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4,376 | 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 : adult ;
Exclusion criteria : temporomandibular disorders (TMD symptom questionnaire)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Condylar Inclination Recorded With Modjaw® Device. | NCT04694040 | Entailment |
3,119 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
1. Provide written informed consent
2. Male or female subjects aged 18 to 80 years, inclusive
3. Have a history of dry eye disease (DED) in both eyes
4. Be on stable regimens of other needed medications
5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy
Study (ETDRS)
6. Have reported symptoms
7. Have the following signs in at least one eye: Schirmer score without anesthesia of >1
and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.
8. Have normal lid anatomy
Exclusion Criteria:
1. Have undergone refractive eye surgery in the past 12 months
2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not
resulting in exposure or abnormal blinking is allowed)
3. Have lid irregularities or deformities
4. Have a history of glaucoma, a history of an elevated lOP within the past year, or an
lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
5. Have any clinically significant, uncontrolled, or unstable medical or surgical
conditions that could affect his or her ability to participate
6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct
obstruction. Removable punctal plugs are allowed if they have been used regularly for
at least 60 days prior to the screening visit. However, if a plug comes out during the
study it must be promptly replaced.
7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
8. Are pregnant or breast feeding
9. Use of any investigational product or device within 28 days prior to the Screening
Visit or during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease | NCT02831387 | Contradiction |
645 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria for patients:
- Man or woman older than 18 years
- Subject having a liver iron overload greater than or equal to 100 umol /g dry liver
weight, confirmed by MRI (done performed with body antenna and complete deactivation
of the surface antenna) and / or by biochemical assay on liver biopsy, and related to
dysmetabolic hepatosiderosis or ferroportin disease.
- The ferroportin disease will be retained when patients will present an
hyperferritinemia without elevated transferrin saturation and a heterozygote
mutation in the gene encoding ferroportin.
- A dysmetabolic hepatosiderosis will be retained following the usual diagnostic
investigation including sequencing of the gene for ferroportin (mutation proven
negative), if patients do not show any other cause of iron overload and
hyperferritinemia is not related to excessive alcohol intake, non-metabolic liver
cytolysis (hepatitis C virus, wilson, autoimmune hepatitis, ...), hemolysis, or
inflammatory syndrome.
- Status towards the iron-depletive treatment : either no venesection performed
(Dysmetabolic HepatoSiderosis and Ferroportin disease groups) or attack iron depletive
treatment completed (Treated Dysmetabolic Hepatosiderosis and Treated Ferroportin
Disease groups) with ferritin level less than 100 ng / ml, without anemia and with no
venesection in the two last months.
- Having given a free and informed consent in writing
- Affiliate to the social security system.
Exclusion Criteria for patients:
- Alcohol consumption greater than 30g/d
- Chronic inflammatory disease.
- HIV, HCV or HBV Infection.
- Blood donation in the last three months.
- Infection during the previous seven days before testing
- Staying in altitude (>1500 m) dating less than 2 months
- Night occupation or shift work.
- Pregnancy
- Exclusion period in the national register of persons suitable for biomedical research.
- Protected adults (judicial protection, guardianship and trusteeship) and persons
deprived of liberty
Inclusion criteria for healthy volunteers:
- Man or woman older than 18 years.
- Body Mass Index between 18 and 25 kg/m².
- Non smoker or quit smoking for more than 6 months
- Examen clinique normal. Normal clinical examination
- Normal ECG.
- Normal values for routine laboratory tests : serum iron, tranferrin saturation, CBC,
ferritin, blood cell count C-reactive protein, AST, ALT, GGT, HDL and LDL cholesterol,
triglycerides.
- Having given a free and informed consent in writing
- Affiliate or beneficiary to the social security system.
Exclusion criteria for healthy volunteers :
- Progressive and/or chronic disease.
- Infection during the previous seven days before testing
- Drug use under 6 months.
- Alcohol consumption greater than 30g/d
- Medication ongoing or stopped from less than a week (except contraceptives).
- History of blood transfusion or martial treatment.
- Staying in altitude (>1500 m) dating less than 2 months
- Night occupation or shift work.
- Known infection by hepatitis B or C.
- Positive serology for HIV.
- Blood donation in the last three months.
- Pregnancy.
- Exclusion period in the national register of persons suitable for biomedical research.
- Protected adults (judicial protection, guardianship and trusteeship) and persons
deprived of liberty.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Analysis of the Modulation of Serum Hepcidin Level in Response to Iron Oral Intake: Potential Interest for the Differential Diagnosis Between Ferroportin Disease and Dysmetabolic Hepatosiderosis. | NCT01949467 | Contradiction |
3,569 | 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:
- Clinical diagnosis of suspected, confirmed, or probable LB or other TBD per CDC case
definitions.
- Has not received antibiotic therapy for tick-borne disease for more than 2 weeks.
- Age >=18 years.
- Able to provide informed consent.
- Subjects must maintain a private physician for non-protocol related medical complaints
and for emergency medical treatment required for these or other disorders.
EXCLUSION CRITERIA:
- Post-treatment Lyme disease syndrome
- Women who report they are pregnant.
- Any other condition or history of unacceptably poor compliance that, in the opinion of
the investigator, would make the patient unsuitable for enrollment or could interfere
with the patient participating in and completing 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.
| Evaluation and Follow-up of People With Tick-borne Diseases | NCT04318925 | Entailment |
6,895 | 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:
- Existence of a probable Alzheimer's disease (AD) according to the NIAA criteria
(McKhann et al., 2011) with a Mini Mental State Examination (MMSE) greater than or
equal to 20 (threshold defined in order not to include certain participants whose
comprehension problems would not be compatible with the ARIADE project) OR Existence
of an Alzheimer-type Mild Cognitive Impairment (MCI) according to the criteria of
Albert et al. (2011)
- Adult person
- Affiliation to a social security scheme
- Free, informed and signed written consent The diagnosis of dementia or MCI of the
probable Alzheimer type will be made by the medical and paramedical team of the
Memory, Resources and Research Center (CMRR) of the Rennes University Hospital
(Department of Dr Serge Belliard). The proposal for voluntary participation in the
ARIADE project will be made by one of the project's clinical investigators to CMRR
patients who have already expressed their interest in participating in a clinical
research project (list already updated by the CMRR team) and to members of the
Association Bistrot Mémoire de Rennes, partner of the ARIADE project, after validation
of the inclusion and non-inclusion criteria by the CMRR team at Rennes University
Hospital.
Exclusion Criteria:
- Clinical history of neurological event in the central nervous system
- Untreated anxiety-depressive syndrome with a sub-score A (anxiety) or D (depression)
on the HADS questionnaire, i.e. Hospital Anxiety and Depression Scale, greater than or
equal to 11
- Moderate or greater deafness (loss of at least 40dB from the "good" ear) or an
asymmetry of more than 10dB between the left and right ear on tone audiometry
- Insufficient corrected visual acuity (decree of August 31, 2010 for driving a light
vehicle) (incompatibility if binocular visual acuity is less than 5 / 10th OR if the
acuity of one eye is less than 1 / 10th and the acuity of the other eye is less than 5
/ 10th)
- Severe comprehension disorder, preventing the understanding of the instructions
- Severe behavioral disorder, not allowing participation in the experiment (DSM-V)
- Acute decompensated pathology (example: heart failure)
- Lack of social security
- Safeguarding effective justice
- Severe balance disorders noted when performing a Timed Up and Go Test with a risk of
falling noted by the assessor or an inability to perform a 6-minute walk test.
- Non-French speaking person
- Pregnant or breastfeeding woman
The existence of a simple curatorship, a reinforced curatorship or a tutorship will not
constitute a criterion for non-inclusion. Indeed, people with a neurocognitive disorder
under legal protection are those who probably present the most loss of autonomy and loss of
social participation and inclusion in the city, in connection with the disease and / or
with isolation. social and family. These are therefore the people most in need of
technological aids that we are going to offer. It therefore seems illogical to exclude them
insofar as they will represent the sub-part of this population that will need them the most
and will probably derive great benefit from them, with minimal risks in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| ARIADE : Augmented Reality for Improving Autonomy in Dementia | NCT04742465 | Entailment |
3,027 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
1. Successfully completed all scheduled visits of the previous protocol ( 22002,
209FX301, or 209FX302).
2. A parent,LAR, or caregiver must be willing and able to accompany the subject to all
study visits, participate in phone calls, complete study assessments, administer study
medication, and report the subject's condition and medication use to site staff
members.
3. Prior to the conduct of any study-specific procedures, the subject must provide
written informed consent to participate in the study ( if developmentally appropriate)
or verbal assent and the parent/caregiver/LAR must provide written informed consent.
If the caregiver attending the clinic visits is not the parents, caregiver, or LAR,
written consent must also be obtained for the caregiver's participation in the study.
4. Current treatment with no more than 3 psychoactive medications, including
anti-epileptics, unless the Medical Monitor is consulted.
5. Subjects with a history of seizure disorder must have been seizure free for 6 months
and be taking anti-epileptics, or seizure free for 3 years if not receiving
anti-epileptic treatment. If currently receiving treatment with anti-epileptics, serum
concentration levels must be tested and be in therapeutic range.
6. Negative pregnancy test for females of childbearing potential or be using a medically
acceptable form of birth control.
Exclusion Criteria
1. Subjects with any condition that might interfere with the conduct of the study,
confound interpretation of the study results, or endanger their own well-being. This
includes, but is not limited to impairment of renal function, evidence or history of
malignancy or any significant hematological, endocrine, cardiovascular, respiratory,
hepatic, or gastrointestinal disease.
2. Subjects who are currently engaged in illicit drug or alcohol abuse.
3. Subjects who had a serious adverse event (SAE) while taking STX209 during their
previous protocol (22002,209FX301,309FX302)that the Investigator considered related to
STX209, unless approval from the Medical Monitor is obtained.
4. The occurrence or continuation of any AE or condition during Studies 22002, 209FX301,
or 209FX302 that, in the opinion of the Investigator, should exclude this subject from
participating in the open-label extension.
5. Subjects taking another investigational drug, other than STX209, currently or within
30 days of Visit 1. Subject must not take any investigational drugs during this study.
6. Subjects who, in the Investigator's opinion, might not be suitable for the study.
7. Subjects treated with vigabatrin, tiagabine, or riluzole currently or within 2 weeks
of Visit 1.
8. Subjects treated with racemic baclofen currently or within 1 week of Visit 1.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 50 Years | An Open Label Extension Study in Subjects With Fragile X Syndrome | NCT01555333 | Entailment |
1,421 | 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:
- Male or Female adults, 18 years or over
- Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP
(diastolic blood pressure) ≥ 90 mm Hg* when blood pressure is measured at Visit 1(week
-2) and at Visit 2(week 0).
If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure
values measured consecutively at least 2 minutes apart)
- Patient who is willing to, and is able to sign the informed consent form
Exclusion Criteria:
- Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected
Duration Of The Study
- Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
- Patient has history of malignant hypertension
- Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac
infarction within the last 6 months
- Patient takes antihypertensive drugs
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.
| LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED) | NCT00496834 | Contradiction |
3,008 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Fragile X Syndrome
Exclusion Criteria:
- Current or past SSRI treatment
- Current or past MAOI (monoamine oxidase inhibitor ) treatment
- Serious co-morbid medical disorder affecting brain function and behavior (not
including fragile X syndrome).
- Uncontrolled seizure disorder or epilepsy
- Bipolar disorder
- Latex allergies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
Subject must be at most 68 Months | Trial of Sertraline to Treat Children With Fragile X Syndrome | NCT01474746 | Contradiction |
61 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. ED complaint ongoing for over 3 months;
2. Age comprise between 45 and 80 years old;
3. Had a stable heterosexual relationship for more than 3 months and anticipates having
the same partner for all the study
4. Has not responded adequately to the highest available dosage of Tadalafil or other
PDE5 inhibitors (20 mg for Tadalafil and Vardenafil, 100 mg for Sildenafil) taken at
least at 4 separate occasions, defined as: a score of 2,3 or 4 at Question 3 of the
IIEF AND a score of 2 or 3 at Question 4 of the IIEF; measured prior to Visit 1
5. Low or low-to-normal serum testosterone level (either on total or bioavailable
testosterone levels) with respect to the range of men under aged than 50 y.o. (TT < 4
ng/ml and/or BT < 1 ng/ml) according to a first assay done prior to Visit 1 and a
confirmation by a second assay at central laboratory Biolille on blood sampled at
Visit 1
6. Agrees to make at least 4 attempts at sexual intercourse on 4 separate days during the
4 weeks run-in period with daily Tadalafil 10 mg
7. At least 50% of attempts during this period must be unsuccessful according an answer
"No" at one of the questions 1 ("were you able to achieve at least some erection (some
enlargement of the penis)?"), 2 ("were you able to insert your penis in your partner's
vagina?") or 3 ("did your erection last long enough for you to have successful
intercourse?").
