:
- Bilateral peripheral vestibular pathology.
- CNS involvement.
- Fluctuating Symptoms (Meniere's disease, migrainous vertigo) or active BPPV.
- Other medical conditions in the acute phase (orthopaedic injury).
- Previous vestibular rehabilitation.
- Pacemaker, Epilepsy (as per Nintendo Wii Guidelines).
- Unwilling or unable to use a Nintendo Wii.
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.
| Conventional Versus Virtual Reality Based Vestibular Rehabilitation | NCT01442623 | Contradiction |
5,213 | 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:
- Are postmenopausal women at least 55 years old and at least 2 years postmenopausal at
the time of entry into the trial, and who have given informed consent before entering
the study and after being informed of the risks, medications, and procedures to be
used in the study. In addition, women below the age of 60 years with indeterminate
menopause due to premenopausal hysterectomy must have their postmenopausal status
confirmed with a serum FSH level > 30 IU/L.
- Posterior-anterior lumbar spine (L1-L4) BMD and/or femoral neck BMD measurement at
least < 2.5 standard deviation (SD) from the mean of healthy, pre-menopausal women.
- Results of lumbar BMD (L1-L4) measurement must be available. The initial lumbar spine
assessment and the determination of the patient's eligibility for entry into the
screening phase will be made by the individual investigator. If the L-1 vertebra
cannot be analyzed due to artifact, vertebral fracture, osteophytes, or other
abnormalities, that vertebra should be excluded from the analysis.
- Normal or clinically insignificant abnormal laboratory values (as defined by the
investigator) including serum calcium, 25 hydroxyvitamin D levels and alkaline
phosphatase.
- Willing to be trained on and use a pen type injection delivery system on a daily basis
for 12 months.
Exclusion Criteria:
- Active liver disease - liver enzymes (ALT, AST) more than three times the upper normal
range, or a bilirubin of > 2.0 mg/dl, or clinical jaundice.
- Abnormal thyroid function not corrected by therapy. Normal thyroid function will be
documented by a normal TSH during screening phase
- History of active nephrolithiasis or urolithiasis in the prior 2 years. Patients with
any documented history of nephro- or urolithiasis must have had an appropriate imaging
procedure within the prior 6 months, such as, an intravenous pyelography (IVP), supine
radiograph of the kidney ureter bladder (KUB), or renal ultrasound, which must
document the absence of stones
- History of malignant neoplasms within the prior 5 years, with the exception of
superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been
definitively treated. If malignant neoplasm was ever diagnosed, patient must presently
be free of disease.
- Current pharmacological treatment for osteoporosis, other than calcium and Vitamin D
- History of Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes
of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis | NCT00532207 | Entailment |
3,650 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Patients with active nose bleeding
- Indication for routine blood sampling
- Aged 18 to 99 years
- Verbal informed consent before implementation takes place
- Written consent of the participating person after investigation and completion of
treatment
Exclusion Criteria:
- No active bleeding
- Routine blood sampling for medical reasons not indicated
- Lack of understanding of the study or investigation
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 99 Years | Hemoglobin and INR Out of Nose Blood | NCT02370381 | Entailment |
5,895 | 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! | Key Inclusion Criteria:
1. Male or female patients > 18 years of age.
2. If female, not of childbearing potential by reason of surgery or menopause, or of
childbearing potential, but using an approved method of contraception since the last
menstrual period. Females of childbearing potential must have a negative serum
pregnancy test before starting the study.
3. Patients must report a history of heartburn at least two days per week over the past
month.
Key Exclusion Criteria:
1. History of erosive esophagitis verified by endoscopy.
2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
3. Patients who have a history of Barrett's esophagus or esophageal stricture.
4. Evidence of any medical condition that may interfere with the conduct of the study,
the interpretation of study results, or the health of the patient during the study.
5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2)
blockers, or prokinetics. Prior intermittent use of these agents is permitted if they
are discontinued at least three days prior to the run-in phase. The H2 blocker,
cimetidine (Tagamet®), must be discontinued for at least seven days before the study
drug is administered.
