cyrilzakka/clinical-trials huggingface dataset:
MedDrive's Responsiveness to Alcohol

This four-way, dose-response, crossover, double blind, placebo-controlled, randomised validation study investigates the responsiveness of MedDrive, a computed battery of neuropsychological tasks, to different doses of alcohol.

The following hypothesis are tested:

1. Measures from MedDrive are influenced by alcohol in a dose dependent way.
2. Effects of alcohol on driving performances are correlated to measures from MedDrive in a dose dependent way.
3. Within a group of healthy young drivers, MedDrive shows consistent results over repeated measures (ICC≥0.7).
4. MedDrive models effects of alcohol on driving performances better than does the UFOV or the trial making task.

Background: There is an increasing need for physicians to advice patients on their fitness to drive. Current guidelines underline the limitations of existing instruments and the poor adaptability of batteries of neuropsychological tests assessing fitness to drive in both experimental and primary care settings. The investigators therefore developed MedDrive, a free, reliable, computer based measuring instrument capable of detecting effects of age and drugs on cognitive functions considered as essential for driving.

Objectives: This study aims to test MedDrive responsiveness to different blood alcohol concentrations (BAC) and validate these measures against performances on a driving simulator. It also aims to measure MedDrive's reliability following repeated measures during the training phase, to compare MedDrive's performances in measuring effects of different BAC against the UFOV, and to model MedDrives measures to predict behaviour on the simulator. Finally, this study also includes a nested experimental study measuring effects of alcohol on attention.

Methods: Using Widmark's formula, 16 healthy young drivers are given cranberry juice with different doses of ethanol to bring their BAC to 0 g/L, 0.5 g/L, 0.65 g/L, and 0.8 g/L. They are blinded to the presence of ethanol by inhaling vapors of ethanol just before drinking. BAC is maintained during the entire experiment by using a breathalyser and administrating drinks throughout the experiment. Three scenarios are planned on a driving simulator (StSoftware PvW-2010), a road tracking task, a car following task, and a car following task including dual tasking using peripheral vision.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 to 40 years
* Obtained drivers license at least 24 months before
* Fit to drive
* Consumed at least once six units of a beverage with alcohol at a single occasion during the previous six months

Exclusion Criteria:

* Under the influence of a medicinal drug affecting their driving performance
* Suffer from a psychiatric condition affecting driving performances
* Suffer from simulator sickness
* Presenting criteria (ICD-10) of alcohol dependence.
* Pregnant or breastfeeding
* Intolerant to alcohol defined by having either headaches or digestive disorders for quantities of alcohol that do not seem to bother other people.
Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement

The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.

In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.

Eligibility Criteria:
Inclusion Criteria:

* subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011

Exclusion Criteria:

* subjects under the age of 18
Linezolid for Syphilis Pilot Study

The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.

This will be a randomized, open-label, non-comparative, adaptive pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for five or ten days, using a contemporaneous historical control group benzathine penicillin G (single dose of 2.4 million units) in participants with and without HIV infection.

In total, 24 participants will be enrolled across multiple clinical sites in the United States. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) at 1 month, 3 months, and 6 months.

Study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with HIV. Study findings may also help address the crisis of penicillin shortages, difficulty in administration, and offer options for those with penicillin allergy.

Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older
* Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
* Able to provide informed consent
* For PLHIV: on treatment for HIV-infection and most recent viral load \<200 copies/mL or most recent CD4 T-cell count \>350 cells/mL

Exclusion Criteria:

* Pregnancy or a positive pregnancy test on the day of enrollment
* Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs
* Patients showing signs and symptoms of neurosyphilis
* Serofast RPR titer
* Recent (\<7 days) or concomitant antimicrobial therapy with azithromycin, doxycycline, ceftriaxone, cefixime, or other beta lactam antibiotics (e.g. amoxicillin)
* Linezolid or penicillin allergy
Study Of GW679769 In Major Depressive Disorder

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.


