cyrilzakka/clinical-trials huggingface dataset:
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax

Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.


Eligibility Criteria:
Inclusion Criteria:

* Neuromuscular disease
* Pimax evaluation indication

Exclusion Criteria:

* pregnant women
* usual contre-indications for nuclear magnetic resonance
Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.

The objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient with intermittent / intermittent claudication / arterial ulcer / mixed ulcer / critical ischemia / acute ischemia, whose need for a revascularization procedure in the patient's medical management was discussed and confirmed as a multidisciplinary staff between 1st November 2013 and September 2018
* endovascular revascularized Patient
* Francophone patients

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients who oppose the use of their data for this research
Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

OBJECTIVES:

* To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
* To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of refractory non-small cell lung cancer
* Received sorafenib tosylate on protocol ECOG-E2501
* Available blood specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung

The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients of more than 18 years old
* Patients with cancer of lung diagnosis carried for less than 2 months and which were not handled yet, either by surgery or by chemotherapy, or by radiotherapy
* Patients whose life expectancy is considered 3-month-old a superior
* Patients having given writed consent
* Patients affiliated to a national insurance scheme or benefiting from such a diet
* Patients having received a treatment (processing) anticoagulating in preventive dose if this treatment was stopped at least 3 days before the 1st taking or patients not receiving an anticoagulating treatment (in case of curative treatment, the latter was before arrested at least 3 months

Exclusion Criteria:

* Patients having a hepatic disease with coagulation disorders
* Patients under anticoagulants with dose guardian in 3 months preceding the study or presenting an active infection
* Patients having a history of other cancer considered as cured and diagnosed for less than 5 years (with the exception of the patients operated for an in situ carcinoma of the neck of the womb or the patients having undergone the excision of a squamous-cell carcinoma)
Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test

Insulin resistance can be assessed by the euglycaemic clamp technique. To date, this is the golden standard, but it is not suited for clinical practice. A 13C glucose breath test will be tested as a valid alternative. The curve of the exhaled 13C CO2 as a function of glucose metabolism can be correlated to the curve of the glucose disposal rate obtained via the clamp technique.

The hyperinsulinemic-euglycemic clamp technique is the golden standard to assess insulin resistance in type 1 diabetes subjects. The plasma insulin concentration is acutely raised and maintained at 100 μU/ml by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.

These data will be compared with the results of a 13C glucose breath test. Breath tests using 13C substrates are based on the principle that 13C CO2 in the exhaled breath can be measured as a metabolic tracer.

Breath testing has a major advantage over the clamp test in that it can be performed non-invasively and repeatedly without necessary supervision by medical staff.

Eligibility Criteria:
Inclusion Criteria:

* Adult type 1 diabetes patients
* 25/50 subjects with confirmed NAFLD (using ultrasound criteria)

Exclusion Criteria:

* pregnancy
* gastric bypass surgery
* cirrhosis
* secondary cause of liver steatosis present
* any cause which makes a 4-hour clamp impossible
NEUROFEEDBACK on Event-Related Potential (ERP)

This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Children and teenagers aged from 8 to 17 years' old
* Children and teenagers with a deficit attention disorder with or without hyperactivity, in the mixed form or in a pure inattentive form according to Diagnostique et Statistique des troubles Mentaux (DSM)-V.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV or V test, not older than two years.
* Children and teenagers without psychostimulant treatment
* Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic break at each visit day and with a stable dose during all the study.
* Children and teenagers whose parents have agreed and signed informed consent form of the study.

