cyrilzakka/clinical-trials huggingface dataset:
Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women

Aim of this prospective randomized study was to evaluate whether a diet with meal replacements can be as effective as a conventional energy-restricted modified diet on weight loss, body composition and cardiometabolic risk profile in overweight women. Moreover, the impact of these two different weight management strategies was observed on cardiometabolic risk profile after a self-directed weight stabilization phase following the weight loss phase. After that, the effect of a specific micronutrient composition with omega-3 fatty acids versus placebo on cardiometabolic risk was observed during a following phase of weight loss maintenance.

Abdominal obesity, atherogenic dyslipidemia and hypertension are essential risk factors for cardiovascular diseases. Several studies showed favorable effects of weight loss in overweight subjects on cardiometabolic risk profile.

The study was divided into a 3-month weight loss phase (phase 1), a subsequent 3-month phase of weight stabilization (phase 2) and a 6-month phase of weight loss maintenance (phase 3).

For a total of 6 months subjects were randomly assigned to the meal replacement (MR) or control (C) group at baseline I.

During weight loss phase both dietary intervention groups followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d. The MR-WL group (MR group during weight loss phase) was advised to replace two of three meals every day with meal replacements. The C-WL group (C group during weight loss phase) was advised to follow a conventional energy-restricted modified diet with 15-20% of energy intake in the form of protein, 50-55% of energy intake in the form of carbohydrates and 30% of energy intake in the form of fat. All participants attended ten group training sessions for nutrition education.

During weight stabilization phase all women of MR-S and C-S group (MR and C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. However, the MR-S and C-S group were instructed to continue the implemented nutrition advice of weight loss phase.

At the beginning of weight loss maintenance phase (baseline II) women were randomly assigned to the verum (specific micronutrient composition with omega-3 fatty acids) group or placebo group. Both groups were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods.

All women participated in an exercise program (fitness walking) on 1-2 days per week during all three phases of the study for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* BMI: between 27.0 and 34.9 kg/m²
* One of the following blood lipids: total cholesterol ≥ 200 mg/dL, LDL-cholesterol ≥ 175 mg/dL, HDL-cholesterol ≤ 50 mg/dL, TG 150-400 mg/dL
* women, 18-60 years

Specific Exclusion Criteria:

* lactose or protein intolerance
* hypo- or hyperthyroidism
* pharmacological treatment of diabetes
* intake of vitamins or mineral supplements
* anticoagulants
* cardiac pacemaker
* contraindications to exercise
Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis
* Male or female, 18 years of age or older;
* Hospitalized patient;
* Covered by a social security scheme.

Exclusion Criteria:

* Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
* Subject under juridical protection.
Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography

The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

* sonography
* chest radiography

A correct position of the intubation probe will be considered if there is :

* Highlighting of the extremity of the intubation probe in endo tracheal
* Highlighting bilateral lung sliding

Oesophageal intubation can cause death. Selective intubation can induce a poor ventilation, hypoxemia, atelectasis etc... It's not rare in paediatric intubation. The prevalence of malposition of endotracheal tube is 30 to 40% in babies and infants less than 1 year old. Currently doctors try to detect malposition of intra-tracheal tube by auscultation and capnograms and chest radiography is needed to confirm it. The Chest X ray is the gold standard.

The aim of the study is to confirm the good positioning of the tube with a lung ultrasonography.

After each intra-tracheal intubation, for patients with qualifying criteria, a lung ultrasonography will be performed, in bed, by two trained doctors (senior and junior) to determine if the position is right. Then, the chest radiography will be performed as usual.

Eligibility Criteria:
Inclusion Criteria:

* Patient less than 18 years old
* Patient intubated and ventilated
* intubation probe considered in place on auscultation
* SpO2\> 92%
* Affiliate or entitled to a social security scheme
* No opposition of any of the parents.

Exclusion Criteria:

* Children too unstable : decompensated shock
* Spontaneous pneumothorax
* Heart massage ongoing
* Chest trauma
* Faulty position of the probe intubation
Feasibility of ECG-Based Glucose Monitoring System

This is a single-center, open-label clinical trial to assess the feasibility of using ECG information in estimating glucose level continuously in adult subjects.

