cyrilzakka/clinical-trials huggingface dataset:
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management (MPowerHub)

Day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. This research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.

MPowerHub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPowerHub (MPowerHub platform + continuous glucose monitoring \& activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.

Eligibility Criteria:
Inclusion Criteria:

* Received outpatient care in the participating health system in the last 12 months
* Has a diagnosis of type 2 diabetes mellitus (ICD10 codes E08.xx, E09.xx, E11.xx, E13.xx,O24.1x , O24.3x, O24.8x, O24.9x)
* Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%
* Currently prescribed at least one non-insulin diabetes medication
* Able to provide informed consent
* Able to interact with a simple smartphone application
* Owns or has access to a smartphone that is able to access an internet website
* Did not participate a prior study related to this protocol

Exclusion Criteria:

* Originally was diagnosed with type 2 diabetes before the age of 21 years
* Has a diagnosis of type 1 diabetes mellitus
* Has a diagnosis of gestational diabetes without any other diabetes diagnoses
* Is currently prescribed insulin
* Currently is using a CGM device
* Has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder
* Has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen)
* Is pregnant or planning to become pregnant within the next 6 months
* Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
* Currently is enrolled in another diabetes management intervention study
Feasibility Study of the Taïso Practice in Parkinson's Disease

This is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's disease with mild to moderate postural instability.

The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. Patients are included in the month before the start of the treatment of the intervention. Four standardized evaluation sessions are conducted: a first evaluation during the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. The quality of life assessment and the MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation of incidents is also carried out during this end-of-study visit.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and \<85 years old,
* Parkinson's disease diagnosed by a neurologist, treated and sensitive to dopaminergic treatment without limitation of the duration of the disease since the date of diagnosis,
* Patient with mild to moderate postural instability (equivalent to grade 2.5 and 3 on the Hoehn and Yahr scale),
* Naive patient of any practice of Taiso,
* Patient available to perform the Taïso program planned in the study,
* Patient with written informed consent

Exclusion Criteria:

* Patient with a contraindication to the practice of sport
* Pregnant woman, parturient and breastfeeding mother
* Patient deprived of liberty by administrative or judicial decision
* Patient admitted to a health or social facility for purposes other than that of research
* Adults under guardianship or trusteeship or unable to express consent
* Patient not affiliated to a social security system
* Patient already participating in a therapeutic research protocol that aims to improve physical or mental abilities
Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer

sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.

Eligibility Criteria:
Inclusion Criteria:

* aged 1 -10 years old
* Malay race
* scheduled for general anesthesia procedure with laryngeal mask

Exclusion Criteria:

- disagree to be included in the study
A Multidimensional Behavioral Intervention for Those at Risk for Alzheimer's Dementia

This intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.

The purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (SCC). The goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. This multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. Importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).

Eligibility Criteria:
Inclusion Criteria:

* A positive complaint in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?'; 'Does this worry you?')
* normal cognitive performance corrected for age and education on a global measure of cognitive functioning
* independent in all activities of daily living.
* English speaking;
* Available informant to complete surveys;
* Ambulatory

Exclusion Criteria:

* Known neurological condition;
* Severe psychiatric illness (e.g., current depression).
Clinical Analysis of Suction Drainage in Cementless Hip Replacement

Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* age between 30-80
* primary hip osteoarthritis

Exclusion Criteria:

* secondary hip osteoarthritis
* autoimmune disease
* congenital or secondary coagulopathy
* vein or artery thrombosis
* renal or liver failure
* cemented or hybrid alloplasty,
* no consent from the patient
Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:

Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal lesioning (RTL) in the management of chronic plantar fasciitis.

Based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of CSI, ESWT and RTL for recalcitrant plantar fasciitis. In this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.