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.
| E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers | NCT00236197 | Contradiction |
786 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Osteo-arthritis of knee joint diagnosed through X-Ray evaluation
2. Moderate or sever level of pain due to knee osteoarthritis and no other known reason
3. Male of Female patients of 18 to 85 years old
4. Pain interfering with activities of daily life
Exclusion Criteria:
1. Cancer pain or any other concurrent cancerous condition
2. History of Knee replacement surgery in the study joint
3. Local infection or any kind of inflammatory or allergic skin lesion
4. Rheumatoid arthritis
5. Mobility disorders or not being able to walk
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 | The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee. | NCT03679507 | Entailment |
6,921 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Signed and dated written informed consent obtained from the subject or the subject's
legally acceptable representative ( if applicable) in accordance with the local
regularities.
2. Both male and female, aged > 50 and <90, if women, must have no childbearing potential
3. Controls did not have subjective memory complaints or any of 28 diseases and did not
have a history suggestive of a decrease in cognitive function (stroke or transient
ischemic attack, seizures, Parkinson's disease, multiple sclerosis, cerebral palsy,
Huntington's disease, encephalitis, meningitis, brain surgery, vascular surgery of the
brain, diabetes requiring insulin control, improperly managed hypertension, cancer
diagnosed within the past 3 years excluding skin cancer, shortness of breath while
sitting still, use of home oxygen, heart attack with changes in memory, walking, or
solving problems lasting at least 24 hours afterwards, kidney dialysis, liver disease,
hospitalization for mental or emotional problems in the past 5 years, current use of
medications for mental or emotional problems, alcohol consumption greater than 3
drinks each day, drug abuse in the past 5 years, treatment for alcohol abuse in the
past 5 years, unconsciousness for more than one hour other than during surgery,
overnight hospitalization due to head injury, illness causing a permanent decrease in
memory or other mental functions, trouble with vision that prevents reading ordinary
print even with glasses, or difficulty understanding conversations because of hearing
even with a hearing aid)
4. The controls also had scores that were at least one standard deviation above the mean
scores of the respective age- and education-matched population on the K-MMSE and an
average score of 0.42 or less on the Korean Instrumental Activities of Daily Living
(K-IADL)
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years | Biomarker Study to Diagnose Alzheimer's Disease | NCT01874418 | Entailment |
1,490 | 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:
- to present with GI symptoms that are secondary to EMD such as dysphagia, regurgitation
and/or non-cardiac chest pain.
- the EMD patients to be recruited under this study are achalasia type I, II and III;
OGJ outflow obstruction; distal oesophageal spasm, hypercontractile oesophagus or
disorders not fulfilling Chicago Criteria v3.
- Receive a treatment such as POEM, neumatic dilatation, LHM, botox injection.
Exclusion Criteria:
- Exclusion criteria are the inability to fill in symptom questionnaires, intolerance of
pre or post procedure test, incomplete therapeutic procedures or technical failure of
baseline manometry investigation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Pressure and Flow Study Before and After Treatments for EMD. The pFlow Study | NCT03904004 | Entailment |
3,968 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Voluntary signature of the IRB approved Informed Consent
2. Unilateral osteoarthritic male or female ages 35-85
3. Pain, swelling, and/or functional disability in the affected knee consistent with
osteoarthritis in one knee joint
4. Physical examination consistent with osteoarthritis in one knee joint
5. Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0
degrees of extension)
6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of
the affected knee showing osteoarthritis
7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible
joint fluid on ultrasound examination of the knee.)
8. Normal range of motion of the unaffected knee
9. No sign of pain, swelling, and/or functional disability of the unaffected knee
10. No history of acute injury in the unaffected knee
11. Is independent, ambulatory, and can comply with all post-operative evaluations and
visits
Exclusion Criteria:
1. Knee injections of any type within 6 months prior to the study.
2. Inflammatory or auto-immune based joint diseases or other lower extremity pathology
(e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis,
polymyalgia, polymyositis, gout pseudogout)
3. Quinolone or Statin induced myopathy/tendinopathy
4. Symptomatic lumbar spine pathology (e.g. radicular pain)
5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e.
evidence of complex regional pain syndrome or central sensitization with allodynia
present on exam).
