cyrilzakka/clinical-trials huggingface dataset:
A Blended Intervention to Promote Physical Activity, Health and Work Productivity Among Office Employees

The primary objective of this study is to examine between-group differences in changes of objectively measured MVPA levels (min/week) among a randomly selected sample of office employees who are physically inactive in Hong Kong.

Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers.

Methods: The study will comprise of a three group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops, and a control group. Physically inactive office employees (N = 141) from will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioural theories and behavioural change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, and health-related quality of life, and work-related variables including absenteeism and presenteeism.

Eligibility Criteria:
Inclusion Criteria:

* physically inactive (do NOT meet the WHO's recommended MVPA levels)
* office employees in Hong Kong.

Exclusion Criteria:

* participants are engaging other ongoing programs involving MVPA promotion
* if they report any conditions preventing them from being active.
Establishing of the Reliability of the Purdue Pegboard Test in Adults After a Stroke

The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got by testing adults patients after a stroke by the use of Purdue Pegboard Test administered according to the new Czech extended version of its manual.

New Czech manual for the Purdue Pegboard Test which is updated and extended by new rules for unification of their performing will be used for testing adult people with disability - adults after a stroke. The manuals include instructions for performing three trials of each subtest.

At least 30 adult patients after a stroke will be tested by use of Purdue Pegboard test administrated according to the new Czech extended version of its manual. Video of performance of each adult will be obtained. Performance of each patient, firstly in real time and secondly from video record will be evaluated twice, to obtain result for establishing all types of variability and reliability mentioned below.

The inter-rater reliability, internal variability and variability of results will be established.

Eligibility Criteria:
Inclusion Criteria:

* Czech language as a mother tongue
* age from 18 to 65 years
* patient after a stroke hospitalized at Rehabilitation institute Kladruby
* fine motor skills allowing them correct manipulation with components of Purdue Pegboard Test

Exclusion Criteria:

* severe disorder of orientation (neglect syndrome)
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete complete testing due to severe spasticity or spastic dystonia
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the Rehabilitation institute Kladruby
Self-Reported Surgeon Health Behaviours: A Multicentre, Observational Exploration With the Association of Surgeons in Training Into the Modifiable Factors That Impact Surgical Performance

Introduction: Surgeons regularly educate patients on health promoting behaviours including diet, sleep and exercise. No study thus far has explored surgeons' personal compliance with these health-behaviours and their relationship with surgical performance.

The primary outcomes this study were self-reported health, health related behaviours, wellbeing, fatigue and surgical performance. Methods: A survey of validated themes on health-related behaviours, workplace variables and performance was distributed to surgical trainees and consultants in the UK and Ireland through the Association for Surgeons in Training (ASiT). Non-parametric analysis was used to determine inferential associations. Results: Ninety five surgeons (median age 35-44, 51.5 % female, 39.9% registrars) completed the survey. 94% reported having at least 'good' overall health. . A majority (54.7%) report inconsistent sleep patterns, while less than a quarter engage in regular exercise. 74% reported having at least 'good' overall mental and emotional well being.

Sixty two and 64.2% reported being regularly fatigued and bothered by feelings of anxiety and/or depression respectively. Poor self-reported health and wellbeing were associated with poorer reported off-call performance (p\&lt;.01). Higher levels of fatigue negatively impacted self-reported surgical and non-surgical task proficiency (p\&lt;.01). Discussion and Conclusion: Surgeons reported high levels of overall health. However, healthy behaviours around sleep, diet and exercise were not consistently reported. Fatigue, anxiety and regular rumination were reported by greater than half of respondents. When compared to overall health numbers, 20% less surgeons reported overall mental health and emotional well-being that good or better. Self-reported health behaviours including sleep and physical activity were associated with surgical performance. Strategies to improve modifiable lifestyle factors, which will optimise physical health, mental wellbeing and levels of fatigue may optimise surgical performance. Further research should target these behaviours to elicit desired changes.