Exclusion Criteria:

* Children aged less than 8 and teenagers are more than 18 years' old.
* Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) \< 80 of WISC IV or V test, not older than two years.
* Children and teenagers with developmental disorder except "Dys" disorders.
* Children and teenagers with pure hyperactivity (without attentional deficit)
* Children and teenagers with epilepsy except benign epilepsies (without brain damage), free of crisis for two years and without treatment.
* Children and teenagers with ADHD with conduct disorders and aggression
* Children and teenagers with ADHD and Tourette's syndrome.
* Patients treated by anti / epilepsy or psychotropic treatments (with the exception of psychostimulant treatment).
* Patients with psychostimulant treatment and whose parents aren't agreed to achieve a therapeutic break at each visit day.
* Patients with visual deficiency uncorrectable with lenses or glasses.
CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese Volunteers
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

* Clinically significant infections within the past 3 months
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
* Pregnant or nursing women
Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands

This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic subjects treated with BHI 30
Assessment of Risk Factors for Childhood Obesity and Nutrition Education Intervention on Infant Growth and Development

The period from conception to 2 years of age ('first 1000 days') has been recognized as a critical period for long-lasting programming effects on later obesity and associated NCD and a window of opportunity to implement intervention for reducing and treating childhood obesity. However, there is a dearth of prospective intervention studies that address this nutritional problem in Jamaica and there are no reports of sustainable intervention.

Jamaica is a middle income country in which overweight and obesity in children are also increasing at an alarming rate. The investigators in Jamaica are seeking to provide a more comprehensive knowledge on the link between early life nutrition and later childhood health and to assess the impact of an intervention of infant feeding counselling/education in mothers on growth and body composition in their offspring.

At least 41 million children younger than 5 years are overweight or obese most of whom reside in low-income and middle-income countries (LMIC). Obese children tend to remain obese in adulthood predisposing to the huge personal health and economic burden of the non-communicable diseases (NCD).

Several early life factors identified to contribute to development of obesity and adverse metabolic profile; pre-pregnancy underweight and overweight, high weight gain in early pregnancy in addition to inappropriate infant feeding pattern and rapid weight gain in early life have major role.

The aims of the study are:1) to assess intrauterine and postnatal risk factors for childhood obesity in children followed from the second trimester in mother's pregnancy to age 1 year and 2) to assess the impact of a nutrition-based educational intervention on infant feeding, growth and body composition in the first year of life.

This study design is a cluster randomized clinical trial with key outputs being : 1) The use of deuterium dilution method to provide new data on body composition of mothers from during pregnancy and during infancy in addition to obtain accurate measurement of breastmilk intake 2) new data on the relationship between maternal body composition and/or infant body composition and non-communicable disease risk factors; 3) new data on the impact of a nutrition-based educational on infant's growth and body composition.

Eligibility Criteria:
Inclusion Criteria:

* Women (18-40 years)
* Women 30 -32 weeks gestation
* First or second pregnancy
* Healthy term infants ( \> 37 completed weeks)
* Infants with birthweight \>2.5kg)

Exclusion Criteria:

* Pre-gestational diabetes
* Pre-gestational hypertension
* Sickle cell disease
* HIV infection,
* Psychiatric disorder
* Gestational diabetes
* Infants with congenital abnormalities
* Infants with chromosomal disorders
* Infants admitted in neonatal period \> 48 hours
Phototherapy Remediation of Black Stain

This study investigates the remediation of black-stained tooth surfaces using antimicrobial photodynamic therapy. In this crossover trial, a cohort of patients received standard dental prophylactic cleaning to remove the black stain. Later, following the washout period, (reappearance of the black stain) received photodynamic therapy in addition to the standard cleaning. Stain-free period in each of the arms was the main outcome variable. Additional microbial plaque testing was also carried out.

The standard treatment practice for black dental stain is dental prophylaxis, however this is often harmful to the enamel surface and can result in tooth sensitivity. In this study we aim to explore the application of antimicrobial photodynamic therapy (aPDT) for the treatment of adult black dental stain. aPDT has demonstrated positive results in the treatment of periodontitis.

Patients received an oral examination and the extent of black stain was scored (score 1, pigmented spots or incomplete lines parallel to the gingival margin, score 2: solid lines pigmented, readily observable and limited to the cervical third of the tooth surface, score 3: pigmentation extending beyond the cervical third). The patients' oral cavity was photographed in sextants, along with a complete picture of the jaw (lingual plane) and the maxillary arch (palatal plane). For bacterial analysis, 1mg of black plaque was collected by scraping with a plastic scaler from buccal tooth surfaces taking care to avoid unnecessary removal of enamel hydroxyapatite. The first dental prophylaxis was performed to remove the black stain.