6. Contraindications for MRI
7. Tested positive or has been treated for a malignancy in the past five years or is
suspected of having a malignancy or is currently undergoing radiation or chemotherapy
treatment for a malignancy anywhere in the body, whether adjacent to or distant from
the proposed injection site
8. Condition represents a worker's compensation case
9. Currently involved in a health-related litigation procedure
10. Is pregnant
11. Bleeding disorders
12. Currently taking anticoagulant or immunosuppressive medication
13. Allergy or intolerance to study medication
14. Use of chronic opioid
15. Documented history of drug abuse within six months of treatment
18) Any other condition, that in the opinion of the investigator, that would preclude the
patient from enrollment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 Years | A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment | NCT02370823 | Entailment |
5,375 | 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:
- Age 18-35
- Normal menstrual periods (24-35 days)
- Good general health
- Willing to use a non-hormonal form of contraception for the entire study (Acceptable
forms of contraception include condoms, spermicide, sexual contact with a sterilized
partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- Willing and able to return to clinic for bi-weekly blood tests
Exclusion Criteria:
- Pregnant or breast feeding
- Polycystic ovarian disease
- Gastrointestinal conditions (i.e.gastric ulcer)
- Currently using birth control
- Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or
Sulfa-drugs
- Diabetes
- Cardiac disease or hypertension
- Moderate to severe heartburn (GERD)
- Obesity (BMI greater than 30)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle | NCT00614406 | Entailment |
1,369 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Children below 5 years of age
- Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of
the following:
- Two or fewer defecations per week
- At least 1 episode per week of incontinence after the acquisition of toileting
skills
- History of excessive stool retention
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- History of large- diameter stools that may obstruct the toilet
Exclusion Criteria:
- Irritable bowel syndrome
- Mental retardation
- Endocrine disease (e.g. hypothyroidism)
- Organic cause of constipation (e.g. Hirschsprung disease)
- Spinal anomalies
- Anatomic defects of the anorectum
- History of previous gastrointestinal surgery
- Functional nonretentive fecal incontinence
- Use of drugs that influence gastrointestinal motility
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 5 Years | Lcr35 for Children With Functional Constipation | NCT01985867 | Contradiction |
2,422 | 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:
- Ability to provide written informed consent (parental/guardian consent if
applicable)/assent (if <18 years of age).
- Male sex.
- Age ≥5 years.
- Phenotypic evidence of DMD/BMD based on the onset of characteristic clinical symptoms
or signs (that is, proximal muscle weakness, waddling gait, and Gowers' maneuver) by 9
years of age, an elevated serum CK level, and ongoing difficulty with ambulation.
- Documentation of the presence of a nonsense point mutation in the dystrophin gene as
determined by gene sequencing from a laboratory certified by the College of American
Pathologists (CAP), the Clinical Laboratory Improvement Act/Amendment (CLIA), or an
equivalent organization.
- Documentation that a blood sample has been drawn for confirmation of the presence of a
nonsense mutation in the dystrophin gene.
- Ability to walk ≥75 meters unassisted during the screening 6-minute walk test. Note:
Other personal assistance or use of assistive devices for ambulation (for example,
short leg braces, long leg braces or walkers) were not permitted.
- Confirmed screening laboratory values within the central laboratory ranges (hepatic,
adrenal, renal, and serum electrolytes parameters).
- In participants who were sexually active, willingness to abstain from sexual
intercourse or employ a barrier or medical method of contraception during the study
drug administration and 6-week follow-up periods.
- Willingness and ability to comply with scheduled visits, drug administration plan,
study procedures, laboratory tests, and study restrictions. Note: Psychological,
social, familial, or geographical factors that might preclude adequate study
participation (in particular, the ability to satisfactorily perform the 6MWT) should
have been considered.
Exclusion Criteria:
- Treatment with systemic aminoglycoside antibiotics within 3 months prior to start of
study treatment.
- Initiation of systemic corticosteroid therapy within 6 months prior to start of study
treatment or change in systemic corticosteroid therapy (for example, initiation,
change in type of drug, dose modification not related to body weight change, schedule
modification, interruption, discontinuation, or reinitiation) within 3 months prior to
start of study treatment.
