cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Hybrid Learning Mode of Volunteer Training

As the effectiveness of the hybrid volunteer training in Hong Kong is under-studied, this experimental study aims to develop a hybrid learning mode of volunteer training that increase volunteering-related self-efficacy and its associated outcomes among volunteer. In particular, this study compares the efficacy of hybrid volunteer training with the wait-list control group.

The volunteer training will consist of a 6-module online course, followed by 5 face-to-face courses. Each module will consist of the key volunteer training component presented in in written or video format. Materials will be presented interactively to facilitate engagement.

Mental illness poses a challenge to public mental health services because of its high prevalence, symptom chronicity, and impacts on patients and society. Although there is a huge amount of need to serve people with mental illness, there is insufficient manpower. There is much empirical evidence to support the volunteer programs for people with mental illness. However, the literature on hybrid volunteer training is mainly focused on teaching and learning in education, and the effectiveness of the hybrid volunteer training in Hong Kong is under-studied. Therefore, The present study aims to compare the efficacy of hybrid volunteer training with the wait-list control group. We hypothesize that (1) participants who receive hybrid volunteer training will increase their self-efficacy of volunteering after the intervention as compared with the wait-list controls; (2) participants from hybrid volunteer training will have better mental health knowledge and less mental health-related stigmatized beliefs and behavior after the intervention as compared with the wait-list controls.

The volunteer training will consist of a 6-module online course, followed by 5 face-to-face courses, incorporating the key volunteer training components, including Keyes theory, bio-psycho-social model, stress bucket model, recovery model and CHIME model. Each module will consist of the key volunteer training component presented in in written or video format. Materials will be presented interactively to facilitate engagement.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Age ≥18 years
* Willing to participate in volunteer service
* Being able to read Chinese
* Have a computer, tablet and/or smartphone device with Internet access
* Have a regular email address
* Willing to give informed consent and comply with the trial protocol

Exclusion Criteria:

* Unable to communicate with Cantonese.
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or over
* Clinically stable haemodialysis or peritoneal dialysis
* Stable phosphate control
* On a stabilised phosphorus diet
* Female and of child-bearing potential have a negative serum pregnancy test.
* Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* Body Mass Index (BMI) \<=16.0 kg/m2 or \>=40.0 kg/m2
* A current or history of significant gastrointestinal motility problems
* A positive test for HIV 1 and 2 antibodies
* A history of substance or alcohol abuse within the last year.
* Seizure disorders
* A history of drug or other allergy
* A temporary catheter as a vascular access
* Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy

The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.

The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 year old
* arthroscopic shoulder surgery on interscalen block
* able to understand the protocol
* inform consent signed

Exclusion Criteria:

* chronic pain or chronic used of narcotics
* Use of IMAO
* Use of ISRS
* Pulmonary chronic disease
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation

To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:

  * (1)Clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration).
  * (2)Patients who meet either of following criteria

    * ECG changes compatible with new ischemia \[e.g. ST depression (at least 1 mm), T wave inversion (at least 2 mm), or hyperacute peaked T waves in 2 contiguous leads\].
    * already elevated CK at least twice the upper limit of normal or CK-MB or Troponin I or T above the upper limit of normal or positive qualitative test for Troponin T.
  * (3)A percutaneous coronary intervention is planned within 96 hours after the first study drug administration

Exclusion Criteria:

* A)Factors that affect participation in study:

  * (1)Previous disabling stroke
  * (2)Previous intracranial hemorrhage or hemorrhagic stroke
  * (3)Severe co-morbid condition such that the patient is not expected to survive 1 month
  * (4)NYHA Class IV heart failure
  * (5)Uncontrolled hypertension
  * (6)Requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or NSAIDs (excluding unum sumatur), during study period,
* B)Factors related to ASA and/or ticlopidine treatment:

  * (1)Use of ticlopidine within 1 week prior to randomization
  * (2)History of ASA or ticlopidine intolerance or allergy
  * (3)Contraindications to ASA or ticlopidine
A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke

This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life satisfaction during the first year after stroke. In addition use of health services, caregiver burden and significant others' life satisfaction will be studied. Study design, methods and power analysis are based on our previous pilot study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: \< 3 months after stroke, dependent in at least two activities of daily living, understand instructions and referred to a participating rehabilitation unit. Data are collected at baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In addition qualitative longitudinal studies will be performed in order to describe how CADL is integrated.


Eligibility Criteria:
Inclusion Criteria:

* \< 3 months after stroke
* Dependent in at least two activities of daily living
* Able to understand instructions
* Referred to a participating rehabilitation unit.

