cyrilzakka/clinical-trials huggingface dataset:
PRescriptiOn PattERns Of Oral Anticoagulants

Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate use of anticoagulants in non-valvular AF patients.

Atrial fibrillation, the most common sustained arrhythmia, is the major cause of acute ischemic stroke. The prognosis of ischemic stroke associated with atrial fibrillation (AF) tends to have a worse prognosis for recovery compared with other ischemic stroke subtypes. The risk of stroke was shown to decline to 68% by oral anticoagulant (OAC) therapy.The investigators have evaluated appropriate use of anticoagulants in non-valvular AF patients. Appropriate use of oral anticoagulants was assessed by Medication Appropriateness Index (MAI). The MAI consists of 10 criteias namely, indication, choice, dosage, modalities and practicability of administration, drug-drug interactions, drug-disease interactions, duplication, duration, and cost-effectiveness. The tenth criteria was not evaluated because of limited data regarding cost-effectiveness of the drugs.

Eligibility Criteria:
Inclusion Criteria:

* Non valbular AF \>18 years

Exclusion Criteria:

* Not currently receiving anticoagulant
Thalamic Recordings in Children Undergoing SEEG

Stereoelectroencephalography (SEEG) forms a key part of the pre-surgical evaluation in children who may be candidates for epilepsy surgery. It can help delineate the location of the putative epileptogenic zone, guiding further treatments including resective, disconnective and ablative epilepsy surgery techniques. However, less than 35% of children undergoing SEEG end up becoming seizure free following further treatment.

Open and closed loop stimulation of thalamic nuclei via deep brain stimulation (DBS) and responsive neurostimulation (RNS) are emerging treatment options for epilepsy. Thalamic target nuclei vary between studies and there are currently no gold standard personalised methods for choosing a target. This stems from the limited systematic neurophysiological recordings from thalamic nuclei; investigators currently do not understand the ictal and interictal thalamic signatures of involvement in epilepsy and do not understand how functional connectivity can be altered within and between patients.

In this prospective study, the investigators aim to recruit 30 patients undergoing SEEG as part of their pre-surgical evaluation for drug resistant epilepsy at Great Ormond Street Hospital over a period of 3 years. Once recruited, the investigators will target 3 nuclei bilaterally in each patient - the anterior, centromedian and pulvinar nuclei - using additional SEEG electrodes. Following clinical recording, the investigators will conduct two stimulation experiments, the first using single pulse electrical stimulation to measure effective connectivity between the thalamus and cortical regions and the second to study the effects of simulated DBS currents on cortical local field potential signatures.

This study will lay the foundation for a personalised approach to thalamic neuromodulation for drug-resistant epilepsy by identifying neurophysiological biomarkers of thalamic involvement in epilepsy, paving the way for closed loop neuromodulation strategies that aim to optimise response using these biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. All children undergoing SEEG as part of their pre-surgical evaluation at GOSH
2. Participants/parents/legal guardian provide informed consent for inclusion

Exclusion Criteria:

1) Lack of informed consent
A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
* Age: 18 years old, or older.
* Body Mass Index: between 18 and 35 kg/m2, inclusive.
* Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
* Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.

Exclusion Criteria:

* History of known hypersensitivity to any of the components in the study medication
* Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
* Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
* Consistent recent hypoglycemic unawareness within the last six months
* History of more than two severe hypoglycemic events within six months prior to screening
Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate.

On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.

Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.

Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.


Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ age \< 38
* breast cancer histologically proved
* under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy
* verbal agreement given

Exclusion Criteria:

* age ≥ 38
* metastatic breast cancer
* non able to follow the design of the study (geographic, social or psychological reasons)
Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years old;
* single tubular (tract length \>2 cm) ECF;
* low output volume (\<200 ml/24h);

Exclusion Criteria:

* fistulas of cancer-infiltrated;
* associated abscess;
* foreign bodies;
* distal bowel obstruction;
Glutathione vs. Curcumin Clinical Trial

The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

In the Investigator's prior study "Dynamic Modeling in GWI", the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. The investigator's research team applied an integrative systems-based approach rooted in computational biology connecting gene expression and biomarkers to pathways and to symptoms in order to identify potential therapeutic targets as well as optimal strategies for manipulation of these targets. Using this data the investigator's research team has developed a virtual model of the illness, which has been used to identify potential therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with Gulf War Illness
* 35 to 70 years old
* Good health by medical history prior to 1990
* Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity

Exclusion Criteria:

* Major depression with psychotic or melancholic features
* Schizophrenia
* Bipolar disorder
* Delusional disorders
* Dementias of any type
* History or current alcohol abuse
* History or current drug abuse
* Current tobacco use
* Organ failure
* Defined rheumatologic
* Inflammatory disorders
* HIV
* Hepatitis B and C
* Primary sleep disorders
* Steroids
* Immunosuppressives
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis

A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis

To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :

i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis
* Plaque psoriasis covering ≥ 10% BSA
* Disease duration ≥ 6 months
* PASI ≥ 12.0 at screening

Exclusion Criteria:

* Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease
* Clinically significant psoriasis flare during screening or at time of enrollment
* Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment
* Topical treatment for psoriasis within 14 days prior to enrollment
* Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization
* Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the main component of DW224aa(Test drug) and DW224a(Reference drug).


Eligibility Criteria:
Inclusion Criteria:

* a healthy adult male within the range of 20 to 45 years old at the time of screening
* one with weight of more than 55kg, in the range of IBW 20%

  * IBW(kg)={height(cm)-100}\*0.9
* one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion Criteria:

* one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
* one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
* one who is allergic or has clinically significant allergic history to the quinolone antibiotics, or to other drugs(Aspirin, antibiotics, etc)
* one who shows the following result in clinical laboratory test: AST,ALT\>1.25 times of the upper limit of normal range
* one who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
* one who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
* one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
* one who has participated in other clinical study within 2 months before study drug administration
* one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
* one who drank Over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
* one who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
* one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
* one with clinically significant observations considered as unsuitable based on medical judgment by investigators
Rheumatic Heart Disease in Peru: Prevalence and Cardiovascular Outcomes Among Schoolchildren

Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic prevention, and may prevent progression of disease to severe valvular damage and heart failure. The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will evaluate progression of disease in children with early stages of subclinical rheumatic heart disease.

The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation.

Background

Rheumatic fever complicated by rheumatic heart disease continues to be a major contributor to morbidity and premature death in low- and middle-income countries where it accounts for up to a quarter of a million deaths every year. Rheumatic fever results from an autoimmune response to groups A streptococcal pharyngitis and may progress to rheumatic heart disease with cumulative exposure. Data on prevalence of rheumatic heart disease in Latin America is scarce and ranges from 1.3/1000 as assessed by cardiac auscultation to 4.1/1000 as assessed by echocardiography.

Secondary antibiotic prevention and inclusion of patients with rheumatic heart disease in a registry with close follow-up has been demonstrated to reduce the cardiovascular sequelae associated with disease progression.

The natural course of early, clinically silent stages of rheumatic heart disease is largely unknown. Disease regression has been reported in up to one third of children with early morphological valvular changes consistent with rheumatic heart disease.

Objective

The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will investigate progression of disease in children with early stages of subclinical rheumatic heart disease.

Methods

The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation. Children diagnosed with rheumatic heart disease will be started on secondary antibiotic prevention and included into a prospective registry with longitudinal follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren aged 5 to 15 years
* Written informed consent

Exclusion Criteria
A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
* Nursing females;
* Females of childbearing potential.
Motivation as a Strategy for Adherence to a Stretching Program for Basketball Players

Background: Basketball is considered a medium-high injury sport, because of the mechanisms of injury, which can be acute, by repetition mechanisms or by overload. An effective way to avoid muscle overload injuries is to perform an extensibility workout such as an analytical active stretching program. The objective of this study is to achieve adherence to a stretching program by motivating young basketball players.

Methods: Randomized experimental clinical trial controlled by a single blind person. 21 child players between 11 and 12 years, divided into intervention group (IG) and control group (CG). IG carries out a supervised static stretching program at the end of training 3 days/week for 12 weeks and CG has normally developed the standard stretches of their Basketball Club. The extensibility of various muscle groups was valued in both groups. In addition, motivation was valued by Sport Motivation Scale.

The inclusion criteria were: to be between 12 and 13 years of age (both included), to be an active player at the time of selection, to sign the informed consent form and failure to meet the exclusion criteria. The exclusion criteria were: to have an injury at the time of selection and psychological and/or psychiatric illnesses. The main outcomes were: the adherence to a stretching program (monitoring calendars), the extensibility of the posterior musculature (fingertip-to-floor test), the adductor extensibility (sideways leg splits test), the gastrocnemius and soleus extensibility (weight-bearing lunge test through the Leg Motion system), the hamstring extensibility (goniometer with the passive straight leg raise and it was considerated shortening if it doesn't reach \>80 degrees of elevation, the extensibility of the quadriceps (Ely test by a goniometer), the extensibility of the psoas (modified Thomas test using a goniometer).

Eligibility Criteria:
Inclusion Criteria:

* To be an active player at the time of selection, to sign the informed consent form, failure to meet the exclusion criteria.

Exclusion Criteria:

* To have an injury at the time of selection, psychological and/or psychiatric illnesses.
Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea

This study is a cross over randomized study which aims to compare the effect of 2 modes of noninvasive ventilation on the occurence of central apnea, as measured by electrical activity of the diaphragm

Eligibility Criteria:
Inclusion Criteria:

* Children born at gestational age \> 36 weeks gestation
* Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
* Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia \< 80 / min, 2/Associated with desaturation \< 85% or 3/Duration more than 10 seconds
* Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)

Exclusion Criteria:

* With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
* Ventilated in NIV for more than 48 hours before inclusion
* Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
* Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
* Patient not affiliated to health care insurance