- Any change (initiation, change in type of drug, dose modification, schedule
modification, interruption, discontinuation, or reinitiation) in prophylaxis/treatment
for congestive heart failure within 3 months prior to start of study treatment.
- Treatment with warfarin within 1 month prior to start of study treatment.
- Prior therapy with ataluren.
- Known hypersensitivity to any of the ingredients or excipients of the study drug
(Litesse® UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127
[poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla,
Cab-O-Sil® M5P [colloidal silica], magnesium stearate).
- Exposure to another investigational drug within 2 months prior to start of study
treatment.
- History of major surgical procedure within 30 days prior to start of study treatment.
- Ongoing immunosuppressive therapy (other than corticosteroids).
- Ongoing participation in any other therapeutic clinical trial.
- Expectation of major surgical procedure (for example, scoliosis surgery) during the
12-month treatment period of the study.
- Requirement for daytime ventilator assistance.
- Clinical symptoms and signs of congestive heart failure (American College of
Cardiology/American Heart Association Stage C or Stage D) or evidence on
echocardiogram of clinically significant myopathy.
- Prior or ongoing medical condition (for example, concomitant illness, psychiatric
condition, behavioral disorder, alcoholism, drug abuse), medical history, physical
findings, electrocardiogram findings, or laboratory abnormality that, in the
investigator's opinion, could adversely affect the safety of the participant, makes it
unlikely that the course of treatment or follow-up would be completed, or could impair
the assessment of study results.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Phase 2B Study of PTC124 (Ataluren) in Duchenne/Becker Muscular Dystrophy (DMD/BMD) | NCT00592553 | Entailment |
1,808 | 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... | Healthy volunteers
Inclusion criteria:
- No gastrointestinal symptoms or history of gastrointestinal disease meeting ROME III
criteria for functional dyspepsia and Irritable Bowel Syndrome (IBS).
Exclusion criteria:
- Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14
days prior to endoscopy and within two days prior to multi-sugar test.
- Inability to stop the intake of medication affecting gastrointestinal function (e.g.
proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy,
multi-sugar test and combined meal- and gastric emptying test
- Current use of antidepressants
- Medical history of diabetes mellitus
- Medical history of coeliac disease
- Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis,
Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma,
esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal
erosions or duodenal ulcer)
- First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's
disease or ulcerative colitis
- Medical history of food allergy or anamnestic evidence of food allergy
- Presence of coagulation disorders or use of the following anticoagulants: coumarin
derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and
clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic
acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy
controls using higher doses of calcium carbasalate will be excluded from the study).
- Dieting
- Pregnancy or lactation
- Smoking
- Excessive alcohol use (>20 alcoholic consumptions/week) and inability to avoid use of
alcohol in the 2 days prior to endoscopy and multi-sugar test
Functional dyspepsia patients
Inclusion criteria:
- Patients referred for upper gastrointestinal endoscopy by either general practitioners or
physicians from the gastroenterology outpatient clinic and meeting ROME III criteria for
functional dyspepsia.
Exclusion criteria:
- Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14
days prior to endoscopy and within two days prior to multi-sugar test.
- Inability to stop the intake of medication affecting gastrointestinal function (e.g.
proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy,
multi-sugar test and combined meal- and gastric emptying test
- Current use of antidepressants
- Medical history of diabetes mellitus
- Medical history of coeliac disease
- Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis,
Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma,
esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal
erosions or duodenal ulcer)
- First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's
disease or ulcerative colitis
- Medical history of food allergy or anamnestic evidence of food allergy
- Presence of coagulation disorders or use of the following anticoagulants: coumarin
derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and
clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic
acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy
controls using higher doses of calcium carbasalate will be excluded from the study).
- Dieting
- Pregnancy or lactation
- Smoking
- Excessive alcohol use (>20 alcoholic consumptions/week) and inability to avoid use of
alcohol in the 2 days prior to endoscopy and multi-sugar test
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 | Functional Dyspepsia and Symptom Perception | NCT02522000 | Contradiction |
1,023 | 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:
- hand arthritis
- pain over 40/100
- stable treatment since 4 weeks at least with non-steroid analgesic
- between 45 et 85 years
Exclusion Criteria:
- pregnancy or breast feeding women
- hyaluronic acid injection within the past 6 months
- cortisonic derivated injection within the past 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 40 Years old.
