cyrilzakka/clinical-trials huggingface dataset:
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome

This study was planned as a randomized controlled study to determine the effect of hot and cold water application on complaints and sleep quality in pregnant women with restless legs syndrome (RLS). Pregnant women with a total of 90 RLS, including 30 people in each group, will be included in the study. The data of this study will be collected by Personal Information Form, RLS Diagnosis Criteria Questionnaire, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index, Post Application Follow-up Chart and Application Satisfaction Form.

While hot and cold water is applied in the intervention groups in the study, no application other than routine maintenance and follow-up will be done to the control group.Data analysis obtained in the research will be performed in TURCOSA statistical software (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr).In comparisons, a value of p \<0.05 will be considered statistically significant.In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (September 09, 2020 and number 2020/445) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.


Eligibility Criteria:
Inclusion Criteria:

1. Least literate
2. 24-32. between the weeks of gestation
3. Having a single pregnancy
4. The presence of RLS is detected according to the RLS Diagnostic Criteria Questionnaire
5. Having RLS due to pregnancy
6. Uses Iron, Vitamin D, Magnesium and Calcium
7. Pregnant women who have a severity of 11 or more according to the RLS Severity Rating Scale will be included in the study

Exclusion Criteria:

1. Those who have a communication disability,
2. Risky pregnancy (Preterm labor risk, Cervical insufficiency, etc.),
3. Chronic disease (Diabetes, Hypertension, Thyroid, Cardiovascular disease, epilepsy, etc.),
4. With maternal obesity, BMI\> 30
5. He has heirs in his legs,
6. Pre-pregnancy sleep apnea,
7. Having any psychiatric disease and using antipsychotic, antidepressant medication,
8. Using antihistamine, antiepileptic, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
9. Using heparin,
10. Pregnant women with a history of deep vein thrombosis, or atherosclerosis history or risk will not be included in the study.
Effects of Negative Energy Balance on Muscle Mass Regulation

The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 27 kg/m2 (adults)
* postmenopausal state

Exclusion criteria:

* weight loss of more than 5kg in the last 2 months x
* unhealthy patients with: severe chronic diseases including cancer within the last 5 years, severe heart disease, severe impairment of hepatic or renal function, severe anaemia or disturbed coagulation
* eating disorders or any other psychiatric condition that would interact with the trial intervention
* malabsorption
* acute or chronic infections
* severe hypertension
* myopathy
* food allergies
* any other uncontrolled endocrine disorder
* changes of smoking habits, diets or medication that strongly affects energy homeostasis within the last 3 months prior to study inclusion
Insulin Resistance Indices and Coronary Artery Disease

In this retrospective study from professor Kojuri clinic registry, total number of 1017 patients with first angiography were included and all data were recorded from registry. Insulin resistance was calculated using laboratory data

This was an analytical cross-sectional retrospective study involving patients with suspected CAD who underwent coronary angiography between December 2018 and May 2023. The information was obtained from patients referred to the outpatient cardiovascular clinic (Professor Kojuri Cardiology Clinic, Shiraz, Iran, www.kojuriclinic.com). Data was extracted from Professor Kojuri Cardiology Clinic database, including patient's information about the clinical history, presence or absence of specific diseases, angiography/angioplasty results, medications, and laboratory values.

A total of 14,708 patients who had undergone coronary angiography at least once were examined. After applying exclusion criteria, 1017 eligible cases were selected for data analysis.

The following data was recorded for the included patients: demographic data, past medical history (such as DM, hypertension, etc.), systolic and diastolic blood pressure, weight and height, fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum creatinine (Cr). Body mass index (BMI) was calculated as weight (Kg) divided by the square of height (m2). Obesity was defined as BMI ≥ 30 Kg/m2.

Laboratory values were selected from the time before angiography, and if not available, from the time shortly after the angiography. This helped us find those values which could best represent the metabolic state of patients at the time of angiography, while reducing the confounding effect of statin use.

Eligibility Criteria:
Inclusion Criteria:

* patients with age more than 18 years and having undergone coronary angiography

Exclusion Criteria:

* incomplete data
* history of prior coronary angiography or revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG))
* serum creatinine \&gt; 1.4 mg/dL
* history of chronic kidney disease (CKD)
* cancer,
Effect of Online Education Given to Young Adults on Testicular Cancer Health Beliefs and Behaviors

Aim: One of the cheapest, easiest and most effective ways to detect testicular cancer early is to resort to early detection screening methods associated with health beliefs about testicular cancer, and the second is to self-examine the testicles. In the country, there are a limited number of studies on the health beliefs and early diagnosis behaviors of young adult men for testicular cancer. For this reason, the study was conducted to determine the effect of online education given to young adults on testicular cancer health beliefs and behavior.

Material and method: The research was conducted as a randomized controlled experimental study. The study population consisted of 768 individuals who applied to Family Health Centers affiliated to Agri Provincial Health Directorate between April 2021 and June 2022, and the sample of the research consisted of 90 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form", "Champion's Health Belief Model Scale in Testicular Cancer Screenings" were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman-Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.


Eligibility Criteria:
Inclusion Criteria:

* Being 18-35 years old,
* Being literate,
* Computer can be used,
* Being able to access the Internet,
* Not having a testicular diagnosis before,
* Deciding to participate in the research.

Exclusion Criteria:

* Being outside the age range of 18-35,
* To be diagnosed with testicular cancer before
VAS Correlation With BMI

The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery.