Eligibility Criteria:
Inclusion criteria:

* Subjects must have the ability to comprehend the key components of the consent form.
* Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
* If female, subjects must be practicing an acceptable method of birth control.
* Subjects must have rating scores as outlined.

Exclusion criteria:

* Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
* Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
* Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
* Subjects with an unstable medical disorder.
* If female, pregnant or lactating.
* Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy.

Docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer. Zoledronic acid has been used in the treatment of bone metastasis from prostate cancer. This is a study of the combination of these two agents. The Zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6 and maximum of 12 cycles.

Sequence A: Docetaxel on day 1 and zoledronic acid on day 2

Sequence B: Zoledronic acid on day 1 and docetaxel on day 2

Patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36 patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Hormone refractory prostate cancer
* Stage IV disease with bone metastasis
* No immunotherapy, hormonal therapy or radiotherapy within the previous month
* Performance status \< or = 2 (ECOG)
* Serum creatinine \< 1.5 mg/100ml
* Serum bilirubin \< or = 1.25 x UNL (upper normal limit) (or \< or = 1.5 x UNL in the presence of hepatic metastases); SGOT e SGPT \< or = 1.5 x UNL (or \< or = 2.5 x UNL in presence of hepatic metastases)
* Left ventricular ejection fraction \> or = 50% (measured by cardiac ultrasound or MUGA scan)
* Neutrophils \> 1500/mm3; platelets \>100000/mm3; hemoglobin \>10 g/100 ml· Life expectancy of at least 3 months

Exclusion Criteria:

* Previous malignancies with the exception of radically treated epithelioma
* Previous chemotherapy
* Comorbidities that would, in the Investigator's opinion, contraindicate the use of the drugs in the study
* Uncontrolled Diabetes
* Severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
* severe infection
* cerebral metastasis
* Pre-existing motor or sensory neurotoxicity \> or = grade 2 according to CTC (Common Toxicity Criteria).
Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.

Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost.

Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing.

A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.

Eligibility Criteria:
Inclusion Criteria:

* Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
* Patients with or without previous orthopaedic treatment
* Presence of nonunion 9 month or more
* Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length

Exclusion Criteria:

* Evidence of infection at the nonunion site (Osteomielitis)
* Evidence of cutaneous lesion at the site of pseudoartrosis
* Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
* Autoimmune diseases
* Neoplastic diseases
* Pregnancy
* Major metabolic disorders
* Treatment with steroids
* Other conditions or circumstances that compromise the study participation according to medical criteria
Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics.

Outcomes of probiotic treatment versus bacteriotherapy will be compared.

The investigators would like to examine the extent of rehabilitation of the composition and functioning of the intestinal bacteria in healthy people after the consumption of antibiotics.

Since the digestive mocus enables the connection between the host and the bacteria that live within it, the investigators would like to characterize the microbiome in the different areas along the digestive system - before antibiotic treatment and after rehabilitation by probiotic treatment versus bacteriotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age: 18 years and up
* Gender: women and men

Exclusion Criteria:

* Pregnancy
* Age under 18 years
* antibiotic treatment 3 months prior to enrollment
* Viral Hepatitis
* HIV positive
Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement

The bioprosthetic aortic valve replacement is a frequent intervention because of the predominance of calcified aortic stenosis, which is the most common valvular disease, and aging of the population.

International guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions.

Questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations.

However, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis.

The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.

The study will include consecutive patients who agreed to participate in the study, which meet the criteria for inclusion, that is to say consecutive patients operated on by a bioprosthetic aortic valve replacement during the 3 months of inclusion. Patients will be included immediately after completion of aortic valve replacement.

The data will be entered directly by the referent of each center, based on data from the French Society of Cardiology accessible by Internet on a secure site.

