cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Sternum Guard in Post Cardiac Surgery Patient

This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.

A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was conducted from May 17th, 2020 until October 20th, 2021 (current status: completed). This study assessed the efficacy of Sternum GuardTM, a commercially-available nonwoven cellulose based, single use, sterile surgical drape used for covering the dissected sternal bone edge during median sternotomy for cardiac surgery. The active comparator/ control group in this study is the use of Bone wax, a vaseline and beeswax-made materials widely used during sternotomy as a mean of bleeding control. The subjects were adults undergoing elective cardiac surgery with median sternotomy approach for any indication. Both the patients and the principal investigators were blinded for the treatment-control allocation, but the surgeon were not blinded for the materials used. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative. The minimum sample size was 414 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages \> 18 years old
* Patients who are scheduled electively for cardiac surgery
* Cardiac surgery with the usage of cardiopulmonary bypass machine
* Patients who are agreed to participate in this study

Exclusion Criteria:

* Patients who are scheduled for surgery in emergency or urgent manner
* Patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus.
* Patients with the history of past cardiac surgery

Drop - out Criteria:

* Patients who are pronounced death on operation table
* Patients who are pronounced death within hospitalization
* Patients who are lost to follow up (Day 30 post-operative)
* Patients who are not committed for the whole stage of the research
To Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Direct-acting oral anticoagulants (DOACs) have provided benefits to patients requiring anticoagulation for certain diseases by decreasing the burden of subcutaneous injections and the requirement for frequent monitoring through regular blood tests. DOACs do not require monitoring, have a more predictable pharmacokinetic (dosing) profile and have fewer interactions with other drugs. Various studies have reported the efficacy and safety of different dual-acting anticoagulants around the globe. However, there is little data available from Pakistan. Therefore, investigators propose this study to assess the efficiency and safety of rivaroxaban and clopidogrel along with aspirin in patients suffering from acute coronary syndrome. The objective of this study is to investigate the efficacy of dual anticoagulants i.e. aspirin plus rivaroxaban versus aspirin plus clopidogrel in patients suffering from acute coronary syndrome in terms of secondary prophylaxis. All the patient records will be documented in Case Report Form (CRF) at each visit. All data will be recorded in individual source documents. All CRF information is to be filled in by site staff. If an item is not available or is not applicable, this fact should be indicated. Blank spaces should not be present unless otherwise directed. The study monitor will perform source data verification of data entered into the CRF. The data entered into the CRF will be subject to data validation checks for consistency and completeness by the data management group. All CRFs should be maintained on the system with details of any changes logged accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged ≥ 18 years and above
* Participants able to understand the study procedures and willing to give written informed consent/assent to participate in the trial
* Participants willing to follow the study procedures of the study and available for the entire duration of the study.
* Female participants of childbearing potential must have a negative urine pregnancy test
* Women of childbearing potential (WOCBP) must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of study treatment, to avoid pregnancy. (This is in line with regulatory Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals)

Exclusion Criteria:

* Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
* Arrhythmias
* Pre-existing hepatic disease
* Pre-existing renal disease
* Already taking any drug
* Pregnancy
* Thyroid dysfunctions
Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection

To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.

Objectives To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.

Background Detection of cardiac rejection is a major problem in cardiac transplantation. Invasive screenings at predefined time intervals for cellular rejection with using endomyocardial biopsies are standard procedures. However, cardiac biopsies are distressing and risky and are also costly. Moreover, as the histological expression of allograft rejection is patchy, endomyocardial biopsies may lead to sampling error. Thus, as the sensitivity is low and variable (range for 40 to 95%), indication of biopsy is still of debate.

Materials and methods All patients who undergone cardiac transplant are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine endomyocardial biopsies and cardiac MRI. Histological diagnosis of cellular rejection is given by the BILLINGHAM classification which is used in daily practice. Diagnosis of rejection of cardiac MRI is defined by the association of hyperintensity on T2-weighted sequence, and on gadolinium-enhanced sequences including SSFP (study state free precession) and myocardial delayed enhancement. Both MRI parameters attest of the presence of myocardial oedema related to acute rejection. Myocardial oedema is also associated with segmental abnormalities of myocardial contraction which is assessed by both CMR-tagged sequence.

Written informed consent will be required from the patients. Institutional review board approval will also be required.

Expected results and clinical implications We expect to demonstrate that CMRI is effective for detection of cellular rejection with a high sensitivity (expected sensitivity\>95%) as compared to cardiac biopsy. In that condition, cardiac MRI could replace the invasive biopsy for serial detection and follow-up of rejection in heart transplant.

Eligibility Criteria:
Inclusion Criteria:

* all patients who had undergone cardiac transplants are eligible

Exclusion Criteria:

* no consent
* allergy to contrast agent (Gadolinium)
* severe renal failure (clearance \< 30ml/min/1.73m²)
* claustrophobia
* severe arrhythmias
* absence of medical care insurance
* pregnancy
Internet Intervention for Adolescents With Chronic Pain

The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.

An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.

Eligibility Criteria:
Inclusion Criteria:

* Literate in English
* Age 11-17 years
* Pain present for at least 3 months duration
* Pain occurs at least 1 time per week and interferes with daily functioning
* Pain is not related to a chronic disease
* Receiving evaluation or treatment in a pediatric pain clinic
* Has access to a computer, the Internet, and a phone

Exclusion Criteria:

* A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
* Non-English speaking
* More than 4 sessions of CBT for pain management in the 6 months prior to the time of screening.
"FU-IFM2009" Database Post IFM/DFCI 2009 Study

Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators


Eligibility Criteria:
Inclusion Criteria:

* Patient randomized in the IFM/DFCI 2009 study.
* Patient still alive must give their non-opposition to the post IFM/DFCI 2009 study data collection until 30 November 2020
* Patient non-opposition.
Basic Life Support by Children

A controlled clinical trial will be performed.