Subject must be at most 85 Years | Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo | NCT01068405 | Entailment |
3,535 | 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:
- Adults, male or female aged 19 years or older
- newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma,
primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma
Exclusion Criteria:
- previous or current history of adrenal diseases
- using oral or intravenous steroids
- history of major depressive disorder
- history of chronic alcoholics
- history of any cancer with suspicious adrenal metastasis
- those with acute illness (ex- patients with acute coronary syndrome within 4 weeks,
acute febrile disease)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| A Prospective Cohort Study for Patients With Adrenal Diseases | NCT03474237 | Entailment |
388 | 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:
- Both ovaries are present
- Day 2 FSH <10 mIU/L
- Day 2 Estradiol <50 pg/L
Exclusion Criteria:
- Polycystic ovarian syndrome (PCOS)
- Abnormalities affecting the uterine cavity
- Uncontrolled diabetes
- Allergy to gonadotrophins
- Cancelled cycles during the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Evaluation of the Role of Follicular Sensitivity Index in the Prediction of Pregnancy in Women Undergoing ICSI/IVF Without Polycystic Ovarian Syndrome | NCT02158026 | Contradiction |
6,440 | 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:
- Healthy patients 18-55 years of age with erythematotelangiectatic rosacea (as verified
by the the PI).
- Subjects who are willing to provide informed consent for participation in the study.
Exclusion Criteria:
- Pregnant or lactating individuals
- Subjects who are unable to understand the protocol or to give informed consent.
- Subjects who have a known history of photosensitive conditions (e.g. Systemic lupus,
polymorphous light eruption)
- Subjects who have facial telangiectasia of diameter greater than 2 mm.
- Subject who have significant (as determined by the PI) acute inflammatory papules,
pustules, and vesicle involving the central face.
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 | Pulsed Dye Laser (PDL) vs. Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness | NCT01529996 | Entailment |
3,609 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- ≥18 years of age
- cognitively intact
- consent to participation.
Exclusion Criteria:
- patients arriving to the ED regarding injury
- patient with the highest triage level
- demented patients
- intoxicated patients
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department | NCT04226040 | Entailment |
5,482 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
Any patient admitted to our Emergency Department who is
- age > 16 years
- pain lasting =< 1 week or
- no pain on admission but pain during the ED stay
Exclusion Criteria:
- life-threatening condition requiring immediate admission in the OR or ICU
- no pain or pain lasting >1 week
- inability to give informed consent (intoxicated, psychiatric disorder, language
problem, prisoner)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Management of Acute Pain in the Emergency Department | NCT00470652 | Contradiction |
1,501 | 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. 65 years of age or older
2. Dysphagia diagnosis based on videofluoroscopic swallow study with observed airway
invasion (Penetration-Aspiration Scale score of 3 or higher)
3. Ability to provide consent
4. Ability to submit oral samples
5. Ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed)
6. Ability to return to UWHC for week 2 and week 4 visits.
Exclusion Criteria
1. Currently taking antibiotics or probiotics
2. Actively receiving immunosuppressive therapy
3. Non-oral feeding with inability to swallow probiotic
4. diagnosis of head and neck cancer or upper airway disease
5. prior surgery to the head and neck region that would have affected the muscles of
swallowing or the salivary glands
6. history of chemotherapy or radiation to the head and neck region
7. severe periodontal disease.
8. currently pregnant or planning to become pregnant
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.
