cyrilzakka/clinical-trials huggingface dataset:
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients

The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor, enavogliflozin, effectively reduces glycated hemoglobin (HbA1c) levels and body weight without increasing the risk of serious adverse events. However, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. It will also clarify role of enavogliflozin in preventing vascular complications in this patient population.

The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes, representing the first large-scale SGLT2 inhibitor outcome study targeting this population.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 19 years and older at screening
2. Subjects diagnosed with T2D at screening
3. Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria

Exclusion Criteria:

1. Subjects with different types of diabetes mellitus other than T2D
2. Subjects with moderate to severe hepatic impairment
3. Subjects with contraindications to SGLT-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (eGFR) \<60 mL/min/1.73 m2, end stage renal disease (ESRD), or on dialysis
4. Subjects with major comorbidities
5. Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
6. Pregnant or breastfeeding women
Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula

The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.

Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.

Eligibility Criteria:
Inclusion Criteria:

* \>20 y/o
* Any extubated patients after tolerating spontaneous breathing trial

Exclusion Criteria:

* Presence of tracheostomy
* Recent facial trauma
* Active gastro-intestinal bleeding
* Do-not-intubate status and
* Planned use of BiPAP after extubation.
* Patients with unstable spinal lesions or fractures.
* BMI\> 50
* Patients with a cardiac pacemaker
* Burn injury with skin defect
Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.

The investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Both patients required surgical intervention, which included manual reduction of the plication followed by subtotal gastrectomy en bloc with Roux-en-Y reconstruction. In the second case, an Omega Brown anastomosis was performed, and a jejunostomy was created after the anastomosis in both patients.


Eligibility Criteria:
Inclusion Criteria:

- Patients with gastro-duodenal intussusception following a gastric plication procedure.

Exclusion Criteria:

* children
Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia

The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-60 years old
* Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* History of alcohol or substance abuse
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery

Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective valve replacement

Exclusion Criteria:

* chroic renal failure
* chronic liver failure
Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs

The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.

The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.

This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.

Eligibility Criteria:
Lay End Users

Inclusion Criteria:

* 18 years of age or older
* Able to read and write English.
* Employees of the study test sites

Treatment Subjects

Inclusion Criteria

* 18 years of age or older
* Body Mass Index (BMI) \<= 30 kg/m2

Exclusion Criteria

* Pregnancy
* Open wounds (sores, cuts, ulcers, etc.) on or around the waist, hips and/or thighs
* Currently have or are being treated for any cancerous growths on or around the waist, hips and/or thighs
Effect of Oral Cinnamon Intervention in Metabolic Syndrome

This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 25 -65 years
2. Subjects identified with any three of following:

   1. Fasting blood glucose ≥100 mg/ dL
   2. Waist circumference ≥ 90 cm ( males) ≥ 80 cm (females)
   3. Triglycerides ≥ 150 mg/dL
   4. High density lipoprotein cholesterol ≤ 40 mg/dL ( in males) , ≤ 50 mg/dL (in females)
   5. Blood pressure Systolic BP ≥ 130 mm Hg
   6. Diastolic BP ≥ 85 mm Hg
3. Subjects who were willing to participate in the study.
4. Subjects, if on medication for high blood pressure were stable and there was no change in the dosage for the past 3 months.

Exclusion Criteria:

1. Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders.
2. Subjects who were allergic to wheat flour and cinnamon.
3. Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs.
4. Subjects who had undergone bypass procedure.
5. Subjects suffering from any debilitating disease such as tuberculosis, HIV etc.
6. Subjects suffering from uncontrolled hypothyroidism/ hyperthyroidism
7. Pregnant and lactating mothers
Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the influence of diaphragm mobility on exercise capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

Chronic Obstructive Pulmonary Disease (COPD) is characterized by progressive obstruction of the airways which is partially irreversible. COPD patients commonly present increased resistance to airflow, air trapping, and pulmonary hyperinflation that alters the chest wall placing the respiratory muscles in mechanical disadvantage, thereby increasing both respiratory drive and the sensation of dyspnoea. Furthermore, to prevent dyspnoea, COPD patients reduce their daily living activities leading to loss of physical condition, social isolation, depression and anxiety,whilst compromising their quality of life.

Forced expiratory volume in one second (FEV1) is the main parameter used to establish the severity of pulmonary impairment and disease progression.

Nevertheless, some studies have suggested that FEV1 does not adequately reflect the clinical manifestations of the disease and is only weakly associated with the severity of dyspnoea, health related quality of life (HRQOL) features, and the ability to perform activities of daily living.

Moreover, FEV1 appears not to be a predictor of mortality in COPD patients. Pulmonary hyperinflation has been related with adaptation in diaphragm muscle maintaining the muscle's capacity to generate power whilst reducing its displacement. The importance of the diaphragm in lung mechanics associated with hyperinflation has been the subject of frequent discussion owing to widespread use of lung volume reducing surgery which results in increased movement range of the diaphragm muscle. However, to date, the relationship between diaphragm mobility and functional capacity in COPD patients remains unknown.

The objective of the present study was to evaluate the influence of diaphragm mobility in the exercise capacity and dyspnoea of patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic obstructive pulmonary disease clinically stable (no respiratory crises or hospitalizations within the 30 days preceding the study outset)
* patients receiving optimized clinical medical treatment

Exclusion Criteria:

* patients suffering from other cardiorespiratory diseases
* patients with oxygen-dependent for any reason
* patients classified as obese or as underweight
* patients presenting other respiratory diseases or pleural scars on chest X-rays
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study

The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the Bethesda Classification 2008 (vesicular lesion of undetermined significance (Bethesda 3); follicular neoplasm or Hürthle cells (Bethesda 4); lesion suspicious for malignancy (Bethesda 5)), and to be operated on
* Patient affiliated to a social security scheme
* Informed consent and signed

Exclusion Criteria:

* Thyroid nodules \<15 mm
* Coalescing nodules preventing proper individualization of targeted nodule;
* Thyroid nodule with non-diagnostic cytology (Bethesda 1), benign cytology (Bethesda 2) or malignant cytology (Bethesda 6)
* Hot thyroid nodule on the thyroid scan
* Major subject to a measure of legal protection or unable to consent
* Pregnant women / nursing
* Refusal to participate
A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate

Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions.

Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC).

There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.

The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.

1. Study design: endoscopist-blinded, prospective, randomized controlled trial
2. Subjects

   1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study.
   2. Exclusion criteria:

   gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate \< 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.
3. Sampling design: Consecutive recruitment of consenting patients
4. Variables Predictor

   1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
   2. group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure
   3. group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure;
   4. group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.
5. Primary Outcome: Quality of bowel preparation (Ottawa scale)
6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study

Exclusion Criteria:

* gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate \< 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.
Ketamine Interleaved With Electroconvulsive Therapy for Depression

Pragmatic, randomised, controlled, parallel group, pilot clinical trial of ketamine vs. midazolam interleaved with electroconvulsive therapy (ECT) as an adjunctive treatment for a major depressive episode. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Patients referred for treatment with ECT at St Patrick's Mental Health Services for treatment of a depressive episode will be eligible for recruitment to the clinical trial. Participants will be invited to be randomised to a course of twice-weekly ketamine or midazolam infusions for the duration of ECT. Participants will receive the first allocated infusion following the first or second treatment with ECT. Block randomisation will be independently performed. Infusions will be delivered on separate days to ECT. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions.Treatment-as-usual will continue throughout the entire trial.

Trial Interventions: participants will receive twice-weekly infusions of either ketamine at 0.5mg/Kg or midazolam at 0.045mg/Kg. All infusions will be administered by a Consultant Anaesthetist. Repeated infusions of allocated drug have been shown to be safe and well tolerated by patients with mental illness. Minor haemodynamic changes and psychotomimetic side effects can occur and will be assessed regularly during infusions and for 120 minutes afterwards. Participants will be followed-up at six weeks and three months after the final infusion to assess for relapse according to standardised criteria.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Able to provide informed consent
* Voluntary admission for treatment of an acute depressive episode
* Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
* Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of ≥20
* Referred for treatment with ECT
* Sufficiently physically healthy to receive ketamine/midazolam and ECT

Exclusion Criteria:

* Inability to provide informed consent
* Current involuntary admission
* History of Axis 1 diagnosis other than major depression
* Medical condition rendering unfit for ECT
* Active suicidal intention
* Presence of major neurological or organic brain disorder
* Alcohol/substance dependence in previous six-months
* Pregnancy or inability to confirm use of adequate contraception during the trial
* Breastfeeding women
* Contraindications to ketamine
* Contraindications to midazolam
Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18 years or more
* Patients hospitalized in intensive care unit
* Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours

Exclusion Criteria:

* Pregnant or breast-feeding women
* Previous known tracheal lesions
* Persons deprived of freedom
Urinary Human Papilloma Virus Test in the General Population in Brittany

This is a population-based, prospective, multicenter and open-label study. 12,500 female non-respondents to the uterine cervix smear from 30 to 65 years of age in the context of the organized cervical cancer screening of the uterus, in the 4 Breton departments, will be proposed after stratification by age and socio-economic level at the revival of the cervical cancer of the uterus screening by the structure of management of Rennes, an invitation to the Human Papilloma Virus urine test thanks to the sampling kit sent to the home. It is planned a revival by simple mail after 4 months in one woman out of two who did not respond to this invitation to assess the impact of a recovery. This group represents about 5% of the eligible population in Brittany. The specimen will be sent by post with the signed consent and a questionnaire to the Hospital of Brest in virology laboratory for the detection of Human Papilloma Virus DNA (QPCR) in the urine (HPU test) and typing (LipA). In the case of a positive Human Papilloma Virus test, the woman being tested has a strong incentive to do the cervical cancer of the uterus with her doctor or midwife. In the case of abnormal smear, follow-up continues according to national recommendations to a gynecologist. All the data is collected on a software from the LINKS company, with the networking of the 4 Breton centers, the virology laboratory, and the Anatomy-Cytology-Pathology laboratories in Brittany; this collection will allow after extraction, a statistical analysis of the data. The analysis of the participation rate in this new screening, for each level of the socio-economic level, will allow a comparison with the participation in smear's revival of organized screening, between women's groups according to the socio-economic level of their residential place.

The project will take place over 24 months in 3 phases:

1. D0-M6: Pre-inclusion phase with implementation of the protocol (regulatory procedures, production of newsletters, consent, questionnaire, preparation of urine collection kits, postal validation).
2. M6-M18: Inclusion phase with start of the study, sending invitations and inclusion, Human Papillomavirus Urinary testing and uterine cervix smear monitoring.
3. M18-M24: Post-inclusion phase with assessment of the inclusions on the 4 Breton departments, verification and analysis of the data according to the socio-economic level, recovery of the uterine cervix smear stimulus data, realization of the statistical analyzes and budget impact analysis, communications and publications.


Eligibility Criteria:
Inclusion Criteria:

* Women from 30 to 65 years old who did not do uterine cervix smear and who live in Brittany

Exclusion Criteria:

* Women under 30 years or over 65 years
* Women of 30-65 years who have responded to the uterine cervix smear invitation
* Women who have had an uterine cervix smear raise
* Women who have already had an uterine cervix smear within 3 years
* Women who had a total hysterectomy