cyrilzakka/clinical-trials huggingface dataset:
The Effect of Fasting on Serum Osmolarity in Diabetic Patients

In Ramadan, Muslims perform a special kind of fasting. Their fasting start with the first lights of the sunrise and end with the sunset. Especially in summer, it is a real challenge, as the time for fasting might be as long as 18 hours, and hot weather might cause severe dehydration. This might be dangerous, especially in patients with diabetes. Serum osmolarity is a good surrogate marker to evaluate the body's fluid content. We aimed to investigate if summertime Ramadan fasting causes further fluid loss in patients with type 2 diabetes.

Till recently, it was assumed that patients with type 2 diabetes have to eat frequently, especially to avoid hypoglycemia, which is still true if they are using sulphonylurea or insulin. Especially because patients with diabetes often have one or more diabetic complications, they were advised against Ramadan fasting, as it is not allowed to eat or drink anything for long hours. There are increasing data supporting intermittent fasting, where individuals won't eat anything for 12-18 hours but are permitted to drink sugar-free beverages. The new antihypoglycemic agents have the advantage of causing very low or no hypoglycemia, which allows these patients to eat less frequently. There are studies about the metabolic effect of intermittent fasting in patients with type 2 diabetes, but we don't have enough data for the safety of religious fasting where no kind of fluid intake is allowed. In this study, we aimed to investigate the effect of fasting on the fluid status of diabetic patients. To this effect, we used serum osmolarity to determine fluid status. The patients who preferred to fast were our study group, and the patients who were healthy otherwise but preferred not to fast were our control group. In Ramadan, contrary to the customary practice of intermittent fasting, fasting starts with the sunrise and continues till sunset. We planned to take the first blood sample at 10 am and the second blood sample at 06 pm in both groups and compare the serum osmolarity accordingly.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes
* will accept to give two different blood samples
* will prefer to fast during Ramadan ( for the intervention group)
* will prefer not to fast during Ramadan ( for the control group)
* have good glycemic control

Exclusion Criteria:

* if the patients are not eligible for fasting
Efficacy and Safety of TTM in Adults With ECPR.

Investigators hypothesize that there is a difference in the 30-day survival rate and good neurological outcome rate between two groups of cardiac arrest patients undergoing ECPR, one group receiving hypothermia and the other group receiving normothermia. Among the patients undergoing extracorporeal cardiopulmonary resuscitation, after screening with inclusion criteria as well as exclusion criteria, informed consent for the experiment was signed and randomly assigned into 2 groups. One group underwent extracorporeal cardiopulmonary resuscitation combined with hypothermia (34°C) and the other group underwent extracorporeal cardiopulmonary resuscitation combined with normothermia (36.5-37.5℃). Information related to the prognosis of the participants in both groups was obtained, evaluated statistically, and final conclusions were drawn.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 and ≤60 years;
2. Patients with in-hospital and out-of-hospital cardiac arrest of any initial rhythm;
3. Patients who have received cardiopulmonary resuscitation for \>10 minutes without achieving return of spontaneous circulation;
4. Patients with a reversible cause of cardiac arrest (acute myocardial infarction, pulmonary embolism, all initial defibrillatable rhythm, cardiomyopathy);

Exclusion Criteria:

1. cardiac arrest due to trauma;
2. pregnant and lactating women;
3. unwitnessed cardiac arrest;
4. out-of-hospital cardiac arrest not receiving CPR within 5 minutes;
5. \> 60 minutes from the onset of cardiac arrest to the initiation of extracorporeal cardiopulmonary resuscitation;
6. achievement of return of spontaneous circulation before the start of external cardiopulmonary resuscitation;
7. intracranial hemorrhage or suspected intracranial hemorrhage;
8. pre-existing neurologic impairment (CPC ≥ 3) prior to the onset of cardiac arrest;
9. those with end-stage heart failure;
10. those with new-onset cerebral hemorrhage or cerebral infarction;
11. other vascular conditions such as severe plaque in bilateral femoral arteries that cause difficulty in tube placement;
12. patients with combined malignant tumors;
13. other serious diseases with a life expectancy of \<1 year;
14. refusal to perform extracorporeal cardiopulmonary resuscitation and/or target temperature administrators.
15. Temperature \<30°C.
CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study

The purpose of this study is to evaluate pulmonary capillary wedge pressure (PCWP) and other hemodynamic measurements at rest and during exercise in healthy volunteers across the age spectrum.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy volunteers are eligible to participate in this study if they are free of symptoms of exertional breathlessness or fatigue and any diagnosis of heart failure.
* Patients will also be required to have left ventricular ejection fraction (EF) ≥ 50%.
* Patients discovered to reduced EF or abnormal resting hemodynamics or other pathologic findings previously undiscovered will be considered screen failures and can be replaced by others to reach the goal enrollment.
* Informed consent were obtained.
* No history of heart failure.
* Willing and able to undergo invasive hemodynamic exercise testing, MRI, and other study assessments.

