cyrilzakka/clinical-trials huggingface dataset:
Effect of a Grape Seed Extract (GSE) on Insulin Resistance

In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. These measurements will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood.

In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. Each of these can be elevated after eating high fat meals, which are commonly found in the average Western diet. To better assess the impact of these high fat eating patterns, three standardized high fat meals will be served during the study day: breakfast, lunch, and dinner. Measurements in the blood will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood when this 24 hour study day protocol is repeated and breakfast, lunch, and dinner are again served.

Insulin resistance will be measured using a comparison of insulin and glucose levels in the blood. Oxidative stress, a measure of inflammation, will be measured by cytokines levels in the blood. The level of oxidized LDL will be measured in the blood. The investigators also plan to undertake a subsidiary pharmacokinetic study on the various polymers which are known to be present in grape seed extracts to determine their bio-availability and their relationship to the biological effects observed.

Eligibility Criteria:
Inclusion Criteria

* Metabolic Syndrome, based on subject meeting at least 3 of the following criteria:
* Abdominal obesity with waist circumference \> 40 inches in men or \> 35 inches in women,
* Pre-hypertension with blood pressure \> 135/85,
* Fasting blood glucose levels above 110 mg/dl,
* Plasma triglyceride levels in excess of 150 mg/dl,
* HDL levels below 40 mg/dl in men or 50 mg/dl in women.

Exclusion Criteria:

* Any known systemic disease,
* Diabetes,
* Alcohol consumption \> 1-2 drinks/week,
* Taking any medications or supplements that will affect metabolism, their ability to exercise or oxidative status,
* Smokers,
* Female subjects having abnormal menstrual cycles, taking oral contraceptives, pregnant or lactating.
A Study of RO5036505 in Patients With Moderate to Severe Asthma

This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age
* moderate to severe asthma for \>/=2 years
* ACQ score \>/= 1.5
* ICS and LABA regimen at moderate to high dose
* non-smokers

Exclusion Criteria:

* oral corticosteroid use within 4 weeks prior to screening
* current escalating immunotherapy
* acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection
* pulmonary disease other than asthma
* therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening
* previous exposure to investigational monoclonal antibodies or biologics
Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)

France and in particular the paris area was one of the countries most affected by the pandemic Covid19.

School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.

The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.


Eligibility Criteria:
Inclusion Criteria:

* Birth to 15 years old
* taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week

Exclusion Criteria:

* refusal to participate
Radiographic Evaluation of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques

Eighteen patients will be selected from the outpatient clinic of the Prosthodontic Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.

patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.

All patients will receive conventional maxillary and mandibular complete dentures.

2. The mandibular denture will be modified by shortening the flanges and cutting the posterior part till the 1st molar then 3D scanned for recording the correct dimension of each tooth to be concerned during the construction of the superstructure and the final prosthesis.

3. Abutment level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of superstructure with abutments.

4. patients will be randomly divided into three groups according to the framework materials: PEEK, Soft metal, and selective laser melting construction.

5. The fit of the framework will be verified intraorally, and the final prosthesis will be digitally constructed; according to the dimensions of the scanned denture; to fit over the framework.

Evaluation Radiographic evaluation of circumferential bone level around implants and bone changes in the posterior mandible will be done using CBCT at one, two, three, and five years after insertion of the final prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous maxillary ridges and mandibular arch with four implants placed according to the All-on-4 distribution. All patients were recruited from the previous study.
* All selected patients will be with sufficient inter-arch space and restorative space.
* All selected patients will have healthy ridges covered by the compressible oral mucosa and free from any ridge flabbiness.

Exclusion Criteria:

* History of para-functional habits (Bruxism, clenching), smoking, and alcoholism.
* History of radiation therapy in the head and neck region.
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).

Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Informed consent for PLCRC with specific consent for:

  * additional blood withdrawals
  * collection and use of tissue for scientific research
  * invitation for future (experimental) research within the cohort, including TwiCs studies
* Inclusion in observational PLCRC -MEDOCC substudy
* Histological confirmed stage II colon cancer
* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician

Exclusion Criteria:

* Indication for adjuvant chemotherapy according to treating physician
* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
* Incomplete primary tumor resection (R1 or R2 resection)
* Contra-indication for fluoropyrimidines or oxaliplatin
* Pregnancy
Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial

To examine how a low glycemic index diet (LGID) changes biochemical parameters, body measurements, and body image perception in obese individuals with insulin resistance. Obesity groups with insulin resistance who received a control diet (CD) and a LGID will be compared with each other in terms of biochemical parameters, body image perception and body measurements. In addition, each group will be compared with the start and end measurements over the same values.

The main purpose of this study is to determine the effect of LGID on body image perception, biochemical parameters and body measurements in obese individuals with insulin resistance.

Sub-objectives of the study;

Determination of the effect of LGID on fasting blood glucose, fasting insulin level and HOMA-IR levels compared to CD.

Determination of the effect of LGID on body weight, fat mass, muscle mass, body muscle ratio and body mass index (BMI) compared to CD.

Determination of the effect of LGID on body image perception status compared to CD.

Eligibility Criteria:
Inclusion Criteria:

* BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline \> 80 cm)
* Can provide informed consent
* Can be contacted by telephone
* Waist circumference \> 90 cm for men and \> 80 cm for women

Exclusion Criteria:

* Pregnancy or lactation
* Active or suspected chronic infection
* Treatment affecting insulin sensitivity
* A secondary disease state (Cardiovascular disease, cancer, psychiatric, etc.)
* Any weight loss operation (gastric bypass, gastric balloon, etc.)
* A special nutritional program (cancer, kidney disease, etc.)
* Using any food supplement or medication known to affect whole body metabolism
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent
* Ability to adequately understand the verbal explanations and the written subject information provided in English
* Subjects seeking augmentation therapy for the lips
* Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
* Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
* Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
* Previous facial surgery, within 6 months, below the level of the lower orbital rim
* Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
* Participation in any interventional clinical study within 30 days of screening
Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy

Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named "High flow conditioned oxygen therapy (HFCO)". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients mechanically ventilated for \> 48 hours and at least one of the following:
* \>65 years
* cardiac failure as the primary indication of mechanical ventilation
* Chronic Obstructive Pulmonary Disease
* Severity score (APACHE II \>12 points) the extubation day
* Body Mass Index \>30
* inability to manage respiratory secretions
* 1 failed spontaneous breathing trial
* 1 comorbidity
* 7 days under mechanical ventilation

Exclusion Criteria:

* \<18 years
* tracheotomized patients
* recent facial or cervical trauma/surgery
* active gastro-intestinal bleeding
* lack of cooperation
* patients with any failed spontaneous breathing trial because of hypercapnia development.
Shanghai At Risk for Alzheimer's Disease: a Cohort Study

The goal of this cohort study is to estimate the incidence of AD in the first-degree relatives of patients with AD. The main questions it aims to answer are:

* cognitive changes of subjects at high risk of AD as ageing;
* environmental and behavioral factors affecting AD incidence.

This study is a prospective cohort study focusing on the first-degree relatives of patients with Alzheimer's disease (AD). Multiple methods including the neuropsychiatric assessment battery, magnetic resonance imaging (MRI) and fluid biomarkers (blood and urine) are used to estimate the longitudinal changes of the participants at high risk of AD. Besides, a structured questionnaire is designed to investigate how environmental, behavioral and other factors influence the incidence of AD. This study is of great significance in establishing novel guidelines for the prevention and treatment of dementia suitable for Chinese population, and for clinicians to predict the risk of AD in first-degree relatives.

