cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings.

One promising strategy is Internet-based interventions for problem drinkers. The first randomized controlled trial found that the investigators could reduce alcohol consumption by about six drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. The investigators second randomized trial demonstrated that an extended Internet-based intervention that contained a range of cognitive-behavioural and relapse prevention tools could produce greater reductions in problem drinking compared to that provided by the same minimal intervention at a six-month follow-up. Building upon this research, the current project will assess whether this extended Internet-based intervention can have a sustained impact on problem drinking. Specifically, the major objective of this project is to conduct a randomized controlled trial comparing the impact of an extended Internet-based self-help intervention for problem drinkers to a minimal Internet-based intervention in the general population of problem drinkers over a two year period.

Problem drinking participants will be recruited through media advertisements across Canada and will be randomly assigned to the minimal or extended Internet-based interventions. Six-month, twelve-month and two-year drinking outcomes will be compared between experimental conditions. It is predicted that participants receiving the extended Internet intervention will display sustained improved drinking outcomes compared to participants in the minimal Internet intervention condition. This programmatic line of research will advance the science of Internet-mediated intervention.


Eligibility Criteria:
Inclusion Criteria:•Resident of Canada

* 18 years of age or over
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Indicate an interest in receiving self-help materials
* Have home access to the Internet
* Are willing to participate in follow-up at six month, twelve month and 2 year intervals

Exclusion Criteria:None

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Intervention in Habit, Automatic Affective Evaluations and Physical Activity Among University Students

The goal of this clinical trial is to test the effectiveness of the LifelongU intervention in habit, automatic affective evaluation and physical activity among university students. The main questions aim to answer are:

* What is the difference in habit, automatic affective evaluation and physical activity between the intervention and control groups?
* What is the difference in habit, automatic affective evaluation and physical activity between the before and after intervention?

Participants will attend 12 sessions of four modules that performed face-to-face physical education lessons. Lesson content included 10-min health-related fitness knowledge, 30-min fitness test and training, 50-min motor skill training with behavior change techniques (90 min per a lesson, once a week).

Researchers will compare control group to see if any effect difference.

A range of behavior change techniques derived from habit formation and self-regulation domain strategies will be used. These include behavioral rehearsal/practice, prompts/cues, and self-monitoring. The overall aim was to help students increase perceptions of physical competence and confidence, build positive affective attitude of physical activity, and develop autonomous association between physical activity and cues of time or events. Moreover, this intervention used student-centered learning strategies, game-centered approach in terms of mode of learning, and flexible in choice of timing, frequency, duration, and intensity of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-25 years
* failure meeting the recommended physical activity guidelines (\< 150 minutes MVPA or \< 70 minutes VIPA in total a week) at the time of recruitment, screened via the Global Physical Activity Questionnaire

Exclusion Criteria:

* student athletes
* the presence of health conditions that prevented safe engagement in physical activity, screened via the PAR-Q+.
Simultaneous Assessment of FFR and SPECT

The overall purpose of this research study is to identify the disparity in ischemia measurement between fractional flow reserve (FFR) used in the cardiac catheterization laboratory and myocardial perfusion stress- single-photon emission computed tomography (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT obtained using regadenoson in the catheterization laboratory.

Patients who are previously scheduled for diagnostic coronary angiography will be approached for consent to be part of the study. If the patient is found to have one or two vessel disease and it is planned by the interventional cardiologist that FFR will be used, then the previously consented patient will be deemed appropriate for the study. The standard procedure will be followed for FFR testing using regadenoson. The patient will then receive the standard dose of Tc-99m sestamibi. The interventional cardiologist will proceed with percutaneous coronary intervention (PCI) if appropriate. Patients will proceed to the cardiac catheterization laboratory holding area post procedure. Patients will then be scheduled to be taken to the nuclear cardiology laboratory one to three hours following the coronary angiogram for standard SPECT acquisition. Patients will be monitored for 2-6 hours or overnight as clinically indicated following diagnostic coronary angiography and PCI. Low dose resting myocardial perfusion scanning may be performed the next day if stress myocardial perfusion study was abnormal.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing clinically-indicated FFR measurement (to determine the hemodynamic significance of intermediate degrees of stenosis) for single or two -vessel epicardial coronary disease during diagnostic coronary angiography for suspected coronary artery disease.

Exclusion Criteria:

1. Patients with 3-vessel disease
2. Prior coronary artery bypass grafting
3. Patients with second or third- degree atrioventricular block, without a functioning pacemaker
4. Patients who have ingested caffeine-containing products within the past 12 hours.
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study

The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.


Eligibility Criteria:
Inclusion Criteria:

* acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals

Exclusion Criteria:

* patients already on therapeutic anticoagulation
* patients with an estimated life expectancy of \<3 months
* pregnancy
* patients hospitalized for COVID-19
An Observational Study of Kadcyla Safety in Breast Cancer

This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.

Exclusion Criteria:

* Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
* A pediatric patient (age ≤18 years)
* Hypersensitivity for Kadcyla or any ingredient in this product
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)

The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.


Eligibility Criteria:
Inclusion criteria:

* Seasonal allergic rhinitis.
* Nasal allergy symptoms during the spring allergy season.