Exclusion Criteria:

* Clinically significant symptoms of exertional dyspnea or fatigue in daily life in the opinion of the investigators.
* Any diagnosis of heart failure
* Symptomatic coronary artery disease (e.g., patients with chronic angina)
* Symptomatic valvular heart disease
* Pulmonary hypertension
* Cardiomyopathies
* High output heart failure
* Pericardial disease
* Clinically significant chronic lung disease in the opinion of the investigators
* Anemia (hemoglobin \<12 gm/dL in women and \<13 gm/dL in men)
* Estimated glomerular filtration rate ≤30mL/min
* Pregnant women
* Any other disorders or problems that would interfere with the ability to participate safely in the study (e.g. psychiatric disorder or substance abuse)
The Incidence,Factors,and Importance of Brown Adipose Tissue in Chinese Adults

Previous studies have shown that active brown adipose tissue (BAT) is present in adults and may play important roles in material and energy metabolism. However, most of these studies were tumor-based populations and retrospective study. Due to the large amount in our cohort, the investigators are able to promote a cross-sectional study of the incidence and factors of BAT in adult chinese. In addition, the investigators can analyse the metabolic profiles in healthy adults with active BAT.

The investigators will perform a cross sectional analysis on the chinese adults who use 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) to scan the whole body at Huashan Hospital from 2009 to 2013. BAT activity will be measured by PET/CT. Not only demographic data on sex, age, medication and medical history,but also data on body composition and physical examination will be collected for all subjects. Imaging date,outdoor temperature and fasting blood samples will be collected as well. In addition, the investigators will analyse the metabolic profiles in healthy adults with active BAT and their negative controls,such as lipid profiles,fasting glucose and insulin sensitivity, adipokines and other biochemical markers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with detectable brown adipose tissue
* Negative controls,consisting of one subject who underwent PET/CT scans at the same day but without detectable BAT

Exclusion Criteria:

* Younger than 18 years
* Pregnant women
* With implantable medical electronic instrument
Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)

Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).

Historically, testing and treatment for hepatitis C has been confined to centralised laboratories and tertiary hospitals respectively. Recent advancements in point-of-care testing for hepatitis C (anti-HCV antibody and HCV RNA/VL) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings.

This study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis C testing and treatment at community-based clinics in Yangon, Myanmar. Generalist doctors trained in hepatitis C treatment will prescribe direct acting antiviral therapy to eligible participants.

The study will utilise SD Bioline HCV RDT and Cepheid GeneXpert HCV VL test; and sofosbuvir/daclatasvir to treat hepatitis C. Test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (SVR).

Study inclusion criteria prior to recruitment into study:

* Aged ≥18 years
* Attendance at study site
* Willing and able to provide written informed consent

Study exclusion criteria prior to recruitment into study:

* Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
* Treatment experienced (either DAA or pegylated interferon)
* Hepatitis B virus (HBV) infected
* Human Immunodeficiency Virus (HIV) infected
* estimated glomerular filtration rate (eGFR) \<30
* Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
* Pregnant women
* Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Attendance at study site
* Willing and able to provide written informed consent

Exclusion Criteria:

* Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
* Treatment experienced (either DAA or pegylated interferon)
* Hepatitis B virus (HBV) infected
* Human Immunodeficiency Virus (HIV) infected
* estimated glomerular filtration rate (eGFR) \<30
* Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
* Pregnant women
* Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking
Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19

Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.

Introduction: COVID 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in December 2019. Many studies were conducted to identify the predictive factors of mortality of those infected with the virus. The previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.

Methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of Mohamed VI Oujda, in Morocco, from March 2020 to October 2021, including all the patients tested positive for the infection.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting an infection with SARS-CoV-2 that were hospitalized in the intensive care unit.

Exclusion Criteria:

* None
Pilot Study,Diode Laser 808 nm Supported Direct Pulp Capping in Permanent Teeth

The purpose of this study was to compare the conventional and diode 808 nm laser-assisted techniques in direct pulp capping in permanent teeth .The present study was based on a series of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated areas, its ability in the fast and better haemostatic, and pain reduction.