Patients were reviewed monthly and in each visit, were photographed as previously described, and the level of pigmentation scored according to the mentioned criteria. The monthly visits were continued until the black stain score returned to the initial value. The period between the first and the last appointment was noted. At this point, each volunteer received dental prophylaxis once again, followed by the application of aPDT. Antimicrobial photodynamic therapy was applied to 31 orally healthy volunteers with black stained teeth, using the GLO home whitening device (GLO™ Science LLC, New York, USA) in 2 cycles of 8 minutes. Outcome variables were area, color and time taken to reappearance of black stain following dental prophylaxis with and without antimicrobial photodynamic therapy. Differences in bacterial composition of black stain (specifically Aggregatibacter actinomycetemcomitans, Tannerella forsythia and Porphyromonas gingivalis) were analyzed DNA extracted from plaque samples. Following the application of aPDT, patients were reviewed monthly until the black stain score returned to the initial value.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers with black stained (plaque on) teeth

Exclusion Criteria:

* Children
* Pregnant women
* Volunteers having completed antibiotic therapy during 15 days prior to the start of the study
Effect of Carbohydrate Consumption on Fatigue and Muscle Damage in Jiu-Jitsu Athletes

The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle damage in Jiu-Jitsu athletes.

Brazilian Jiu-Jitsu (BJJ) is a sport characterized by intermittent high-intensity efforts separated by periods of low intensity. Muscular strength is considered one of the most important physical components to be developed, especially in the upper limbs through dynamic and static actions. The activities of high intensity (relation effort-pause) carried out by the upper and lower limbs during BJJ can induce muscle fatigue. In order to minimize the glycogen depletion and to guarantee the availability of energy substrate to the athlete during the physical exercise, the carbohydrate intake before moderate intensity exercises should be between 5-7 g / kg of weight / day. The intervention group will receive a 30g maltodextrin beverage and the placebo group a non-carbohydrate drink. There will be 3 combat simulations of 8 min each, with intervals of 10 min between fights. Athletes will be instructed to remain with their usual intake during the study. The outcomes will be: manual grip strength (dynamometer), upper limb strength (KGST), lower limb strength (vertical jump), subjective exertion perception (Borg scale), pain perception (Nilsson scale), blood markers of muscle damage (CK and LDH), lactate, and glycemia.

Eligibility Criteria:
Inclusion Criteria:

* Compete in the categories of weight between 70kg and 88,3kg (weight classification from light to medium heavy, belonging to the bands purple to brown).
* Age between 18 and 33 years.
* Be training at least three times a week, minimum of 1,5 hours per day, for at least 3 consecutive months.
* Have not used anabolic steroids in the last 6 months during the study period.
* Do not use any type of dietary supplement in the last 3 months.
* Self-declared healthy individuals.

Exclusion Criteria:

* Recent muscle injury (within the last 3 months) that compromises and / or impedes the performance of the exercise requested in the study.
* Be in a time of rapid weight loss (pre-competition).
Effects of Intravenous Lidocaine on Endometriosis Pain

We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.

This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.


Eligibility Criteria:
Inclusion criteria:

* Reproductive age women ages 18 - 50
* Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria
* Pain for \> 6 months
* Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
* Receiving regular monthly menses (cannot be receiving Depo-provera injections)

Exclusion criteria:

* Pregnant or breastfeeding
* On lupron therapy
* History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
* History of seizure disorder
* Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures
* History of alcohol or substance abuse
* Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)
* Known hypersensitivity to amide type anesthetics
* Known hypersensitivity to diphenhydramine (benadryl)
* History of treatment with lidocaine or mexiletene
* Having or showing signs and symptoms of liver disease