About 165 subjects distributed in 3 categories according to the risk of developing events of hyperglycemia or hypoglycemia will be enrolled. Subjects will wear a portable ECG recorder to monitor ECG information and use 3 blood glucose monitoring methods to monitor blood glucose level over time. All data will be pooled together to train a specific artificial intelligence (AI) algorithm to conduct a blood glucose detection model using ECG features. The trial period is about 21 days.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 years or older.
* Subjects can communicate clearly, fully understand the informed consent form, and are aware of the rights and obligations of the study.
* Category 1: Subjects without a medical history of hyperglycemia / hypoglycemia or type 1 / type 2 diabetes.

Category 2: Subjects having diabetes mellitus (DM) and HbA1c value of. 5.5% to 10%, with eGFR ≥ 60 mL/min.

Category 3: Subjects having chronic kidney disease (CKD) and diabetes. mellitus (DM), with eGFR \< 60 mL/min.

• Willing and able to participate in all aspects of the study.

Exclusion Criteria:

* Subjects suffering from insomnia or severe digestive system disorders within 3 months prior to the screening visit.
* Subjects who are addicted to alcohol or caffeine.
* Existing severe cardiac conditions such as recent myocardial infarction or advanced heart failure within 6 months prior to the screening visit.
* Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) within 6 months prior to the screening visit.
* Subjects who are vulnerable groups or with higher risks, such as HIV carriers, pregnant women or planning to become pregnant within the study duration, breast-feeding mothers, subjects with rare diseases, physical disabilities, incurable fatal diseases, dependents in nursing homes, incapacity, or intellectual or mental disabilities.
* Has a concomitant disease or condition that may compromise subject safety such as unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical conditions.
* Any active infection or malignancy requiring acute therapy.
* Having coagulation disorders.
* Has known allergy to medical adhesives.
* Subjects using any cardiac related implantable medical devices such as a pacemaker and so on.
* Subjects on certain drugs known to cause arrhythmias or significantly impact kidney function or blood glucose levels (except for the current daily use medication).
* Subjects have used defibrillators within 3 months prior to the screening visit.
* Currently participating in another device or drug study.
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Risk Analysis of Intensive Care Mangement on Maternal and Fetal Outcome of Severe Preeclampsia and Eclampsia

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management during conduction of the research study included the following:

Control of convulsions using magensium sulphate. Control of blood pressure Diastolic blood pressure above 110 mmHg, nifedipine was administered.A plasma volume expansion with saline was used in all women to maintain sufficient intravascular volume. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .

Laboratory monitoring of patients included serial measurement of complete blood cell count, liver function tests, coagulation profile, and renal function tests.

ICU management included the following:

Control of convulsions by Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose then Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip.Control of blood pressure if Diastolic blood pressure above 110 mmHg, nifedipine was administered. Delivery was performed immediately after hemodynamic stabilization and clinical control of general condition .Termination of gestation decision was based on the the presence of maternal complications, fetal distress.After delivery the patient is retrurned to ICU under clinical and careful observation of the following:Heart rate, blood pressure,every 15 min,Temperature and respiratory rate ,evey 4 hours. Duration of admission in the ICU was assessed

Eligibility Criteria:
Inclusion Criteria:

* women with severe preeclampsia or eclampsia or HELLP syndrome admitted to ICU

Exclusion Criteria:

Non eclamptic causes of fits, including hysterical causes and epilepsy

-
Folic Acid and Vitamin B12 in Young Indian Children

Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.

Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.

Pneumonia and diarrhea are among the leading causes of poor health and death in young children of developing countries.

Many of these children have inadequate intakes of several vitamins and minerals. Folate and vitamin B12 are important for normal function of the immune system. Deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children. In a recent cohort study in almost 2,500 Indian children we demonstrated that those with poor folate status had higher rates of diarrhea and pneumonia. This study also showed that children that were not breastfed had poor folate status and our analyses suggested that the effect of breastfeeding in preventing respiratory and gastrointestinal infections could be explained by the folate content of breast milk. The finding that poor folate status is related to increased susceptibility to childhood infections needs to be confirmed in well conducted clinical trials in populations where folate deficiency is prevalent.