Subject must be at most 99 Years | Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia | NCT03682094 | Entailment |
6,545 | 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 ≥ 12 years and ≤ 55 years
- severe haemophilia A (FVIII < 1%)
- absence of inhibitors (Bethesda titre < 0.6 BU/ml)
- Previous Treated Patients (prior exposure days > 200)
- Kogenate Bayer administered 20-30 IU/kg -3 times a week, for the prophylaxis group
- ≥ 6 joint bleeds requiring treatment with FVIII concentrates in the previous 6 months
before enrollment, for on-demand group
- written informed consent
Exclusion Criteria:
- concomitant severe and chronic diseases or congenital skeletal malformation
- unreliability of patient or likelihood of follow-up failure
- presence of inhibitors or history of inhibitors (in the previous 2 years)
- currently on immune tolerance treatment
- hepatic cirrhosis or liver disease in rapid progression
- AIDS
- platelet count < 75,000/mm3
- presence of conditions that influence negatively patient´s compliance
- participation in another study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 55 Years | Prophylaxis Versus On-demand Therapy Through Economic Report | NCT01159587 | Contradiction |
4,459 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Age 18-65
- Pain at the lateral side of the elbow ≥8 weeks
- Local tenderness on palpation of the lateral epicondyle
- Pain on resisted extension of the wrist
Exclusion Criteria:
- Rheumatic disorder
- History of fibromyalgia or generalised pain
- Elbow surgery (on the painful side)
- Active infection
- Glucocorticoid treatment during the duration of symtoms of epicondylalgia
- NSAID use within 1 w before presentation and during the study
- Pregnancy
- Taking drug that might interact with doxycycline
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 | Doxycycline for Lateral Epicondylalgia - RCT | NCT00631501 | Contradiction |
2,836 | 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
- Diagnosis of probable or definite ALS
- At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow
extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better
- At least 5 years from onset of symptoms
Exclusion Criteria
- Requires tracheostomy ventilation
- History of renal disease
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 | Creatine for the Treatment of Amyotrophic Lateral Sclerosis | NCT00070993 | Entailment |
4,652 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit
1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during
the menstrual period of the screening period
- Good general health (except for findings related to dysmenorrhea) as proven by medical
history
- Patients aged 18 years or older at the time of obtaining informed consent; smokers
must not be older than 35 years at the time point of informed consent
- Normal or clinically insignificant cervical smear not requiring further follow up (a
cervical smear has to be taken at screening visit or a normal result has to be
documented within the previous six months). Human papilloma virus (HPV) testing in
subjects with atypical squamous cells of undetermined significance (ASCUS) can be used
as an adjunctive test. Subjects with ASCUS can be included if they are negative for
high-risk HPV strains (HPV 16, HPV18).
- Women of childbearing potential must agree that adequate contraception will be used
when they are sexually active. This applies from signing of the informed consent form
until 2 weeks after the last study drug administration.
Exclusion Criteria:
- Pregnancy (confirmed or suspected) or lactation (less than three months since
delivery, abortion, or lactation before start of treatment)
- Patients who wish to become pregnant during the course of the study
- Body Mass Index (BMI) > 32 kg/m2
- Hypersensitivity to any ingredient of the study drug
- Laboratory values outside inclusion range before randomization
- Any diseases or conditions that can compromise the function of the body systems and
could result in altered absorption, excessive accumulation, impaired metabolism, or
altered excretion of the study medication
- Any diseases or conditions that might interfere with the conduct of the study or the
interpretation of the results
- Any disease or condition that may worsen under hormonal treatment according to the
assessment and opinion of the investigator.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea | NCT02617537 | Entailment |
1,988 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients diagnosed with adenocarcinoma in the gastroesophageal junction
- Patients assumed to be resectable
Exclusion Criteria:
- lack of consent
- non-adenocarcinomas
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.
| Gastric Microperfusion in Patients Undergoing Gastroesophageal Resections | NCT02077673 | Entailment |
3,444 | 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:
- Diagnosis of type 2 diabetes for at least 6 months
- Diabetes for a maximum of ten years
- Updated HbA1c level of between 8.5 and 11% from the last month
- Agreement to participate and sign an informed consent
Exclusion Criteria:
- Pregnancy
- Insulin therapy
- Psychiatric disorder from the first or second line according to the Diagnostic and
Statistical Manual of mental disorders (DSM)
- Active oncology disease [excluding squamous cell carcinoma (SCC) and basal cell
carcinoma (BCC)
- Planed bariatric surgery for the next 6 months
- Cardiac hospitalization in the previous year
- A severe hypoglycemia event three months prior to allocation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Financial Incentives for Low Socioeconomic Diabetic Patients | NCT03506230 | Entailment |
814 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- 1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3
out of 10) because our aim of the study to reduce pain with combined treatment and
pain lower than 3 out of 10 score might not allow to compared the pain reduction
between the group.