School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza.

One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year.

The investigators think that the knowledge will be better in the group that receives two interventions.

A controlled clinical trial will be performed.

72 participants between 10 and 11 years old will be selected and randomized to participate.

Control group and experimental group will enrolled 36 participants each one. Control group will receive BLS training once. Experimental group will receive BLS training in two consecutive years.

Previous and after training a test will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Children from 10 to 12 years old that are attending to the selected school at the moment of the intervention
* Children with signed consent given by parents at the moment of the intervention

Exclusion Criteria:

* Children not attending all the theorical and practical interventions
* Children not completing all test.
* Children with learning disabilities
Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles

The purpose of this study is to test the external validity of the systemic ultrasound protocol for data acquisition and interpretation, in order to diagnose soft tissue and osteochondral abnormalities in hemophilic children.

Ultrasound has advantages over MRI as it is less expensive, does not require sedation and is more readily available in centres around the world. Given these characteristics of ultrasound it is an ideal imaging tool for early assessment of hemophilic joints in countries whose access to MRI is limited. Early evaluation of soft tissue changes in young hemophilic patients may lead to earlier interventions and better mid-term and long-term clinical outcomes. By this way the joint function of hemophilic patients can be preserved, saving their joints from severe arthropathy and offering them the possibility of a normal professional life in the society.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemophilia A (factor VIII deficiency ≤1%) or B (factor IX deficiency ≤1.0%)
* Cooperative patients (age of 7 to 18 years old)
* Patients under 7 years old who have clinical evidence of arthropathy and imaging studies are required for clinical reasons. In these cases, the procedures may be done under sedation.
* Male sex (higher prevalence in males)
* History of previous ankle or knee bleed

Exclusion Criteria:

* Co-morbid illness such as juvenile idiopathic arthritis, muscular dystrophy, neuropathic arthropathy that cause osteoarticular findings that may obscure or confound the hemophilia-based joint findings
* Non-cooperative patients
* Active bleed (defined as evidence of a recent bleed with one week of the proposing imaging studies and/or musculoskeletal changes on physical examination suggestive of a bleed within one week of the proposed imaging studies).
* Prior synovectomy
Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=3 days from enrollment
* Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
* Able to provide informed consent

Exclusion Criteria:

* Unable to take oral medication
* Pregnant or breastfeeding
* On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
* Requiring ≥6L oxygen or respiratory rate ≥30
* Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
* Known hypersensitivity to bicalutamide or its components.
* A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin \> 3x the upper limit of normal
* Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction \< 40%
* Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.
Accessible Weight Loss for Adults With Low Vision: A Feasibility Study

This study will examine the feasibility of an all-remote approach to enrollment in and implementation of an 8-week weight loss program for adults with low vision. The weight loss program will provide asynchronous support (information, automated texting feedback, tailored emails) for adopting and maintaining lifestyle-based strategies for safe and effective weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* English speaking
* BMI ≥ 25 and weight \< 300lbs (weight limit due to scale limitations)
* Legally blind
* Have an email for personal use and ability to check and respond to email daily
* Have a smart phone with texting for personal use
* Sufficient internet plan for daily email checking
* Sufficient phone plan for 12 or more texts per week
* Ability to send and receive emails and text messages
* Ability to join a zoom call on a personal phone, tablet, or computer
* Ability to complete Qualtrics surveys
* Willing to lose weight through recommended dietary changes, weight tracking and physical activity
* Interest in one of the specific dietary strategies supported by the text messaging platform
* Willing to use the study scale with cellular technology to report weights
* Willing to join an 8-week weight loss program and interested in losing weight
* Completion of screening, enrollment and baseline data collection

Exclusion Criteria:

* Lost 5% of body weight in the last 6 months
* Currently participating in a weight loss program or another weight loss study
* Previously diagnosed eating disorder, or treatment for an eating disorder
* Pregnant, nursing, or planned pregnancy in the next 6 months
* Planned weight loss surgery or procedure in the next 6 months
* Currently using medication for weight loss (prescribed or over the counter)
* History of cardiovascular events
* History of type 1 or type 2 diabetes
* Prescribed medication that might promote weight change such as lithium, steroids, or antipsychotics
* Medical contraindicate to weight loss (e.g., end-stage renal disease, cancer diagnosis with active/planned treatment)
* Psychiatric hospitalization in the past 12 months
* Investigator discretion for safety or to ensure appropriate treatment of study staff
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Primary Objective:

To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.

Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Eligibility Criteria:
Inclusion criteria :

* Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.
* Signed written informed consent.

Exclusion criteria:

* At the screening visit: age \<20 years.
* At the screening visit: HbA1c \<7.5% or \>10%.
* At the screening visit: fasting plasma glucose (FPG) \>250 mg/dL (13.8 mmol/L).
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit.
* Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).
* Laboratory findings at the screening visit, including:
* Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN),
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN,
* Calcitonin ≥20 pg/mL (5.9 pmol/L),
* Positive serum pregnancy test.
* Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol.
* Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
* Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 or end-stage renal disease for patient not treated with metformin.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.


Eligibility Criteria:
Inclusion Criteria:

* Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria:

* Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment.