cyrilzakka/clinical-trials huggingface dataset:
Overfeeding Induced Fat-tissue Stimulation

Type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (WAT) dysfunction. A key factor in its development is chronic overnutrition, usually with a high-fat diet (HFD), leading to disturbances of glucose and lipid metabolism. However, the mechanism of short-term HFD-induced tissue-specific insulin resistance remains poorly understood. This project aims to further unravel the underlying mechanisms of short-term HFD overnutrition-mediated WAT insulin resistance. The model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. Based on recent studies, the hypothesis is that 21-day hypercaloric HFD induces WAT insulin resistance via a diacylglycerol, novel protein kinase C-insulin receptor signaling model in both fasting and insulin-stimulated states.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* BMI \< 29 kg/m2
* Sport inactive (\<1x /week)
* Capacity to consent

Exclusion Criteria:

* Diabetes mellitus disease
* Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation)
* Acute infectious disease
* Taking blood glucose-lowering drugs
* Diseases or drugs affecting the immune system and allergies to drugs used in the study
* Drugs with potential metabolic effects
* Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT \> 300 U/L))
* Chronic inflammatory bowel diseases
* Rheumatic diseases
* Hyper- or hypothyroidism of the thyroid gland
* Renal insufficiency, administration of iodine-containing contrast media in the last 2 days
* Chronic lung diseases
* cancerous diseases
* Addictive diseases, psychiatric diseases
* Pregnancy, breastfeeding
* Shift workers
* Anemia (Hb \<12 g/dl)
* Disorders of hemostasis
* Regular use of antithrombotic drugs
* Alcohol consumption, smoking
* Conditions that do not permit an MRI examination
Assessment of Ovarian Reserve Tests in Unexplained Infertile Women

IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS.

IN UNEXPLAINED INFERTILITY OVARIAN RESERVE TESTS WERE ASSESSED.

IN THIS STUDY, A COMPARISON IS DONE BETWEEN 35 WOMEN WITH UNEXPLAINED FERTILITY(THE PATIENT) AND 35 WOMEN WHO DON'T HAVE ANY FERTILITY PROBLEMS AND HAVE AT LEAST A CHILD (THE CONTROL GROUP).

THE STUDY PARTICIPANTS SHOULD HAVE THE FOLLOWING CRITERIA

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX. THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

FOR THE CONTROL GROUP

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES AT LEAST HAVE A CHILD THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

THE STUDY INCLUDES THE FOLLOWING TESTS BEING DONE ON THE PATIENTS:

THE FOLLOWING HORMONES' LEVELS WERE STUDIED:AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICULAR STIMULATING HORMONE) , E2 (ESTRADIOL) AND INHIBIN B.THE FORMER THREE HORMONE LEVELS SHOULD BE ASSESSED ON THE THIRD DAY OF MENSES IN THE STUDY,TRANSVAGINAL ULTRASONOGRAPHIC OVARIAN VOLUME ,OVARIAN ANTRAL FOLLICULE NUMBER,OVARIAN STROMAL BLOODFLOW AND OVARIAN ARTERIAL RESISTANCE WAS MEASURED USING DOPPLER ULTRASONOGRAM.

Eligibility Criteria:
Inclusion Criteria:

* LESS THAN 35 YEARS OLD,
* MARRIED WOMEN
* SHOULD HAVE REGULAR MENSES
* SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

Exclusion Criteria:

* HAVING ANY SYSTEMIC DISEASE.
* LONG HISTORY OF ANY DRUG USAGE.
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor

Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia


Eligibility Criteria:
Inclusion Criteria:

* consenting ability

Exclusion Criteria:

* language barrier
* uncompleted questionary
Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota

The aim of the present randomized double-blind placebo-controlled trial is to evaluate the efficacy of a probiotic formulation, containing the probiotic strain Lacticaseibacillus rhamnosus CA15 (DSM 33960), in the treatment of vaginal dysbiosis in terms of: (i) modulation of the microbiota (increase of lactobacilli and decrease of pathogens), (ii) reduction of clinical signs of inflammation, (iii) improvement of quality of life.

The aim of the present randomized double-blind placebo-controlled study is to evaluate the ability of the potential probiotic Lacticaseibacillus rhamnosus CA15 (DSM 33960) strain, orally administrated, to balance the vaginal microbiota of women with vaginal dysbiosis. Two hundred women, with signs and symptoms of vaginal dysbiosis, are recruited and randomly allocated to receive oral capsules containing the L. rhamnosus CA15 (DSM 33960) strain or placebo once daily for 10 days. Clinical and microbiological parameters are evaluated in three scheduled appointments: at baseline (T0), 10 days after the start of the treatment (T1), and 30 days after the end of the treatment (T2). In addition, at baseline (T0) and 30 days after the end of the treatment (T2), the quality of life will be evaluated through a quality of life assessment questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, subjective vaginal discomfort);
* Presence of at least 3 Amsel criteria;
* Nugent score greater than 7;
* Lactobacillary grade greater than 2 (LBG) (according to Donders classification);
* Vaginal dysbiosis based on microbial cell count.

