cyrilzakka/clinical-trials huggingface dataset:
The Effect of T-CPR on the Quality of CPR and AED Use

The purpose of the study is to examine the effect of telephone assistance and standardized basic life support courses on the quality of cardiopulmonary resuscitation (CPR) and the use of automated external defibrillator (AED).

The investigators hypothesize that bystanders can provide compressions in correct frequency and use an AED correctly as well as safely from telephone instructions but that correct and successful ventilations including correct open airway require training on a course.

The study aims at answering the following research questions:

1. How is the quality of CPR and use of AED when performed by an inexperienced bystander who receives telephone assistance compared to the quality when performed by a trained bystander, who has passed a standardized European Resuscitation Council (ERC) course in basic life support (BLS) but does not receive telephone assistance?
2. How is the quality of CPR and use of AED when performed by a trained bystander who has passed a standardized ERC course in BLS and who receives telephone assistance compared to the quality when performed by a trained bystander who does not receive telephone assistance?

The questions are sought answered through simulated cardiac arrest scenarios in non-classroom settings.

Participants are recruited from ERC courses in BLS.

Participants are randomised to one of three groups (stratified for course type using computer-generated randomisation lists with blocks of variable sizes):

1. Cardiac arrest scenario test before BLS course with telephone-assistance.
2. Cardiac arrest scenario test after BLS course, no telephone-assistance.
3. Cardiac arrest scenario test after BLS course with telephone-assistance.

Eligibility Criteria:
Inclusion Criteria:

* Participant at a European Resuscitation Council standardized basic life support course. Participants are enrolled from courses for university students, courses for elderly and courses for recruits in the Danish Emergency Management Agency.

Exclusion Criteria:

* Basic life support course within the last two years.
* Healthcare professional or background as healthcare professional.
* Instructor in basic life support or first aid.
* Lifeguard or background as lifeguard.
* Does not want to participate.
Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major

Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia

Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration.

General objective:

To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major

Specific objectives:

1. To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section.
2. To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major
3. To examine the effect of tranexamic acid on platelet level for caesarean section for PP major
4. To observe the side effects of tranexamic acid

This study will be conducted at University Kebangsaan Malaysia Medical Centre (UKMMC). Patients who meet the inclusion criteria will be invited to participate in the study. Patient will be given the information sheet regarding the study and consent will be taken if agreeable to participate. Patients' demographic data will be recorded.

Patients will be classified randomly into two groups using a computer-generated randomization system (Microsoft Office Excel). The list of randomization will be concealed and numbered on sealed opaque envelopes. Each number will be given a readily prepared 10ml syringe of colourless solution, which could either contain the tranexamic acid or placebo.

Each patient will be assigned a serial identification number. The data will be analysed using the Statistical Package for Social Sciences (SPSS).

Eligibility Criteria:
Inclusion Criteria:

* all placenta previa major pregnant women

Exclusion Criteria:

1. Any cardiac disorder or liver disease
2. Patient on anticoagulant therapy
3. History of allergy to tranexamic acid
4. Any contraindication for tranexamic acid
Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus

This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo.

ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin resistance as a result of NF-KB reduction in diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 of diabetes diagnosed for 1 to 10 years
* age 30-60 years
* BMI = 18.5-35 kg/m\*m
* treatment with Metformin or Glibenclamide

Exclusion Criteria:

* Treatment with insulin
* Weight loss more than 10% in 6 months
* Treatment with TZDs (thiazolidinediones)
* Pregnancy and breast feeding
* Smoking and alcohol consumption
* Multivitamin-mineral and polyphenols and omega-3 and 6 supplementation in the last 3 months and during study
* Ginger supplementation and herbal medicines
* Anticoagulation consumption such as heparin and warfarin
* NSAIDs such as diclofenac and salicylate drugs such as aspirin, corticosteroids such as prednisone consumption during 1 month ago and during the study
* Infectious and inflammatory diseases such as rheumatoid arthritis
* Impaired hepatic, renal and gastrointestinal function
* Cancer
* Currently suffering from acute illness that needs medical treatment
Insulin Glargine During and After the Period of Fasting in Ramadan

Primary Objectives :

* To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.

Secondary Objectives :

* To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary).
* To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan.
* To assess patient satisfaction
* To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
* BMI \> 25 and \< 40 kg/m2;
* Willingness to participate and to fast during Ramadan;
* Patients should be either:

  * Insulin naïve patients
  * Patients already receiving insulin

Exclusion Criteria:

* Pregnancy (as determined by pregnancy blood test at inclusion visit)
* Breast- feeding
* Women of childbearing potential who do not have adequate contraceptive protection
* Need for treatment during the study period with medications that may interfere with the study protocol
* Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
* History of drug or alcohol abuse
* Severe and unbalanced diabetic retinopathy
* Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
* Night shift workers
Effect of a Probiotic on the Urinary Tract Microbiota of Participants with Recurrent Urinary Tract Infection.

Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI).

The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).


Eligibility Criteria:
Inclusion Criteria:

* Adult women with aged between 18 and 55 years old, diagnosed with recurrent UTI (defined as at least two episodes during the last six months or three during the last 12 months).
* Diagnosed, the last 7days, for a new UTI episode.
* Written informed consent signed.