2- Definitive medial joint narrowing higher or equal to the lateral side and
osteophytes on X-Ray A-P or PA view in weight bearing position if possible.
3- Medial joint tenderness either by patient's indication or the clinician under the
clinical examination indicating tenderness in the tibiofemoral joint.
4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as
their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological
plain x-ray will be used.
5- Being able to walk without assisted devices for 100 meters non-stop because he or
she will not be able to complete this study protocol.
Exclusion Criteria:
- 1- More pain localized to patellpfemoral or lateral joint than the medial knee side on
examination.
2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or
orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any
other realignment operation. 6- Total knee replacement. 7- Any condition
contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected
intra-articular knee joint space in the previous month.
9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher
will be excluded because previous study showed that individuals with 33 BMI.
11- Lower than 35 years and higher than 85 as this period was identified to highest
incidence period (Losina et al., 2013). Although individuals with 86 and higher has
high prevalence to the knee OA, exclusion this population was important due to high
amount of walking and balance test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 Years | Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis | NCT03225911 | Entailment |
6,880 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion criteria:
1. Patients diagnosed of diabetes mellitus type 2 with time evolution ⋝5 years.
2. Age between 65 and 85 years old (both included).
3. Ability to read and write.
4. Active treatment with hypoglycemic agents.
5. Diagnosed with mild cognitive impairment.
Exclusion Criteria:
1. Familiar history of Alzheimer's' disease.
2. Patients with any type of dementia.
3. History of neurological or psychiatric conditions not stabilized that can
substantially affect cognition.
4. Severe metabolic or systemic disease that affects the cognitive state. This includes:
- Unstable acute cardiovascular disease.
- Renal failure with glomerular filtration rate <30 ml/min/m2.
- Decompensated cirrhosis or liver failure.
- Untreated hypothyroidism or vitamin B12 deficiency. If known.
- Active cancer or chemotherapy treatment the previous year.
5. Treatment with drugs that alter the cognitive state, for example:
- Antipsychotic.
- Daily consumption of opioids.
- Benzodiazepines (BZD) long action (for example Diazepam). Benzodiazepines (BZD)
short-acting at high doses such as Alprazolam at doses greater than 1 mg / day;
Lorazepam at doses greater than 1 mg / day and Lormetazepam at doses greater than
1 mg / day.
- Fentanil patches in doses greater than 2.5 mg every 72 h.
- Gabapentin in doses greater than 600 mg / day.
- Pregabalin in doses greater than 50 mg / day.
- Amitriptyline in doses greater than 25 mg / day.
6. Limitations of mobility that can avoid or restrict the application or evaluation of
the intervention.
7. Patients with other types of diabetes: diabetic mellitus type 1, LADA; MODY
8. Unstable advanced diabetic retinopathy
9. Patients with serious uncorrected sensory deficits that make assessment impossible
(blindness, deafness).
10. Patients with access to other online platforms for patients.
11. Patients with access to other intelligent electronic dispensing devices for improved
adherence to treatment.
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.
Subject must be at most 85 Years | Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease | NCT03578991 | Contradiction |
506 | 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:
- Age ≤ 40.
- AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
- OR 3 ≤ AFC ≤7.
- Normal shape of uterus (based on ultrasound).
- Body mass index within 28 - 37 kg/m2
Exclusion Criteria:
- Asherman's syndrome.
- Endometriosis.
- Leiomyomas distorting the endometrium
- Sperm extracted from surgical procedures (i.e. PESA, TESE).
- Patients refuse to continue participating in the study.
- Patients injected with wrong dose of gonadotropins during the treatment.
- Serious complications or accidents arise forcing the patients to discontinue the
treatments.
