cyrilzakka/clinical-trials huggingface dataset:
Education and Fitness: EDUFIT Study

EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical fitness and other health-related factors in a school setting in adolescents.

Physical fitness is a powerful marker of cardiovascular health already at early stages in life. To promote physical fitness enhancement from the school is therefore needed and this is the main aim of the EDUFIT study (EDUcation for FITness).

The participants were randomly allocated to control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). The CG received 2 physical education sessions/week, the EG1 received 4 physical education sessions/week (volume increased) and the EG2 received 4 physical education sessions/week of high intensity (volume+intensity increased). Several health-related parameters were assessed before and after a 16-weeks intervention: physical fitness (primary outcome), body composition (secondary), and lipid-metabolic profile, ventilatory parameters, blood pressure, and cognitive and academic performance (tertiary outcomes).

The hypothesis of the EDUFIT project was that to double the number of physical education classes will improve physical fitness in adolescents. The confirmation of the hypothesis could have important public health implications.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents enrolled in the Spanish Educational System, free of any muscle-skeletal problem not allowing take part in Physical Education lessons or fitness testing.

Exclusion Criteria:

* Clinical diagnosis of diabetes
* Pregnancy
* Drugs/alcohol abuse
* In general, any chronic disease that does not permit the person to perform exercise and physical education lessons.
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach

This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain

This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:

Part I (Demographic data):

* Age, Gender, Weight, Height ,Smoke history

Part II (Preoperative data):

* Medical history, Clinical assessment, Preoperative investigation

Part III (Intraoperative data):

* Surgical time, and Ischemic time

Part IV (Postoperative data):

* Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with mitral valve disease indicated for valve surgery

Exclusion Criteria:

* Double valve disease or other valve disease
* Mitral or aortic valve disease associated with ischemic heart disease
* Mitral or aortic valve disease associated with congenital heart disease
* Patients subjected to prior heart surgery
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML with no history of previous clonal/malignant hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
* Newly diagnosed patients will be age 70 or older
* Relapses patients will be age 60 or older any time following first relapse, if patient is not considered candidate/not interested in salvage chemotherapy.
* Refractory disease patients will be age 18-59 who have failed at least 2 lines of conventional chemotherapy (1 induction and 1 salvage)
* Patient must have discontinued all previous therapies for AML at least 14 days and recovered from the non-hematologic side effects of the therapy.
* Laboratory tests must be within protocol-specified ranges
* Patient must be able to swallow and tolerate oral medication.

Exclusion Criteria:

* Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging.
* History of antecedent pre-leukemic hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
* Diagnosis of acute promyelocytic leukemia (APL)
* Patients who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort are not eligible.
* Patients with active corneal erosions or history of abnormal corneal sensitivity test.
* Patients with serious illness such as: significant ongoing or active infection, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable angina (anginal symptoms at rest), new onset angina (began within the last 3 months), myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or psychiatric illness that would limit compliance with the study requirements.
Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

This study evaluates the antithrombotic therapy in patients suffering from atrial fibrillation after stent implantation in Germany. Patients prescribed with the novel oral anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the medication schedule and for complications that occurred after index PCI.

Patients suffering from non-valvular atrial fibrillation and presenting with an acute coronary syndrome require special attention with regard to antithrombotic therapy. Current guidelines recommend use of oral anticoagulation for almost all of these patients, the optimal antithrombotic strategy, however, has still to be defined. As with the use of any antithrombotic drug, clinicians need to balance the risks of ischemic stroke and thromboembolism, recurrent cardiac ischemia and/or stent thrombosis, and bleeding and haemorrhagic stroke.

A recently published randomized clinical trial (PIONEER AF) compared the combination of a novel oral anticoagulant (NOAC; Rivaroxaban) plus dual anti-platelet therapy (DAPT) with standard therapy consisting of vitamine K inhibitor plus DAPT. Patients treated with Rivaroxaban showed less incidence of bleedings, whereas ischemic complications, death or stroke were equal in the groups compared.