8. At the end of the run in phase with Tadalafil 10 mg daily, the patient should provide:
a score of 2, 3 or 4 at Question n°3 of the IIEF AND a score of 2, 3 at Question n°4
of the IIEF
9. Agrees not to use any other ED drug or non-drug (devices) treatment during the full
course of the study;
10. Provides a signed informed consent.
Exclusion Criteria:
1. Impotence caused by other primary sexual disorder (e.g. premature ejaculation);
2. History of penile implant or significant penile deformity;
3. Body mass index >35kg/m2;
4. Diabetes mellitus that is uncontrolled (HbA1c level > 10%). HbA1c will be checked at
screening for each diabetic patient or suspected to be;
5. Uncontrolled thyroid disorders;
6. Known hyperprolactinemia (serum prolactin > 30ng/ml in local laboratory);
7. Organic hypothalamic-pituitary pathology;
8. History of alcohol, drug or substance abuse within 6 months before Visit 1;
9. Renal insufficiency defined as receiving renal dialysis, having a creatinine clearance
< 30 ml/mn, or serum creatinine > 30 mg/ml;
10. Severe hepatic impairment, Child Pugh class C, elevation of AST and/or ALT > 3 x the
ULN;
11. Systolic Blood Pressure > 170 or < 90 mm Hg or diastolic blood pressure > 110 or < 50
mm Hg at screening;
12. Cardiac disease contra-indicating any sexual activity;
13. Unstable angina within 6 months before Visit 1;
14. Angina during sexual intercourse within 6 months before Visit 1;
15. Myocardial Infarction within 90 days before Visit 1;
16. Coronary artery by-pass graft surgery or percutaneous coronary intervention
(angioplasty or stent insert) within 90 days before Visit 1;
17. Severe cardiac rhythm disturbances e.g. supraventricular arrhythmia with a ventricular
response >100 bpm. at rest despite medical or device therapy, history of refractory
spontaneous or induced sustained ventricular tachycardia (heart rate > 100 bpm. for >
30 sec) or fibrillation, automatic internal cardioverter-defibrillator, history of
sudden cardiac arrest) within 6 months before Visit 1;
18. Known new and significant conduction defect that was not evaluated with regard to
significance within 90 days prior to Visit 1;
19. Congestive heart failure (NYHA Class II or above) within 6 months before Visit 1;
20. History of stroke within the 6 last months;
21. Epilepsy not adequately controlled by treatment;
22. Polycythemia with hematocrit >52% at study entry (i.e. screening visit/visit 1);
23. Suspicion of current, or past history of prostate or breast cancer;
24. Severe symptomatic Benign Prostate Hyperplasia;
25. PSA value exceeding the age specific reference ranges published by Richardson and
Oesterling, Urol Clin North Am, 1997, 24: 339-351
26. Diagnosed sleep apnea;
27. Extensive skin abnormalities that could affect absorption of the gel;
28. Any clinically significant chronic disease that might, in the opinion of the
investigator, compromise patient's safety, interfere with the evaluations, or preclude
completion of the trial (e.g. hemochromatosis, chronic lung disease, chronic
malabsorption disease);
29. History of HIV infection;
30. Severe psychiatric disease;
31. Illiteracy, lack of fluency in the language used for the writing of the protocol and
questionnaires, unwillingness, medical, psychiatric or other conditions that
compromise the patient's ability to understand the patient information, to give
informed consent, to understand or complete diary or questionnaires or otherwise
comply with the trial protocol, or to complete the study;
32. Known hypersensitivity to Cialis(Tadalafil);
33. Hypersensitivity to the active substances or any of the excipients of Androgel®/
Testogel®;
34. Use of androgen therapy or anabolic steroids within 6 months of entry into the study
(i.e. screening visit/visit 1);
35. Concurrent use of the following medications:
androgens including dehydroepiandrosterone (DHEA) and anabolic steroids,
antiandrogens, estrogens, corticotrophin (ACTH), oxyphenylbutazone, clomipramine,
Serotonin Reuptake Inhibitors, long or short-acting nitrates, NO donors, potent
cytochrome P3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, saquinavir,
macrolides like erythromycin), cancer chemotherapy;
36. Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra,
or other therapy for ED;
37. Patients seeking conception or on treatment for infertility;
38. Concurrent participation in another clinical trial within 1 month of entry into this
study (i.e. screening visit/visit 1) or throughout the duration of the study;
39. Previous randomization into this study.
40. History of temporary or permanent partial or complete blindness
Male
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone | NCT00244023 | Contradiction |
904 | 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:
- Subjects who are capable of giving written informed consent, which includes compliance
with the requirements and restrictions listed in the consent form.
- Ambulatory non pregnant females and males 40-<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief
for OA hand for a total of at least 30 days before screening visit 0.
- Pain at or below 40 mm on a 100 mm VAS in the index knee joints.
- A documented diagnosis of OA of the knee joint, or meeting American College of
Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for
at least 6 months prior to screening.
- Subject has been documented radiographic evidence of OA of the knees from the
screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence
Radiographic Grading.
- Subject has no any contraindication for MRI
- Subject is able to understand and complete pain/function, global arthritis evaluation,
and health outcome assessment.
Exclusion Criteria:
- Subjects with history of hypersensitivity to hyaluronate.
- Subjects with skin lesion at the knee joint.
- A history of knee surgery within 6 months prior to screening V0.
- Significant prior injury to the knee joint within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect
the knee joint.
- Treatment with other drugs potentially affecting bone or cartilage metabolism as
described below:
- chronic systematic corticosteroids
- Diacerin or glucosamine treatment within the last 12 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 80 Years | Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee | NCT00750724 | Entailment |
3,196 | 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:
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Exclusion Criteria:
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
No condition on gender to be admitted to the trial.
Subject must be at least 20 Years old.
| A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | NCT02503163 | Entailment |
555 | 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:
- Females aged 18 to 42 years with regular menstrual cycles of 26-34 days
- Undergoing ovarian stimulation for IVF/ICSI & PGS.
- Receiving recombinant FSH for stimulation
- hCG 5000iu IM as trigger injection for oocyte maturation.
- Ovarian stimulation in GnRH-antagonist protocols
- BMI 18- 35 kg/m2
- Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.
Exclusion Criteria:
- Poor ovarian reserve as defined by Bologna criteria
- PCOS in accordance with Rotterdam criteria
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 42 Years | A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation | NCT04417569 | Contradiction |
4,692 | 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. Age 18 through 45 years (inclusive) at screening
2. Able and willing to provide written informed consent to be screened for and enrolled
in the study
3. Able and willing to provide adequate locator information at screening
4. HIV-uninfected based on testing performed by study staff at
5. In general good health as determined by the site clinician
6. Agree to abstain from any vaginal insertions, including products, douches, devices
such as sex toys, or penile or oral intercourse from 5 days prior to Visit 2
(Enrollment Visit) until the final Study Visit (one week after last dose of study
film). Only tampons during menses and clinically indicated speculum exams are allowed.
7. Agree to use condoms provided by the study staff from one week after last use of study
film until three weeks after last use of study film
8. Willingness to undergo all study-related assessments and follow all study-related
procedures
9. Be currently using an effective method of contraception at enrollment (used
continuously and with good compliance for the past 60 days as determined by
participant self-report) with plans to continue use throughout the study period.
Acceptable methods include any hormonal method (except vaginal ring); intrauterine
device (IUD) inserted at least 90 days prior to enrollment; female sterilization;
abstinent from sexual activity with male partner for the past 60 days; sexual activity
with vasectomized partner; engages in sex exclusively with women.
10. For participants 21 and older, a Pap result in the 36 calendar months prior to the
Enrollment Visit consistent with Grade 0 according to the Female Genital Grading Table
for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and
Pediatric Adverse Events satisfactory evaluation with no treatment required of
non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology
(ASCCP) guidelines or per local standard of care, within the last 36 calendar months
prior to enrollment. Note: For participants aged 18-21, a Grade-0 or adequately
evaluated abnormal Pap smear is not required as the American Society for Colposcopy
and Cervical Pathology recommends initiating screening at age 21.
11. At screening and enrollment, agrees not to participate in other research studies
involving drugs, medical devices, or vaginal products while enrolled in this trial -
Exclusion Criteria:
1. Menopausal at screening (as defined as amenorrhea or irregular periods for one year or
more without an alternative etiology)
2. Hysterectomy
3. Known adverse reaction to any of the study products (ever)
4. Known adverse reaction to latex (ever)
5. Non-therapeutic injection drug use in the 12 months prior to screening
6. Surgical procedure involving the pelvis in the 90 days prior to screening (includes
dilation and curettage or evacuation, and cryosurgery; does not include cervical
biopsy for evaluation of an abnormal pap smear or IUD placement)
7. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to
screening or anticipated participation in an investigational drug study in the next 8
weeks
8. Pregnancy within 90 days prior to screening
9. Lactating
10. Use of a diaphragm, NuvaRing®, or spermicide for contraception
11. As determined by the PI, a degree of menstrual cycle irregularity that would make it
difficult to schedule follow up visits without interruption by menses
12. Active sexually transmitted infection or documented treatment of sexually transmitted
infections in the last 6 months, including, but not limited to: chlamydia, gonorrhea,
syphilis, trichomonas, cervicitis or pelvic inflammatory disease, or currently active
HSV lesions or other sores. (Participants seropositive for or with a history of HSV
without current active lesions will not be excluded.)
13. Women who by history engage in condom-less intercourse with HIV-infected partners, or
who exchange sex for money, shelter, or gifts, or who in the opinion of the
investigators, may be at risk for HIV acquisition during the duration of the study
14. More than one sex partner within the past 3 months
15. Current sexual partner known by participant to be HIV seropositive
16. Current or planned use of pre-exposure prophylaxis against HIV infection
17. Currently active genital HSV lesions, or other genital tract epithelial disruption or
inflammation
18. Current or episodic use of anti-herpes suppressive therapy
19. Urinary tract infection, symptomatic candidiasis, or symptomatic bacterial vaginosis
within 14 days of enrollment, or currently residual symptoms thereof Note: women with
these infections at screening can be enrolled after treatment and resolution of the
infection.
20. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
21. Use of systemic immunomodulatory medications within 4 weeks of enrollment
22. Menses or other vaginal bleeding at the time of enrollment* or expecting menses in the
10 days after enrollment (Segment A participants) or 16 days after enrollment (for
Segment B participants)
*Note: for women with monthly cycles, every attempt will be made to enroll these
participants in the first half of their menstrual cycle. Women who have vaginal
bleeding at the scheduled Enrollment Visit may return at a different date to be
re-examined and possibly enrolled provided they are still within the screening window
and meet all criteria.
23. Lack of stable living conditions to allow reliable room temperature storage of study
product (Segment B participants only)
24. At enrollment has any of the following laboratory abnormalities per the Division of
AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events,
Version 2.0, Nov 2014:
- Grade 1 or higher AST (aspartate aminotransferase) or ALT (alanine
aminotransferase)
- Grade 1 or higher creatinine
- Grade 2 or higher hemoglobin
- Grade 1 or higher platelets Note: otherwise eligible participants with an
exclusionary test may be re-tested once during the screening process.
25. As determined by the Principal Investigator (PI), any subject who has any significant
uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic,
gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or
infectious disease, anticoagulation with warfarin or heparin; or any other condition
that, in the opinion of the Investigator, would preclude provision of consent, make
participation in the study unsafe, complicate interpretation of study outcome data, or
otherwise interfere with achieving the study objectives.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Vaginal Antibody Safety Trial: Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of Herpes Simplex Virus (HSV) and Human Immunodeficiency Virus (HIV) | NCT02579083 | Entailment |
6,100 | 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:
- All consecutive patients with mild to moderate COVID-19 infection
- Age >18 years,
- Clinical diagnosis of COVID19 infection
- Patients should present fever, cough and myalgia and weakness and radiological
findings of pneumonia.
- All patients should be willing and able to provide written informed consent prior to
performing study procedures.
Exclusion Criteria:
- Age less than 18
- History of thrombophlebitis.
- Patient with latent tuberculosis infection (Quantiferon test).
- Pregnancy and lactation.
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 | Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study. | NCT04320277 | Contradiction |
6,166 | 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:
- Residents of participating nursing home - who benefited from a rapid diagnostic
orientation serological test for COVID-19 - having given their agreement
- All staff members (doctors, nurses, health executives, caregivers, physiotherapists,
ASH, stretcher bearers, psychologists, dieteticians, administrative staff,
secretaries, ...) - who benefited from a rapid diagnostic orientation serologic test
for COVID-19 - having given their agreement
Exclusion Criteria:
- Refusal to participate
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| COVID-19 Prevalence in UNIVI Geriatric Institutions: Epidemiological Study of Immunological Status With Rapid Serological Tests | NCT04790994 | Contradiction |
2,072 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- 45 and 79 years of age.
- Clinical symptoms of IPF for at least 3 months.
- Forced vital capacity (FVC) between 50 to 90% of the predicted value.
- DLco at least 35% of the predicted value.
- PaO2 > 55 mm Hg while breathing ambient air at rest.
- High-resolution computed tomography (HRCT) showing definite or probable criteria of
IPF.
Exclusion Criteria:
- Clinically significant exposure to known fibrogenic agents (birds, molds, hot tubes,
asbestos, radiation and drugs known to cause pulmonary fibrosis (amiodarone,
nitrofurantoin, bleomicin,etc)).
- History of neurofibromatosis, Hermansky-Pudlak syndrome, metabolic storage disorders,
etc.
- History of fever, weight loss, myalgias, arthralgias, skin rash, arthritis.
