cyrilzakka/clinical-trials huggingface dataset:
Gycabiane and Glycemic Control of Prediabetic Subjects

The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

Cinnamon's effects on blood glucose have been the subject of many clinical and animal studies; however, the issue of cinnamon intake's effect on fasting blood glucose (FBG) in people with prediabetes still remains unclear.

The main purpose of this study is to examine the effects of supplementation with Glycabiane, a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight prediabetic subjects in a randomized, placebo-controlled, clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female from 25 to 65 years old
* 1.0g/L ≤ fast blood glucose \< 1.26g/L
* overweight (IMC \> 25)

Exclusion Criteria:

* thyroid disease
* hypogonadism
* History of musculoskeletal, autoimmune or neurological disease
* Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant
* Pregnant or lactating women
Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years or older
* Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (serous, endometrioid or mucinous), who have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons
* Patients are platinum-refractory (no response)
* Complete remission was not reached (partial responders)
* Relapse within ≤6 months of remission (Platinum-resistant)
* Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria:

* FIGO I,II epithelial ovarian cancer
* FIGO III, IV clear cells epithelial ovarian cancer
* Non-epithelial ovarian cancer
* Borderline tumors (tumors of low malignant potential)
* Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\] except first line Platinum-based chemotherapy (with or without bevacizumab)
* Previous radiotherapy to the abdomen and pelvis
* Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
* History of severe forms of primary immune deficiencies
* Systemic immunosuppressive therapy for any reason
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS

The aim of the study is to analyse the biomechanical stiffness of red blood cells extracted from subjects with type I diabetes with and without microvascular complications through a biophysical characterization of red blood cells using microscopy, spectroscopy and scattering measurements. 48 subjects with type 1 diabetes, 24 with and 24 without microvascular complications will be enrolled. From all subjects a single blood sample will be taken to perform the analysis of red blood cells morpho-mechanical properties.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 10 years
* Stable metabolic control (HbA1c \<7.5%) for at least 6 months
* BMI between 18.5 and 30 Kg/m\^2
* Systolic blood pressure \< 140 mmHg and diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Blood pressure higher than 140/90 mmHg
* Unstable metabolic control (HbA1c \>7.5%)
* BMI \> 30 Kg/m\^2 or \< 18.5 Kg/m\^2
* Liver failure
* Concomitant acute infections
* Uncontrolled thyroid diseases
* Pregnancy
Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation

Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent Atrial fibrillation (20\~80 years old)
* LA diameter \< 55mm
* patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

* Structural cardiac disease
* Contraindication to brain perfusion CT
* Catheter ablation history for AF, Cardiac surgery
* active internal bleeding
* Impossible to anticoagulation or antiarrhythmic drug
* valvular AF ((MA\> GII, Mechanical valve, Mitral valve replacement)
* LVEF \< 30%
* With severe medical disease
* Expected survival \< 1 year
* Severe alcoholics, drug addiction
Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

Pediatric emergency department (PED) physicians frequently encounter children with symptoms that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP) such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED physician, is considered an essential modality for assessment of the optic disc and the diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient compliance, the ability to open the eyelids, the absence of opacities in the ocular media and a sufficiently large pupillary aperture. Hence, different levels of PED physician training, lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis and severe photophobia may hinder direct fundoscopic evaluation.

In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic examination. The investigators aim to evaluate the yield of optic disc height as measured with ocular point of care ultrasound to detect optic disc swelling in comparison to ophthalmologic examination as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients from the PED,
* Aged 0-18 years,
* Who require funduscopic examination and referred to ophthalmologic evaluation.

Exclusion Criteria:

* Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid,
* History of glaucoma.
The Observer Variation of Shear Wave Elastography

Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. Therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Hypothesis:

1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation.

The study will be conducted as part of a larger PhD study, and an evaluation of the diagnostic value of thyroid SWE will be evaluated in a larger study.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.


Eligibility Criteria:
Inclusion Criteria:

* patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter),
* Patients undergoing thyroid surgery.

Exclusion Criteria:

* Nodules located in the isthmus of the thyroid
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

The aim of the study will be to compare functional outcomes of the two surgical hip approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical approach may have influence on patients functional outcome.

Patients with primary hip osteoarthritis will be included in a randomized controlled trial and assigned to total hip arthroplasty using one the of hip approaches: anterior or anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative.

Biomechanical gait parameters will be collected using tree-dimensional motion analysis system "BTS SMART".

Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG) percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of the gluteus medius muscle during isometric muscle contraction.

Balance and coordination as well as fall risk will be assessed with use of dynamometric Biodex Balance platform. The study will determine the values of individual indicators: general stability index (OWS), anterior-posterior stability index (APW), the median lateral stability index (MLW) and the fall risk index (RU).

Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score

Eligibility Criteria:
Inclusion Criteria:

* patient's consent for anticipation in the study
* BMI less than 35
* ability to walk the distance of 10m and stand up from the chair
* arthroplasty in one hip

Exclusion Criteria:

* patient's lack of consent for anticipation in the study
* neurological diseases
* balance disorders
* reoperations in the area of endoprosthesis
* muscles diseases
* rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis)
* dizziness, vasovagal syncope
Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.

The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.

This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF\> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.

Description of the study:

Patients with myocardial infarction (STEMI or NSTEMI) without alteration of left ventricle systolic function, agreeing to participate at a cardiac rehabilitation program will be included in the study and randomized into two groups:

* Group A (= control): standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.)
* Group B (= strategy to the study): individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).