Eligibility Criteria:
Inclusion Criteria:

* Persistant heel pain for ≥ 6 months
* No response to at least 6 weeks of conservative treatment (including at least two of the following: NSAIDs, stretching exercises, ice, heel pads, physical therapy, or night splints)
* Age ≥ 18
* BMI ≤ 35
* VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity
* Willingness to participate in the study

Exclusion Criteria:

* Previous foot or ankle surgery, major trauma
* Tumor, osteomyelitis, or complex regional pain syndrome in the affected limb
* Allergy to local anesthesia or NSAIDs
* Pregnancy or breastfeeding
* History of calcaneal fracture
* Previous cortisone injection, ESWT, or RTL for similar complaints
* BMI \>35
* Age \< 18
* Use of medications for neuropathic pain (Pregabalin, Gabapentin)
* Proximal nerve lesion (e.g., spinal stenosis, sciatica, tarsal tunnel syndrome)
* Regional skin or subcutaneous infections, fat pad atrophy
* History of rheumatic disease, or hematologic conditions
* History of peripheral vascular disease
* Seronegative arthropathies, heart failure, hepatic or metabolic disorders
* Pacemaker
* History of clubfoot, pes cavus, or calcaneovalgus
* Diabetic neuropathy
Bleeding Pattern Study

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers aged between 18 and 40 years requiring contraception.

Exclusion Criteria:

* Pregnancy or lactation.
* Any conditions that might interfere with the outcome as well as all contraindications for OC use.
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease

This is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with Parkinson's disease

The primary aim of this study is to compare the efficacy of timed-BLT (BLT group) in reducing excessive daytime sleepiness in patients with Parkinson's disease, when compared to a timed-inactivated negative ion generator (active-control group).

The secondary aims of the study are to examine the effect of timed-BLT on other non-motor symptoms, including depression, fatigue; and the quality of life.

Additional analyses will be carried out to examine the efficacy of the timed-placebo as compared to the random-time placebo (placebo group).

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease diagnosed by neurologist according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria
2. Capable to give informed consent
3. Maintained on stable dose of medications for Parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study
4. Score 14 or more on the Epworth Sleepiness Scale

Exclusion Criteria:

1. A current or past history of manic or hypomanic episode, schizophrenia, mental retardation, or substance use disorder. (Subjects with depression or anxiety disorders will not be excluded)
2. Unstable medical or psychiatric condition
3. Presence of substantial suicidal risk as judged by the clinician and/or screening instruments
4. Presence of active psychotic symptoms that might impair the ability to consent or validity of the interview
5. Cognitive impairment with score of 19 or below by the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
6. Contraindication to bright light therapy: history of light induced migraine. Epilepsy, current use of photosensitizing medications, presence of eye disease, e.g. retinal disease, severe cataract, glaucoma and blindness
7. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview
8. Regular shift worker or trans-meridian flight in the past three months
9. Enrolment in another clinical trial of an investigational medicinal product or device
10. Subjects who are on exogenous melatonin
11. Patients with deep brain stimulation (DBS) implant
12. Patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome
The Effect of Lamina-G on Gastrointestinal Symptom After Gastric Biopsy

Sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy and biopsy. The aim of this study is to investigate the effect of sodium alginate (Lamina-G®) on biopsy-related gastrointestinal symptom.

This study is an open labeled, single-center randomized controlled trials. Patients who underwent upper enoscopy with biopsy were randomly assigned to medication and control group. In the medication group, sodium alginate was administered after EGD during 3 days. All patients underwent a questionnaire to check the presence of gastrointestinal symptoms at baseline and on the day after return home. After 3 days, gastrointestinal symptoms were investigated by telephone survey. Gastrointestinal symptom was scaled by upper gastrointestinal symptom rate score (GSRS). Upper GSRS contains 8 items and 3 scales; abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom (Heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).

Eligibility Criteria:
Inclusion Criteria:

Age from 18 to 80 years Persons who assigned on the written consent for the clinical trial. Persons who underwent upper endoscopy and gastric biopsy

Exclusion Criteria:

Gastrectomy Severe cardiovascular, pulmonary, or endocrine disease Renal or hepatic dysfunction Hematologic disease Gastric cancer Active peptic ulcer User of proton pump inhibitor, H2 blocker, mucoprotectant Immediate significant bleeding after biopsy Pregnant women Allergy history for sodium alginate
Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention

Excessive alcohol use is associated with a range of serious and costly health, social, and economic consequences at the individual and societal level. This program of research serves as a venue by which to produce and test an innovative, science-based, and cost-effective means to intervene in a private, convenient, and individualized way with employed adults who report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored intervention sessions directed at increasing readiness to limit drinking to national guidelines for low-risk drinking and a complementary dynamic web portal providing additional information, activities, and strategies designed to activate and reinforce the change process. The primary objective is to complete and enhance the development of Responsible Drinking and test it in an effectiveness trial. In Phase II the program capabilities and innovation will expand to integrate the e-Health components (CTI and e-Workbook) with m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a more interactive and engaging user experience. In addition, m-Health technologies (text messaging and mobile device browsing optimization) will be integrated to support engagement in the program and flexible delivery options. 996 employed adults will be recruited to participate in the randomized trial. The treatment group will receive three intervention sessions during the course of six months and group differences on a number of outcomes will be evaluated at 12 and 18 month follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. 21 years of age or older
3. not enrolled full-time in college
4. employed part or full time
5. not pregnant
6. consumed alcohol in the past 30 days
7. exceeded the NIAAA gender-specific low-risk drinking guidelines in the last 30 days
8. not currently interested in or ever having received treatment for substance abuse or dependence
9. not ever having received a physician recommendation to avoid or reduce alcohol use
10. scoring 9 or less on the Alcohol Use Disorders Identification Test (AUDIT-C).
Freestyle Libre and Hospital Admissions in Type 2 Diabetes

This study aims to investigate the utility of a combination of structured nurse led intervention and the use of Freestyle libre in adults with type 2 diabetes who have suffered an episode of severe hypoglycaemia in terms of mortality, unscheduled healthcare contacts and quality of life.

It is increasingly recognised that hypoglycaemia carries risk to individuals with all forms of diabetes. Research has shown high rate of mortality in those with type 2 diabetes following an episode of severe hypoglycaemia and a previous pilot trial conducted in the UK suggested that this could be improved by a structured nurse led intervention aimed at modifying glycemic therapy to avoid hypoglycaemia, instigating regular blood glucose monitoring and providing education to participants on common triggers for hypoglycaemia and how to avoid them.

In this trial, the investigators will randomise individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia requiring emergency service call out to two arms. One arm will receive standard of care/treatment as usual and the other will receive a structured nurse led intervention as well as the use of a flash glucose monitoring system, Freestyle libre.

Active participation in the trial for both arms will be a total of twelve months (with the main intervention months 0-6.) Participants electronic records will be analysed for death and unscheduled healthcare contacts for a total of two years after recruitment.

The primary outcome measure is mortality between groups. Secondary outcomes include the use of estimated HbA1c (a variable produced by the freestyle libre device) compared to laboratory HbA1c, quality of life measures, effects on glycemic control and the number of unscheduled healthcare contacts.

Eligibility Criteria:
Inclusion criteria

* Aged \>18
* Confirmed diagnosis of type 2 diabetes
* Suffered an episode of severe hypoglycaemia requiring ambulance call out
* Able to provide informed written consent

Exclusion criteria

* A form of diabetes mellitus which is not type 2 or the diagnosis is uncertain
* Currently pregnant
* Dialysis dependent renal failure
* Unable to provide informed written consent
Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis


Eligibility Criteria:
Main Inclusion Criteria:

* Men or women aged ≥ 19 years and ≤ 75 years
* Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy within 7days prior to the randomization
* Subjects who have one or more erosions identified on upper gastrointestinal endoscopy within 7days prior to the randomization
* Subjects who voluntarily signed a consent form

Main Exclusion Criteria:

* Ineligible for upper gastrointestinal endoscopy
* Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy within 7days prior to the randomization
* Subjects with hypersensitivity to investigational drugs and similar drugs
* Pregnant or breastfeeding women
Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)

This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.


Eligibility Criteria:
Inclusion Criteria:

* Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
* Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
* Detectable serum HCV RNA at Screening
* Serologic evidence of HIV infection by HIV RNA detection
* CD4 cell count greater than or equal to (\>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
* Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
* Compensated liver disease
* No evidence of hepatocellular carcinoma

Exclusion Criteria:

* Pregnant or breastfeeding
* Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
* Any investigational drug within 6 weeks prior to first dose
* Positive for hepatitis A immunoglobulin M antibody
* Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
* Severe psychiatric or neurologic comorbidity
* History of any significant medical conditions, such as immune disorders or disease of the major organ systems
* Uncontrolled thyroid disease
* Severe retinopathy
* Evidence of drug abuse