cyrilzakka/clinical-trials huggingface dataset:
The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.

Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems.

Core stability training may have a positive effect for these problems experienced by children with AIS.

Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing.

The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with AIS between the ages of 10-20
* Cobb angle is between 15-40 degrees
* The child's and family's consent to participate in the study
* The child does not receive any other treatment that will affect his scoliosis.

Exclusion Criteria:

* Surgical operation in the last 3 months
* Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
* Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
* Exercising 3 or more days a week.
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Hypothesis The overall hypothesis is that non-obese (BMI \<30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.

Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.

Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.

Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 39 years, inclusive
* 30 ≤ BMI
* History of irregular menstrual cycles
* Clinical and/or biochemical androgen excess (determined during screening)

Exclusion Criteria:

Medical Exclusion Criteria

* History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
* Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.

Psychiatric and Behavioral Exclusion Criteria

* Pregnant or breast-feeding women
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Women must be of non-childbearing potential.
* 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 (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes

This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, both sex, aging 18 to 45 years;
* Availability for all procedures during the study period;
* Provide free informed consent to join the study

Exclusion Criteria:

* Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;
* Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;
* Previous or current diagnosis of cardiac disease;
* Severe asma or Chronic obstructive pulmonary disease (COPD);
* Abnormal neurological clinical assessment, particularly chorea;
* Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;
* Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;
* Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;
* History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;
* Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;
* Electrocardiogram disturbances;
* Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;
* Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;
* Pregnancy, breastfeeding mother or intention to became pregnant during the study period;
* Any other condition that might affect the study process according to the investigators.
Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells

Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The effectiveness of allogeneic NK cells is a function of HLA-differences between donor and recipient that give rise to NK cell clones which do not express inhibitory receptors matching for the HLA molecules of the recipient. Aim of the study is to evaluate cellular therapy with alloreactive, IL-2 activated NK cells after transplantation of T-cell depleted stem cell grafts from one haplotype mismatched family donors in patients with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML or ALL in first CR with the following high risk features:

  1. AML with aberration Del (5q) -5, del (7q) -7, t(9;22) or t(6;9), abn 3q, 9q, 11q, 20q, 21q, 17p;
  2. AML with a complex caryotype;
  3. secondary AML after previous chemo- or radiotherapy or MDS;
  4. Ph-positive ALL
* Patients with AML or ALL after induction failure or in second CR
* Patients with CML in second chronic or accelerated phase
* Patients with malignant Lymphoma and the following high risk features:

  1. relapse after autologous transplantation
  2. primary chemotherapy refractory disease
* All patients must fulfill the following criteria:

  1. lack of a suitable HLA-identical family, unrelated or cord blood donor
  2. no active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
  3. blast count in the marrow \< 30%
  4. informed consent

Exclusion Criteria:

* active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
* blast count in the marrow \> 30%
* unable or unwilling to sign and/or understand informed consent
Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study

There is a high prevalence of FGID among infants : 30 % for regurgitations, 20 % for colitis , 15 % for functional constipation.This represents a frequent motive for pediatrics consultation : 23 to 28 % of medical consultations in this population are consequent to gastrointestinal symptoms among infants aged under 4 months old. This can lead to numerous inappropriate or unrecommended medication prescriptions.

Currently, fecal calprotectin threshold are only validated by science societies for children aged 5 years old and more. This study aims to quantify the difference of fecal calprotectin between a population of infants for whom no FGID has been finally detected, and a population of infants for whom FGID have been detected during the gastro-pediatrics consultation, , in order to later determine wether it is possible to validate a threshold in a population of infants aged under 4 months old.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged under 4 months old benefiting from a special gastro-pediatrics consultation
* FGID arm : infant with one or several FGID detected
* Free from FGID arm : infant without any FGID detected

Exclusion Criteria:

* Born before 37 week of amenorrhea.
* Neurologic failure, heart failure, respiratory failure, hepatic failure, pancreatic failure, renal failure, cancer or hematological malignancy.
* History of enteral feeding by tube (nasogastric, nasojejunal, gastrostomy, gastrostomy-jejunostomy, jejunostomy) or parenteral feeding.
* History of digestive tract surgery
* Suspicion of Immunoglobulin E-mediated Cow's Milk Protein Allergy (CMPA): anaphylactic-type reaction observed within a few minutes to 2 hours after ingestion of cow's milk protein, such as pruritus, erythema, angioedema, intense abdominal pain, projectile vomiting, acute diarrhea, bronchospasm, faintness, loss of consciousness, arterial hypotension or even anaphylactic shock.
Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial

Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.


Eligibility Criteria:
Inclusion Criteria:

1. Hebrew speaking pregnant women week 32 + 0 to 37 + 0
2. fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).

Exclusion criteria:

1. Women who suffer from a psychotic disorder, PTSD or suicidal ideation
2. High risk pregnancies
3. Alcoholism or drug abuse and dependence.
ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders.

Multidisciplinary cohort studies of children with Autism Spectrum Disorders (ASD) followed from childhood to adulthood exist abroad but not in France. The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders. The patients will be monitored every 18 months for at least 36 months and during a maximum of 10 years. Clinical, social, environmental, and genetic data, as well as data relating to the parental quality of life will be collected. The primary endpoint will be the adaptive level in three domains of the Vineland II (Communication, Socialization and Daily living skills). The secondary endpoints will be parental quality of life, comorbidities, interventions and severity of ASD.