Eligibility Criteria:
Inclusion Criteria:

* surgeon
* working in TUH or member of ASIT

Exclusion Criteria:

* non surgeon
* not a member of ASIT or TUH
Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
* Male or female outpatients ≥ 18 years old.
* Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and \<200 mmHg at Study Visit 5 (randomization).
* Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National \*Cholesterol Education program (NCEP) criteria:

  * Abdominal obesity (waist circumference \> than 102 cm for men and \> 88 cm for women)
  * Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
  * Current HDL- Cholesterol \<40 mg/dL in men and \<50 mg/dL in women or medical treatment for this condition.
  * Fasting glucose \>100 mg/dL and \<126 mg/dL

Exclusion Criteria:

* Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
* History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
* History or evidence of secondary form of hypertension.
* Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
* Patients on 4 or more antihypertensive medications.
Evaluation of Repeat Administration of Purified Poloxamer 188

The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.


Eligibility Criteria:
Inclusion Criteria:

* Completed participation in study MST-188-01 (EPIC study)
* Subject age 4 through 65 years
* Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia
* Subject requires hospitalization

Exclusion Criteria:

* Subject has acute chest syndrome
* Subject's laboratory results indicate inadequate organ function
* Subject is pregnant or nursing an infant
* Subject had a painful crisis requiring hospitalization within the preceding 14 days
* Subject has been transfused within the past 14 days
* Subject has complications related to SCD
Effects of Glutathione on Immunity in Individuals Training for a Marathon

The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model.

A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in a randomized, double-blinded, 18 week placebo-controlled trial. Subjects will receive either a placebo or glutathione while participating in a stepwise exercise approach that mixes periods of high and low training volume to train subjects and improve running efficiency. Upper Respiratory Tract Infection-related health conditions will be monitored and assessed throughout the study period. Blood and saliva samples will be collected at baseline, and before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, male or female.
* Between the ages of 19-45 years.
* Have no medical restrictions and no health conditions that would inhibit participant from marathon run.
* Be willing and able to comfortably abstain from any food supplements.
* Not participating as a subject in another study.

Exclusion Criteria:

* BMI \< 20.0 or \> 28.5.
* Current or prior use of tobacco products or other inhaled substance.
* More than a moderate intake of alcohol (\>1 drink per day in women; \>2 drinks per day in men).
* Metabolic or inflammatory disease.
* Excellent fitness based on the American College of Sports Medicine criteria for VO2max based on age and gender.
* Recent weight loss of \>10 pounds in the last 3-months.
* Daily intake of ibuprofen, acetaminophen, aspirin, polyphenol supplements, multivitamins, and/or antioxidant supplements.
* Actively attempting (or planning) to lose or gain weight and/or alter body composition.
* Currently taking cholesterol-lowering medications.
* Currently taking prescription anti-inflammatory medications.
* Currently using mouthwash on a regular basis (\>4 times per week).
* Orthopedic problems that would limit running capacity.
* Currently in very poor or poor fitness.
* Highly aerobic exercise trained.
* Pregnant or planning to become pregnant during the study period.
* Breast feeding
* Currently taking blood pressure medications.
* Contraindications to strenuous exercise.
* Anemic (blood hemoglobin \<10 g/dL and/or hematocrit \<35%).
* Diagnosed with asthma or other lung disease.
Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease

The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).


Eligibility Criteria:
Inclusion Criteria:

* hypertension
* CKD stage 2-5
* requiring antihypertensive medication per clinician judgement.

Exclusion Criteria:

* renal transplant anticipated or occurred within 6 months of screening
* transfer out of our practice setting anticipated within 6 months
* unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations
Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Patients who were diagnosed as postoperative CME and administrated with intravitreal OZURDEX injection were reviewed. Outcome will include best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded.