Exclusion Criteria:

* Diagnosed dementia
Examining Change Mechanisms in Psychotherapy

This research project seeks to acquire a deeper understanding of the complex influences of common factors and specific ingredients in psychotherapy. By using frequent process-outcome measures, it will address individualized mechanisms of change in psychotherapy by assessing both between and within patient change processes, using a wide spectrum of change indicators.

The study is a naturalistic study conducted by collecting data from in-patient units at Modum Bad (psychiatric hospital). The sample includes different patient groups with a variety of psychological disorders. Further, sample is gathered from units using different treatment approaches (short-term psychodynamic treatment, cognitive-behavioral treatment, metacognitive therapy, compassion-focused therapy, relational psychodynamic therapy, existential therapy and stabilizing trauma-therapy).

The following specific research questions will be explored:

1. The role of common factors:

   1. What are the relative influences of different common factors such as agreement on task and goals, treatment credibility and 'the real relationship', across treatments and diagnoses?
   2. Do some common factor variables stand out regarding ability to explain variance in outcome and across outcomes?
   3. Do measures of common factors have a consistent effect on outcome across treatment models and diagnoses, or does the explanatory value of common factors vary across diagnose and treatment model?
2. The role of specific change mechanisms (affective, cognitive and meta-cognitive):

   1. To what extent do specific change mechanisms predict change in various outcome domains?
   2. Are these specific change mechanisms equally important predictors, or do they vary across treatment or diagnose?
3. Are there interaction effects between common factors and specific factors across treatment models, patient diagnoses and outcome domain?

Self-report data will be collected three times a week on mechanisms of change and symptoms, established by psychotherapy theory and research evidence as important for psychological change. The data collection consists of three different forms administered once per week on different days. The forms are separated by topic; symptoms, contextual factors, and change processes. The questions in the forms are selected from short instruments with good psychometric qualities. The data collection procedure has at present been tested on five patient cohorts with good results.

Eligibility Criteria:
Inclusion Criteria:

* Must be a patient at Modum Bad
* Have a psychological disorder
* Must have rights to treatment according to the rules of specialist health care in Norway. Includes the following:

  1. Patient is expected to have poorer prognosis of life quality if not given treatment
  2. It is expected that the patient will benefit from treatment
  3. It is expected that there is a reasonable cost-effect balance regarding the treatment given and the patient's benefit from treatment.

Exclusion Criteria:

* Acute suicidality
* Ongoing/active abuse of harmful drug(s)
* Under 18 years
The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma

The purpose of this study is to determine whether using non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelines)

Children with severe asthma pose a management dilemma; it is difficult to reduce their treatment while they are symptomatic, but the plateau of the dose response curve for inhaled corticosteroids (ICS) may have been reached. Studies in symptomatic adults and asymptomatic children with asthma suggest measuring induced sputum eosinophils allows better asthma management. We will recruit 80 children with severe asthma (treated with at least 500 mcg/day inhaled fluticasone or equivalent). We will see them every three months for a year, and perform sputum induction and measurements of exhaled nitric oxide (eNO). Half will be randomised to conventional management; half will have a reduction of ICS if there are no sputum eosinophils, or (if a sample cannot be produced) eNO is normal. The trial endpoint is whether there is a significant reduction in the median dose of ICS in the inflammatory markers group, with no increase in total number of asthma exacerbations. This study is also hypothesis generating. We will use our panel of markers (a) to try to improve clinical monitoring; and (b) to determine the molecular mechanisms of relapse of severe asthma.

Eligibility Criteria:
Inclusion Criteria:

Children \>8 years with severe asthma defined as:

Taking at least 500mcg fluticasone propionate (or equivalent) per day, plus a long acting beta agonist plus a leukotriene antagonist or previous trial

Exclusion Criteria:

Children taking steroid sparing agent (cyclosporin, azathioprine, methotrexate) Children with other major respiratory diagnoses such as bronchiectasis

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Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals

Cardiovascular exercise adjustments are required during in order to redistribute blood flow from non-exercising vascular areas to active muscles. This hemodynamic adjustments, which are partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990). Static handgrip exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005) and activation of muscle metaboreflex that increases arterial blood pressure and peripheral vasoconstriction, respectively. Functional electrical stimulation (FES) treatment used in physical therapy in patients who are unable to tolerate conventional exercise showed to be a good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic abnormalities (Karavidas, 2006). However, the effect of FES on metaboreflex activation in healthy individuals has never been investigated. Therefore, this study aims to evaluate the metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and also to compare their results with the effects caused by isometric exercise.

