cyrilzakka/clinical-trials huggingface dataset:
Video-Based Social Learning or Didactics for Car Seat Education

This study compares a video-based social learning method to the traditional didactic method as a new way to teach caregivers about child passenger safety, including how to install a car seat. Half of the caregivers will attend the video-based social learning class, while the other half will attend the traditional didactic class. The investigators hypothesize that the video-based social learning method will lead to an equal or greater increase in caregiver child passenger safety proficiency when compared to the traditional didactic method.

Previous studies have demonstrated the effectiveness of child passenger safety education, however, there is limited research identifying an optimal teaching method.

Social learning teaching methods are beneficial in promoting health-behavior change. The social learning theory hypothesizes that people learn and change their behavior by observation and modeling. The video used in the social learning method shows parents as role models methodically teaching proper car seat installation in a vehicle.

Traditionally, child passenger safety education classes are didactic in design, relying on lecture formats and live demonstrations. The didactic method includes verbal instructions from a child passenger safety technician about car seat installation.

Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers of car seat-age children (age zero to three years)
* Participation in the Kids Ride Safe Program

Exclusion Criteria:

* Spoke a language other than English or Spanish
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and warfarin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study
Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.

The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age \>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) \>25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

- Adults undergoing colonoscopy.

Exclusion Criteria:

* 1.presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
* 2.Patients with galactosemia;
* 3. hypersensitivity to any of the ingredients;
* 4.Pregnancy or lactation;
* 5.Use of lactulose,prokinetic agents or purgatives within 7 days;
* 6.Unwilling to sign informed consent.
Safety and Tolerability of Seroguard Use

The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

The present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. After successful completion of screening procedures, patient underwent a planned laparoscopy. Randomization of patients into groups was performed on the day of surgery using envelops. The test drug or the placebo were used at the completion stage of surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. Discharge of patient from the hospital with no contraindications was possible on Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis. Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients.
2. Age from 18 to 75 years, inclusive.
3. Signed informed consent form.
4. One of the following diagnoses as per International classification of diseases -10:

   4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of gallbladder without cholecystitis
5. Indications for planned laparoscopic cholecystectomy.

Exclusion Criteria:

1. Recall of informed consent by patient.
2. Non-compliance with the rules of participating in the study by patient.
3. Getting pregnant.
4. Required conversion during surgery.
5. Required repeated surgery.
6. Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient.
7. Another reasons appeared during the study and interfering conduction of the study as per the protocol.
Optimizing Fluid Status

Title of study: Optimizing Fluid Status

Study code: HD-IIT-01-E

Study design: Prospective open design in study centre at two locations

Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight

Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.

Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:

* time averaged fluid overload (TAFO),
* proportion of patients with severe overhydration OH \> 2.5 L,or OH/ECW \> 15 %)
* proportion of dehydrated patients (OH \< -1.0 L, or OH \< -7 %),
* mean overhydration,
* variance of overhydration,
* time outside the reference range (-1.0L \< OH \< 2.5L).

Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes

Patients: 60 patients


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure stage V
* Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
* Ability to understand the nature and requirements of the study
* Age: at least 18 years
* Signed informed consent.

Exclusion Criteria:

* Interventional clinical study during the preceding 30 days or previous participation in the same study
* Acute or chronic infection (HIV, Hepatitis B or C, ...)
* Severe disease (malignant tumour, tuberculosis ...)
* Usually single needle HD
* Problems with shunt or high recirculation,
* Severe intra-dialytic blood pressure instability in the last month
* Instable angina pectoris
* Major amputation at arm or leg, or a pacemaker.
Assessing the Efficacy of Steroid Treatment of Achalasia

Would systemic steroids be an effective treatment in early variants of achalasia?


Eligibility Criteria:
Inclusion criteria:

* Adults ages 18-90 with a diagnosis of achalasia confirmed by findings on esophageal manometry and barium esophagogram will be eligible for the study.
* Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation
* Symptoms less than 2 years

Exclusion criteria:

* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy and injection;
* Greater than mild esophageal dilation
* Type 1 achalasia as defined by the Chicago classification scheme7 and/or esophageal diameter \> 3cm;
* Prior treatment for achalasia
* Use of medications that might affect LES pressure such as anticholinergics or calcium channel antagonists
* Symptom duration greater than 2 years
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
* Pregnant and lactating females will be excluded as steroids are not thought safe for the fetus.
Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs. Based upon these national COPD prevalence data, we estimate that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the care of these patients costs up to $490 million annually. Therefore, to alter the impact of COPD on the State and People of Colorado, we propose to introduce a telephone-dependent, internet-supported, self-monitoring "eHealth" management system in both urban and rural Colorado settings in order to decrease healthcare utilization, improve the management of COPD based upon current national guidelines, improve quality of life, reduce health care costs decrease COPD exacerbations. We base this program on a successful clinical pilot study, performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated dramatic improvements in quality of life and decreased health care costs. We propose to enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the patients with the highest healthcare costs, the greatest disability, and the highest mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy of this proactive management strategy as it is disseminated throughout urban and rural Colorado. In this first phase we will target two Denver Metro sites, UCH and Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites because of their strong interest in enacting the eHealth Program, because of their organized systems of healthcare delivery and because of the numbers of COPD patients that they serve. We are particularly enthusiastic about the application of this technology to rural, underserved areas, because this approach has the potential to dramatically improve delivery of healthcare to a large portion of Colorado that is chronically plagued by inadequate health care networks and lack of specialty care. More broadly, we are enthusiastic about the prospect that eHealth programs may hold the potential to improve healthcare delivery for many chronic illnesses, in addition to COPD.