Exclusion Criteria:

* Presence of sexually transmitted diseases due to Chlamydia, Neisseria gonorrhoeae or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
* Clinically evident herpes simplex infection;
* Human papillomavirus or human immunodeficiency virus infections;
* Use of antibiotics, antifungals, probiotics, or immunosuppressants within the past four weeks;
* Use of vaginal contraceptives and any other physiological or pathological condition that could potentially interfere with the results of the study (e.g. pregnancy or breastfeeding, chronic diseases, neoplastic diseases, diabetes, genital tract hemorrhages);
* Enrollment in other programs that involve the administration of products that may affect the composition of the vaginal microbiota.
Telephone-linked Home-based Exercise Training in PD

This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.

Background/Rationale:

Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.

Objective:

The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.

Methods:

The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
* At least 2 of 3 cardial signs of PD
* Response to dopaminergic medication
* Depression

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy
Determining the Extent of Diffusion Tensor Abnormalities in Focal Cortical Dysplasia

Focal cortical dysplasia (FCD) is a common finding in epilepsy surgery in pediatric patients. Children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes MR brain, video EEG and magnetoencephalography (MEG). The white matter next to FCD is frequently found to be abnormal on pathology. Diffusion tensor imaging (DTI) can be used to study the abnormal white matter and the area that often extends beyond the area that is visible.

Focal cortical dysplasia (FCD) is a highly epileptogenic form of malformation of cortical development that may require surgical resection for epilepsy control. With abnormal development and organization of neurons within the cortex, the white matter projecting from the abnormal cortex is likely to be abnormal as well. The abnormality in the white matter involves not only the subcortical white matter, but also the long tracts in the deep white matter associated with the dysplastic cortex. Histologically, the subcortical white matter adjacent to the dysplastic cortex has been found to be abnormal. Studies using diffusion tensor imaging (DTI) to investigate the white matter adjacent to the MR visible abnormality have demonstrated reduced fractional anisotropy. However, electrographic abnormality in FCD often extends beyond the visible MR abnormality and surgical outcome of epilepsy surgery in FCD is dependent on excising the MR visible abnormality as well as electrographically abnormal area beyond the MR visible abnormality. The cortical and white matter abnormalities are therefore assumed to extend beyond the MR visible lesion. The short-term goal of this study is to determine whether quantitative measures of the abnormal white matter using DTI are able to provide surrogate markers for the extent of FCD. Whilst surgical outcome data is not available for the purpose of this study, these children will be followed up and in the longer term, the extent of FCD as determined by DTI will be compared with clinical outcome post surgery. This study will help determine the potential value of this technique in identifying areas of FCD that appear normal on structural MR. In the long term, this technique can be extended to study children with intractable epilepsy with (i) MR occult lesion and (ii) developmental tumor with MR occult FCD adjacent to the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Children with intractable epilepsy with suspected FCD for MRI \& MEG

Exclusion Criteria:

* Children with contraindications to MRI such as those with pacemaker
Changes in Anthropometry Following Ambulatory Orthopaedic Surgery

The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years-old
* scheduled to undergo knee or shoulder ambulatory surgery

Exclusion Criteria:

* weighs greater than 350 pounds
* pregnancy
* history of bariatric surgery
* dieting or engaged in a weight loss program
* taking weight loss supplements
* undergoing other types of surgery during study period
Comparison of TSTVs NT Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients

Comparison of Task Specific Training Vs Neurodevelopmental Training Along with Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients

To compare Task Specific Training versus Neurodevelopmental Training along with conventional therapy for upper limb motor function among chronic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic ischemic stroke patients( after 3 months of stroke ).(41)
* Patients from both gender.(42)
* Patients of around age of 45-65.(43)
* Patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44)
* Patient with good cognitive function minimum 20 or more on Mini Mental State Examination (MMSE).(45)

Exclusion Criteria:

* Patients with history of the recurrent stroke.(41)
* Patient with fracture or dislocation of upper limb.(46)
* Patient with any peripheral vascular disease (47)
* Patient with any comorbid neurological disease like Parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21)
* Patient with skin discoloration, skin ulcers and skin allergy.(48)
Comparison of Biphozyl® and Phoxilium® as a Replacement Fluid During CVVH for AKI in Adults and Their Effects on pH-, Bicarbonate-levels and Respiratory Situation

The primary objectives of the BiPhox-Trial are to demonstrate, that the use of Biphozyl® as a replacement fluid in adult critically ill acute kidney injury (AKI) patients, results in a lower rate of pH excursions and of bicarbonate (HCO3-) excursions compared to the use of Phoxilium® during the studied continuous veno-venous hemofiltration (CVVH) interval with regional citrate anticoagulation (RCA).

