cyrilzakka/clinical-trials huggingface dataset:
Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D)

Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes.

Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes.

This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.

The traditional view of mitochondria as isolated, spherical, energy producing organelles is undergoing a revolutionary transformation. Emerging data show that mitochondria form a dynamic networked reticulum that is regulated by cycles of fission and fusion. The discovery of a number of proteins that regulate these activities has led to important advances in understanding human disease. Data show that activation of dynamin related protein 1 (Drp1), a protein that controls mitochondrial fission, is reduced following exercise in prediabetes, and the decrease is linked to increased insulin sensitivity and fat oxidation. The proposed research will test the hypothesis that mitochondrial dynamics is a key mechanism of insulin resistance in type 2 diabetes. Translational first-in-man studies will use an acute lipid challenge to investigate the physiological significance of altered skeletal muscle mitochondrial dynamics on insulin sensitivity in humans. The experimental approach harnesses innovative molecular and cellular tools, interfaced with physiologically significant human studies to obtain meaningful data on insulin resistance, and has the potential to generate insights that will lead to new diabetes therapies for future generations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Sedentary
* Normal glucose tolerance
* BMI \<25 kg/m2
Relationship of Serum Zinc Level with Severity of Diabetic Nephropathy

Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production.

However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease "CKD" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD

Chronic kidney disease (CKD) is an irreversible , progressive disease with high morbidity and mortality that occurs commonly in the general adult population, especially in people with diabetes and hypertension . It's defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause .

Diabetic kidney disease represents the most common cause of CKD in developed countries. Approximately 30% to 40% of diabetes mellitus (DM) subjects develop Diabetic kidney disease "DKD", and its presence significantly increases the risk for morbidity and mortality.

Zinc is an essential element and is the second most abundant divalent cation in the human body (2-4 g). It is mainly distributed in skeletal muscles (57%) and bone (29%) and acts as a cofactor for more than 300 enzymes. In addition, zinc is involved in the cellular mechanisms of proliferation, maintenance of structural integrity, and in the systemic regulation of the immune system . Zinc seems to have a potential role in kidney and body homeostasis in diabetic individuals which include stabilization of insulin hexamers and pancreatic insulin storage and improved glycemic control. Decreased zinc levels can impair insulin function and glucose metabolism, potentially worsening diabetes control and increasing the risk of kidney damage. Zinc is important for maintaining endothelial cell integrity and function. Endothelial dysfunction is a hallmark of DKD, and decreased zinc levels can exacerbate vascular complications associated with diabetes. Lower serum zinc levels have been associated with increased proteinuria, a common symptom of DKD. Proteinuria indicates kidney damage and is a predictor of disease progression. Zinc is involved in modulating the immune response. Deficiency can lead to a heightened inflammatory state, exacerbating kidney damage. Several studies underline the critical role of zinc in reducing oxidative stress levels, which is considered the common denominator of the mechanisms responsible for the progression of kidney disease. Zinc is a cofactor for various enzymes involved in heme synthesis and erythropoiesis

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic kidney disease

Exclusion Criteria:

* patients on dialysis. Patient refuse to participate
* Other renal disease "lupus nephritis,GlomeruloNephritis
Cardiac Biomarker in Pediatric Heart Disease

The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* children who receive surgery for congenital heart disease
* require cardiopulmonary bypass for surgery
* under 18 years old

Exclusion Criteria:

* simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)
Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure

The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.

The main questions it aims to answer are:

* Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
* Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.


Eligibility Criteria:
Inclusion Criteria:

* patients younger than 14 years of age
* congenital heart failure (LVEF\<55%, or LVFS\<25%)

Exclusion Criteria:

* single ventricle
* congenital heart disease without anatomical correction
* Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
* Patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 Wood·U)
* Patients with severe liver and kidney failure
* Patients who are allergic to related medications
* Patients with symptomatic hypotension who cannot tolerate related drugs
* Refuse to sign the informed consent or refuse to participate in this experiment
Using Urine Color as a Marker of Hydration Status

The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space

The study will examine if urine color expressed in CIE color space can reflect hydration status. Hydration staus will be rapidly altered via exercise in the heat.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age,
* no previous heat intolerance

Exclusion Criteria:

- Pregnant women,
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged over 40 years (male or female).
* Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
* Able to understand the content of informed consent and willing to sign the informed consent.
* Able to complete the diary card independently.
* For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
* Axillary temperature ≤37.0°C.

Exclusion Criteria:

* Prior history of herpes zoster.
* Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
* History of allergic disease likely to be exacerbated by any component of the vaccine.
* Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
* Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
* Participation in another research study involving receipt of an investigational product in the last 30 days.
* Prior administration of attenuated vaccine in last 28 days.
* Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
* History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
* Taking immunosuppressive therapy in last 6 months.
* Any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease.
* Active tuberculosis patient.
* Acute or chronic infections at the vaccination day (axillary temperature\>37.0°C).
* Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
* Woman who is breast-feeding.
* Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization

The investigator's aim in this study is to compare the results of tubal ligation surgery, one of the contraceptive methods, between different surgical techniques. 194 patients were included in the study. Of these patients, 104 had vaginal approach, 44 had laparotomic and 46 had laparoscopic tube ligation surgery. These surgical techniques are statistically was compared; Visual Analog Pain Scale (VAS) after surgery, in terms of duration of surgery, length of hospital stay, cost to hospital and amount of blood loss. As a result of the analysis; tubal sterilization technique performed with vaginal colpotomy were found to be more successful than other techniques; Visual Analog Pain Scale score, postoperative hospital stay, operation time and cost.

The study compared the peroperative effects and postoperative results of different surgical techniques with three different techniques in patients undergoing tubal sterilization.

surgical techniques used:

1. Mini Laparotomic tubal ligation
2. Laparoscopic tubal ligation
3. tubal ligation by posterior colpotomy

A total of 194 patients were included in the study. Tubal ligation was performed in 44 patients with mini laparotomy, 46 patients with laparoscopy and 104 patients with posterior colpotomy technique.

The following parameters were evaluated in the study

1. Parity
2. How many of their previous births are vaginal delivery, how many are cesarian section
3. 6th hour Visual Analog Pain Scale (VAS) score
4. 24th hour Visual Analog Pain Scale (VAS) score
5. Preoperative - postoperative hmg differences
6. Surgery time
7. Length of hospital stay

Eligibility Criteria:
Inclusion Criteria:

* Over 31 years old
* Have completed the fertility request
* Accepting informed consent

Exclusion Criteria:

* Being under the age of 32
* Having a child desire
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Eligibility Criteria:
Inclusion Criteria:

* Subject has agreed to participate by providing written informed consent.
* Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
* Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
* Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
* Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

* Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
* Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).
A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle

This is a single-center, prospective, randomized controlled study. Patients with single blastocyst transfer in the freeze-thaw cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle were enrolled as the study participants. They were randomized into two groups using an Excel table, and the efficacy was evaluated in a blinded manner by a third party who was unaware of the grouping; the data summary phase was performed by blinded statistical analysis with triple separation of the investigator, operator, and statistician.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 20 to 38 years.
2. Less than three transfers.
3. Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
4. Having consented to participate in this study and signed the informed consent form.

Exclusion Criteria:

1. Chromosomal abnormality in either the patient or their partner
2. Contraindications to hormone replacement therapy.
3. Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
4. Currently participating in another clinical study.
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects, 19-80 years of age;
* Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
* Voluntarily consent to participate in the study
* Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
* IUD in place for at least 3 months prior to study;
* Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
* Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
* Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
* Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion Criteria:

* Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
* Presence of alcoholism or drug abuse
* Participation in another investigational drug or device clinical trial within 30 days prior to the study
* Female subjects who are pregnant or lactating
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison

The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).


Eligibility Criteria:
Inclusion Criteria:

* Referred for scintigraphy to assess myocardial ischaemia
* Ability to give informed written consent.

Exclusion Criteria:

* Impaired capacity to consent
* Pregnancy, or breastfeeding
* Allergy to iv contrast
* Renal failure
* Severe Uncontrolled asthma
* Claustrophobia
Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

This is an intervention study of the effects of food preparation on the gut bacteria in patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention consistent of consuming low amounts of advanced glycation end products (AGEs), the products of protein and sugar interaction during food processing and preparation using high direct heat.

Gut microbes can influence numerous aspects of human biology. Alterations in the function and composition of gut microbial flora (gut microbiota) have been linked to different diseases such as obesity, diabetes and inflammation. Advanced Glycation End products (AGEs) are formed via the Maillard reaction, which consists of a complex network of non-enzymatic reactions involving the carbonyl groups of reducing sugars which react with the amino groups of proteins. AGEs are produced in vivo and being consumed. They have been implicated in increased risk of different diseases including atherosclerosis, CAD and kidney diseases. In this study, the investigators are evaluating the effects of consuming a low AGE diet in participants on peritoneal dialysis on the gut bacteria and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Patients with ESRD on PD.
* Patients are able to understand and give consent.
* Patients with estimated daily dietary AGE intake \> 12 AGE Eq/day (12,000 kiloUnits/day) based on 3-day food records.

Exclusion Criteria:

* Patient on antibiotics in the last three months.
* Liver cirrhosis, and heart failure with EF \< 30%.
* The use of chemotherapy, immunosuppressive medications, probiotics, and steroid in the last month.
* Oral iron supplementation in the last month.
* History of small or large intestine resection or small bowel obstruction