- Ovarian surgery
- Previous chemotherapy or pelvic irradiation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Double Stimulation in Women With Low Prognosis in ART | NCT04531644 | Contradiction |
3,566 | 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:
1. Signed informed consent, demonstrating that the patient understands the procedures
required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with
mothers)
3. Diagnosis of Lyme Disease
Exclusion Criteria:
1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or
proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's
ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee
and/or comply with the requirements of the entire study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease | NCT04148222 | Entailment |
6,156 | 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:
- pcr positive for covid -19 who are survived
Exclusion Criteria:
- dead patient uncooperative
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Post Covid-19 Cardiopulmonary and Immunological Changes | NCT04388436 | Contradiction |
3,112 | 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
Patients will be eligible for inclusion if all these criteria are respected:
1. Age of at least 18 years
2. Provides written informed consent prior to study-related procedures at the screening
visit
3. Is able to understand and willing to comply with the procedures and the actions asked
of him/her
4. History of dry eye syndrome for at least 3 months
5. Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body
sensation, pain, itching, stinging, epiphora, photophobia or blurred vision
6. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
7. OSDI score ≥ 23 points
8. Normal ophthalmic findings except dry eye syndrome
Exclusion Criteria
Patients will be excluded under the following circumstances:
1. Participation in a clinical trial in the 3 weeks preceding the study
2. Symptoms of a clinically relevant illness in the 3 weeks before the first study day
3. Presence or history of a severe medical condition as judged by the clinical
investigator
4. Intake of parasympathomimetic or anti-psychotic drugs
5. Wearing of contact lenses
6. Glaucoma in the medical history
7. Treatment with corticosteroids in the 4 weeks preceding the study
8. Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks
preceding the study
9. Ocular infection or clinically significant inflammation not related to dry eye
syndrome
10. Ocular surgery in the 3 months preceding the study
11. Sjögren's syndrome
12. Stevens-Johnson syndrome
13. History of allergic conjunctivitis
14. Pregnancy, planned pregnancy or lactating
15. Known hypersensitivity to any component of the study medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome | NCT03161080 | Contradiction |
4,597 | 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:
- Mobile uterus.
- Uterine size up to 12 weeks gestation.
- Benign lesions.
Exclusion Criteria:
- Enlarged uterus > 12 weeks gestation.
- Suspected malignancy.
- Large adnexal masses.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Total Laparoscopic Hysterectomy vs Minilap Hysterectomy | NCT03251677 | Contradiction |
6,095 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Parents with babies with Down Syndrome between 4 and 8 months old.
Exclusion Criteria:
- Parents with babies without Down Syndrome.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies | NCT03126734 | Entailment |
4,075 | 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:
- idiopathic RBD (criteria of the international classification of sleep disorders-3)
For healthy controls : no neurologic or psychiatric disorder
Exclusion Criteria:
- Contraindication to MRI
- Do not speak French
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE) | NCT03072940 | Contradiction |
4,992 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Consenting male and female participants, aged 18 years to 80 years
- PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease or ET
with hand tremor in their motor dominant hand
- Stable IPD/ET medication management for the 6 month duration prior to their enrollment
in the study
- Individuals with IPD will be eligible for the study only if tremor is their primary
and most bothersome symptom as determined by clinical exam and patient report
- Participants who are botulinum toxin naïve for tremor management
Exclusion Criteria:
- History of stroke
- Muscle weakness or any related compartmental muscle syndrome
- Smoking
- Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic
agonists (e.g. salbutamol))
- Contradictions per the Xeomin® drug monograph
- Patients prescribed zonisamide
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 | Kinematic-guided BoNT-A Treatment for ET and PD Tremor | NCT02427646 | Entailment |
768 | 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:
- sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating
scale (NRS) pain score ≤ 4.
Exclusion Criteria:
- current medication use related to arthritis;
- current use of FAC containing products;
- clinical or radiological diagnosis as moderate degree arthritis accompanied by
peri-articular spur formation, irregular joint margin, and/or subchondral cyst;
- previous history of knee surgery;
- pregnant, breastfeeding, or practicing contraception with reliable methods, or not
accepting our guidelines during the research periods;
- major pain other than knee joint pain;
- current treatment of gastritis or gastric ulcer;
- abnormal screening laboratory results;
- major cardiac, renal disease, or disability that could affect adverse effect
assessment or interfere with study completion when enrolled;
- history of major procedures or operations that might affect study results;
- enrollment in another clinical trial or human application testing; and
- judged as unsuitable for human application testing.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain | NCT02800759 | Contradiction |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.