The follow-up time will be 6 months

The incidence of thromboembolic complications and bleeding and mortality within 6 months will be analyzed in a standardized manner according to the recommendations on the analysis of morbidity and mortality after valve surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients operated on for single bioprosthetic aortic valve replacement during the study period:

  * with or without reinforcement
  * with or without associated CABG
  * with or without action on the ascending aorta
  * whether a first intervention or reoperation
* Patients who agreed to participate in the study

Exclusion Criteria:

* Replacement aortic valve homograft or autograft
* Surgical procedures on another valve (conservative or prosthetic replacement)
* Permanent Atrial Fibrillation
* Processing anticoagulant vitamin K-long course
Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

The aim of this study is to explore if an already established diet with anti-inflammatory effect in paediatric inflammatory bowel disease would have an anti-inflammatory effect in children with JIA. The diet is called specific carbohydrate diet.

Children classified with JIA, in a low-to-medium disease activity and without having changed DMARD or bDMARD in the last 12 weeks are included. Only motivated children and parents can participate. Before inclusion the family are informed orally about the study plan, the diet and practical issues regarding the study and they receive written information including for example a product list and a recipe booklet. A dietician and the principal investigator follows the child and parents during visits, by mail and phone. After the baseline visit, the family has two weeks to get used to the new diet. At baseline, after two, four and twelve weeks on the diet the child is examined, blood exams are performed and blood is stored at -70, fecal samples and urine is also collected. At inclusion and after four weeks saliva sample for bacteria is collected. The child fills in the child health assessment questionnaire, (CHAQ) for a score of the physical ability and DisabKids for an overall assessment of the childs well-being.

Eligibility Criteria:
Inclusion Criteria:

* Participants should fulfill criteria for JIA according to the ILAR criteria
* Participants should not be older than 16 years at onset of disease
* Participants should have a low-medium disease activity with an E-SR of 30 at the most and/or no more than two active joints at inclusion.
* DMARD and bDMARD should not have been changed within the last 12 weeks before inclusion.
* Any gastro- intestinal complaints should be investigated before inclusion.
* Fecal calprotectin should be normal.
* The child as well as the parents need to be motivated for the child to try a dietary intervention for at least four weeks, preferably longer.

Exclusion criteria:

* Children with the systemic category of JIA.
* Children with an unstable inflammatory situation with \> 2 inflamed joints and/or an E-SR of more than 30.
Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics

This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as saliva, serum, and feces from the study subjects. We combined 16S rRNA sequencing and metabolomics to explore the differences in microbial and metabolic characteristics between gastric cardia cancer and non-cardia gastric cancer for early screening of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Study population signing informed consent form
* Age: 18-75 years old
* The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.

Exclusion Criteria:

* Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.
* Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.
* People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.
Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females

This study was conducted to determine the difference between impact of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.

Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was significantly more frequent in students from rural residence (Shaimaa et al., 2018).

There is only one previous study investigate effect of aquatic exercise on primary dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of aerobic ex , however non of the previous studies compared between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore this study was the first one which aimed to investigate the difference between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonsmoking, virginal girls having moderate to severe primary dysmenorrhea (score on pain rating scale \> 3).
* Their ages ranged from 14 to 20 years
* Their body mass index (BMI) ranged from 18 to 25 kg/m2.
* They haven't practice any sports at least one year

Exclusion Criteria:

* Any musculoskeletal disorder.
* Cardio-respiratory disease.
* Diabetes, hypertension, or anemia.
* Adolescent girls who have utilized hormonal treatment in the six months prior to study commencement.
* currently undergoing pharmacological therapy for menstrual pain management
Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia

A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia

To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients

Eligibility Criteria:
Inclusion Criteria:

* Age of 19 years old at the time of written informed consent
* Patients with dyslipidemia

Exclusion Criteria:

* Secondary dyslipidemia
* Patient who does not meet the specified TG, LDL-C level
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE by American College of Rheumatology guidelines.
* On stable SLE treatment
* Active SLE disease
* Serologically active
* 18 years of age or older
* Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria:

* Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
* Liver disease.
* Anemia, neutropenia, or thrombocytopenia.
* Malignancy within past 5 years
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
* History of active tuberculosis or a history of tuberculosis infection.
* Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
* Prior administration of any B cell depleting therapy in the past 18 months.
* Pregnant or nursing
* History of congenital immunodeficiency