This trial aims to examine whether daily supplementation of 2 recommended doses of folate or vitamin B12 or both will lessen the incidence of acute lower respiratory tract infections and diarrhea. We will also measure if the supplementation improves the weight and length of supplemented children.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 to 30 months
* Either sex
* Likely to reside in area for next 6 months

Exclusion Criteria:

* Severe systemic illness requiring hospitalization
* Severe malnutrition, i.e. weight for height \< -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
* Non consent
* Consuming vitamin supplements that include folic acid and vitamin B12.
* Severe anemia (Hb \< 7 g/dL).
Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

Study design :

Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two parallel groups

* Arm control workshops around storytelling
* Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.

Population concerned :

Patients with stabilized chronic heart failure (last episode of acute heart failure dating back more than a month) followed at the Pitié Salpêtrière cardiology institut

The study may be offered to any stabilized heart failure patient followed in the study centre. Visit V1 (D0): Information, Inclusion and randomization Visit V2 (M3): final visit. Between V1 and V2: weekly workshop sessions around storytelling (arm C) or Hatha yoga (Arm Y).

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old
* Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of measurement method)
* Stabilized (last episode of acute heart failure dating back more than a month) in NYHA stage I to III dyspnoea, ambulatory, discharged from hospital for \> 1 month
* Drug treatment optimized according to the judgment of the investigator
* Ability to participate in activities as proposed (remote or face-to-face)
* Patient affiliated with a social security scheme
* Written consent to participate

Exclusion Criteria:

* Patients who have practiced yoga regularly (\> once a month) in the six months prior to selection.
* Current pregnancy / lactation
* Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or severe curable valve disease
* Severe renal impairment GFR\<25ml/min/1.73 m2 or on dialysis.
* Persons subject to legal protection measures (guardianship, curatorship)
* Person not "receptive" to the practice of yoga
* Participation in intervention research
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects

This study will compare the gastric pull up (GPU) with the free flap \[(specifically, anterolateral thigh (ALT) and radial forearm free flap (RFFF)\] techniques used in the reconstruction of alimentary tracts in patients who require laryngectomy and circumferential pharyngectomy for carcinoma resection. These two interventions will be compared by block randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or RFFF. The primary outcome will be the type and number of postoperative complications. The secondary outcomes will include swallowing function, speech, and quality of life measures along with cancer specific endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent, attend follow-up visits and complete questionnaires
* Have an Eastern Cooperation Oncology Group (ECOG) performance status of 0-2
* Patients with carcinoma of thyroid, larynx, hypopharynx, or cervical esophagus requiring surgery as a primary treatment modality or after chemoradiation treatment failure
* Laryngectomy and circumferential pharyngectomy as recommended by the head and neck tumor board

Exclusion Criteria:

* Serious medical co morbidities or other contraindications to surgery
* Metastatic disease
* Pregnant or lactating women
* Patients whose clinical circumstances are such that one surgical intervention would be recommended over the other: The cancer extends into the the thorax as seen on pre-operative CT scan. In these patients, the GPU reconstruction is preferred.
* Patients who have liver cirrhosis or multiple previous surgeries on the stomach would not be candidates for the GPU and thus will be excluded from the study
Diaphragmatic Breathing for the Treatment of Bloating and Distension

The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Referred for breath testing for the indication of bloating.

Exclusion Criteria:

* Not referred for breath testing for the indication of bloating.
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.

Informed, signed consent will be obtained from the patient before surgery. In patients with acute consciousness disorders, the consent will be obtained from a legal representative and confirmed by the local court - accordingly to Polish legacy.

Patients willing to participate into the study and fulfilling at least one of two inclusion criteria will be randomly assigned to one of the three study groups. The treatment will be applied for 24 hours.

Intention to treat analysis will include comparison for differences of continuous, homogeneous distributed data with use of parametric tests, parametric or inhomogeneous distributed data - with use of nonparametric tests. The treatment effect will be assessed by comparison of the odds ratios for primary and secondary outcomes between the groups.

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery
* at least one risk factor for acute renal failure:

  1. oliguria \< 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously
  2. at least 60 mg furosemide/12 hours iv to maintain diuresis \> 1 ml/kg/hour

Exclusion Criteria:

* refused or none consent
* chronic renal failure with chronic renal replacement therapy
* chronic increase of serum creatinine \> 2 mg/dl