The secondary objectives of the BiPhox-Trial are to evaluate the time to pH level normalization and the HCO3- substitution rates after initiation of CVVH treatment. Further, to demonstrate that the use of Biphozyl® as a replacement fluid in adult critically ill AKI patients, results in a more stable acid-base-status as well as improved respiratory situation due to lower intracorporeal HCO3- and carbon dioxide levels compared to the use of Phoxilium® during the studied CVVH interval with RCA.

After being fully eligible by meeting all inclusion and none of the exclusion criteria, participants will be randomly assigned to one of two groups, either the Phoxilium® - Group or Biphozyl® - Group. After randomization, patients receive either Phoxilium® or Biphozyl® for CVVH initiation and maintenance as a replacement fluid during the first 48 hours (h) of treatment. After the first 48h of CVVH with either Phoxilium® or Biphozyl® a cross-over follows, with another 48h of CVVH with the opposite replacement fluid (Phoxilium® switched to Biphozyl® or Biphozyl® switched to Phoxilium®). In comparison, all patients should receive one session of CVVH with 96h. Resulting from 48h of CVVH with Phoxilium® and 48h of CVVH with Biphozyl® as a replacement fluid. The order is determined by randomization.

Anticoagulation is always delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Admission to Intensive Care Unit
3. Indication for CVVH as determined by the attending physician
4. Planned CVVH treatment time ≥ 48 hours
5. Written informed consent or deferred consent or legally acceptable representative consent

Exclusion Criteria:

1. Lack of commitment to provide CVVH as part of limitation of ongoing life support
2. Presence of a drug overdose that may result in acid-base-disorders and/or a shift of electrolytes
3. Receipt of CVVH within the previous 72 hours
4. Dialysis dependent end-stage renal disease
5. Pregnancy, must be ruled out by anamnesis and/or blood or urine pregnancy test
6. Combination of severely impaired liver function and shock with muscle hypoperfusion
7. Co-enrollment in another trial, which could have a plausible interaction with the acid-base-status and/or any electrolytes
8. Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)
Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder

The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.

AIM AND HYPOTHESES

The primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.

Controlled design:

First, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).

Prospective design:

We aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression
3. Recurrent MDD evaluated a being the primary disorder.
4. Danish literacy

Exclusion Criteria:

1. A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy
2. Formal concurrent psychotherapy
3. Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction
4. Anti-psychotic medication and benzodiazepines
5. Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:

1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

Exclusion Criteria:

* Type 1 diabetes mellitus
* Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening
* HbA1c \< 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
* Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:

  * Platelet count \< LLN (see Central laboratory manual).
  * Serum albumin \< LLN (see Central laboratory manual).
  * International Normalized Ratio (INR) \> ULN (see Central laboratory manual).
  * ALT or AST \> 5× ULN (confirmed by 2 values during screening).
  * Total bilirubin \> ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
  * Alkaline phosphatase \> 300 IU/L (confirmed by 2 values during screening).
  * History of esophageal varices, ascites or hepatic encephalopathy
  * Splenomegaly
  * MELD score \>12
Thiamine as an Adjunctive Therapy in Cardiac Surgery

The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.

The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.

Over 230,000 patients in the United States undergo Coronary Artery Bypass Grafting (CABG) each year. While mortality is relatively low, morbidity remains substantial with a significant risk of prolonged time on mechanical ventilation, prolonged length of hospital and intensive care unit stay and many other complications. CABG causes a profound stress response and significant metabolic alterations occur, including a shift from aerobic to anaerobic metabolism, causing increased levels of pyruvate and lactate. Elevated lactate, a marker of anaerobic metabolism, is a common and significant finding in patients after CABG and is correlated with increased mortality and morbidity.

Aerobic metabolism occurs when pyruvate enters the mitochondria through pyruvate decarboxylation to acetyl-Coenzyme A, facilitated by the enzyme pyruvate dehydrogenase (PDH). Decreased PDH activity may cause a shift toward anaerobic metabolism and play a role in the changes seen in patients undergoing CABG. Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states. The investigators hypothesize that thiamine administration will increase PDH activity in patients undergoing CABG, leading to increased cellular oxygen consumption, as represented by decreased lactate levels after surgery, and ultimately improved clinical outcomes.

In order to test the investigators' hypothesis and to obtain data for a large-scale clinical trial evaluating relevant clinical endpoints, the investigators are conducting a randomized, double-blind, pilot trial of thiamine in high-risk patients undergoing CABG.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 21 years)
* Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
* EuroSCORE II \> 1.5%

Exclusion Criteria:

* Current thiamine supplementation
* Known allergy to thiamine
* Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
* Research-protected populations (pregnant women, prisoners, the intellectually disabled)
* Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)
* Off-pump surgery (i.e. surgery without cardiopulmonary bypass)