The RIVA-PCI Registry aims at providing an overview of the current antithrombotic treatment regimen in Germany in real life. Moreover, for patients receiving Rivaroxaban as part of their medication follow-up data with regard to their adherence to antithrombotic medication as well as complications over an interval of 14 months after index procedure will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and capable of giving written informed consent
* Known or newly diagnosed non-valvular atrial fibrillation
* PCI with stent implantation during index hospital stay
* Written informed consent for participation in observational study (incl. telephone follow-up)
* Not simultaneously participating in any randomized trial

Exclusion Criteria:

* None
Health-Kit Enabled Mobile App for Tobacco Cessation

Tobacco use is the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API).

This Phase I Small Business Innovation Research (SBIR) explored the effects of one such innovative health IT solution. refresh is a highly individualized tobacco cessation HealthKit enabled app that 1) implemented a full range of best practices in tailored health behavior change communications based on readiness to change; 2) provided individualized behavior change guidance based on Health app data; and 3) concisely provided data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message delivered by clinicians to reinforce and accelerate a patient's behavior change progress. This interoperability provided value to both patients and clinicians; empowered and supported successful and lasting behavior change; and enabled the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.

Extensive end user and stakeholder input ensured that refresh was designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=51) were recruited to participate in a 30-day pilot test. Pre-post comparisons of Patient-Reported Outcomes Measurement Information System (PROMIS) measure for tobacco (psychosocial expectancies) and confidence for quitting provided preliminary data on the effects of the program. The hypothesis was that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up and greater confidence to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Current cigarette smoker
* Having an iPhone 6s or higher
* Willing and able to download a mobile app
* Able to read and speak English
* Having an upcoming appointment with a participating clinician in the next 42 days

Exclusion Criteria:

* Younger than 18
* Non-smoker
* Unable to read and speak English
* Not having an iPhone 6s or higher
* Not having an appointment with a participating clinician in the next 42 days
Comparability of Invasive and Non-invasive Haemodynamic Monitoring

During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called "extended hemodynamic monitoring" depending on the operation and patient. Frequently an invasive arterial cannula is used to provide continuous information on the blood pressure. This invasive method is very accurate and clinically established, but can be linked to adverse effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a non-invasive manner. It thus offers beat-to-beat information even about the extended hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform EV1000 (Edwards Lifescience).

Assuming that the two methods are equal we plan to measure extended hemodynamic parameters before, during induction and during ongoing anesthesia both invasive and non-invasive. Data will be recorded every 30sec.

Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters is to our knowledge rare and further assessment in this field is needed to offer patients a potentially equally reliable but less invasive monitoring. Furthermore the study should model the effect of remifentanil, propofol or its combination on haemodynamics .


Eligibility Criteria:
Inclusion Criteria:

* elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

* patient not consented
* peripheral vascular disease
Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health

The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning?

Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills.

Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks.

Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health


Eligibility Criteria:
Inclusion Criteria:

* child entering kindergarten in school that is participiating in the study

Exclusion Criteria:

* being in a classroom in which the teacher or EA was previously trained in another closely-related treatment protocol
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Primary Objective:

The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.


Eligibility Criteria:
Inclusion criteria:

* Males and females aged \>=18 and =\<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:

  * Crohn's Disease Activity Index (CDAI) score of \>=220 and =\<450
  * A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening
  * Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization
* Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:

  * Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion
  * Responded and became intolerant
* Further inclusion criteria apply

Exclusion criteria:

* Patients with ulcerative colitis or indeterminate colitis
* Patients with symptomatic known obstructive strictures
* Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial
* Patients with an ostomy or ileoanal pouch
* Patients with short bowel syndrome
* Patients who have previously used infliximab and have never clinically responded
* Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial
* Further exclusion criteria apply
Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2

The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study.