- Active infection within one week before enrollment.
- Alternative cause of interstitial lung disease.
- Ratio of the forced expiratory volume in one second (VEF1) to FVC of less than 0.6
after the use of a bronchodilator.
- Residual volume more than 120% of the predicted value (when available).
- More than 20% of lymphocytes or eosinophils in bronchoalveolar lavage (BAL) (when
available).
- Granulomas, infection or malignancy in the transbronchial or surgical biopsy (when
available).
- Previous therapy with azathioprine, prednisolone (>0.5 mg/kg/day or more for at least
3 months), cyclophosphamide or novel biotech drugs.
- Unstable cardiovascular or neurologic disease.
- Uncontrolled diabetes.
- Pregnancy.
- Lactation.
- Likelihood of death, as predicted by the investigator, within the next year.
- White cell blood count < 4000/mm3.
- Platelet count < 100000/mm3.
- Hematocrit < 30% or > 59%.
- Liver enzymes more than 3 times the upper limit of the normal range.
- Creatinine level > 1.5 mg/dL.
- Albumin level < 3 g/dL.
- Refusal to sign informed consent by patient or guardian.
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 79 Years | Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis | NCT00518310 | Entailment |
2,585 | 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. Patients who underwent elective inguinal hernia repair (will consider the hernia
size).
2. Age from 18-70. (70 with no other comorbiditeis)
3. Their ASA score 1,2 or 3 (American Society of Anesthesia)
4. General Anesthesia.
5. Open inguinal hernia repair.
- Exclusion criteria:
1. All emergency inguinal hernia repair and recurrent hernia.
2. Children and pregnant women.
3. Patients having regional anesthesia. (Spinal/Local).
4. Laparoscopic inguinal 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.
Subject must be at most 70 Years | Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair. | NCT04792164 | Contradiction |
956 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patients who have symptomatic basal joint arthritis.
- Patients who are capable of providing informed consent
Exclusion Criteria:
- Patients younger than 18 years old at the time of enrollment
- Patients with neuromuscular disease affecting the operated hand, not caused by the CMC
operation
- Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic
arthritis
- Patients with a history of or current infection of the basal joint of the affected
hand.
- Patients who are demented or are unable to provide informed consent.
- Patients unable to comply with study guidelines.
- Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These
patients will be followed and if they receive a capsulodesis or other procedure at the
MCPJ at the same time as their basal joint arthroplasty this will be noted in their
data records.
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.
| Basal Joint Arthritis Prospective | NCT01376024 | Entailment |
3,791 | 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 diagnosed with primary Osteoarthritis of the knee.
- Have at least 3 months in symptom duration prior to screening visit.
- Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective
cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
- Pain walking on flat surface within specific interval prior to study start.
Exclusion criteria:
- History of hypersensitivity to NSAIDS.
- Allergy to Ibuprofen.
- Use of assistive devices other than a cane or knee brace.
- History of specified diseases/illnesses.
- Abnormal blood tests pre-study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 80 Years | Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee | NCT00372801 | Entailment |
2,748 | 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:
- Subjects scheduled for laparoscopic unilateral inguinal hernia repair
- ASA 1 or2.
- Age >18 years.
Exclusion Criteria:
- Pregnancy or lactating
- Allergy to NAC
- History of chronic pain
- Use of opioids or neuropathic analgesics
- Use of NAC prior to trial (< 1 month of planned surgery)
- Alcoholism
- Diabetes Mellitus (insulin therapy)
- Asthma or Chronic Obstructive pulmonary Disease
- Known renal function disorders (MDRD <ô0)
- Known liver failure (bilirubin >1.Sx upper limit of normal)
- No written lC by patient
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Pilot Study: Postoperative Pain Reduction by Pre Emptive N-Acetylcysteine | NCT03354572 | Entailment |
142 | 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. | - ELIGIBILITY CRITERIA FOR IGD PATIENTS:
INCLUSION CRITERIA:
Males or females with clinical findings consistent with IGD who are greater than or equal
to 18 years old and treated with hormone replacement therapy for IGD at the full adult
replacement dose for at least 3 months. Clinical findings of IGD will be confirmed by a
nurse or physician associated with this protocol, and include: clinical presentation
consistent with a diagnosis of IGD, such as delayed, incomplete, or absent pubertal
development, and a record of serum hormone levels demonstrating low total testosterone
(males) or estradiol (females) in association with low or inappropriately normal
gonadotropin levels in a clinic note or history and physical, and individuals with records
demonstrating failure to undergo normal puberty. Anosmia may or may not be present. Since
IGD presents as a phenotypic spectrum, there are no specific exclusion criteria for this
study, except as noted below.
EXCLUSION CRITERIA:
- Patients with a diagnosis of IGD who are <18 years old;
- Patients with a diagnosis of IGD who are not on a full adult replacement dose of sex
hormone therapy for at least 3 months;
- Patients who do not have a diagnosis of IGD as indicated by the inclusion criteria
above;
- Patients without access to a computer connected to the internet;
- Patients who cannot read, write, and understand English at an eighth grade level or
above.
ELIGIBILITY CRITERIA FOR HEALTHY CONTROLS:
INCLUSION CRITERIA:
Healthy males or females who are greater than or equal to 18 years old.
EXCLUSION CRITERIA:
- Subjects with any chronic medical condition, other than seasonal/environmental
allergies;
- Subjects with a BMI < 18.5 or > 29.9;
- Subjects with prior history of abnormal pubertal development, infertility, or anosmia;
- Subjects with a family history of IGD;
- Subjects without access to a computer connected to the internet;
- Subjects who cannot read, write, and understand English at an eighth grade level or
above.
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 200 Years | Psychological Outcomes in Isolated GnRH Deficiency | NCT02356172 | Contradiction |
2,047 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- The only subjects to be included in this study are those diagnosed with Idiopathic
Pulmonary Fibrosis with diagnosis based on the criteria published by the American
Thoracic Society in the International Consensus Statement.
1. Exclusion of other known causes of interstitial lung disease.
2. Abnormal pulmonary function studies.
3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT
scan.
4. Biopsy or lavage showing no features supporting alternative diagnosis.
5. Patient older than 50 years of age.
6. Insidious onset of otherwise unexplained dyspnea on exertion.
7. Duration greater than 3 months.
8. Bibasilar, inspiratory crackles.
Exclusion Criteria:
- under the age of 50
- history of hypersensitivity to interferons
- history of hypersensitivity to biological products such as vaccines
- pregnant or lactating women
- women of child bearing age not pregnancy protected during the study
- unresolved serious cardiovascular disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis | NCT01442779 | Contradiction |
6,487 | 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:
- A diagnosis of papulopustular rosacea
- Grade 3 or 4 on the 5-point Investigator Global Assessment scale
- Presence of telangiectasia
Exclusion Criteria:
- steroid rosacea or subtype 3 (phymatous rosacea)
- clinically significant abnormal findings that would interfere with study objective or
risk to safety for the subject.
- nodular rosacea (lesions greater than 5mm with more than 2 modules)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A 21 Day Pharmacokinetics Study in Papulopustular Rosacea | NCT02028286 | Entailment |
6,124 | 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:
- Clinical, radiological and PCR positive COVID-19 diagnosis
Exclusion Criteria:
- less than 18 years old
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Prognostic Factors in Patients Admitted to an Urban Teaching Hospital With COVID-19 Infection | NCT04484545 | Contradiction |
1,832 | 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:
- In principle, all patients treated for gastrointestinal tumors will be included (only
with the permission (informed consent) of the patient)
Exclusion Criteria:
- In case of a known contraindication for MRI (eg pacemaker), the patient will not be
admitted to the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors | NCT01224990 | Entailment |
6,026 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a
history of EE or a documented diagnosis of GERD within 6 months prior to screening,
with or without a history of EE.
2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the
following formula: weight (kg)/height (m)2.]
3. Able to communicate with the investigator and to understand and comply with the
requirements of the study.
Exclusion Criteria:
1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an
ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or
chronic hepatitis.
3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional
weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious
or malignant disease.
4. Abnormal lab test results, as indicated in the protocol.
5. Other diseases, as indicated in the protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) | NCT00629564 | Entailment |
588 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response
to estrogen (< 7 mm) after at least two standard preparation protocols, of which one
was canceled due to thin endometrium
Exclusion Criteria:
- none
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 54 Years | Platelet-Rich Protein and the Endometrium | NCT02973555 | Entailment |
3,259 | 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:
- Male or female patient ≥ 18 years
- Primary sjögren syndrome according of age to 2002 or 2016 classification criteria
Exclusion Criteria:
- Secondary sjögren syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease | NCT04212572 | Entailment |
4,833 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
Individuals eligible for enrollment into this study are adult male and non-pregnant female
adult patients who:
- Are at least 18 years of age
- Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or
ACTH independent etiologies, including
1. Cushing's Disease (that has recurred after primary pituitary surgery, or has
failed pituitary surgery, or has been treated with radiation therapy to the
pituitary, or is not treatable with surgery, or exists in patients who are not
candidates for surgery, and is confirmed by documentation of ACTH
immuno-reactivity on a pathological evaluation of pituitary tissue from a
previous surgical specimen or IPSS with a central-to-peripheral gradient (ratio)
of >2 before or >3 after CRH administration).
2. Ectopic ACTH
3. Ectopic CRF secretion
4. Adrenal adenoma
5. Adrenal carcinoma
6. Adrenal autonomy
- Require medical treatment of hypercortisolemia
- Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension *Note:
To be eligible for inclusion subjects must have documented evidence of persistent
endogenous hypercortisolemia
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
- Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
- Have an acute or unstable medical problem, which could be aggravated by mifepristone
treatment.
- Taking medications within 14 days of the baseline visit (Day 1) that a) have a large
first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin
and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or
unwilling to use medically acceptable, non-hormonal methods of contraception during
the study.
- Have received investigational treatment (drug, biological agent or device) within 30
days of Screening
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia
(exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or
therapeutic use of ACTH
- Have Pseudo-Cushing's syndrome.
- Receive PPARgamma agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of
Baseline (Day 1).
- Postmenopausal women with an intact uterus who have experienced unexplained vaginal
bleeding within 12 months of Screening are excluded.
- Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome | NCT00569582 | Contradiction |
6,280 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients over 18 years of age
- Of both sexes
- Confirmed case of Covid-19 (by RT-PCR) and CT less than 32 in the E
- That they go to the ER service due to COVID symptoms, and that they voluntarily agree
to participate in the study by written the informed consent
- With at least 1 of the following symptoms: fever, headache, nausea, dyspnea, myalgia,
vomiting, or diarrhea
- With chest X-ray without pneumonia criteria
- With SO2> 90
- No history of allergic reaction to methylene blue
- No history of treatment with medication with methylene blue negative interaction
Exclusion Criteria:
- Pregnancy and breastfeeding
- Preadmission anticoagulation
- Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- Active chronic hepatitis
- Patients with history of allergic reaction or significant sensitivity to methylene
blue
- Treatment with immunosuppressive agents
- Diagnosis of cancer at any stage and of any type.
- Pregnancy and breastfeeding
- Patients who plan to become pregnant during the study period or within 6 months after
the end of the study period.
- Participation in another clinical trial with an experimental drug in the last 30 days.
- Other pathologies that, in the medical opinion, contraindicate participation in the
study.
- Uncompensated comorbidities
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.
| Outpatient Treatment With CoVid-19 With Prexablu | NCT04619290 | Entailment |
6,398 | 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:
- Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the
GHPSJ or in one of the establishments in the Paris Plaisance hospital city.
Exclusion Criteria:
- Asymptomatic patient
- Patient objecting to the use of their data
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City | NCT04365530 | Entailment |
4,317 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male or female with confirmed diagnosis of CF based on consensus criteria
- Aged 19 years or older
- Stable clinical status
- Pre-bronchodilator FEV1.0 between 30% and 90% predicted
- Body mass index between 16 and 30 kg/m2
- Currently non-smoking or a past smoking history of less than 20 pack-years
Exclusion Criteria:
- A disease other than CF that could importantly contribute to dyspnea or exercise
limitation
- Chronic airway infection with Mycobacterium abscessus, Burkholderia cepacia complex,
or other organisms with infection control implications according to the treating
physicians Contraindications to clinical exercise testing
- Use of supplemental oxygen or desaturation less than 80% with exercise
- History of solid organ transplantation
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.
| CF Bronchodilation | NCT03522831 | Entailment |
993 | 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:
- Eligible patients are those aged 40 years or older who are diagnosed with KOA and have
signed the informed consent.
- The diagnosis of KOA will follow the diagnostic criteria according to the Chinese
Guidelines for the Medical Management of Osteoarthritis:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by
X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and
white blood cell count < 2000/mm3;
- age 40 years or older;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. A person is
confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1
and 2), or (1,3 and 5), or (1,4,5 and 6).
Exclusion Criteria:
Patients will be excluded if they:
- Can not adhere to the study protocol in the future 6 months;
- Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis,
tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
- Have sprain or other trauma;
- Are unable to walk properly due to foot deformity or pain;
- Are present with mental disorders;
- Have comorbidities including severe cardiovascular disease, liver or kidney
impairment, immunodeficiency, diabetes mellitus or blood disorder;
- Females who are pregnant or lactating;
- Were using physiotherapy treatments for osteoarthritis knee pain;
- Had used intra-articular injection of glucocorticoid or viscosupplementation in the
past 6 months;
- Received knee-replacement surgery;
- Were participating or had participated in the other clinical trials.