Group I : Patients with BMI\<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI \>50

After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.

Exclusion Criteria:

* patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression
Validation of a Community Worker Administered Stroke Symptom Questionnaire

This is a validation study. A stroke symptom questionnaire will be adapted and translated into local language. Two community health workers will be trained in its administration. Their findings will be validated against assessment by two neurologists.

The study hypothesis is that the chance corrected agreement between the community worker administered stroke symptom questionnaire and the assessment by neurologist based on history and physical examination is at least moderate.

Overall Objective: To translate, adapt and validate a stroke symptom questionnaire for identification of stroke symptoms by community health workers ( CHW) in a peri-urban Pakistani community

Specific Aims:

1. To translate and adapt a stroke symptom questionnaire for identification of stroke symptoms by community workers in a peri-urban Pakistani community
2. To validate community workers administered stroke symptom questionnaire against assessment by neurologist in a peri-urban Pakistani community
3. To determine the feasibility of utilizing community workers for identification of stroke patients in the community in terms of subject refusals and difficulty in understanding questions

The study will be conducted at the community site of AMAN community health project in Ibrahim Hyderi. Community health workers will systematically select households and from them individuals meeting eligibility criteria will be interviewed. Community workers will administer stroke symptom questionnaire to them at their homes. Those unable to answer will have a surrogate answering for them. In the second part of the study, two neurologists will independently assess all individuals. The purpose of this would be to validate the findings of the community workers based on the stroke symptom questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 and above
* Permanent resident of Ibrahim Hyderi
* All ethnicities
* Can answer for themselves or have a surrogate willing to provide necessary information. Surrogate is defined as one who lives in the same household as the individual, who is the primary caregiver and has access to the medical record / information of the patient.
* Willing to give written informed consent

Exclusion Criteria:

- Individuals refusing to participate in any of the two components of the study i.e. CHW interview or neurological assessment
CytOSorb TreatMent Of Critically Ill PatientS Registry

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care


Eligibility Criteria:
Inclusion Criteria:

1. Planned OR actual CytoSorb® 300 mL device utilization
2. Informed consent for prospective registry participation

Exclusion Criteria:

1. Use of the CytoSorb® 300 mL device for antithrombotic removal only
2. Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only
3. The occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of CytoSorb® 300 mL Adsorber is contraindicated or no longer appropriate.
A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 to 70 years of age
* Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
* Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* HCV treatment-naïve
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance ≥ 50 mL/min
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
* Screening laboratory values within defined thresholds for alanine aminotransferase (ALT), aspartate aminotransferase (AST), leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Exclusion Criteria:

* Autoimmune disease
* Decompensated liver disease or cirrhosis
* Poorly controlled diabetes mellitus
* Severe psychiatric illness
* Severe chronic obstructive pulmonary disease (COPD)
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
* History of hemoglobinopathy
* Known retinal disease
* Subjects who are immunosuppressed
* Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
* Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
* Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Comparison of Biodegradable Stents: Orsiro and BioMatrix

The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.

The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.

The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 20 years old
2. Patients in the treatment of subjects with all-comer who are to undergo PCI

Exclusion Criteria:

1. Pregnant women or women with potential childbearing
2. Life expectancy \< 1 year
The Value of HBA in the Evaluation of Idiopathic Infertility

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate

Eligibility Criteria:
Inclusion Criteria:

* . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups

  1. Abnormal Semen Analysis (sperm count \<10 million/ml and /or rapid progressive motility \< 50 %, WHO morphology \<30%) normal HSG , normal ovarian reserve testing and ovulation testing
  2. Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH\< 10, AMH\>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
  3. Tubal infertility as assessed by HSG or laparoscopy

Exclusion Criteria:

* women over 40, prior failed IVF
A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and HLX10 for up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate and have signed the informed consent form (ICF);
2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF
3. Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
4. Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. First-line chemotherapy includes any of the following:

   1. Platinum-based drugs + taxanes;
   2. Platinum-based drugs + topotecan;
   3. Taxanes + topotecan.
5. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
6. Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).
7. An ECOG score of 0 or 1.
8. Conforming to laboratory measurements;

Exclusion Criteria:

1. Patients who have previously received albumin-bound paclitaxel.
2. Patients with other active malignancies within 5 years or at the same time.
3. Patients who are preparing for or have received an organ or bone marrow transplant.
4. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
5. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.
6. Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) \< 50% by cardiac colour Doppler.

8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.
Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia

The investigators hypothesized that the CRP/troponin ratio measured in patients presenting to the ED with elevated troponin levels could differentiate between patients with cardiac ischemia and those who present due to a systemic inflammatory or infectious disease. The aim of the study was to determine the necessary CRP/troponin ratio required to rule out cardiac ischemia in a large ED population and determine its impact on long-term prognosis.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ED in the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (\>0.014 nanogram/milliliter).

Exclusion Criteria:

* None
Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Population-based retrospective studies suggest an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis. While the overall incidence of myocarditis is estimated to be 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher. Adult health care workers who received the BNT162b2 vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign had blood samples taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days. Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and \>50% increase from the first measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis including electrocardiogram and echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Adult health care workers (≥18 years old)

Exclusion Criteria:

* Acute coronary syndrome, peri/myocarditis, cardiac catheterization, cardiac surgery, cardiac ablation, or any other invasive cardiac procedure within 14 days prior to study enrollment.
* Chronic renal failure (creatinine clearance ≤30 mL/min), or dilated or hypertrophic cardiomyopathy