cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C

The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated. The investigators hypothesize that patients receiving DAAs do not experience higher rates of adverse events compared to patients who have not received DAAs. The study population is adults between the ages of 18 and 88 with any indication of a diagnosis of HCV. An intervention group (those receiving a DAA) and comparison group (those who are not treated) will be created using medication dispensing data. Eligibility for the study will be determined from January 1, 2011 through December 31, 2017. Covariates will be collected from January 1, 2011 through December 31, 2017. Individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with HCV. The primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death. The secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia. Outcomes will be assessed from January 1, 2011 through December 31, 2017. The investigators will use two different analytic approaches to answer the question of interest: a Poisson regression model and marginal structural modeling (MSM). The simpler Poisson model is an extension of tabular rate of event analysis. The more complicated MSM model incorporates modeling of the treatment decision to more flexibly control for confounding by indication. For each outcome, the investigators will only record the first date an outcome occurs. Each outcome will be modeled separately.


Eligibility Criteria:
Inclusion Criteria:

* HCV viral load
* HCV genotype
* HCV qualitative
* HCV antibody
* HCV drug
* Continuously enrolled 12 months

Exclusion Criteria:

* Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.

The results will be examined for sensitivity to the following possible exclusion criteria:

* Achieved SVR-12 prior to index date
* HCV treatment experienced prior to index date
* No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
* No positive HCV test (genotype, viral load, or qualitative)
* No recent positive HCV test (genotype, viral load or qualitative)
Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.


Eligibility Criteria:
Inclusion Criteria:

* age superior or equal to 18 years and inferior to 80 years.
* patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
* prostate cancer histologically proven.
* performance index OMS (World Health Organization) of grade 0-2.
* indication of external beam radiotherapy validate by the medical commission of the institution.
* IPSS (International Prostate Symptom Score \< 15/35 (without alpha-blocker).
* the signed consent form.

Exclusion Criteria:

* Rectal surgery antecedents.
* prostate resection less than 6 mois.
* Involvement of the seminal vesicles or of the capsule on MRI.
* patient who can't cooperate during the treatment.
* pelvic irradiation antecedents.
* antecedents of inflammatory intestinal pathologies.
* neoplasia.
* patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect).
* patients receiving anticoagulant treatment.
* other undergoing study that may interfere with the present study.
* patient under legal protection measure.
* hypersensitivity to hyaluronic acid.
* patient with auto-immune disease.
* patient receiving immunosuppressive medication.
* severe allergies.
* history of endocarditis.
Medial Rectus Fenestration vs Recession for PAET

This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.

All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.

Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is \> 15PD.

Exclusion criteria:

1. Patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 PD or more.
2. Patients with paralytic or restrictive strabismus.
3. Patients with previous strabismus surgery
4. Patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months

All patients will receive complete ophthalmic and orthoptic assessment including:

i) A full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination.

ii) Measurement of the deviation at distance (6 m) and near (33 cm). iii) Assessment of ductions and versions in all cardinal directions of gaze

Patients will be randomly allocated using a random table to one of two groups:

1. Group 1: Unilateral or bilateral conventional MR recession. Augmented formula will be used to decide the Surgical dosage using the standard tables (3)
2. Group 2: unilateral or bilateral MR fenestration All surgeries will be performed by one experienced surgeon (H.SH)

Eligibility Criteria:
Inclusion Criteria:

* patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is \> 15PD.

Exclusion Criteria:

1. convergence excess esotropia.
2. paralytic or restrictive strabismus.
3. previous strabismus surgery
4. neurologic, ocular, or developmental disorders or follow-up less than 6 months
A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

This prospective randomized controlled clinical Trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. The objectives of the trial are to compare the efficacy and safety of Capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. histologically type： squamous cell carcinoma
2. head and neck squamous cell carcinoma (HNSCC), Tumor staged as III to IVb (according to the 8th AJCC edition).
3. Eastern cooperative oncology group (ECOG) performance status 0 or 1
4. Age between 18 and 65 years old
5. Prior treatment with chemo-radiotherapy (CRT) based Platinum drugs.
6. Adequate marrow: WBC count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
8. Adequate renal function: creatinine clearance ≥60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Nasopharyngeal carcinoma and/or salivary gland carcinoma.
2. Any other malignancy (except for primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ)
3. currently recurrent of metastatic disease
4. received research drug in 4 weeks
5. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
6. Severe hematological abnormality and intolerance to chemotherapy
7. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
8. Pregnancy or breast feeding
9. patients who cannot obey to completion of the study
Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study

Jangzhuo Qinggan prescription and irbesartan in the treatment of essential hypertension(Hepatogastric Damp-heat), randomized, parallel-controlled, multi-center clinical study.

Charged by the five research centers in line with traditional Chinese medicine hepatogastric Damp-heat syndrome 240 cases have hypertension, and overweight, as well as blood lipid disorders or diabetes were randomly divided into Chinese herbal compound Jiangzhuo Qinggan prescription group and western medicine irbesartan group.The treatment groups were compared 4-week step-down and regulation of blood lipids, blood sugar effect.

Eligibility Criteria:
Inclusion Criteria:

1. Consistent with diagnosed hypertension, blood pressure, for 1-2 grade.
2. Aged 18-65 years old.
3. Body mass index (BMI) ≥ 24kg/m2, but \<35 kg/m2.
4. Waist circumference ≥ 85cm (male) or waist circumference ≥ 80cm (women).
5. Comply with any of the following 3 : triglyceride (TG) elevated levels of:\> 150mg/dl (1.7mmol / l), or has received appropriate treatment; high-density lipoprotein - cholesterol (HDL-C) levels reduced: Men \<40mg/dl (0.9mmol / l), women \<50mg/dl (1.1mmol / l), or has received appropriate treatment; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.
6. Hepatogastric Damp-heat syndrome differentiation.
7. To sign informed consent.

