cyrilzakka/clinical-trials huggingface dataset:
Alternate Day Fasting and Exercise in Overweight or Obese Adults

Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. The purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-65 years
* Body mass index (BMI) more than 23.0 kg/m² (overweight or obese for Asian populations, according to the World Health Organization)

Exclusion Criteria:

* Participants with weight gain more than 5kg in the last 3 months
* Participants with history of bariatric surgery
* Participants with secondary obesity, such as hypothyroidism
* Participants with uncontrolled hypertension or type 1 diabetes
* Participants who are taking anti-diabetic medications due to type 2 diabetes
* Participants with hepatic disease (AST or ALT ≥200 mg/dL)
* Participants with renal disease (serum creatinine ≥2.0 mg/dL)
* Participants with pancreatitis or related disorders
* Participants with acute infectious diseases (i.e., pneumonia, acute enteritis, or urinary infection)
* Participants with chronic inflammatory diseases (i.e., rheumatoid arthritis, or lupus)
* Participants with overeating behavior
* Participants with history of cardiovascular diseases
* Participants with history of cancer
* Participants who are taking anti-obesity, anti-diabetic, diuretic, central-nervous system, antidepressant, antipsychotic, or steroid medications
* Pregnant or lactating women
* Participants who intake more than 30 g of alcohol daily
* Night-time or shift-work workers
* Participants with chronic malabsorption syndrome or cholestasis
* Participants with other medical conditions that would preclude subjects from participating in exercise and physical test
Role of Color Doppler Ultrasound in Lymphadenopathy

Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes Accurate lymph node characterization is important for a wide number of clinical situations, including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis itself (cancer, lymphoma, or inflammatory nodes)

Various ultrasound criteria that can help in differentiation of benign and malignant lymph nodes have been well described in literature. On Gray scale ultrasound imaging, the benign enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On the other hand, the malignant lymph nodes are round with short to long axis ratio \>0.5 and show loss of echogenic hilum, while the Color and Power Doppler features documented for the diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale ultrasound findings are equivocal. However, it can neither replace histopathology nor can eliminate the need for biopsy

Eligibility Criteria:
Inclusion Criteria:

* clinically enlarged lymph nodes

Exclusion Criteria:

* previous medical treatment or radiotherapy
* previous biopsy
Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

The purpose of this study is to examine whether co-administration of rifampin with neratinib has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of neratinib.


Eligibility Criteria:
Inclusion criteria:

* Healthy men or women (of non childbearing potential)
* Ages 18 to 50 years old.
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* have time to participate in the study,
* treatment for HF according to the European Society of Cardiology guidelines2
* stable HF (NYHA class I-III) and not being hospitalized for HF the latest month
* signs of suffering of depressive symptoms (Patient Health Questionnaire-9 \>9 points

Exclusion Criteria:

* severe HF (NYHA IV) or another severe chronic life threatening disease.
* severe depression assessed to need hospital care
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH

This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.


Eligibility Criteria:
Key Inclusion Criteria:

* Presence of ≥ 8% liver fat content on screening MRI-PDFF.
* Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
* Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.

Key Exclusion Criteria:

* Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
* Evidence of other causes of chronic liver disease.
* Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
* Any contraindications to a MRI scan.
* Treatment with vitamin E (unless stable dose of \< 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
* Known history of alcohol or other substance abuse within the last year or at any time during the study.
* Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.
* Known positivity for antibody to Human Immunodeficiency Virus (HIV).
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

Globus sensations are associated with gastroesophageal reflux disease as well as the presence of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic gastric inlet patches of the esophagus improves patients' chronic globus sensations.

Some data suggest that ablation of gastric inlet patches by argon beamer therapy might lead to alleviation of chronic globus sensation or sore throat. Acid reflux or its treatment is unlikely to influence these results (Meining et al. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70). Within the present study we will perform a randomized, sham-controlled and blinded trial, where patients with heterotopic gastric mucosa (HGM) of the cervical esophagus and globus sensations (a chronic or intermittent lump in the throat for at least 3 months) are going to be randomized after histological verification of HGM in the study center (Technical University Clinic Munich). Either a beamer ablation of HGM or a sham-therapy will be performed after patients complete a validated questionnaire. Patients are blinded for 3 months, then after completing another questionnaire endoscopy is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus

Exclusion Criteria:

* Malignancy in the ear, nose, and throat (ENT)-field
* Scleroderma
* Mental disability affecting a patient's ability to sign an informed consent document
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.


Eligibility Criteria:
Inclusion Criteria:

* macular edema due to retinal vein occlusion
* visual acuity in the study eye between 20/320 to 20/40

Exclusion Criteria:

* cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
* use of injectable drugs in the study eye within 2 months prior to day 1
* active eye infection in either eye
* visual acuity in the non-study eye of 20/200 or worse
Prevention of Type 2 Diabetes Mellitus by Changes in Diet

investigators evaluated the efficacy of two types of diet with different macronutrients, on prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or control group (n=109) and followed for 2 years. For calculating daily energy requirement in subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal body weight with no attempt for losing body weight. Control group were encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and saturated fat to less than 10 percent of total energy. The primary outcome variable was incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association criteria.

322 participants were randomized and stratified into a control group and two study groups according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were anthropometric measurements, food diary and laboratory exams. Anthropometric measurements were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA in this group was olive oil. In the intervention groups diet regimen was written for each participant by a registered dietitian. Group three or the control group was encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy consumption and saturated fat to less than 10 percent of total energy.

Eligibility Criteria:
Inclusion Criteria: Adults over 20 years Exclusion Criteria: Diet therapy; severe physical activity; accompanying diseases such as cancer which reduce their life expectancy; receiving thiazide diuretics; receiving systemic ß blockers; receiving glucocorticoids; receiving nicotinic acid; receiving weight lowering drugs
Nantes Bariatric Surgery Cohort

While current research suggests that inflammation of adipose tissue in obesity is linked to accelerated aging, it has yet to be determined in humans how this could enhance preventative and personalized medicine for obese individuals. The NBC study aims to investigate :

1. Whether bariatric surgery is associated with changes in biological age
2. If bariatric surgery alters adipocyte dysfunction, the microbiota and biological rhythms
3. Whether changes in adipocyte dysfunction, microbiota and biological rhythms are linked to changes in biological age.

To achieve this, establishing a biocollection before, during and after bariatric surgery will be crucial in addressing these questions

The study of the Nantes Bariatric Surgery Cohort (NBC) aims to evaluate the impact of bariatric surgery on biological age, adipocyte dysfunction, microbiota, and biological rhythms in individuals with obesity. This observational study will include 300 participants over 3.5 years. It involves pre-operative, peri-operative, and post-operative visits to collect clinical, biological, and lifestyle data. Key assessments include anthropometrics, blood tests, questionnaires, and biocollections

Eligibility Criteria:
Inclusion Criteria :

Individuals selected for bariatric surgery (starting the BC pathway within the Nantes University Hospital bariatric unit). Inclusion criteria are those of the Bariatric Surgery program.

* male or female, adult over 18 years of age
* BMI ≥ 35 kg/m2 with complication(s) or ≥ 40 kg/m2 with or without complication (the list of eligible complications is referenced in HAS 2024 recommendations). In the event of a change in access to bariatric surgery, this threshold could be revised without any substantial change to the protocol.
* having consented to their participation in the cohort
* participant affiliated to or benefiting from a social security scheme

Exclusion Criteria :

* Persons protected by law (guardianship or trusteeship) or deprived of their freedom,
* Pregnant women (contraindication to CB) or nursing mothers.
YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the treatment of endothelial dysfunction in patients with diabetes mellitus.

The primary purpose of this study is to demonstrate superior effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference of flow-mediated dilation (FMD), compared to placebo group after treatment of 12 weeks.

The secondary purposes of this study are divided into three as follows;

* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference of FMD, compared to placebo group after treatment of 8 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on insulin resistance in diabetes mellitus indicated as mean change difference of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), compared to placebo group after treatment of 4, 8 and 12 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on mean change difference of blood pressure in diabetes mellitus, compared to placebo group after treatment of 4, 8 and 12 weeks.

The exploratory purposes of this study are divided into two as follows;

* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on blood glucose level in diabetes mellitus indicated as mean change difference of HbA1c, compared to placebo group after treatment of 12 weeks.
* Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on vascular stiffness in diabetes mellitus indicated as mean change difference of blood lipids (LDL, HDL and TG), compared to placebo group after treatment of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent), Endothelial dysfunction: FMD below 6.7%, LDL cholesterol level less than 140 mg/dl, Patients agreed to Informed Consent Form

Exclusion Criteria: (Key exclusion criteria) Uncontrolled arterial hypertension (above 139/90 mmHg) or hypotension (below 80/50 mmHg), Severe diabetic complication: diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, diabetic vascular complications
Atraumatic Restorative Treatment Sealants in First Permanent Molars

The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 \].

Exclusion Criteria:

* patients presenting any physical and/or medical health issues and having non-cooperative behavior.
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection

1. Infection control and health-care-associated infections and Safety of medical service providers
2. Evidence based management of common medical and surgical problems

Surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. Superficial sternal wound infection (SSWI) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). Deep sternal wound infection (DSWI) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced DSWI(3). Sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). Although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. Recent clinical practice guidelines from the Centers for Disease Control, World Health Organization, and International Consensus Meeting on Musculoskeletal Infection advocate the use of a dilute povidone-iodine solution prior to wound closure. This experience suggests that this practice is safe, inexpensive, and easily implemented(5). The present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* age from 1 to 65 years, primary or redo cases

Exclusion Criteria:

* diabetic patients
Probiotics for Preterm Infants

Probiotics will be used for preterm infants under 32 weeks of gestation and under 1500 g birthweight. Our aim was to investigate the effects of probiotics for stable preterm infants after extubation and who reached full enteral feeding. There are some hesitations among care-givers to start probiotics early due to safety issues although there are many positive effects of these products reported int the literature.

Our study included premature babies with a birth weight of less than 1500 grams, born at less than 32 weeks of gestation, and without congenital anomalies.

Approval was obtained from the hospital's clinical research ethics committee before starting the study. The decision to start probiotics was made when these premature babies were fully enteral fed. The study design was created as a cohort and case-control study (No randomisation). When clinicians decided to start probiotic support for premature babies with good general health and no additional problems, probiotics were added to the baby's order.

Eligibility Criteria:
Inclusion Criteria: \<32 weeks, \<1500 g birthweight -

Exclusion Criteria: Congential anomalies, still parenteral feeding, BW\<800 gr and \<23 weeks of GA

-
Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali

This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.

Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.

Life for a Child (LFAC) has been providing diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to Santé Diabète in Mali since 2008. In 2021, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Mali, one of the world's poorest countries.

Eligibility Criteria:
Inclusion Criteria:

(i) diagnosed with T1D in accordance with World Health Organization criteria

(ii) duration of T1D ≥12 months at time of enrolment

(iii) aged \<25 years at time of enrolment

(iv) current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin

(vi) willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips

(vii) live in or within one hour's travelling distance of Bamako

Exclusion Criteria:

(i) Previous use of analog insulin