Many older adults rely on a manual wheelchair for community mobility but are not provided with skills for independent and effective use. Suboptimal or disuse of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This represents a poor use of financial resources, including the cost of wheelchair acquisition and demands for attendant care. Access to skills training is constrained by the cost and limited availability of skilled therapists, the demands of patient and clinician travel, and lack of programs designed specifically for the needs of older adults. Enhancing Participation In the Community by improving Wheelchair Skills (EPIC WheelS) is an individualized home-training program that optimizes learning for older adults while limiting the demands on expert clinician trainers. It is delivered using a portable computer tablet that allows interactive learning, customized updating, and communication with an expert trainer. A monitored, home program that is effective and efficient for older adults has potential application for other target groups as well, particularly those with limited access to rehabilitation services in rural and remote locations.

Eligibility Criteria:
Inclusion Criteria:

* at least 50 years old
* live in the community within metropolitan Winnipeg
* self-propel a MWC (Manual Wheelchair) at least 1 hour per day
* use their MWC for mobility outside of the home
* have used a MWC for less than 2 years

Exclusion Criteria:

* cannot communicate and complete study questionnaires in English
* anticipate a health condition that contraindicates wheelchair training
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.


Eligibility Criteria:
Inclusion Criteria:

* Medically-confirmed diagnosis of chronic idiopathic constipation
* Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
* Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

* Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial Advagraf minimum of 3 months.
* Subjects will be with clinically stable graft function for at least 3 months.

Exclusion Criteria:

* Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty

The aim of this study is to evaluate Virtual reality (VR) on perioperative anxiety, pain, hemodynamics, and stress hormones in patients undergoing Total hip arthroplasty (THA).

VR is a computer technology that provides the feeling of being immersed in a simulated three-dimensional (3D) world where the user may interact with the virtual environment. Clinical studies have shown that VR technology is effective in reducing pain perception and anxiety. It has also been proposed as an effective non-pharmacological alternative for reducing acute procedural pain and providing anxiety relief.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or above.
* Both sexes.
* The American Society of Anesthesiologists (ASA) physical status I-III.
* Scheduled for elective THA under spinal anesthesia.

Exclusion Criteria:

* Cerebrovascular disease.
* Psychiatric-cognitive dysfunction.
* Claustrophobia.
* Deaf and blind patients.
* Uncooperative.
* Adrenal insufficiency.
* Chronic alcohol and substance addiction.
* Chronic sedative and narcotic use.
Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence

Aim of the study is to compare effect of High Intensity Focused Ultrasound (HIFU) and platelet-rich fibrin in management of stress urinary incontinence.

It is a randomized prospective study. After assigning to one of the two groups, patients will undergo relevant treatment.

First group will undergo 3 cycles of intravaginal HIFU treatment in 6-weeks interval.

Second group will undergo 3 injections of platelet-rich fibrin under urethra. Before the treatment and after 2, 6 and 12 months after treatment is finished patients will be asked to fill questionaries concerning quality of life ICIQ-UI SF, ICIQ-LUTS, PISQ12, FSFI.

Before each treatment cycle patients will be examined and asked to fill daily micturition plan.


Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence of low grade
* separate episodes of urinary incontinence (associated with increase of abdominal pressure)
* no cystocoele or cystocoele POPQ1
* positive cough test when filled bladder

Exclusion Criteria:

* POPQ 2 and more
* patients after urogenital operations or radiation
* neuromuscular, hematologic, autoimmune, uncontrolled psychiatric diseases
* uncontrolled diabetes
* pregnancy, lactation
* patients undergoing conservative treatment for stress urinary incontinence
* ASA or other anti-platelet drug intake less than 7 days before and 7 days after procedure
* active carcinomas or status less than 5 years after treatment
* sepsis
* infection in treated region
The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm

After endoscopic resection of early gastric cancer (EGC), there remained concerned about the development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from January 2007 to May 2013 in single tertiary center, retrospectively. The baseline characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for the development of the MGN.


Eligibility Criteria:
Inclusion Criteria:

* The patients who tested serum PG concentration test and H. pylori status at the time of ESD and revealed pathologically complete en bloc resection after ESD for EGC.

Exclusion Criteria:

* previous history of ER; proven pathologically incomplete resection or lympho-vascular invasion on the resected ESD specimen; additional treatment after ESD; and follow-up loss less than 2 years.