Eligibility Criteria:
Inclusion Criteria:

1. Permanent teeth with deep caries
2. Vitality of teeth
3. No peri-apical radiographic changes
4. Acceptance research program

Exclusion Criteria:

1. Symptoms
2. Peri-apical radiographic changes
3. No stopped bleeding within 3 minutes after exposure
4. No acceptance study program
Tissue-resident Immune Cell Subsets in aGVHD

This is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. Approximately 40 subjects(including 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients ).

This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2024.11 to 2025.02.It is planned to enroll 40 subjects, divided into 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients. No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. All recipients will be followed for aGVHD evaluation,overall survival(OS) ,disease-free survival (DFS). aGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form;
2. Age 16-65 years old
3. Clinically diagnosed with GVHD for the first time/receiving GVHD treatment.

Exclusion Criteria:

1. Have a history of other tumors
2. With poor compliance or mental disorders
3. Infected with HIV and HCV
4. With uncontrolled HBV infection
5. With other autoimmune diseases
6. Those who are judged by the researcher to be unsuitable to participate in this study
Biorepository and Registry for Plasma Exchange Patients

Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG/IgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.


Eligibility Criteria:
Pts undergoing plasma exchange therapy are eligible to be in this protocol
Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Subject has signed written informed consent
* Subject is a female at least 18 years of age
* Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency (ISD)
* Subject understands all study requirements including five year follow-up schedule
* Subject is psychologically stable and suitable for intervention as determined by the Investigator

Exclusion Criteria:

* Subject has an acute urogenital tract inflammation or infection
* Subject is pregnant or intends to become pregnant within one year
* Subject has had a sling placement within 12 weeks
* Subject has had a bulking agent treatment within 12 weeks
* Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse, untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow incontinence
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Eligibility Criteria:
Inclusion Criteria:

* Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

* Pregnancy or lactation
What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?

The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Women with a regular cycle (between 21 and 35 days).
* Embryos with 50% intact blastomeres after thawing.
* Embryo and endometrium are synchronized.

Exclusion Criteria:

* Embryo storage time not longer than 5 years.
Respiratory Muscle Functions With Balance and Gait in Stroke Patients

Stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, respiratory problems such as changes in breathing patterns and decreased ventilation function may accompany these patients. Respiratory problems are an important risk factor in the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, a serious decrease in patients' activity performance is observed. While the focus is on motor function losses in stroke rehabilitation, problems in pulmonary functions do not receive the necessary attention. In stroke rehabilitation, evaluating and treating patients from every perspective will further increase the effectiveness of the treatments applied.

According to WHO, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. Stroke, which ranks third among the causes of death, is one of the leading causes of disability. Brain damage following stroke affects the central control of respiration, leading to various respiratory disorders. Dysfunction of the main respiratory muscle, the diaphragm, and particularly of the respiratory muscles on the paretic side of the body, is the most common and serious problem, causing asymmetric chest wall movements, changes in respiratory patterns, decreased lung volumes, and pulmonary complications. These changes in respiration cause further decreases in aerobic capacity, walking function, and the ability to perform daily living activities, especially in stroke patients who require an intensive rehabilitation program, and may increase the risk of pulmonary complications. At the same time, this situation may increase the risk of mortality by 2-6 times in stroke patients in the acute phase, prolong the average hospital stay, and worsen neurological dysfunctions. Therefore, evaluation of pulmonary functions and respiratory muscles before rehabilitation is very important to protect patients from possible accompanying pulmonary complications and to increase the effectiveness of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Having had a stroke for the first time
2. Being 18 years of age or older
3. Having an ischemic type of stroke
4. Having had a stroke for at least 6 months
5. Having a Modified Rankin Score of ≥3
6. Being able to communicate
7. Agreeing to participate in the study

Exclusion Criteria:

1. Hemispatial neglect
2. Having a psychiatric disease
3. Having any respiratory problems before the stroke
4. Having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied
Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial

This prospective cohort study aims to determine whether maternal and neonatal outcomes are affected by GBS carrier status in women undergoing transcervical balloon catheter insertion.


Eligibility Criteria:
Inclusion Criteria:

* During the study period and in the absence of contraindications, women anticipating induction of labor with unripe cervix will be screened for eligibility.
* Inclusion criteria are singleton gestation with confirmed cephalic presentation
* Gestational age between 37+0/7 and 41+6/7 weeks'
* Intact membranes
* Reactive non-stress test and Bishop's score \< 6.

Exclusion Criteria:

* Women less than 18 years, with multiple gestation pregnancies, pregnancies with major fetal anomalies, vaginal infection, intrauterine fetal death and those who were not candidates for vaginal delivery (placenta previa, non-cephalic presentation, planned cesarean delivery).