Exclusion Criteria:

1. Has been used to control lipids, blood sugar drugs, but use the time for those below the 1 month.
2. Nearly 3 months, weight loss ≥ 5%.
3. Suffering from congenital heart disease, rheumatic heart disease, congestive heart failure, unstable angina, and had a myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or off-line clinical significance of arrhythmia.
4. Bilateral renal artery stenosis, solitary kidney, serum creatinine\> 133μmol / L .
5. Active liver disease, history of chronic persistent hepatitis, ALT\> upper limit of normal.
6. Peptic ulcer or malabsorption syndrome .
7. With insulin-treated diabetes.
8. There is a history of appetite or abuse of laxatives by hyperthyroidism.
9. Pregnancy, pregnancy or breast-feeding women to prepare.
10. For those who are allergic Chinese medicine, allergic people.
11. Mentally ill.
12. Hyperkalemia in patients.
13. Cancer.
14. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA).
15. Nearly 3 months in patients receiving other clinical studies.
16. Alcohol and / or psychoactive substances, drug abuse and dependency.
Use of Public Health Surveillance Models in the French National Health System Database

Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF). This drug is at high risk for severe ADR and requires thus careful pharmacovigilance monitoring.

Primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with AF under the same treatment.

DABISURV study consists in an analyze of a cohort of patients with AF who have received at least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in the French National Health Insurance System.

The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with this molecule among first users.

The ability to detect quickly substantial ADR of new drugs is of critical importance to public health in order to facilitate timely public health response. If the public health surveillance models are found useful for this topic, then semi-automated procedures would be needed to detect ADR associated with new generation anticoagulants in medico-administrative databases. If the public health surveillance models are found not useful for the detection of ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-valvular atrial fibrillation
* Patients receiving an first prescription of anticoagulants

Exclusion Criteria:

* Patients with valvular atrial fibrillation
Gut Microbiota in ITP

Prospective, observational study to explore the significance of gut microbiome in the diagnosis of ITP, and to identify the predictive value of baseline gut microbiome for GC resistance/relapse.

A prospective, observational study to (1) collect fecal samples from ITP patients at initial diagnosis (baseline) and after first-line GC treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of ITP, and (5) identify the predictive value of baseline gut microbiome for GC resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of ITP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Isolated thrombocytopenia (platelet count of less than 100×10\^9/L);
* Normal leukocyte and erythrocyte counts according to routine blood tests;
* Did not receive any medication for thrombocytopenia for 6 months.

Exclusion Criteria:

* Secondary ITP such as drug-associated thrombocytopenia;
* Thrombocytopenia caused by viral infection (HIV, Hepatitis B virus or Hepatitis C virus);
* Nursing or pregnant women;
* Severe dysfunction of the heart, kidney, lung or liver;
* Active or previous malignancy;
* Patients with other diseases were undergoing treatment with immunosuppressants;
* Myelodysplastic disorder or myelofibrosis;
* Patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months.
PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

This study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. Machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.

This proposal innovatively leverages a brief but informative digital test with machine learning to examine the subtlety of pre-surgery cognition within an extremely large number of older individuals screened preoperatively within an academic tertiary medical center. It also incorporates a unique group of well characterized non-surgery peers for demographic matching to assist with normal versus abnormal machine learning analyses.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 65 years of age
* screening within the University of Florida (UF) Health Preoperative clinic
* presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)

Exclusion Criteria:

* \< 65 years of age
* did not complete screening within the UF Health Preoperative clinic
* did not complete the presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

GH plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.In this study, a prospective randomized control was used to explore the effect of GH adjuvant therapy on embryo quality.


Eligibility Criteria:
Inclusion Criteria:

* 1)infertility women whose age ≥20 and ≤39 years old; 2)women has done IVF/ICSI assisted treatment ≥1 times； 3)number of IVF/ICSI assisted treatment cylces with ≥6 oocytes retrieved ≥1； 4)number of IVF/ICSI assisted treatment cylces with ≥50% fertilization rate ≥1 ; 5)historical assisted reproduction cycles without ≥6C-Ⅱ level embryos at the third day after oocytes retrieval or without blastocyst formation after blastocyst culturing.

Exclusion Criteria:

- 1) Diseases related to IVF treatment outcome, such as untreated hydrosalpinx, uterine fibroids affecting uterine cavity, myometriosis, endometrial lesions, obvious uterine abnormalities,etc; 2)Severe acute or chronic liver or kidney diseases, such as cirrhosis, acute or chronic renal failure, hepatitis B virus activity period,etc.;in patients with abnormal liver and kidney function, the AST or ALT detection value was 2.5 times higher than the upper limit of normal, and the serum creatinine was 2 times higher than the upper limit of normal.

3)Endocrine and metabolic diseases and adrenal diseases, such as diabetes, Cushing's syndrome,etc.; 4)People has allergy history of growth hormone product; 5)Participating in other clinical research; 6)Other conditions that researchers determined not fit to be enrolled.
Maintenance of Efficacy.

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
* Pain score greater than or equal to 4 on an 11-point NRS
* FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

* Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
* Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
* Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)

Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.


Eligibility Criteria:
Inclusion Criteria:

* male and female healthy subjects aged 10-60 years old

Exclusion Criteria:

* history of rabies immunization
* previous exposure to a suspect rabid animal within the last 12 months
* any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
* treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
* known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
* known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Give their signed written informed consent to participate
2. Are at least 40 years of age and no older than 80 years
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

Exclusion Criteria:

1. Current diagnosis of asthma,
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
4. Long-term-oxygen therapy (≥ 12 hours a day).