Eligibility Criteria:
Inclusion Criteria:

1. the AD diagnostic criteria of probands meet the 2011 National Institute on Aging - Alzheimer's Association framework, and participants are the first-degree relatives (including parents, children and siblings of the same father and mother) of the proband;
2. not patients with dementia;
3. ≥ 50 years, males and females;
4. subjects have lived in Shanghai for more than 1 year and have no plan to move out of Shanghai within 5 years;
5. subjects are able to complete investigation, physical examination, imaging examination and biological specimen collection.

Exclusion criteria:

Individuals will be excluded if they have:

1. other diseases which could cause cognitive decline, e.g. cerebrovascular diseases, Creutzfeldt-Jakob disease and Parkinsons disease;
2. history of psychological disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
3. uncorrectable visual or auditory impairment that hampers the completion of related examination.
4. pre-menopausal women will also be excluded.
Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD

This randomized study will pilot test an intervention, based on self-efficacy theory and involving personal digital assistant (PDA)-based dietary self-monitoring, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups. Group A will receive a 4-month active intervention of decreasing intensity over time delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education. With this study the investigators will:

1. Explore the impact of the intervention on dietary sodium intake,
2. Explore the intervention on blood pressure,
3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell for continuous ambulatory peritoneal dialysis (CAPD) patients, AND
4. Explore the feasibility and acceptability of the intervention


Eligibility Criteria:
Inclusion Criteria:

The investigators will recruit those individuals:

* who are 18 years of age or older,
* who are literate, community-dwelling adults, and
* who have been receiving maintenance PD for at least 3 months. Individuals on maintenance PD less than 3 months are excluded to allow for patients to adjust to the PD regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis)

Exclusion Criteria:

Excluded from the study will be individuals:

* who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments),
* those who cannot read or write, those who do not speak English,
* those who plan to move out of the area or change dialysis centers within the next 5 months,
* those with a terminal illness and life expectancy of less than 12 months,
* those who are scheduled for a living donor transplant,
* individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen, or
* individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients

The purpose of this study is to help researchers investigate if a new imaging agent named 18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well as whether disease will reoccur in the future. The study will also investigate whether a 18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond to standard therapy. Information obtained from this study may help doctors design future studies in which they may target tumor areas that do not respond to therapy or may likely reoccur in the future.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of NSCLC at MSKCC
* No prior treatment for this diagnosis of NSCLC
* Patient to be treated with neoadjuvant chemotherapy (35 patients total) or patient to be treated with definitive RT,sequential chemo-RT, or concurrent chemo-RT (minimum dose of 50 Gy in 25 fractions) (25 patients total)
* Tumor must measure ≥ 2cm on CT
* Age ≥ 18 years
* Ability to hold the breath for 10 seconds.
* Karnofsky performance status ≥ 70%
* Women of childbearing age must have a negative blood pregnancy test

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Severe diabetes (fasting Blood Glucose \> 200 mg/dl)
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

Eligibility Criteria:
Inclusion Criteria:

* OVER 18 YEARS OLD
* PATIENTS AGREED WITH THE STUDY
* SCORE ASA 1 OR 2
* Patient recorded in a social safety organism
* patients presenting with superficial lesions with an endoscopic indication of resection

Exclusion Criteria:

* under 18 years old
* Patients not agreed with the study
* pregnant women
* patient included in an another study
* medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
* coagulation disorders
* score asa over 3
* patients with another neoplasic lesion
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury

This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years and equal to or less than 75 years
* Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury
* Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised

Exclusion Criteria:

* Spinal cord injury at C1-C2 0r C2-C3 level
* Patients not to able to start rehabilitation within a week by setup of respirator or other reason
* First dose of the study drug will not be given within 78 hours since the injury
* History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage
* Outcome assessment will not be conducted adequately through damage on injuries other than the injury
* High-dose steroid therapy within 30 days before the entry
* Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections
* History of malignant tumor
* Patients who participated in other clinical study within 30 days before the entry
* Patients who have allergies to drug scheduled to be used in the study
* Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor
* Patients not able to understand "informed consent" properly
* Patients who are nursing or may be pregnant
* Investigator considers that the patient is not appropriate for participating in the study