The duration of the rehabilitation program will be 4 weeks with 5 training sessions per week (Monday to Friday), or 20 training sessions. At the end of the program, patients will benefit from an assessment of functional abilities and their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Man, Woman ≥18 years old and \<70 years old
* STEMI or NSTEMI having undergone angioplasty revascularization at least 8 day before the beginning of reeducation
* Sinus rhythm
* LVEF\> 40% (Simpson Biplane echocardiography

Exclusion Criteria:

* Contraindications to cardiac re-training:
* Ventricular or supraventricular rhythm disorder
* Heart failure.
* Pericardial effusion.
* STEMI or NSTEMI \<J8
* NSTEMI or STEMI , post revascularization by bypass surgery
* Non-sinus rhythm
* Comorbidity preventing all sports activity: severe AOMI; amputation; neurological disorder, hemiplegia.
* Pathology leading to modifications of the HRV:
* Chronic lung disease
* Renal insufficiency with clearance \<30 ml / min (MDRD)
* LVEF \<40%
* Electrical cardiac stimulation
* Linked to the person:
* Protected Majors
* People unable to express their consent.
* Pregnant woman
Use of the Motivational Interviewing in the Treatment of Smokers in Groups in Primary Health Care

The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups.

Smoking is the leading cause of preventable death and a major public health problem worldwide. Primary health care is a strategic setting in the treatment of this problem. The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups. Methodology: A randomized community trial was carried out in the 12 units of this service, starting in July 2016, with randomization by cluster, where the intervention group received an 8-hour training in MI in order to associate the technique with the conventional approach, while the units of the control group used only the conventional approach.

Eligibility Criteria:
Inclusion Criteria:

* Smokers.
* Participate in group smoking treatment.

Exclusion Criteria:

* Missing more than two sessions of the smoking group.
Fiber Tolerability in Children Aged 3-7 Year

Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.

The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old.

As it is an exploratory study there is no categorization between primary and secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children
2. Aged between 3 and 7 years old
3. Acceptance of the taste of the product
4. Having breakfast on daily basis
5. Consent and/or assent received according to regulation
6. Informed consent of both parents/guardians (in respect with the French regulation)
7. Parents/guardians affiliated to a health insurance (in respect with the French regulation)

Exclusion Criteria:

1. Specific food regimen
2. Intolerability or food allergy
3. Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
4. Chronic gastrointestinal disease
5. Gastroenteritis in the 2 weeks preceding the study
6. Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)
7. Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking)
8. Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
9. Having participated in another clinical trial for 1 month, or currently participating in a clinical trial
10. Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years and \<70 years of age
* Diagnosis of hepatitis C
* Assessment of viral load prior to treatment (mandatory for genotype 1 only)
* Liver biopsy
* Co-morbidities data
* Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
* Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008

Exclusion Criteria:

* Co-infection with human immunodeficiency virus
* Co-infection with hepatitis B virus
* Presence of hepatocarcinoma
* Patients submitted to hemodialysis
* Organ transplant patients
Gene Therapy for Wiskott-Aldrich Syndrome (WAS)

This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.

This clinical trial is an ex vivo gene therapy trial. The investigational product corresponds to autologous CD34+ cells transduced with a lentiviral vector harboring the human WASP gene.

Eligibility Criteria:
Inclusion Criteria:

* males of all ages
* severe WAS (clinical score 3-5) or absence of WAS protein in peripheral blood mononuclear cells determined by Western blotting and flow cytometry
* molecular confirmation by WAS gene DNA sequencing
* lack of HLA-genotypically identical bone marrow or of a 10/10 antigen HLA-matched unrelated donor or cord blood after 3 month search
* parental, guardian, patient signed informed consent/assent
* willing to return for follow-up
* only for patients who have received previous allogenic hematopoietic stem cell transplant:
* failed allogenic hematopoietic stem cell transplant
* contraindication to repeat transplantation

Exclusion Criteria:

* patient with HLA-genotypically identical bone marrow
* patient with 10/10 antigen HLA-matched unrelated donor or cord blood
* contraindication to leukapheresis
* contraindication to bone marrow harvest
* contraindication to administration of conditioning medication
* HIV positive patient
Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.

* Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice.
* Evaluate the impact of VR on the level of anxiety induced by invasive procedures
* Report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques.
* Evaluate the impact of VR on the short-term consequences of procedural pain, especially in terms of phobia of care.

Diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. These are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of Hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...).

The short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention.

The quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. The non-pharmacological methods are numerous and still insufficiently used by the care teams. Virtual Reality is on interesting option.

Eligibility Criteria:
Inclusion Criteria:

* Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria:

* Serious behavioral disorders
* Serious neurosensory deficit
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)

This is a study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with relapsed and refractory CD19+/CD20+ NHL.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as R/R NHL
3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
4. Having at least one measurable lesions
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
6. Life expectancy no less than 3 months
7. enough main organ function
8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study
9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months
2. Active GVHD
3. History of severe pulmonary dysfunction
4. Active malignant tumor need be treated at the same time
5. Uncontrolled active acute/chronic infection
6. Severe autoimmune diseases or congenital immunodeficiency
7. Untreated active hepatitis
8. HIV-positive, AIDS patients and syphilis infection
9. History of severe allergies to biological products
10. Patients with a history of mental illness
11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results