All participants will be invited to attend four separate days for completion of the study protocols. On the first day, the metaboreflex activation in upper limb will be randomly assigned to isometric exercise or FES intervention. On the second day, at least two days apart, random isometric exercise or FES intervention will be performed in the upper limb. On the third day, at least one week apart, all participants will be assigned to perform metaboreflex in a lower limb induced by isometric exercise or FES intervention. On the fourth day, at least two days apart, random isometric exercise or FES intervention will be performed in a lower limb. To evaluate the isometric exercise and FES intervention the post-exercise ischemia will be randomly performed to evaluate the accumulation of metabolites in response to activated limb (PECO +) and evaluation control without ischemia (PECO-). The experiments between PECO+ and PECO- will be separated by a 30 min interval. During isometric exercise and FES protocols the blood flow and peripheral vascular resistance will be assessed by venous occlusion plethysmography. Fatigue will be determined every minute by the 10-point Borg scale to assess rate of perceived exertion and by blood lactate. Blood lactate will be evaluated through capillary action at pre, immediately post exercise and at 5 minutes during the recovery period. Hemodynamic variables such as BP and HR will be recorded every minute during the protocols.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Both genders
* Aged 35-70 years
* Sedentary
* Not using continuous medications

Exclusion Criteria:

* Cardiovascular disease
* Neurological disease
* Malignant disease
* Peripheral vascular disorders (varicose veins or deep vein thrombosis)
* Peripheral sensitivity alterations
* Contraindication to performing physical exercise
* Refusal to sign the consent form
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).

* This is a prospective, double-blinded, multicenter, randomized study
* Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3, 6, 9 and 12 months
* Patients will be randomized at enrollment to either Group 1 ("QuickOpt Group") or Group 2 ("Control Group").
* Group 1 - The patient's device is programmed to sequential biventricular pacing mode with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.
* Group 2 - The patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and inter-ventricular (VV) delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post implant. Any AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT¬D device with VV timing and a compatible lead system.
* Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
* Patient has the ability to independently comprehend and complete a QOL questionnaire.

Exclusion Criteria:

* Patient has an epicardial ventricular lead system.
* Patient has the ability to walk ≥ 450 meters in 6 minutes
* Patient has limited intrinsic atrial activity (≤ 40 bpm).
* Patient has persistent or permanent atrial fibrillation (AF).
* Patient has a 2° or 3° heart block.
* Patient's life expectancy is less than 1 year.
* Patient is pregnant.
* Patient is on IV inotropic agents.
The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs

Donor-specific antibodies (DSAs) are essential causes of graft rejection in haploidentical hematopoietic stem cell transplantation (haplo-HSCT). DSAs are unavoidable for some patients who have no alternative donor. Effective interventions to reduce DSAs are still needed, and the cost of the current therapies is relatively high. Investigators wanted to retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center and evaluated the therapeutic efficacy of the combination of intravenous immunoglobulin (IVIG), dexamethasone and megadose of transfused peripheral blood stem cells (PBSCs) for DSA desensitization.

Investigators retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center. All patients received 1 g/kg IVIG on day -1 and 25 mg/m2/d dexamethasone on days -4\~-1 before transplantation, and approximately three doses of PBSCs were transfused. On the basis of the conventional transfusion amount of hematopoietic stem cells, additional PBSCs were transfused based on the DSA level of each patient: 3±2×108/kg, 6±2×108/kg and 9±2×108/kg mononuclear cells for participants whose DSAs were weakly positive, positive and strongly positive, respectively.

Blood samples from participants were collected at the following 5 time points: before HSCT and +1 day, +8 day, +15 day and +22 day after transplantation.

The primary endpoint was the incidence of PGF. The secondary endpoints were the incidence of poor graft function, acute and chronic GVHD, relapse, nonrelapse mortality (NRM), overall survival (OS) and disease-free survival (DFS).

Eligibility Criteria:
Inclusion Criteria: DSA positive, receive HSCT in our hospital. -

Exclusion Criteria: Have alternative DSA-negative donor, expended life-span less than 1 month.

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Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions. Dose escalation will be supervised by a Safety Monitoring Board (SMB). Dose escalation to the next dose level will not take place until the SMB has determined that adequate safety, tolerability, PK, and core-lab analyzed ECGs from the previous cohort and all previous cohorts have been demonstrated to permit proceeding to the next cohort. PK data from all available cohorts will be used to guide the dose-escalation decisions.

Eligibility Criteria:
Major Inclusion Criteria:

* Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
* Body mass index (BMI) ≥ 18 and ≤ 30.0 kg/m2 at screening.
* Medically healthy with no clinically significant finding in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as judged by the PI or designee. Creatinine must be within the upper limit of normal at screening.
* Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Major Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History of clinically significant hypotension.
* History of lightheadedness, dizziness or syncope in the 12 months prior to screening.