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.
| A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints | NCT03008668 | Entailment |
2,268 | 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:
- Written consent/assent by patient and/or legal guardian as per regional and/or
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
- Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase
(CK) and documentation of mutation(s) in the dystrophin gene known to be associated
with a DMD phenotype
- Able to perform stand from supine without assistance in ≤ 10 seconds
- Able to perform the 10MWT and 4-stair climb
- Followed by a doctor or medical professional who coordinates Duchenne care on a
regular basis and willingness to disclose patient's study participation with medical
professionals
Exclusion Criteria:
- Use of corticosteroids within 24 weeks prior to Day 1; use of inhaled, intranasal, and
topical corticosteroids is permitted
- Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4
weeks. Exception: Patients who have received at least 24 weeks of a stable dose of
eteplirsen prior to Day 1, and expected to continue treatment, will be eligible
- Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy,
warfarin, phenytoin, S mephenytoin, cyclosporine, dihydroergotamine, ergotamine,
fentanyl, alfentanil, pimozide, quinidine, sirolimus, tacrolimus, or paclitaxel
- Use of human growth hormone within 3 months prior to Day 1
- Other prior or ongoing significant medical conditions
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy | NCT03703882 | Contradiction |
5,503 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion criteria :
- Diagnosis of giant cell arteritis (GCA) according to European League Against
Rheumatism/American College of Rheumatology classification criteria.
- New onset active disease or refractory active disease.
- At least one of the symptoms of GCA within 6 weeks of baseline.
- Either erythrocyte sedimentation rate ≥30 mm/hour or C-reactive protein ≥10 mg/L
within 6 weeks of baseline.
- Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
Exclusion criteria:
- Organ transplantation recipient (except corneas, unless it is within 3 months prior to
baseline visit).
- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- Any prior use of the following therapies, for the treatment of GCA:
- Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
- Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to
baseline level.
- Abatacept within 8 weeks of baseline.
- Anakinra within 1 week of baseline.
- Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks;
infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at
least 5 half-lives have elapsed prior to baseline, whichever is longer.
- Therapeutic failure, including inadequate response or intolerance, or
contraindication, to biological IL-6/(R) antagonist (prior experience with IL-6/(R)
antagonist that was terminated for reasons unrelated to therapeutic failure at least 3
months before baseline is not exclusionary).
- Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
- Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine,
mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate
(MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to
baseline is not exclusionary).
- Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.
- Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8
weeks of baseline for GCA therapy.
- Pregnant or breastfeeding woman.
- Patients with active or untreated latent tuberculosis.
- Patients with history of invasive opportunistic infections.
- Patients with fever associated with infection or chronic, persistent or recurring
infections requiring active treatment.
- Patients with uncontrolled diabetes mellitus.
- Patients with non-healed or healing skin ulcers.
- Patients who received any live, attenuated vaccine within 3 months of baseline.
- Patients who are positive for hepatitis B, hepatitis C and/or HIV.
- Patients with a history of active or recurrent herpes zoster.
- Patients with a history of or prior articular or prosthetic joint infection.
- Prior or current history of malignancy.
- Patients who have had surgery within 4 weeks of screening or planned surgery during
study.
- Patients with a history of inflammatory bowel disease or severe diverticulitis or
previous gastrointestinal perforation..
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | NCT03600805 | Entailment |
1,886 | 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:
Two groups of symptomatic patients aged 40 to 70 years old, who are long term residents of
a high gastric cancer risk area:
- Approximately 1300 patients who need upper endoscopy (examination of the lining of the
stomach with a flexible tube).
- Approximately 100 patients recently diagnosed with stomach cancer who need surgery as
treatment for the disease.
EXCLUSION CRITERIA:
- Pregnant women
- Children
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 | Gastric Cancer Precursor Lesions (GCPL) Study | NCT03188406 | Entailment |
4,843 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Are at least 18 years of age.
- Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH
secreting pituitary tumor).
- Have previously had pituitary surgery and/or pituitary radiation with the intent of
curing or treating Cushing's disease.
- Have clinical symptoms and signs of hypercortisolism.
- Are able to provide written informed consent.
- Are expected to complete the study.
Exclusion Criteria:
- Are surgical candidates for pituitary surgery or have had pituitary surgery within 8
weeks before screening.
- Have taken any medication that may interfere with protocol testing procedures within
30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine,
primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz,
neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral
contraceptives).
- Have received investigational treatment (drug, biologic agent or device) within 30
days of screening.
- Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia
(exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or
therapeutic use of ACTH.
- Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such
as those with severe obesity, major depression or a history of alcoholism.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Have renal failure as defined by a serum creatinine of 202 mg/dL.
- Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia | NCT00796783 | Contradiction |
6,842 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- History of dysphagia necessitating a dynamic fluoroscopic swallow study
- Age > 18 years
- Ability to complete a comprehensive dynamic fluoroscopic swallow study
- Ability to provide informed consent for study participation
Exclusion Criteria:
- Age < 18 years
- Pregnant women
- Prisoner or other institutionalized individual
- Cognitive disability precluding the ability to provide informed consent or complete a
comprehensive swallow study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Two Different Thickening Products in Patients With Dysphagia | NCT01651975 | Entailment |
2,481 | 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:
- No significant supplementary carotenoids within last 10 weeks. Without significant
media opacity, cataract or congenital / acquired retinal disease other than atrophic
AMD or diabetic retinopathy. Minimum 20/25 to enroll.
Exclusion Criteria:
- Unwilling or medically / psychiatrically unable to take part in a 6 month study.
- Recent ophthalmologic surgery or treatment.
- Tricare, Retirees & Enlisted Navy Personnel excluded. Already taking an OTC product to
improve their night vision (containing carotenoids, polyphenols like bilberry).
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.
| "Night Vision and Carotenoids" | NCT04741763 | Entailment |
6,641 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Severe Haemophilia A (FVIII:C < 1%)
- Male patients >= 18 years of age
- Previous treatment with a FVIII concentrate for at least 150 EDs
- Good documentation regarding dosing and bleeding frequency in the 6 months preceding
study start
- Immunocompetence (CD4+ count > 200/uL)
Exclusion Criteria:
- Any coagulation disorder other than Haemophilia A
- Present of past FVIII inhibitor activity
- Severe liver or kidney disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A | NCT02256917 | Contradiction |
606 | 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:
- Primary or secondary infertility due to:
- Ovulatory dysfunction
- Mild male infertility
- Unexplained infertility
- Endometrium < 6 mm at time of hCG during previous treatment with clomiphene citrate
- Age 18-35
Exclusion Criteria:
- Serious adverse effects under clomiphene citrate or known sensitivity to either
tamoxifen or clomiphene citrate
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle | NCT00449514 | Entailment |
2,433 | 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: Patients meeting all the following criteria will be eligible for
inclusion in the study:
- Age group of 18 to 75 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of
the chest
- Ability to provide informed consent to participate in the study
Exclusion Criteria: Patients with any of the following will be excluded:
- Hypoxemia (SpO2 <92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as
skin biopsy or peripheral lymph node biopsy
- Failure to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Study Evaluating the Diagnostic Yield and Safety of the ProCore vs Conventional EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis | NCT03656003 | Contradiction |
2,708 | 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:
- unilateral groin hernia
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA I-III
- fluent Danish
Exclusion Criteria:
- converting to open operation
- low compliance
- daily use of morphine or similar drugs daily in the last month
- complications to the operation
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP) | NCT01000116 | Entailment |
1,661 | 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:
INCLUSION CRITERIA:
- Subjects will be over 18 years of age.
- Healthy life-time non-smokers
Exclusion Criteria:
- Presence of airflow obstruction (COPD, asthma, bronchiectasis)
- Other concomitant inflammatory pulmonary disorders
- Subjects with known pulmonary malignancies within 5 years
- Subjects with prior thoracic surgery
- Subjects with respiratory infection that required use of oral corticosteroids and/or
antibiotics within the prior 3 months
- Subjects with allergies to study medications
- Subjects incapable of providing informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of Acute and Subacute Effects of Nicotine Free Electronic Cigarette(NCFE) Vapors | NCT02585791 | Entailment |
3,903 | 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:
- with clinical and radiological hip or knee OA confirmed by a physician,
- whatever their status regarding flare of OA. The intention of the Flare-OA tool is not
to detect current flare only, but also a flare that may have occurred before the
encounter with the health care professional. Therefore patient will not be selected on
flare, and patients with flare will not be excluded.
Exclusion Criteria:
- Patients who never experienced nor currently report having a flare of OA
- Patients with both hip and knee OA
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.
| Self-assessment of Flare in Osteoarthritis of Lower Limbs | NCT02892058 | Entailment |
1,590 | 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:
- Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for
standard care
- Patients that are ≥18 years of age.
Exclusion Criteria:
- Body habitus that precludes patients from wearing a device on their wrist
- Subjects without normal palpable radial artery pulse, whether congenital, due to
medical intervention, or otherwise
- Subjects with wrist circumference less than 155mm or greater than 210mm
- Subjects implanted with pacemaker, VAD's or other mechanical circulatory support
device whether intracorporeal or extracorporeal
- Patients that do not have an intra-arterial blood pressure line.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Wrist Worn Blood Pressure Measurement | NCT03919136 | Contradiction |
1,515 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Men/Women, 40 or older, diagnosed with hip or knee Osteoarthritis.
- Hypertensive patient with treated and controlled essential hypertension.
- Must receive at least one antihypertensive treatment from the following drug classes:
Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker
(ARB) or Beta-Blocker (BB).
- Must be current chronic user of NSAIDS or acetaminophen.
- Must discontinue all analgesic therapy at Screening.
Exclusion Criteria:
- More than two different classes of antihypertensive drugs.
- Uncontrolled diabetes.
- Hepatic or renal impairment.
- A history of alcohol/drug abuse.
- Diagnosis of gastric or duodenal ulceration and/or history of significant
gastro-duodenal bleeding.
- History of congestive heart failure.
- Clinically relevant abnormal ECG.
- Current or expected use of anticoagulants.
- Current or history of any medical disease that could interfere with the study
objectives or put the patient's safety at risk.
- Participation within 30 days prior to pre-screening in another investigational study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure | NCT00662610 | Entailment |
1,008 | 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:
- Self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30
days
- Recreationally active (2 or more days per week)
- Not obese (BMI < 30kg/m2)
Exclusion Criteria:
- Tobacco users/Smokers
- Allergic to coconut, walnuts, oak, olives
- Currently using anti-inflammatory medicines or dietary supplements (and not willing to
cease for one-month prior to participation and throughout study)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Yeahhh Baby! Ointment on Hip and/or Knee Pain in Men and Women | NCT04764552 | Entailment |
2,149 | 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:
Age 18-65 years old those who are willing to accept assessment and sign informed consent.
Under the normal purine diet, two fasting blood uric acid levels on different days:
420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l
(female)
Exclusion Criteria:
Patients currently receiving treatment for hyperuricemia； Suffering from diseases that
affect the digestion and absorption(such as chronic diarrhea, constipation, severe
gastrointestinal inflammation, active gastrointestinal ulcers, after gastrointestinal
resection, cholecystitis/cholecystectomy, etc.)； Suffering from cardiovascular and
cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors,
anemia, mental illness and memory disorders, epilepsy and other diseases; At the same time
receive other functional food nutrition support (plant active substances, health food);
Patients with abnormal liver function (alanine aminotransferase or/and aspartate
aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal
renal function (serum creatinine exceeds the upper limit of normal value)； Suffering from
infectious diseases such as active tuberculosis and AIDS; People who are severely allergic
to the ingredients of research； During pregnancy or lactation; Patients with physical
disabilities and clinicians think it is not suitable to participate in the study (for
example, suffering from serious diseases not included in the discharge criteria)； Gouty
arthritis attack ≥ 2 times; One episode of gouty arthritis with blood uric acid >480
umol/l, or any of the following: age <40 years old, evidence of gout stone or urate
deposition in the joint cavity, uric acid nephrolithiasis or renal impairment
(GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes,
dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency; Blood uric
acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal
impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes,
dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Effects of Barley Green in Patients With Hyperuricemia | NCT04438486 | Contradiction |
4,628 | 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:
- Assigned female sex at birth
- Note: Participants who are female at birth, who now identify as male, will not be
excluded so long as they are not on female-to-male transition therapy.