Exclusion Criteria:

* Menopausal
* Pregnant, breastfeeding or planning to become pregnant during the study.
* Congenital abnormalities of the urinary tract.
* Renal functional alterations, such as neurogenic bladder or vesicoureteral reflux.
* Relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc.
* Permanent catheter.
* Immunocompromised (eg: cancer and/or transplant, patients who are taking immunosuppressive drugs, patients with hereditary diseases that affect or may affect the immune system).
* Type I diabetes.
* With a defect in the intestinal epithelium barrier (eg: chronic diarrhea, inflammatory bowel disease).
* Heart failure and cardiac medical history (eg, artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
* Under antibiotics prophylactic treatment without willingness to leave it at the time of inclusion.
* Probiotics supplementation during the previous 2 weeks.
* To have received Urovac, Uro-Vaxom or equivalent vaccine during the last year.
* Currently participating in another clinical trial.
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).

Gastrectomy is a well-known risk factor for TB. Also, there were some reports about malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of recently used first line anti-TB drugs in the gastrectomized patients have not been well evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary TB through this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years and less than 80 years
2. pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
3. usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)

Exclusion Criteria:

1. patients with liver disease (bilirubin ≥ 1.5 mg/d or AST ≥ 2 x normal upper limit) or chronic renal failure (Cr ≥ 2.0 mg/d) who cannot use first-line anti-TB drugs
2. patients with AIDS or hypoalbuminemia(albumin \< 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
3. patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
4. patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
5. discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
6. follow-up loss before completion of anti-TB treatment
7. any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group
Prediction of Outcome of Interventional Pain Management

Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.

Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.

Central pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.

NFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.

The study will be a prospective observational trial of diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic low back or neck pain (duration \>3 months)
* scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation

Exclusion Criteria:

* inability to understand the patient information or the study questionnaires
* patients \<18 years old
* patients with implanted pacemakers or defibrillators
Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters.

Investigators will include 24 patients without ventricular dysfunction (LVEF\> 50%) and with AV block pacing indication after TAVI.

Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional).

PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)

Clinical, and echocardiographic follow-up will be performed for 1 year.

Inclusion of 24 more patients to those already included in the context of PHYSTAVI I (NCT04482816). Exploratory trial.

Eligibility Criteria:
Inclusion Criteria:

* Successful implantation of TAVI according to VARC-3 criteria.
* Indication of cardiac pacing due to AV block according to ESC Guidelines.
* LVEF\> 50%.
* The patient must indicate their acceptance to participate in the study by signing an informed consent document.

Exclusion Criteria:

* Ventricular dysfunction: LVEF \<50%.
* Transapical TAVI.
* Participating currently in a clinical investigation that includes an active treatment.
* Patients with left bundle branch block but without indication of pacing (AV block).
* Life expectancy \<12 months.
Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed diagnosis of stage III or IV epithelial ovarian cancer
* Have cancer that is resistant to platinum/taxane-based chemotherapy regimens
* Have measurable, progressive disease
* Have an ECOG PS ≤ 2

Exclusion Criteria:

* Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
* Have a life expectancy \< 3 months
* Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
* Received prior treatment with any platinum agent other than cisplatin or carboplatin.
* Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
The Acute Effects of Static and PNF Stretching Exercise With Blood Flow Restriction in Athletes

The study aims to examine the acute effects of static and proprioceptive neuromuscular facilitation stretching exercises with blood flow restriction on hamstring flexibility, muscle strength, and single leg hop in athletes. Outcome measures were hip range of motion, isometric and eccentric hamstring muscle strength, and single leg hop distance.

A total of 109 athletes were included in the study. Participants were randomized into five groups: (1) static stretching, (2) proprioceptive neuromuscular facilitation (PNF) stretching, (3) blood flow restriction (BFR) + static stretching, (4) BFR + PNF stretching, and (5) control groups. Stretching exercises were performed on the dominant leg hamstring muscle group for 3 sets of 15 seconds each. BFR was applied during the stretching to the blood flow restriction (BFR) + static stretching and BFR + PNF stretching groups. No stretching was applied to the control group.

Assessments were performed at baseline and immediately after stretching. Hamstring flexibility (hip joint range of motion) was assessed via the passive straight leg raise test. Isometric and eccentric hamstring muscle strength were measured using a hand-held dynamometer, and muscle power was assessed using the single leg hop distance.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-40 years old
* Engaged in regular physical activity for at least 8 hours a week for the last 6 months
* Body mass index (BMI) \< than 30 kg/m²
* Momentary blood pressure less than 135/85 mmHg

Exclusion Criteria:

* History of fractures or surgical operations involving the lower limbs, hips, or lumbar region
* history of fractures, surgeries and other diagnosed medical conditions on the lower extremity, hip, and lumbar region
* Systemic musculoskeletal disease
* Pain in the lower back, hips, or lower extremities
* Known hip deformity or diagnosis of scoliosis
* History of deep vein thrombosis or embolism
* Diagnosis of circulatory system diseases such as hypertension or peripheral vascular disease
* History of anemia
* Previous cerebrovascular disease or myocardial infarction.
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days.

The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 Diabetes Mellitus
* Body Mass Index (BMI) between 18.5 and 28.5 kg/m\^2, both inclusive
* HbA1c \<= 75 mmol/mol (\<=9.0%).
* Fasting negative C-peptide (\<= 0.30 nmol/L).
* Total insulin dose of \< 1.2 (I)U/kg/day.
* Stable insulin regimen (with respect to safety of the subject and scientific integrity of the study) using continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) for at least 2 months.

Exclusion Criteria:

* Known or suspected hypersensitivity to IMP(s) or related products.
* Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
* Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
* Any history or presence of clinically relevant comorbidity capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
* Signs of acute illness as judged by the Investigator.
* Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator.
* Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
* Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (\<1.5 years) ophthalmologic examination.
* Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 3 months prior to screening.
Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life

The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

In this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants.

Differences between relatively healthy and sick preterm infants will be explored. A focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Very low birthweight infants