Exclusion Criteria:

* Prior use of beclomethasone dipropionate or flunisolide.
* Significant concomitant medical conditions.
* Use of corticosteroids.
* Use of allergy and other identified medications during the study.
* Current tobacco use or tobacco use within the past year.
RISE for Nurse Preceptors

The purpose of this study is to determine whether RISE for Nurse Preceptors has a significant impact on nurse preceptors' burnout, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years old
2. Licensed as an RN
3. Employed by AdventHealth Rocky Mountain Region
4. Completion of the AdventHealth preceptor training
5. Has precepted ≥ 48 hours within the past calendar year in an AdventHealth hospital setting or outpatient emergency center
6. Able to speak, read, and understand English fluently
7. Able to provide informed consent
8. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

1. Has precepted \< 48 hours within the past calendar year
2. Does not pass the brief risk assessment in the pre-intervention introduction meeting with the LMHC facilitator
3. Unwilling or unable to comply with all study procedures and requirements for the duration of the study.
Video-respiratory Polygraphy in Children

The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires the performance of a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is a cumbersome exam, sometimes difficult to carry out in children, with several sensors and electrodes to install (electroencephalogram (EEG), myogram (EMG), occulogram (EOG), necessary to determine awakening and sleep periods and intra-sleep micro-arousals, nasal cannula, thoraco-abdominal straps, pulse oximetry, actimetry to score respiratory events). PSG is time-consuming for installation and analysis. Simplified methods of recording and analysis are preferable in children but require validation in this population.

Respiratory polygraphy (RP) which uses only respiratory signals (without EEG, EMG and EOG) can be used for the diagnosis of OSA but studies showed that it underestimated the OAHI because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.

The hypothesis of this study is that video-RP can identify OSAS in children.

Eligibility Criteria:
Inclusion Criteria:

* Children with suspicion of OSAS
* Interpretable polysomnography

Exclusion Criteria:

* Non-interpretable polysomnography
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life Bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at Risser stage 0, 1 or 2. However, scoliosis braces are traditionally constructed based on the experience of orthotists. Since 3D spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. AI and ML methods therefore constitute a new approach to address the difficulties in designing braces.

The designs of flexible brace include: an artificial hinge bone is used to stabilize the corrective components. Corrective straps are attached to the artificial hinge to exert corrective forces onto the scoliotic spine. Semi-rigid silicon pads with high conformability to the body are used to enhance the corrective forces.

This study is a multi-disciplinary collaborative project with experts in computer science, orthopaedics, materials science, garment technology, engineering and biomechanics. A biomechanical computational model will be developed to recommend modifications to the flexible brace design. The effectiveness of the flexible braces will be evaluated through low-dose X-ray radiography at pre-, post-expert and post-ML designed treatment. A polynomial scoring system will be created to assess the therapeutic similarity of the ML-designed flexible brace to the expert-designed flexible brace based on an estimate of the corrective forces applied through the braces. Reinforcement learning with scores based on estimated pressure force will guide AI training towards superior therapeutic designs.

Eligibility Criteria:
Inclusion Criteria:

* Teenagers diagnosed with adolescent idiopathic scoliosis
* Cobb's angle between 20 to 45 degrees
* Immature skeletons (Risser grade 0-2)
* Types of scoliosis are classified by the Lenke classification system
* Have received rigid brace treatment

Exclusion Criteria:

* Contraindications for x-ray exposure
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical treatment for AIS
* Contraindications for pulmonary and/ or exercise tests
* Psychiatric disorders
* Recent trauma
* Recent traumatic (emotional) event
Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.

BACKGROUND/MAIN OBJECTIVE: The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours. As secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. METHODOLOGY: This multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage I, II, IIIA) in the participating centres, whose standard treatment was completed within the last 3 months. Participants will be assigned to either an intervention or a control group, and followed for five years. Patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. Patients in the intervention group will be involved in a lifestyle program with two components. The dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. Data will be analyzed on an intention to treat basis using time-toevent analysis. HYPOTHESES: We expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. Furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.

Eligibility Criteria:
Inclusion Criteria:

* incident primary breast cancer (ICD-O C50)
* stage at diagnosis I, II, IIIA (or T1-3, N0-N2, M0)
* age at diagnosis below 76 years
* within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease

Exclusion Criteria:

* morbid obesity (BMI \>40kg/m²) or underweight (BMI \<18kg/m²)
* ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months
* diabetes (only if unstable - glycosylated haemoglobin \>9%)
* current medical or surgical treatment to lose weight
* mental illness that would prevent the patient from carrying out the intervention
* logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments)
* pregnant or planning pregnancy
A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

This study was a multi-center, multi-national, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Eligibility Criteria:
Inclusion Criteria:

* An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Secondary hypertension
* Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
* Pregnancy, nursing or women of childbearing age not using appropriate contraception
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus (HCV) infection
* All participants must have HCV genotype 1 or 2 infection, determined at screening
* HCV ribonucleic acid (RNA) plasma levels greater than or equal to (\>=)10,000 international units per Milliliter (IU/mL), determined at screening
* Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
* Participants without cirrhosis or with compensated cirrhosis

Exclusion Criteria:

* Infection with HCV genotype - 3, 4, 5, or 6
* Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen \[HBsAg\] positive)
* Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
* Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
* Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy