cyrilzakka/clinical-trials huggingface dataset:
Thrombosis and Neurocognition in Klinefelter Syndrome

The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is compared to healthy controls by using specific biochemical assays for coagulation and fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the effect of gonadal status and any effects of long- or short-term testosterone treatment on the above mentioned parameters are investigated.

Klinefelter syndrome (KS) affects approximately 1 in every 600 males, but remains severely underdiagnosed. Men with KS are more prone to a wide range of diseases including thrombotic disorders. Also, neurocognitive function is impaired in KS. The background for the increased thrombosis proneness is not understood, and also it is not understood how testosterone treatment affects the thrombosis risk in KS. The effects of testosterone treatment on neurocognition in KS is also not completely understood. However, it is speculated that testosterone treatment at an early point could help improve the overall neurocognitive performance.

In this study 30 males with KS receiving testosterone treatment, 30 males with KS not receiving testosterone treatment and 60 matched healthy male controls are included. After initial examination including blood testing and neurocognitive testing, the subjects are followed for 18 months and examined a second time. After initial examination the group of previously untreated KS males will be put on standard testosterone treatment according to current guidelines.

Groups will be compared by measuring and array of markers for coagulation and fibrinolysis, including thrombin generation and fibrin structure analysis, to assess the haemostatic balance. Also, a wide array of neurocognitive tests and brain fMRI is applied to compare the neurocognitive function between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Klinefelter syndrome with 47 XXY karyotype
* Healthy male

Exclusion Criteria:

* Known thrombophilia
* Previous thrombotic event
* Chronic or acute illness affecting the haemostatic balance (e.g. diabetes, cancer).
* Previous or current disease affecting the brain
* Weight above 120 kg
* Current abuse of stimulants affecting the brain
* Unability to complete MR-scan (e.g. claustrophobia, internal metal objects)
A Study of Megestrol Acetate in HIV-Infected Children

The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).

The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* Failure to thrive as defined by:
* crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
* Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
* Free of significant acute illness (mild upper respiratory tract infections allowed).
* Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms are excluded:

* Gastrointestinal infection or malabsorption.
* Significant acute illness.
* Any identified, untreated cause for failure to thrive other than underlying HIV infection.
* Medical contraindications to megestrol acetate.

Patients with any of the following prior conditions or symptoms are excluded:

Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.

History of prior megestrol acetate therapy in the past six months.
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Weight: BMI from 17.5 to 30.5

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney

Background: Uremic pruritus is one of the common complications in long-term dialysis patients. In general, many factors including xerosis, elevated serum calcium, phosphate, calcium-phosphate product, hyperparathyroidism and inadequate dialysis may contribute to it. Recently, researchers reported that immuno-hypothesis with high serum level of cytokines could be the cause of uremic pruritus. Polymethylmethacrylate (PMMA) artificial kidney (AK) has been reported to adsorb more serum cytokines than other high flux artificial kidneys.

Methods: In July 2006, 30 patients with severe uremic pruritus from 300 chronic hemodialysis patients in a single center entered this prospective study. Their dialyzers were changed to PMMA AK for 4 weeks. The severity of pruritus was evaluated every week using the results of a questionnaire (pruritus score). Laboratory assays including pre-dialysis serum blood urea nitrogen, creatinine, β2-microgblubulin (β2M), calcium, phosphate, intact parathyroid hormone (iPTH), total CO2, ferritin, hematocrit, high sensitivity C-reactive protein (hsCRP), IL-1, IL-2, IL-6, IL-18, TNF-α, KT/V and β2M clearance were measured before and at the end of 4 weeks of PMMA AK use.

Expected Results:To prove the PMMA membrane could improve the uremic pruritus and to reveal the effect of PMMA membrane on serum level of possible factors contributing to uremic pruritus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pruritus (\>3 months) were screened using traditional visual analogue scale (VAS) and then scored using a pruritus questionnaire (pruritus scoring system).
* Other inclusion criteria were that patients enrolled should be dialysed for 4 hours, three times a week, with KT/V \>1.2, serum albumin\> 3.0 mg/dl, hematocrit \> 24%, ferritin \< 900 ng/ml, phosphate \<7 mg/dl, corrected calcium \<11 mg/dl, calcium-phosphate product \< 70, intact parathyroid hormone (iPTH) \<600 pg/ml, and normal serum level of alanine aminotransferase and bilirubin in past 3 months.

Exclusion Criteria:

* Pruritus unrelated to renal failure
* Evidence of malignancy
* Liver cirrhosis diagnosed by echogram or admission within 3 months of the start of the study.
Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis

Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date.

In the last ten years, so-called "genome-whole" or "genome wide" association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence.

The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE.

The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. .

These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.


Eligibility Criteria:
Inclusion Criteria:

* patients of the MARTHA cohort

Exclusion Criteria:

* none
Growth Hormone in Poor Responders to IVF Trial

This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.

We hope that our Adjuvant Growth Hormone study will help answer these questions.


Eligibility Criteria:
Inclusion Criteria:

* Subject with prior poor response(s) to ovarian stimulation for IVF or ICSI. Poor response is defined as a history of producing fewer than four follicles ≥14 mm in diameter during previous COS cycles where FSH or HMG was used from cycle start at a daily dose of ≥450 IU
* Age ≤ 45 years
* Baseline blood labs, measured within previous month, show fasting blood glucose \<6.1 mmol/L and TSH ≤ 5.5 mU/L
* Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
* Subject willing and able to give informed consent

Exclusion Criteria:

* Concurrently enrolled in any other clinical trial
* Previous participation in this study
* Using GnRH agonist in COS protocol
* Any prior early follicular phase serum FSH level ≥12 IU/L
* Use of any of the following is contraindicated or inappropriate: GH, Cetrotide®, FSH, LH or hCG
* Used OCP within the prior month
* Pregnant or lactating
* Untreated hydrosalpinx
* Tobacco smoker
* Diabetic or otherwise at risk of gestational diabetes
* BMI \> 38 kg/m2
* Poorly controlled thyroid disease
* Known cancer or prior history of malignancies
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Indian adult male volunteers.
* No apparent signs or symptoms of ill health.
* Properly informed about the study and having signed the informed consent form (ICF). In case of the volunteer being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
* Subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

* Known or suspected impairment of immunological function;
* Known hypersensitivity to any component of the rotavirus vaccine;
* Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
* History of chronic diarrhea;
* Clinical evidence of active gastrointestinal illness;
* Receipt of any intramuscular (IM), oral, or intravenous (IV) corticosteroid treatment in the past 30 days
* Subjects suspected to be HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) positive from the available clinical history
* Prior receipt of a blood transfusion or blood products, including immunoglobulins;
* Any subject who cannot be adequately followed for safety;
* Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* Subject unable to maintain diary card
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite

Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old?
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
3. Is willing to consent to participate in the study.
4. Is willing to shield the tattoo completely from sun exposure
5. Signs informed consent form
6. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. Subjects who are unwilling to consent to tattoos
2. Subjects mentally ill or incompetent
3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations
4. Subjects who are prisoners
5. Subjects with recent sun exposure and suntan in the area to be treated
6. Allergic tattoos (hypersensitivity to tattoo ink)
7. History of vitiligo or keloidal scarring
8. Tattoos located on the neck or face including cosmetic tattoos
9. Subjects unwilling to tolerate partial removal of the tattoo in this study
10. Infection or skin disease in the area to be treated
11. Subjects who are immunosuppressed (e.g. HIV)
12. Subject is pregnant or nursing
13. Use of oral isotretinoin within past 12 months
14. History of squamous cell carcinoma or melanoma
15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
16. Has any other reason determined by the physician to be ineligible to participate in the study
Cell Therapy in Severe Chronic Ischemic Heart Disease

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of angina or angina equivalent
* documented coronary artery disease (invasive angiography)
* documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
* unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

Exclusion Criteria:

* severe LV dysfunction (EF \< 25% on echo)
* short life expectacy (below \< 1 year)
* diagnosis of cancer in the past 5 years
* diagnosis of hematological diseases
* diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
* diagnosis of acute coronary syndrome in the past 3 months
* diagnosis of chronic kidney disease stage V requiring chronic dialysis
Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders

The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.

Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18-65 years of age.
* Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry.
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.

Exclusion Criteria:

* History of taking antipsychotics or mood stabilizers within past 4 weeks.
* History of DSM-IV substance dependence.
* Mental retardation (IQ \< 70)or patients who are not able to understand the informed consent.
* Definite or suspected organic mental disorders.
* Female patients who are not able to maintain contraception during this study
* Laboratory abnormalities with clinical significance
* History of epilepsy or electroconvulsive therapy within the past 3 months.
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
* Have moderately-to-severely active RA at screening and baseline, defined by the presence of

  * ≥6 swollen joints based on 66 joint count, and
  * ≥6 tender joints based on 68 joint count.
* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.

Exclusion Criteria:

* Have Class IV RA according to ACR revised criteria
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to

  * poorly controlled diabetes or hypertension
  * chronic kidney disease stage IIIa or IIIb, IV, or V
  * symptomatic heart failure according to New York Heart Association class II, III, or IV
  * myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization
  * severe chronic pulmonary disease, for example, requiring oxygen therapy
  * major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to

    * systemic lupus erythematosus
    * psoriatic arthritis
    * axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis
    * reactive arthritis
    * gout
    * scleroderma
    * polymyositis
    * dermatomyositis
    * active fibromyalgia, or
    * multiple sclerosis
Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism \>1D, pseudoexfoliation and any corneal pathology were excluded.

Eligibility Criteria:
Inclusion Criteria:

* All the patients with senile cataract

Exclusion Criteria:

* Previously operated eyes
* Presence of corneal pathology
* Pseudo exfoliation
* With-the-rule (WTR) astigmatism \>1 D
* Presence of diabetes mellitus
* History of connective tissue disease
* Consumption of systemic steroids
Leucine Supplementation in Elderly Men

In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men


Eligibility Criteria:
Inclusion Criteria:

* living independently

Exclusion Criteria:

* Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years