- Age 18 through 45 years (inclusive) at Screening, verified per site standard operating
procedures (SOPs)
- Able and willing to provide written informed consent to be screened for and enrolled
in MTN-038
- Able and willing to provide adequate locator information, as defined in site SOPs
- Able to communicate in spoken and written English
- Available for all visits and able and willing to comply with all study procedural
requirements
- Willing to abstain from receptive vaginal or anal sexual activities for 72 hours prior
to each clinical visit and for 72 hours after biopsy collection
- Willing to use male condoms for penile-vaginal and penile-rectal sexual intercourse
for the duration of study participation
- Per participant report, using an effective method of contraception for at least 30
days (inclusive) prior to Enrollment, and intending to continue use of an effective
method for the duration of study participation; effective methods include:
- hormonal methods (except contraceptive vaginal ring)
- intrauterine device (IUD)
- sterilization (of participant or partner, as defined in site SOPs)
- having sex exclusively with individuals assigned female sex at birth
- sexually abstinent as defined by abstaining from penile-vaginal intercourse for
90 days prior to Enrollment, and intending to remain abstinent for the duration
of study participation
- In general good health as determined by the Investigator of Record (IoR)/designee at
Screening and Enrollment
- HIV-uninfected based on testing performed at Screening and Enrollment (per protocol
algorithm in the study protocol)
- Per participant report at Screening, regular menstrual cycles with at least 21 days
between menses
- Note: This criterion is not applicable to participants who report using a
progestin-only method of contraception at Screening (e.g., Depo-Provera or
levonorgestrel-releasing IUD) nor to participants using continuous combination
oral contraceptive pills, as the absence of regular menstrual cycles is an
expected, normal consequence in this context.
- Per participant report at Screening and Enrollment, states a willingness to refrain
from inserting any non-study vaginal and rectal products or objects into the vagina or
rectum including, but not limited to spermicides, female condoms, diaphragms,
intravaginal rings, vaginal or rectal medications, menstrual cups, cervical caps,
douches, lubricants, and sex toys (vibrators, dildos, etc.) for the 24 hours preceding
the Enrollment Visit and for the duration of study participation.
- Note: Use of tampons is permitted except for 24 hours prior to clinic visits in
which CVF samples are scheduled to be collected.
- Participants over the age of 21 (inclusive) must have documentation of a satisfactory
Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to
the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated
November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events,
Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment
required of Grade 1 or higher Pap result
- At Screening and Enrollment, agrees not to participate in other research studies
involving drugs, medical devices, vaginal or rectal products, or vaccines after the
Screening Visit and for the duration of study participation
Exclusion Criteria:
- Pregnant at Screening or Enrollment or plans to become pregnant during the study
period
- Note: A documented negative pregnancy test performed by study staff is required
for inclusion; however, a self-reported pregnancy is adequate for exclusion from
the study.
- Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract
infection (RTI) at Screening or Enrollment
- Otherwise eligible participants diagnosed with UTI/RTI during screening will be
offered treatment. If treatment is complete and symptoms have resolved within the
45 day screening window, eligible participants may be enrolled.
- Note: Asymptomatic BV and candidiasis are not exclusionary.
- Diagnosed with an acute sexually transmitted infection (STI) requiring treatment per
current Centers for Disease Control and Prevention (CDC) guidelines
(http://www.cdc.gov/std/treatment/) at Screening or Enrollment such as gonorrhea,
chlamydia, trichomonas, pelvic inflammatory disease, and/or syphilis
- Note: Genital warts requiring treatment and frequent recurrence of HSV are
considered exclusionary; however, infrequent HSV outbreaks are not. Genital warts
requiring treatment are defined as those that cause undue burden or discomfort to
the participant, including bulky size, unacceptable appearance, or physical
discomfort. See MTN-038 Study-Specific Procedures (SSP) Manual for additional
information.
- Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study
staff) at Screening or Enrollment. *
- Note: Cervical bleeding associated with speculum insertion and/or specimen
collection judged to be within the range of normal according to the clinical
judgment of the IoR/designee is considered expected non-menstrual bleeding and is
not exclusionary.
- Note: Otherwise eligible participants with exclusionary pelvic exam findings may
be enrolled/randomized after the findings have improved to a non-exclusionary
severity grading or resolved within 45 days of providing informed consent for
screening.
- Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever), including
polyurethane
- Chronic and/or recurrent vaginal candidiasis
- Non-therapeutic injection drug use in the 12 months prior to Enrollment
- Last pregnancy outcome less than 90 days prior to Enrollment
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage,
piercing) 45 days or less prior to Enrollment
- Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap
test as well as IUD insertion/removal are not exclusionary.
- Currently breastfeeding or planning to breastfeed during the study
- Participation in any other research study involving drugs, medical devices,
vaginal or rectal products, or vaccines, in the 60 days prior to Enrollment
- Use of pre-exposure prophylaxis (PrEP) for HIV prevention and/or post-exposure
prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment,
and/or anticipated use and/or unwillingness to abstain from PrEP during trial
participation
- Has any of the following laboratory abnormalities at Screening Visit:
- Grade 1 or higher Aspartate aminotransferase (AST) or alanine transaminase (ALT)*
- Grade 1 or higher Hemoglobin*
- Calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault
formula
- Positive Hepatitis B surface antigen result
- Note: Otherwise eligible participants with an exclusionary laboratory result
may be re-tested during the screening process. If a participant is re-tested
and a non-exclusionary result is documented within 45 days of providing
informed consent for screening, the participant may be enrolled.
- Has any other condition that, in the opinion of the IoR/designee, would preclude
informed consent, make study participation unsafe, complicate the interpretation of
study outcome data, or otherwise interfere with achieving the study objectives
including any significant uncontrolled active or chronic medical condition.
(*) Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse
Events Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for
Use in Microbicide Studies [Dated November 2007])
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir | NCT03670355 | Entailment |
5,685 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Children with overweight and not obese according to the definitions developed by Cole et
al (4). It implies that we include children with the following age specific BMI Inclusion
criteria
- 9 years = AGE < 9 years, 6 months AND 19,0< BMI<23,0
- 9 years, 6 months => AGE < 10 Years AND 19,5 <BMI<23,5
- 10 years = AGE < 10 years, 6 months AND 20,0<BMI<24,0
- 10 years, 6 months=>AGE< 11 years AND 20,5<BMI<24,5
- 11 years = AGE < 11 years, 6 months AND 21,0<BMI<25,5
- 11 years, 6 months =>AGE<12 years AND 21,5<BMI<25,5
Exclusion Criteria:
- Children and his/her parents not able to communicate in Swedish.
- Children with monogenic obesity
- Present less than 80% at school in the latest school year.
- No foster care for the child or his/her brothers or sisters
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 9 Years old.
Subject must be at most 12 Years | Treatment of Overweight in Children on Distance | NCT02720302 | Entailment |
4,840 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | - INCLUSION CRITERIA:
Subjects will be included if they have ALL of the three following criteria:
1. Hypercortisolism from Cushing's syndrome caused by ACTH ectopic secretion
AND
2. Glycemic disorder that is considered to be caused or worsened by the hypercortisolism
AND
3. At least one symptom attributable to the Cushing's syndrome.
EXCLUSION CRITERIA:
- Evidence for Cushing's disease as judged by positive inferior petrosal sinus
sampling or a lesion on pituitary MRI with positive CRH test
- Suspected or known adrenocortical cancer or adenomas, as judged by ACTH values
less than 10 pg/ml and adrenal mass
- Subjects with cyclic Cushing's syndrome defined by any measurement of Urinary
Free Cortisol over the previous 2 months less than 2 N
- Children (age less than 18) and patients over 85 years
- Pregnant or lactating women. A urinary pregnancy test will be performed in women
of childbearing potential unless they have a history of menopause prior to
Cushing's syndrome or hysterectomy
- Life expectancy less than two months
- Surgery planned within 8 weeks after inclusion, especially bilateral
adrenalectomy
- Uncontrolled diabetes (plasma glucose greater than 15.0 mmol/L (270 mg/L) and/or
HbA1c greater than 10%)
- Uncontrolled hypertension (blood pressure greater than 180/110 mmHg)
- Recent (less than two weeks prior to inclusion) initiation of corrective
treatments for depression
- Clinically significantly impaired cardiovascular function (e.g. stage IV cardiac
failure)
- Severe liver disease (liver enzymes greater than or equal to 3 x the
institutional upper limit of normal range)
- Severe renal impairment (serum creatinine greater than or equal to 2.2 mg/dl or
creatinine clearance less than 30 ml/min)
- Severe hypokalemia (plasma K below 3.0 mmol/L)
- Uncontrolled severe active infection
- In women, known endometrial cancer, history of endometrial hyperplasia or vaginal
bleeding of unknown cause
- Premenopausal women with hemorrhagic disorders or on anticoagulants
- Recent (less than two weeks prior to inclusion) initiation of or significant
change in dose of anti-tumor therapy
- Previous treatment with approved or experimental steroidogenesis inhibitors,
somatostatin analogues within one week of admission (eight weeks for patients on
octreotide LAR or on lanreotide autogel)
- Plasma mitotane concentration greater than 5 microgram/ml
- Impaired mental capacity or markedly abnormal psychiatric evaluation that
precludes informed consent
- Body weight over 136 kg, which is the limit for the tables used in the scanning
areas
- Inherited porphyria
- Positive pregnancy test at inclusion
- Use of antiretroviral agents, midazolam, cabergoline, erythromycin, or grapefruit
juice within two weeks of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion | NCT00422201 | Contradiction |
2,211 | 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:
Three or more outpatient/ED visits in a 24-month period prior to selection for study with
one of these primary visit diagnoses:
- Gouty arthropathy
- Gout, unspecified
- Gout with other specified manifestations
- Tophaceous gout of ear (274.81) or other sites
- Gouty nephropathy
At least 2 years of continuous Kaiser Foundation Hospital Plan membership
Baseline uric acid level above 7.0mg/dl
Exclusion Criteria:
- Current cancer diagnosis with active treatment
- End stage renal disease
- Pregnant or lactating
- Patients with a diagnosis of dementia
- Terminally ill patients
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 | Evaluating the Effectiveness of a Chronic Disease Management Program for Gout | NCT01568879 | Contradiction |
2,694 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia.
Exclusion Criteria:
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
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.
| Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation | NCT04532983 | Entailment |
5,467 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Male or female;
- Age 18-75 years;
- vWD-2b - confirmed diagnosis, or;
- TTP Remission - prior episode(s) of primary acute TTP, or;
- Acute TTP - any episode, first or relapse, with presence of all of the following:
1. Microangiopathic hemolytic anemia (schistocytosis present, Coombs test negative);
2. Severe thrombocytopenia;
3. Clinical diagnosis of either a primary or secondary form of TTP:(1) Primary TTP:
e.g., familial TTP (Upshaw-Schulman syndrome), or acquired idiopathic TTP, or
"atypical HUS"; (2) Secondary TTP: e.g., TTP occurring post-bone marrow
transplant, drug-induced TTP, lupus-related TTP, etc.;
- Negative qualitative urine drug test at screening, and no history of alcohol or drug
abuse;
- Not considering or scheduled to undergo any surgical procedure during the duration of
the study;
- Has not donated or lost more than a unit of blood within 30 days prior to screening
visit;
- Has not received an experimental drug within 30 days prior to screening;
- Female patients must be non-pregnant [for TTP Remission and vWD-2b Cohorts, a serum
pregnancy test at screening and a urine pregnancy test at Day 1 pre-dose must be
negative; for the Acute TTP Cohort, a serum pregnancy test at Day 1 pre-dose must be
negative], and willing to use effective, redundant methods of contraception (i.e., for
both self and male partner) throughout the study and for at least 30 days after
participation. If possible, the treatment will be initiated within 5 days of the
cessation of the preceding menstrual period;
- Male patients must agree to use a medically acceptable contraceptive (abstinence or
use of a condom with spermicide) throughout the study and for at least 30 days after
participation;
- Patients must be capable of understanding and complying with the protocol and must
have signed the informed consent document prior to performance of any study-related
procedures.
Exclusion Criteria:
- History of recent surgery or trauma;
- Any major, active health problem, e.g., cancer or heart disease, which could render
the patient medically unstable during the period of participation in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | ARC1779 Injection in Patients With Von Willebrand Factor-Related Platelet Function Disorders | NCT00632242 | Entailment |
4,264 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria
1. Caucasian males defined as persons of a European or Latin American descent
2. Healthy male 30 to 55 years inclusive at the time of informed consent
3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and
their female partners must not be of childbearing potential or must be practicing
highly effective contraception throughout the study period and for 30 days after study
drug discontinuation. No sperm donation is allowed during the study period and for 30
days after study drug discontinuation.
Exclusion Criteria
1. Any history of seizures or epilepsy (not including a history of simple febrile
seizures in childhood) or disturbance of consciousness likely to be due to seizures
2. Any medical condition which, in the opinion of the investigator has high risk of
seizures (e.g., history of traumatic brain injury associated with loss of
consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past
5 years
3. Any history of cerebrovascular disease (stroke or transient ischemic attack)
4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the
QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using
Fridericia?s formula (QTcF) interval (QTcF > 450 ms) as demonstrated by the mean of
triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or
Baseline Period
5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods,
e.g. component of the ECG cycle from onset of atrial depolarization to onset of
ventricular depolarization (PR)>220 ms, component of ECG wave representing
ventricular depolarization (QRS)>110 ms
6. Hypersensitivity to the study drugs or any of their excipients
Male
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 55 Years | An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption | NCT01716897 | Entailment |
5,719 | 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:
- Before starting treatment, the child is diagnosed as GHD according to medical
history,clinical symptoms and signs, GH provocation tests and imaging examinators and
other examinators.
- According to the height statistical data of Chinese children's physical development in
nine cities in 2015, the height of the child is lower than the third percentile of
normal children's growth curve in the same age and same gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH provocation tests with two different mechanisms showed that GH peak concentration
of the child is < 10.0ng/ml.
- Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than
the CA.
- Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
- The child did not receive the treatment of growth hormone within 6 months.
- Subjects are willing and able to cooperate to complete scheduled visits, treatment
plans and laboratory tests and other procedures, and they sign informed consent.
Exclusion Criteria:
- The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of
normal value, Cr> the upper limit of normal value).
- The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen
(HBsAg) and hepatitis B e antigen (HBeAg).
- The child is known as hypersensitivity to PEG Somatropin.
- The child has severe cardiopulmonary, hematological diseases, malignant tumors,
general infection or immunodeficiency diseases.
- The child has potential tumor (family history).
- The child has diabetics.
- The child has abnormal growth and development, such as Turner's syndrome,
constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor
deficiency, short stature girls with potential chromosomal abnormalities.
- The child took part in other clinical trials within 3 months.
- Other conditions are excluded when the investigator preclude the enrollment into 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 3 Years old.
Subject must be at most 18 Years | Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency | NCT02908958 | Entailment |
1,269 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | DISEASE CHARACTERISTICS: Histologically confirmed malignant mesothelioma of the pleura not
amenable to curative surgery Must be radiologically accessible Unidimensionally or
bidimensionally measurable disease Pleural effusions or positive bone scan not considered
measurable No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase, AST, and ALT no
greater than 3.0 times ULN (no greater than 5 times ULN with liver involvement) Albumin at
least 3.0 g/dL Renal: Creatinine clearance at least 45 mL/min Other: No serious systemic
disorders that may preclude study No prior primary malignancy within the past 5 years
except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the
skin No obvious malnourishment or greater than 10% weight loss within 6 weeks prior to
study No active infection Not pregnant or nursing Fertile patients must use effective
contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunomodulators allowed for pleurodesis
No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy At least 1 week
since prior bleomycin for pleurodesis Prior intracavitary cytotoxic drugs allowed for
pleurodesis No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal
anticancer therapy Radiotherapy: At least 4 weeks since prior radiotherapy to target lesion
Lesion must be clearly progressive No concurrent radiotherapy Surgery: See Disease
Characteristics No concurrent surgery for cancer Other: At least 4 weeks since any other
prior investigational agent No concurrent aspirin or other nonsteroidal antiinflammatory
drug from 2 days prior to 2 days after study (5 days prior for long acting agents such as
piroxicam, naproxen, diflunisal, or nabumetone) No other concurrent experimental
medications
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.
| Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery | NCT00005636 | Entailment |
591 | 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:
- have a positive serum or urine beta-human chorionic gonadotropin (hCG)
- estimated gestational age (EGA) of less than 20 weeks
- complaint of pelvic pain and/or vaginal bleeding
Exclusion Criteria:
- prior known documentation of an intrauterine pregnancy
- estimated gestational age (EGA) of greater than 20 weeks
- peritoneal findings on physical examination
- unstable vital signs as deemed appropriate by the attending physician
- prisoners
- open cervix upon physical examination
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography | NCT02268877 | Entailment |
2,770 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- male
- age: 18 - 65
- planned inguinal hernia repair using synthetic implant
- BMI range: 20-35 kg / m2
- written informed consent
Exclusion Criteria:
- prior midline laparotomy
- contraindications for general anaesthesia
- ASA > IV
- cirrhosis (Child B or C) or ascites
- active treatment with use of chemiotherapy
- incarcerated hernia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Lichtenstein Versus TAPP and TEP in Groin Hernioplasty | NCT02928146 | Entailment |
1,034 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age ≥ 18 years
- Symptomatic HOA according to the American College of Rheumatology criteria
- Erosive HOA according to hand radiographs performed in routine practice showing ≥1
erosive digital joint based on Verbruggen-Veys scoring definition
- Hand pain level ≥ 40/100 mm on VAS at inclusion at least half of days of the 30 last
days
- At least ≥1 symptomatic IP joint with clinical soft swelling or erythema at inclusion
- reported inadequate response or adverse effects or contraindication with existing
medication (including acetaminophen, oral NSAIDs)
- Informed written consent
- Patient affiliated to a social security scheme NB: Clinical inflammation, ultrasound
abnormalities and radiographic erosions have not have to be present in the same joint.
Exclusion Criteria:
- Isolated thumb-base OA (i.e., rhizarthrosis)
- Predominance of the pain in the thumb base rather than digital pain
- Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis,
psoriatic arthritis, Lyme disease)
- Psoriasis
- Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection,
external otitis)
- Ear canal not adapted to apply the auricular electrode
- Known history of cardiac rhythm disturbances, atrio-ventricular block > first degree,
or total bundle branch block
- Symptomatic orthostatic hypotension or repeated vasovagal syncope history
- History of vagotomy
- Asthma
- Treated sleep apnea
- Existence of a pain syndrome of the upper limbs, which would interfere with the
monitoring of pain
- Fibromyalgia
- Use of other electrically active medical devices (e.g. pacemaker, TENS for chronic
pain)
- Use of oral, intramuscular or intra-articular or intravenous steroids, other
anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate,
sulfasalazine), intra-articular hyaluronic acid to the hand joints within the last 3
months
- Any new hand OA treatment in the previous 2 months, including physiotherapy and
provision of new hand splint.
- Planned hand surgery in the next 3 months.
- Use of any investigational (unlicensed) drug within 3 months prior to screening.
- Evidence of serious uncontrolled concomitant medical condition, including
cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine,
gastro-intestinal disease or epilepsy, which in the opinion of the investigator makes
them unsuitable for the study
- Pregnant or breastfeeding woman
- Patient under legal protection measure (tutorship or curatorship) and patient deprived
of freedom
- Use of VNS before the study
- Use of NSAIDs or paracetamol less than 48h before the D0 visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis | NCT04520516 | Entailment |
1,732 | 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:
- Hong Kong Chinese
- Computer users (computer usage >2hours/day)
- Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power
≤2.50D
Exclusion Criteria:
- Anyone with visual acuity worse than 0 logMAR, anisometropia more than 2.00D, abnormal
accommodative function, wearing rigid contact lens, and a history of ocular surgery
and pathology
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Effects of Wearing Progressive Addition Lens on Working Distance and Refractive Status in Adult Computer Users | NCT02775396 | Entailment |
3,683 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
1. Ability to give informed consent
2. Able to complete online or paper questionnaire.
3. Patients admitted to the regional neurosurgical unit, Western General Hospital,
Edinburgh with suspected cauda equina syndrome for an MRI scan. Demographic data from
all patients attending any NHS Lothian site who have an MRI scan for suspected CES.
Exclusion Criteria:
1. Age less than 16
2. Inability to communicate (e.g. do not speak English)
3. Inability to complete written or oral surveys or give informed consent
4. Age over 100. The upper age limit is set at 100 to allow the greatest number of
participants the opportunity to take part. As the study is a follow up study concerns
about mortality and high drop out in this age group led to the upper limit of 100
being set.
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 100 Years | BLB Study Back or Leg Pain and Bladder Symptoms Study | NCT03325374 | Entailment |
872 | 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:
- Aged 45 years and onward.
- Clinical diagnosis of knee arthritis with complaints of knee pain for 3-6 months,
early morning stiffness <30 minutes, crepitus, bony tenderness, and no palpable warmth
and radiographically established osteoarthritis (at least score 1 on K/L scale)
- Able to read and write English
- Able to use/access computer or tablet and have access to internet
Exclusion Criteria:
- Inability to give informed consent - (capacity levels are already established under
General practitioner care)
- Terminal or mental illness
- Neurological conditions, inflammatory joint diseases including rheumatoid arthritis,
gout or calcium pyrophosphate deposition disease (CPPD), and dementia
- Patients with sleep apnea
- Acute soft tissue injury to the knee within last 3 months before recruiting
- Unstable heart condition or rapid fluctuations in hypertension
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Effects of Internet / Web-based Exercises on the Population With Knee Arthritis | NCT03545048 | Entailment |
3,380 | 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:
- BMI 28-35
Exclusion Criteria:
- Severe disease
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 65 Years | Dietary Advice on Prescription in Kungsbacka | NCT01385930 | Contradiction |
3,492 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Age 25-75 years old
- BMI between 25 and 42
Exclusion Criteria:
- Severe diseases
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 75 Years | Severe Insulin Resistance in Patients With Type 2 Diabetes | NCT00654056 | Entailment |
988 | 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:
- Healthy men and women that have joint discomfort (WOMAC score >20)
Exclusion Criteria:
- Consumption of pharmacological treatments on an ongoing basis that may affect joint
mobility (chondroprotectors, corticoids and/or interarticular therapy or
infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative
osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or
scheduled basis and will continue to do so during the study, even if they do not have
pain.
- Being unable to perform the physical tests required in the study.
- Have an allergy to some component of the study product.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 70 Years | Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility | NCT04029792 | Entailment |
2,265 | 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:
- Having a Duchenne Muscular Dystrophy diagnosis by a practicing physician,
- Between the ages of 8-16 years,
- Having lost ambulation ability,
- Brooke Upper Extremity Functional Classification (1-5)
- To have motivation and co-operation with physiotherapist for evaluations to be made
Exclusion Criteria:
- To maintain the capacity of independent ambulance,
- Having cooperative disorder or serious mental disorder,
- Any spinal and / or upper extremity injuries and / or surgery in the last 6 months,
- Having any systemic disease other than DMD,
- Not volunteering to participate in the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 16 Years | Investigation Of Factors Affecting Hand Functions in Nonambulatory Patients With Duchenne Muscular Dystrophy | NCT03521271 | Contradiction |
2,271 | 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:
- Individuals diagnosed with DMD confirmed by molecular method and / or by protein
expression of skeletal muscle.
- Individuals undergoing clinical follow-up at the outpatient clinic for neuromuscular
diseases at the Federal University of São Paulo (UNIFESP)
- Individuals who had authorization from their parents or guardians to participate in
the study
Exclusion Criteria:
- Patients with cardiac arrhythmias.
- Patients with atrioventricular block.
- Patients with congenital anomalies such as congenital heart defects, pulmonary
deformity.
- Patients using drugs that interfere with ANS, such as antiarrhythmic agents and drugs
for the treatment of diabetes mellitus, such as insulin.
Male
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
Subject must be at most 18 Years | Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy | NCT04740554 | Contradiction |
3,652 | 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:
- Triaged as stage 3 or more (less acute)
Exclusion Criteria:
- Triaged as stage 2 or less (more acute), AND arriving for purposes of
forensic/criminal evaluations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design | NCT01020513 | Entailment |
4,622 | 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:
- adenomyosis
- request for contraception
- resident in the nearby vicinity to make the follow-up easy and feasible
Exclusion Criteria:
- history of ectopic pregnancy
- puerperal sepsis
- pelvic inflammatory disease
- evidence of coagulopathy
- abnormalities of the uterine cavity
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Levonorgestrel Intrauterine System and Adenomyosis | NCT03104309 | Entailment |
6,953 | 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:
- patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11
to 26)
- in community dwelling
- with an informal caregiver (person living with the patient or providing care 3 times a
week or 8 hours per week)
- is informed and has given his/her consent
- whom caregiver is informed and has given his/her consent
Exclusion Criteria:
- patient with other type of dementia
- living in nursing home or long term care
- with no caregiver
- not informed or has not given his/her consent
- whom caregiver is not informed or has not given his/her consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 100 Years | Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life | NCT01796314 | Entailment |
4,263 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | - INCLUSION CRITERIA:
1. 18 to 45 years of age, either male or female
2. Employees or non-employees are eligible
3. Normal screening examination:
1. history and physical examination, nonsmoker, no concurrent medications
including aspirin or nonsteroidal anti-inflammatory drugs, no active medical
problems;
2. complete blood count with differential and platelet counts;
3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver
enzymes and function tests, electrolytes, prothrombin time, partial
thromboplastin time;
4. urinalysis;
5. female subjects must have negative urine pregnancy test within one week of
participation;
6. electrocardiogram;
7. chest radiograph.
4. If age is 40 to 45 years, normal submaximal stress test to screen for
asymptomatic coronary artery disease.
EXCLUSION CRITERIA:
Pregnancy.
Lactation.
History of recent clinically significant asthma.
Subjects who have an allergy to both sulfa- and penicillin-based drugs will not be eligible
for the endotoxin instillation portion of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effects of Endotoxin in Normal Human Volunteers | NCT00001303 | Entailment |
6,263 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients admitted to the hospital with symptoms of fever, sore throat, cough, nasal
congestion and/or dyspnea who were tested positive for SARS-CoV-2 by PCR
Exclusion Criteria:
- Patients of high clinical suspicion for COVID-19 with only one negative PRC test for
SARS-CoV-2
- Patients with COVID-19 who do not require hospitalization
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Cardiovascular Manifestations of COVID-19 | NCT04335630 | Contradiction |
4,640 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Healthy women aged 18 to 49 years
- Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
- Must be sexually active and at risk for becoming pregnant.
Exclusion Criteria:
- Planned use of any other form of birth control other than the test article.
- Depression requiring hospitalization or associated with suicidal ideation within the
last 3 years.
- High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception | NCT00245921 | Entailment |
3,002 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Abnormal phenotype: intellectual disability and/or multiple congenital anomalies.
- Post-natal cases
- ABCR diagnosed by standard karyotype, including reciprocal translocation, inversion,
insertion and Complex Chromosomal Rearrangement (CCR).
- de novo ABCR. Inherited ABCR could be included if the transmitting parent shows also
an abnormal phenotype or if the rearrangement involves an imprinted chromosome.
- Array-CGH results normal that mean absence of pathogenic imbalances. Identification of
Variant Of Unknown Significance (VOUS) does not prevent from inclusion.
- Information and written consent of patient or his legal representative (information
and consent form available on request).
- Covered by a Health System
Exclusion Criteria:
- Pathogenic genomic imbalance demonstrated by array-CGH.
- Identification of an independent etiology (i.e. monogenic disease, environment,…).
- Rejection to participate ton the study
- Weight inferior to 6 kg
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.
| Apparently Balanced Chromosomal Translocation/ Next-generation Sequencing/ Intellectual Disability | NCT02451761 | Contradiction |
4,358 | 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, 18 to 35 year old man or woman.
Exclusion Criteria:
- smoker
- pregnancy
- taking part in other research.
- followed a weight loss diet in the previous 6 months.
- history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
- neurological or psychiatric condition that may cause cognitive dysfunction.
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 | The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance | NCT02045342 | Entailment |
6,291 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients with Covid 19 PCR (+) results
Exclusion Criteria:
- Cancer Patients
- Patients with known immunodeficiency
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Immune Cell Subgroups in Covid 19 Patients | NCT04531319 | Entailment |
3,920 | 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:
- Patient who met criteria (functional Class I-III in the hip or knee) for
osteoarthritis for at least 3 months before enrollment
- Patient who had moderate to severe chronic pain despite regular use and stable doses
of an NSAID (nonsteroidal anti-inflammatory drug) or an NSAID with opioid analgesic
taken as needed but not on a daily basis for the treatment of osteoarthritis.
Exclusion Criteria:
- Patient intolerant of or hypersensitive to hydromorphone or oxycodone
- Patient of childbearing potential must use medically recognized contraceptive program
before and during the study
- Pregnant or breastfeeding
- Patient who had prior joint replacement of the target knee or hip
- Patient with significant respiratory compromise or depressed ventilatory function
- Patient who was known active drug abuser or alcoholics.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release) | NCT00399048 | Entailment |
4,244 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Males or females 7 years of age or older and able to perform pulmonary function
testing
2. Confirmed diagnosis of CF by the 1997 CF Consensus Conference criteria and followed by
the VCU or EVMS CF clinic
3. Presence of PA in 2 lower respiratory tract (sputum) cultures in the 24 months before
screening
4. Subjects and/or parent guardian must be able to give written informed consent prior to
any study related procedure
5. All sexually active female subjects who are of childbearing potential must agree to
use an effective method of contraception (i.e.condoms or abstinence).
6. All sexually active female subjects must have a negative pregnancy test at screening
(V0).
7. Clinically stable determined by the study physician with no significant new
respiratory symptoms.
8. Presence of PA in nasal culture (swab or secretion) or sinus culture obtained in the
12 months before screening or at screening visit
Exclusion Criteria:
1. Use of oral, IV or inhaled antibiotics within 0 days before study other than low dose
azithromycin
2. Severe pulmonary disease with FEV1<30% predicted of baseline SpO2<0.90
3. ENT surgery within 6 months of screening
4. Allergy or documented adverse reaction to aztreonam
5. Epistaxis or significant (>30mL) hemoptysis in the past 6 months
6. Frequent (weekly or more frequently) or severe headaches
7. Subject is unlikely to comply with the procedures scheduled in the protocol
8. Subject participates in another clinical trial within 30 days prior to study entry
9. Subjects who have had a lung transplant will be excluded
10. Prisoners will be excluded
11. Non-English Speaking patients will be excluded
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 100 Years | Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease | NCT02730793 | Entailment |
3,878 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Osteoarthritis of the knee
Exclusion Criteria:
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
- Other protocol defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
| Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis | NCT00426621 | Entailment |
5,324 | 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 between 35-49 years with regular heavy menstrual bleeding
- menstrual loss requiring more than 5 Pads/tampons per day
- menstrual cycle longer than 6 days
Exclusion Criteria:
- Organic causes of menorrhagia
- History of renal or hepatic impairment,
- Endocrine disorder including diabetes, thyroidism
- Thromboembolic disease,
- Inflammatory bowel disease,
- Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and
--Malignancy.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 49 Years | Trial of Homeopathy on Management of Menorrhagia | NCT01460043 | Contradiction |
1,362 | 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:
- Constipation
- Parental agreement
Exclusion Criteria:
- after surgery on lower gastrointestinal tract
- diagnosis of inflammatory bowel disease
- diagnosis of other disorder that may affect anorectum function
- parental disagreement
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | 3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children | NCT02812836 | Contradiction |
2,976 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Patients with severe intellectual disability (IQ <35 ) or moderate (IQ <50) isolated
or syndromic presentation but undiagnosed . The diagnosis is established during
genetic counseling of a 6 CHU interregion
- Lack of family history ( parents). We are interested in this project to patients who
do not have family history in order to increase the probability of identifying a de
novo mutation . We do not however exclude the hypothesis for some patients a mechanism
recessive autosomal or X-linked .
- Recruitment in 6 CHU HUGO . Patients are required to have been seen in genetics in a 6
CHU interregion . Molecular analyzes of the Fragile X syndrome and the CGH technique
must be negative.
- Indication sequencing exomique adopted by the Scientific Committee. The Scientific
Committee HUGODIMS project role to select patients whose DNA will be studied in order
to optimize the chances of success for sequencing . This selection must take into
account clinical parameters , but also genetic parameters ( potential inbreeding ) .
The files will be selected by videoconferencing at the end of the monthly meeting of
CLAD . The methodologist of the study will be invited to videoconferencing.
- specific consent obtained for the study.
Exclusion Criteria:
- Parents patient with moderate or severe intellectual disability disagree with the
preferred hypothesis of de novo mutation or recessive transmission mechanism.
- Form with known syndromic diagnosis can be targeted molecular studies (clinical
signs).
- Cause molecular DI identified by targeted molecular analysis or CGH.
- Explicit refusal to participate in the study of the patient, parents, or one of the
two parents.
- Any other indication that intellectual disability.
- The parents of the patient or the patient may be removed.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Inter-regional Project of the Great Western Exploration Approach for Exome Molecular Causes Severe Intellectual Disability Isolated or Syndromic | NCT02136849 | Contradiction |
1,440 | 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 FOR NORMAL VOLUNTEERS:
The normal volunteers will be without cardiac, pulmonary, neurological, otolaryngological,
psychiatric or speech, swallowing and hearing problems as determined by medical history and
examination by a physician.
EXCLUSION CRITERIA: SUBJECTS:
For volunteers undergoing either intra-muscular stimulation or submental surface
stiimulation:
History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by
medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to
any study to exclude patients who might be at risk for endocarditis. Subjects will have an
EKG as part of the screening for participation in the study.
Pregnancy will exclude women from participation because the study involves radiation
exposure.
Subjects will also be excluded if they are taking psychiatric or neuroleptic medications
which would interfere with the interpretation of the neurophysiological studies or are
taking herbal medications that can affect coagulation.
Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on
medications for treatment of a psychiatric disorder will be excluded from study. Examples
of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders,
current major depression, or a history of schizophrenia or a bipolar disorder. However, a
history of a previous episode of a minor reactive depression would not exclude a person
from participation.
Normal volunteers who are pregnant, or have any active medical or psychiatric conditions
will not be included for submental surface stimulation, as these may be contraindications.
For volunteers undergoing intra-muscular stimulation:
Subjects will be excluded if they have a history of allergies to lidocaine.
Subjects must be HIV negative. HIV testing for out of town participants may be done prior
to traveling to the NIH. This is required because there is no potential benefit for normal
volunteers from participation in the study. Because multiple needle insertions are required
and the hooked wire electrodes remain in place for 1-2 hours increasing a risk of
contamination, persons who are immuno-compromised would be put at undue risk with no
opportunity for benefit.
None of the normal volunteers will have a reduction in the range of vocal fold movement
during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint
abnormality or neoplasm.
Caution will be exercised in patients with suspected or diagnosed heart problems or
suspected or diagnosed with epilepsy at the discretion of the physician.
INCLUSION CRITERIA FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA:
No peripheral laryngeal nerve injury that results in a lack of glottic closure for
swallowing.
No peripheral nerve injury to the muscles that will be stimulated for hyo-laryngeal
elevation.
No laryngeal trauma that results in a lack of glottic closure for swallowing.
Intact cognition and hearing (30 dB HL in speech range); IQ no less than 85.
Current dependence on alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN);
however, minimal PO is not cause for exclusion.
Have stable vital signs before coming to the NIH for study. To determine if a patient has
stable vital signs prior to admission and a physician has provided approval for
participation, the following information will be required depending upon the location of
the patient prior to admission. For patients in a nursing home setting, vital signs will be
needed 3 days prior to admission and a written form signed by the physician releasing the
patient. For patients not in a nursing home a physician's letter of referral written in the
past year documenting that the patient is medically stable will be required and a telephone
contact with the family or others involved in the patient's care that the patient is stable
before coming to the NIH.
At least 6 months post onset.
A Mini-Mental State Examination (MMSE) score greater than or equal to 21.
Evidence of pharyngeal dysphagia placing the patient at risk for aspiration.
Participants may have other health problems such as diabetes mellitus, arteriosclerotic
coronary vascular disease and a history of smoking. These will not be cause for automatic
exclusion, but will be examined on an individual basis by the otolaryngologist in
determining the potential risk and benefit to the individual participant.
Patients will have restricted per oral intake. Prior history of tracheostomy or current
tracheostomy is not a cause for exclusion.
EXCLUSION CRITERIA:
History of progressive neurodigestive disease, amyotrophic lateral sclerosis, etc.
History of swallowing difficulties prior to most recent or previous CVA's.
Dementia, obtundation, somnolence, and agitation.
More than 90 years of age.
A tracheostomy that fixes the laryngeal position interfering with the possibility of
elevation.
Moderate to severe oral phase swallowing dysfunction.
Pharyngeal structural abnormalities on videofluoroscopy including mass and diverticulum.
Esophageal motility not within normal range of function appropriate for the patient's age.
Patient on a regular diet without difficulties.
A MMSE score less than or equal to 20.
Patients who are pregnant, have a cardiac demand pacemaker, dementia, exhibit non-stop
vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be
included for VitalStim, as these are contraindications for use of the device. Caution will
be exercised in selection of patients with suspected or diagnosed heart problems or
suspected or diagnosed with epilepsy at the discretion of the physician.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 90 Years | Electrical Muscle Stimulation to Aid Swallowing in Dysphagia | NCT00001936 | Contradiction |
3,524 | 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:
- Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to
autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12
months),
- age ≥ 18 years,
- Patient´s written informed consent,
- Ability to comply with the protocol procedures
Exclusion criteria
- Diabetes mellitus,
- Infectious disease with fever at time of investigation,
- Known intolerance to the study drug or constituents oft he study drug,
- Oral contraception,
- Known pregnancy or breast feeding,
- Renal failure (creatinine > 2.5 ULN)
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 64 Years | Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency | NCT01450930 | Contradiction |
5,325 | 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:
- Any patient who had history of arecanut chewing habit with clinical manifestations of
OSMF.
- Patients who had arecanut chewing habit history of more than 1 year and had no
clinical symptoms of OSMF.
- Healthy human volunteers who are indicated for extraction of tooth and had no clinical
features of OSMF and had no habit history
Exclusion Criteria:
- Patients who had bleeding disorders
- patients who are diagnosed with salivary gland disorders that can alter salivary flow
or composition
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Epithelial Mesenchymal Transition Markers in OSMF | NCT03732872 | Contradiction |
2,668 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Male patients
- Aged more than 18 years
- Primary inguinal hernia
Exclusion Criteria:
- Inguinoscrotal hernia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery | NCT02197585 | Entailment |
2,666 | 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:
- Clinical diagnosis of Inguinal Hernia
Exclusion Criteria:
- Cancer
- Pregnancy
- Chronic liver diseases
- Previous abdominal surgery history
- Femoral hernia
- Bilateral inguinal hernia
- Weight loss above the 20% of the body weight in the last 6 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Nutrition and Constipation at Inguinal Hernia Patients | NCT03937739 | Entailment |
4,710 | 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. Good general health
2. Aged 18-44 years, inclusive, at the enrollment visit
3. Intact uterus with at least one ovary
4. Serum progesterone value ≥ 3 ng/mL at the Screening Visit (V0-P)
5. Pap test within the last 12 months or undergo a Pap test at screening prior to
enrollment. If a potential subject states that she has had a Pap test within the last
12 months, then she will need to provide documentation of acceptable test results
6. Cervical mucus score of >7, which is based on the modified Insler scoring system
during the screening cycle. The cervical mucus is collected by aspiration and the
assessment is based on the modified Insler scoring system (the volume and pH of the
mucus are not included in the total scoring) yielding a total possible score of 12 (3,
4)
7. Regular menstrual cycles that occur every 24 - 35 days
1. If subject is postpartum or post-abortal (with abortion in second trimester), she
will be required to have two normal menstrual cycles prior to screening
2. If subject had an abortion in the first trimester, she will be required to have
at least one menstrual cycle (two menses) prior to screening
8. Heterosexually abstinent or, if heterosexually active, must have undergone previous
tubal sterilization, be in monogamous relationship with a vasectomized partner, or
only use male or female condoms (use of condoms that are pre-lubricated with or
without spermicide is acceptable) for the entire duration of the study. Use of a
spermicide applied separately is not allowed. Cervical caps or diaphragms are not
allowed during study participation
9. In the opinion of the investigator, able to comply with the protocol, willing to
record requested information in the daily diary, and live within the study site
catchment area or within a reasonable distance from the site
10. Understand and sign an IRB approved informed consent form prior to screening
activities (including fasting blood draw)
11. Willing to refrain from use of any vaginal creams, lubricants, gels, or spermicides
for 3 days prior to study admission through to the end of the study
12. Agree not to participate in any other clinical trials during the course of this study
Exclusion Criteria:
1. Known hypersensitivity or contraindication to progestins
2. Known or suspected pregnancy
3. Prior hysterectomy or bilateral oophorectomy
4. Prior cervical surgery (LEEP, Cone biopsy)
5. A history (within prior 12 months) of drug or alcohol abuse
6. Undiagnosed abnormal genital bleeding
7. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed
at screening with a Chlamydia or gonococcus infection may not be included in the trial
unless they are treated and proof of cure is documented after treatment (i.e. repeat
test with negative results). In accordance with PI/medical designee assessment and
local standards of practice, women with a history of genital herpes can be included if
outbreaks are infrequent. Antiviral prophylactic therapy is permitted
8. Uncontrolled thyroid disorder
9. Any Pap test finding that would require additional workup or treatment during the
study interval. HPV testing will not be done at screening for these subjects
10. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months
11. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones
within 30 days prior to screening visit
12. Women who are breastfeeding or within 30 days of discontinuing breast feeding
13. Women planning to undergo major surgery within four months of study enrollment
14. Women planning pregnancy within their months of study enrollment
15. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day
must be evaluated by the PI for inclusion based on risk factors that would increase
their risk for cardiovascular (CVD) and thromboembolism
16. Current or past deep vein thrombophlebitis or thromboembolic disorders
17. History of known thrombophilia in a first-degree relative <45 years of age suggesting
familial defect in blood coagulation system, which in the opinion of the principal
investigator, suggests use of a hormonal contraceptive could pose a significant risk
18. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis
19. History of retinal vascular lesions, unexplained partial or complete loss of vision
20. Known or suspected carcinoma of the breast, endometrium, or any other known or
suspected progestin-dependent neoplasia
21. Past history of any other carcinoma (excluding basal cell carcinomas) unless in
remission for more than 5 years
22. Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive, unless she is
stable on antidepressant medication
23. Headaches with focal neurological symptoms only in women over 35 years old
24. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or
other benign or malignant liver tumors; active liver disease
25. Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10
minutes rest
26. Clinically significant abnormal serum chemistry values according to the Principal
Investigator's judgment
27. Participation in another clinical trial involving an investigational drug or device
within last 30 days (prior to screening)
28. Use of liver enzyme inducers within last 90 days (prior to screening) or intention to
use liver enzyme inducers during the study
29. Known HIV infection
30. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need
to use condoms consistently, injection drug users. Women enrolled in the study, who
use condoms to protect against STIs or pregnancy, should be instructed that they can
use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use
a spermicide applied separately and they should record all condom use in their diaries
31. Women who use any medications on the Exclusionary Medication List OR used any within
the past three months prior to the screening visit
32. Women with BMI ≥40 kg/m2 are excluded
33. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 44 Years | A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception | NCT02173808 | Entailment |
6,032 | 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 18-90
- Patients with heartburn and no hiatal hernia undergoing clinically indicated endoscopy
- Patients with heartburn and a hiatal hernia > 3cm undergoing clinically indicated
endoscopy
- Patients undergoing clinically indicated upper endoscopy for indications other than
dysphagia or GERD
- Patients with reflux symptoms, a normal appearing esophagus on clinically indicated
endoscopy undergoing clinically indicated ambulatory pH/impedance testing.
Exclusion Criteria:
- Previous gastric or esophageal surgery.
- Use of proton pump inhibitors 1 month prior to the study
- Patients on anticoagulation other than aspirin or clopidogrel
- Presence of erosive esophagitis or Barrett's esophagus
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 | [Impedance Measurement for Non-Erosive Reflux Disease | NCT02997527 | Entailment |
731 | 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. Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment
at the Lombardi Cancer Center.
2. Presence of hand pain
3. No active signs of ongoing malignant disease
Exclusion Criteria:
1. Known autoimmune disease for example, rheumatoid arthritis, systemic lupus
erythematosis, polymyalgia rheumatica, or seronegative arthritis.
2. Age <18
3. Unable to complete informed consent process
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome | NCT00890058 | Contradiction |
6,217 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Age between 18 and 60 years.
2. Health care worker in the front line of care of suspected or confirmed cases of
COVID-19.
3. Negative IgM antibodies.
Exclusion Criteria:
1. Being a participant in another trial with another drug.
2. Temperature above 38ºC.
3. Having cohabited in the past 15 days with a person diagnosed with CoV-19.
4. Pregnancy.
5. Active o past smoker.
6. Known hypersensitivity to drugs or food.
7. History of respiratory disease.
8. Underlying diseases (Hypertension, cancer, diabetes, cardiovascular disease,
leukopenia).
9. Signs or symptoms of CoV-19 infection: cough, dyspnea, myalgias.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Primary Prevention of Infection by COVID-19 in Health Providers | NCT04420260 | Contradiction |
5,657 | 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:
- Coming from the Lisbon region;
- A BMI ≥ p85 for gender and age;
- Attending the Clinic for the first time;
- Accepted to be enrolled.
Exclusion Criteria:
- Major pathologies (other than obesity or its related comorbidities);
- Inability to perform regular PA;
- Mental disorders;
- Smoking habits;
- Under any kind of prescription (other than antihypertensives or metformin);
- Being involved in another weight loss program.
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 18 Years | Physical Activity Consultation in the Management of Adolescent Overweight | NCT02941770 | Contradiction |
1,431 | 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:
- Age: 65-80 years
- Systolic blood pressure between 130-139 mmHg and diastolic blood pressure lower than
90 mmHg
- Non smoking
- Normal Body-Mass-Index (BMI): 18.5-24.9 kg·m-2
- Normal Lung Function
- Willing to adhere to the general study rules
Exclusion Criteria:
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent
persons
- Intake of blood pressure medication
- Intake of medications affecting sleep or the performance or the respiratory,
cardiovascular or neuromuscular system
- Acute or chronic illness other than prehypertension
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 80 Years | Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects? | NCT03313284 | Contradiction |
3,262 | 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:
- Male or female
- More than 18 years old
- Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
- Consent agreement
Exclusion Criteria:
- No consent agreement
- No sicca symptoms
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 | Ultrasound Elastography of Salivary Glands | NCT02994797 | Entailment |
9 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | - INCLUSION CRITERIA:
1. Men age 65 years or older
2. Serum testosterone level less than or equal to 350 ng/dl
3. Subject is able to complete an informed consent
EXCLUSION CRITERIA:
1. History of Stroke
2. History of Dementia
3. History of Diabetes
4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading
renders subject ineligible
5. Chronic medical condition, i.e. congestive heart failure
6. Arthritis, severe enough to prevent completion of the strength testing, history of
joint replacement of knees or hip.
7. Inability to walk 50 meters
8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.
Fosamax, Evista, Miacalcin
9. History of Gastric surgery
10. History of prostate cancer or any other cancers, including blood dyscrasias
11. History of severe benign prostatic hyperplasia (causing urinary problems)
12. History of heart attack or open-heart surgery within the past 6 months
13. Use of steroids within the past 3 months, including prednisone and/or cortisone
injections, and inhaled steroids. Topical steroid cream is acceptable.
14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the
duration of the study
15. Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone)
Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs
of growth hormone
16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
17. Use of Dilantin or Phenobarbital
18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
wine or cocktail daily)
19. Currently smokes any tobacco product
20. Having started a new medication during the past three months which may interfere with
the outcome measures of the study
21. Polycythemia
22. Prostate specific antigen > 4.0 ng/dl
23. Hematocrit < 36
24. Liver function tests greater than 2 times upper normal limits or abnormal
electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
25. Mini Mental Status Exam score less than or equal to 24
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men | NCT00104572 | Contradiction |
4,577 | 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
To enroll into the clinical trial, potential subjects must:
1. Be healthy women, who are sexually active, at risk for pregnancy and desiring
contraception.
2. Be within the age range of 18 through 40 years inclusive at enrollment.
3. Have a negative urine pregnancy test at the admission visit.
4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not
using hormonal contraception.
5. Have one menses after switching from oral contraceptives to using the Woman's Condom.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Be willing to engage in at least four acts of heterosexual vaginal intercourse per
month for a period of 6 months.
10. Be willing to only use the study product as the primary method of contraception over
the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a diary to record coital information, product use information,
information about the use of other vaginal products, and any symptoms, which occurred
in her or her partner over the course of study participation.
13. Be willing to state that, to her best knowledge, her sexual partner(s):
1. Has not had a vasectomy or been previously diagnosed as infertile.
2. Has not been previously diagnosed or suspected of HIV unless he has subsequently
had a negative HIV test.
3. Has not been known to have engaged in homosexual intercourse in the past 5 years
unless he has had negative HIV test results since then.
4. Has not shared injection drug needles in the past unless he has had a negative
HIV test at least 6 weeks since last use.
5. Has no known history of allergy or sensitivity to polyurethane (condom pouch),
polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
14. Agree not to participate in any other clinical trials during the course of this study.
15. Be willing to give written informed consent to participate in the trial.
Exclusion Criteria
To enroll into the clinical trial, potential subjects must not:
1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl
alcohol (capsule), or other water-based lubricants such as Astroglide.
2. Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis,
or if needed by a urine culture or wet mount (see Schedule of Assessments for
definitions), unless treated and proof of cure is documented by a negative test result
performed at least 2 weeks post-treatment.
3. Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and
her partner(s) complete treatment and proof of cure is documented for the subject only
by a negative test result performed at least 3 weeks post-treatment.
4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
5. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
7. Be in a monogamous relationship of less than 4 months with their partner.
8. Have any contraindications to pregnancy (medical condition) or regularly use category
D or X or exclusionary medications listed in Appendix F.
9. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
10. Have known or suspected to have an HIV infection.
11. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
12. Be lactating or breastfeeding.
13. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
14. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
16. Have received a Depo-Provera® injection in the 9 months prior to enrollment (this
exclusionary time period can be shortened to 6 months if the subject has also had 2
spontaneous menstrual cycles [requires minimum of 3 menses] that meet criteria for
normal menstrual cycles).
17. Have an abnormal Pap test based on the following criteria:
- Pap test in the past 15 months with ASC-US unless:
- less than 21 years of age;
- a repeat Pap test at least 6 months later was normal;
- reflex HPV testing was performed and was negative for high-risk HPV; or
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with LSIL unless:
- less than 21 years of age;
- a colposcopy (with or without biopsy) found no evidence of dysplasia
requiring treatment or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease;
- Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL
unless colposcopy and/or treatment was performed and follow-up at least 6 months
after the colposcopy and/or treatment showed no evidence of disease;
- Pap test in the past 15 months with malignant cells.
18. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
19. Have taken an investigational drug or used an investigational device within the past
30 days.
20. Have previously participated in or completed this study.
21. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study. For example, if the subject is found to have Condyloma
Accuminata, the investigator can decide whether to exclude the subject or not,
depending on its location and if use of the condom may be painful for the subject.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom | NCT01223313 | Contradiction |
886 | 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:
- Knee pain and minimum three of the following
- >50 years
- morning stiffness < 30 min
- crepitation
- bone tenderness
- bone osteophytes
- absence of inflammation
Exclusion Criteria:
- Other causes of symptoms to the knee
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Variable Resistance Training in Patients With Osteoarthrosis of the Knee | NCT03722277 | Entailment |
4,824 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
Inclusion Criteria
1. Patient is a recipient of a first cadaveric kidney, or a kidney living donor
mismatched (at least one mismatch.)
2. Patient is a minimum of 18 years of age at the time of transplant.
3. Patient has type 2 non-insulin dependent diabetes.
4. Patient or legal guardian has signed and dated an Ethics Committee-approved informed
consent document and is willing and able to follow study procedures.
5. If female and is childbearing potential, patient has a negative pregnancy test and
utilizes adequate contraceptive methods.
Exclusion Criteria
1. Recipients of a transplant graft from a donor age 65 and older.
2. Recipient of a multi-organ transplant.
3. Patients who are being re-transplanted will not be eligible for study.
4. Patients who have lost a previous graft to rejection less than one year from
transplant.
5. Patient has any form of substance abuse, psychiatric disorder, or a condition in the
opinion of the investigator, may invalidate communication with the investigator.
6. PRA > 30%
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 | Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM) | NCT00296296 | Contradiction |
Subsets and Splits