Patients who were diagnosed as postoperative CME after uneventful intraocular surgery and administrated with intravitreal OZURDEX injection were reviewed. All patients underwent ophthalmic examinations at the initial visit and were followed up at months 1, 2, 3 and 6 with measurement of best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded. Risk factors of recurrent CME were analyzed

Eligibility Criteria:
Inclusion Criteria:

* patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection were reviewed.

Exclusion Criteria:

* patients with retinal vascular diseases, including retinal vein occlusion (RVO), diabetic retinopathy (DR), hypertensive retinopathy, retinal artery occlusion (RAO), Coats disease, Eales disease;
* patients with macular disease before surgery, such as age-related macular degeneration (ARMD), macular choroidal neovascularization (CNV), myopic macular degeneration, macular hole (MH), epiretinal membrane(ERM);
* patients with uveitis before surgery, including anterior, intermediate, posterior and generalized uveitis;
* patients with autoimmune disease, such as ankylosing spondylitis (AS), Vogt-Koyanagi-Harada (VKH) disease, Behcet disease.
A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.

Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.

Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.
* CMV retinitis diagnosed within one month of study entry.
* Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.

Exclusion Criteria

Concurrent Medication:

The following are excluded:

* Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.

Patients with the following are excluded:

* Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.
* Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.
* Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).
* Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.
* History of hypersensitivity to acyclovir or ganciclovir.
* Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.

Prior Medication:

The following are excluded:

- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.
UK ANDROMEDA-Shock-2 RCT

The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care.

Septic shock is a life-threatening condition caused by a severe infection. It can rapidly cause multi-organ failure and is associated with a high risk of dying. Patients with septic shock need emergency treatment with intravenous fluids, antibiotics and medications to improve blood supply to all organs. However, it is clear that giving too much fluid is harmful and giving not enough fluid can make organ failure worse, too. International guidelines exist but there is still a lot of variation in how doctors apply the guideline. Further, it is likely that a "one-size-fits-all" approach does not help all patients.

Previously, the Andromeda-Shock 1 trial showed that resuscitation guided by regular monitoring of skin perfusion was associated with a lower risk of dying than resuscitation guided by regular blood tests. The UK Andromeda-Shock-2 RCT builds on this. The aim is to investigate whether an individualised approach based on monitoring of skin perfusion combined with individualised treatment of the blood pressure and circulation for 6 hours is better for patients with septic shock and reduces the risk of organ failure and dying compared to usual care.

During the study period, the investigators will also take a total of 40ml of blood and 60ml of urine for special kidney tests to evaluate kidney health and recovery of kidney function.

After the study has finished, the investigators plan to share fully anonymised results with the investigators of the international Andromeda Shock 2 trial to get as much information as possible to answer the research question and help patients in future.

Eligibility Criteria:
Inclusion Criteria:

Consecutive adult patients (≥ 18 years) with septic shock defined by Sepsis-3 consensus criteria. (ie septic shock defined as suspected or confirmed infection, hyperlactatemia and noradrenaline requirement, after a fluid load of at least 1000mL in 1 hour)

Exclusion Criteria:

Any of the following criteria preclude participation to the trial:

1. More than 4 hours since septic shock diagnosis,
2. Surgery or acute renal replacement therapy anticipated to start during the 6h intervention period
3. Active bleeding,
4. Child B-C Cirrhosis
5. Underlying disease process with a life expectancy \<90 days
6. Attending clinician deems aggressive resuscitation unsuitable
7. Refractory shock (high risk of death within 24h)
8. Pregnancy
9. Concomitant severe acute respiratory distress syndrome
10. Capillary refill time cannot be accurately assessed
Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction

The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures \>40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

Eligibility Criteria:
Inclusion Criteria:

* over age 18
* suspected history and clinical features suggestive of sphincter of oddi dysfunction

Exclusion Criteria:

* prior history of endoscopic therapy for sphincter of oddi dysfunction
* no proven sphincter of oddi dysfunction on manometry