Eligibility Criteria:
Inclusion Criteria:

* COPD Diagnosis per GOLD Guidelines
* Airflow obstruction on spirometry defined as an FEV1/FVC less than or equal to 70% and an FEV1 less than or equal to 50% predicted, or an FEV1 greater than 50% predicted with a history of a COPD exacerbation within the previous year.
* Standard telephone access
* US Citizen and Colorado resident

Exclusion Criteria:

* Asthma
* Co-existing conditions that are likely to cause death within two years, CXR evidence of interstitial lung disease or other pulmonary diagnoses at the time of enrollment, end-stage liver disease, end-stage renal disease, end-stage muscle disease, HIV disease or dementia.
Magna Mitral - 23mm

The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.

This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has mitral valve disease requiring surgical replacement
2. Patient has provided written informed consent prior to mitral valve surgery
3. Patient is expected to survive surgery and be discharged
4. Patient is willing to comply with specified follow-up evaluations
5. Patient is 13 years of age or older

Exclusion Criteria:

1. Patient has life expectancy \< 12 months due to non-cardiac co-morbid conditions;
2. Patient has/had active endocarditis within the last 3 months
3. Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
4. Patient was previously enrolled and implanted in the study
5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ
6. Patient has a body surface area (BSA) \> 1.9m2
7. Female patients who are pregnant, planning to become pregnant, or lactating
8. Patient has a documented history of substance ( drug or alcohol) abuse
9. Patient is currently a prison inmate
10. Patient is currently participating in an investigational drug or another device study
11. Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
12. Patient has active myocarditis
13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized \> 30 days prior to the planned v alve implant surgery
14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of a hematologic malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
* Agreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
* Completion of all therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy.
* ANC ≥ 0.5 x 10\^9/L or platelet count ≥ 50 x 10\^9/L unless due to disease involvement in the bone marrow.

Main Exclusion Criteria:

* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
* Central nervous system (CNS) involvement by lymphoma/leukemia
* Any therapeutic antibody within 4 weeks of first dose of study drugs.
* Total bilirubin \> 1.5 x ULN; and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 x ULN.
* Estimated creatinine clearance of \< 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female.
Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients

According to the latest published literature reviews, stroke patients have a prevalence of 19.5% of minor depression and 21.7% of major depression. Furthermore, the loss of autonomy is the most strongly correlated variable in these emotional disorders. In addition, emotional disturbances - in particular anxiety, sadness, crying, and anhedonia - are interpreted as natural reactions to the loss of physical capacity. Along these lines, it has been shown that the use of Virtual Reality (VR) as a co-adjuvant therapy of neuro-rehabilitation in stroke patients with emotional disorders decreases the incidence of these disorders.

. Primary objective

- To evaluate the impact on mood, anxiety and depression in patients admitted to neurorehabilitation units after the use of non-immersive virtual reality with the Nintento Switch device in their rehabilitation treatment.

Secondary objectives

* To describe the emotional state of patients before the use of non-immersive virtual therapy in their rehabilitation.
* To describe the emotional state of patients after the use of virtual reality in their rehabilitation.
* To compare the emotional state of patients before and after the implementation of virtual therapy in their rehabilitation.
* To describe the emotional state of patients who have not used non-immersive virtual reality in their rehabilitation by choice.
* To evaluate the efficacy of the involvement of the use of virtual reality therapy in patients with altered emotional state.

Eligibility Criteria:
Inclusion Criteria:

* To be of legal age
* Fluent in oral and written Spanish.
* Patients with cognitive functions of expression and comprehension.

Exclusion Criteria:

* Patients who are not undergoing neurorehabilitation treatment.
* Patients who have not yet started rehabilitation treatment.
Impact of Periodontal Treatment on Local miRNA Expression

To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent.

The patients selected for the study were divided into 2 groups: group 1 (FM-SRP), group 2 (Q-SRP). Any selected subject underwent anamnestic and periodontal examination, blood and GCF sampling. MiRNA in the GCF was extracted through a commercially available kit and then measured carrying out real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers

The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.

Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.

Eligibility Criteria:
Inclusion Criteria: - age \>15

* need of radiotherapy
* at least half of the mouth in the field of radiation
* dose 50 -70 Gy
* head \& neck malignancy

Exclusion Criteria:

* systemic disease
* FBS \> 150 WBC \> 3000
* history of radiotherapy
* need of chemotherapy
* systemic disease
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow

The purpose of this study was to compare the immediate efficacy of Counterforce brace versus kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a repetitive physical task. The investigators hypothesized that there would be difference in the outcomes with respect to interventions and activity. Patient came for one hour long Single occasion testing session and were not followed up after the testing was complete.

This was a cross over randomized control trial. Thirty patients with clinical diagnosis of lateral epicondylosis/tennis elbow were recruited from a local community and were tested on single occasion (one time testing session) before and after a five minute upper extremity repetitive task first with control and then brace and kinesiotape assigned in cross-over design. The testing session was one hour long and there was no follow up of patients following the testing. The patients were recruited between Jan-June 2013.

Eligibility Criteria:
Inclusion Criteria:

1. Age (18-70 years)
2. Ability to provide written informed consent to participate
3. Were at least three weeks from onset of symptoms
4. Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle
5. Provocation of lateral elbow pain with one of the following test - resisted middle finger extension, resisted wrist extension or passive stretch of wrist extensors

Exclusion Criteria:

1. History of surgery on affected elbow
2. History of cortisone injections on the affected elbow in the past 4 weeks
3. Any physical or mental limitations that precluded performance of the study testing
4. Allergy to adhesive tapes