The inclusion of 900 patients over a 10-year period is expected. This cohort should contribute to a better knowledge of the child with ASD's development, taking into account his physical, social and familial environment, the type of interventions and some genetic components. It should also lay the foundations for a national network of professionals working in the field of autism research by offering them a common tool for promoting translational studies.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 16 years
* Diagnosis of ASD formally established during a multidisciplinary assessment, according ICD 10 criteria and ADI
* Patient who benefited in the last 12 months: Vineland, ADOS, intellectual level
* Parents consent

Exclusion Criteria:

* Subject refusal to participate
* Parental refusal to participate
The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer

Although there are many studies comparing preoperative and postoperative histological diagnoses in the literature, there are no studies evaluating the compatibility of preoperative histological diagnoses obtained from different centers with postoperative histological diagnoses.Therefore, in our study, we aimed to determine whether preoperative pathological specimens need to be re-evaluated in the referenced hospitals by comparing the compatibility of endometrial specimens in secondary care and tertiary centers with their final pathologies.In our study, we aimed to reveal the under and overdiagnosis rates of the preoperative histological diagnoses of our hospitals compared to the final pathology.

Medical data of 960 patients diagnosed with endometrial cancer by endometrial biopsy between 2002 and 2016 were retrospectively analyzed. Of these patients, 41 were excluded from the study due to non-surgical treatment, 254 patients having biopsy only in one center preoperatively, and lack of medical data in 52 patients.The study included 613 patients who had preoperative endometrial biopsy specimens evaluated by two different centers, diagnosed with endometrial cancer and treated surgically. Our study was conducted in the gynecological oncology department of our university after obtaining the approval of the ethics committee numbered 430-2019.The clinicopathological characteristics of the patients were evaluated by examining the hospital records of age, gravida, parity, BM (body mass index), menopausal status and systemic diseases. Histopathological and clinical features of endometrial cancer were reviewed.In this study, endometrial biopsy samples taken in the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the evaluation process was carried out in two steps by examining the repeated endometrial biopsy sampling.Patients diagnosed with endometrial cancer were treated surgically in our clinic. Endometrial sampling results based on uterine cancer risk groups; While histologically endometrioid and nonendometrioid were evaluated in two groups, the greade1-2 (low risk), greade3 (high risk) of uterine cancer were evaluated in four groups as those without malingnancy (benign and premaling lesions).By comparing these preoperative histological diagnoses with postoperative surgical final pathology, the accuracy rates for histological type and greade were determined. In addition, lower diagnosis, comorbidity and higher diagnosis rates compared to final pathology were examined for two different centers.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 40-90 years diagnosed with endometrial cancer according to

endometrial sampling results

Exclusion Criteria:

* Lack of medical data
* Endometrial sampling in only one center
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis

The study aimed to investigate effects of radon (plus CO2) baths on RA in contrast to artificial CO2 baths in RA rehabilitation.

134 patients of an in-patient rehabilitative programme were randomly assigned to the groups. Outcomes were limitations in occupational context/ daily living (main outcome), pain, medication, etc. measured before start, after end of treatment, and up to a year thereafter.

Superiority of radon treatment was found regarding reduced limitations in daily living until 12 months after end of treatment. Steroid consumption and NSAIDs were significantly reduced.

Objective: To replicate former observed beneficial effects of Radon (plus CO2) baths on RA in contrast to artificial CO2 baths and to investigate its long-term effectiveness and impact on drug consumption.

Methods: Randomised double-blinded trial with 2 randomised balanced groups enrolling 134 patients of an in-patient rehabilitative programme (a 3rd non-randomised group of 73 consecutive patients is not reported here). Outcomes were limitations in occupational context/ daily living, pain, functional capacity, morning stiffness and medication measured before start, after end of treatment, and quarterly in the year thereafter. Repeated-measures analysis of covariance (RM-ANCOVA) of intent-to treat population was performed to investigate treatment effects. Hierarchically ordered hypotheses ensured adherence of the nominal significance level and allowed examining of long-term effects. Starting with all measures until 6 months' follow-up, significant main effects for group allocation (GME) or significant group x course-interactions (GxC) were regarded essential to add the next follow-up for analysis.

Results: Radon treatment resulted in significantly lower limitations of daily living over at least 9 months whereas reference patients returned to baseline level after 6 months already (RM-ANCOVA until 6 months: pGME=.15, pGxC=.016/ 9 months: pGME=.11, pGxC=.025/ 12 months: pGME=.17, pGxC=.033). Furthermore, consumption of steroids and NSAID was remarkably reduced in the Radon group (RM-ANCOVA until 12 months: for steroids pGME=.064, interaction pGxC=.025, maximum difference after 12 months; for NSAID pGME=.035, interaction pGxC=.008, maximum difference after 9 months).

Conclusion: Results suggest beneficial long-term effects of Radon baths as adjunct to a multimodal rehabilitative treatment of RA.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis according to the 1987 revised ACR criteria for RA

Exclusion Criteria:

* current exacerbations of the inflammatory process
* other systemic inflammatory diseases
* concomitant musculo-skeletal diseases possibly interfering with outcome measurement,
* pregnancy or breast feeding
* disorders of the central nervous system
* a known tendency toward thrombosis
* malignant hypertension
* coronary heart disease
* heart failure, arrhythmia
* severe disorders of lungs, kidneys, or liver
* advanced malignancies
* abuse of alcohol or drugs,
* major skin lesions,
* severe fever, or infections.
Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Primary Objective:

To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.

Secondary Objectives:

* To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
* To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the immunogenicity of a single SC dose of alirocumab.

4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject, between 20 and 65 years inclusive.
* Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
* Serum LDL-C levels \>100 mg/dL

Exclusion Criteria:

* Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* History or presence of drug or alcohol abuse
* Smoking more than 5 cigarettes or equivalent in any 24 hour period.
* Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
* Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
* Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
* Presence or history of drug hypersensitivity
* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.