cyrilzakka/clinical-trials huggingface dataset:
Together Overcoming Diabetes - Great Plains

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.


Eligibility Criteria:
Inclusion Criteria - Adult Index Participants:

* 18 years and older
* Self-identifies as American Indian or Alaska Native
* Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
* Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
* Caregiver to a 10- to 25-year-old in their home at the time of screening.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

* Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
* Willing to serve as 'support person' for the adult participant.
* Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

* Between 10 years and 25 years old
* Self-identifies as American Indian or Alaska Native.
* Willing to serve as 'support person' for the adult participant.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

* Cognitively or visually impaired
* Youth in foster care (due to potential mobility of foster youth).
Maltese Antibiotic Stewardship Programme in the Community (MASPIC): Antibiotic Prescribing for Acute Respiratory Tract Complaints

Antibiotic resistance has become a major threat to global public health. It is driven by a multitude of factors, however one of the leading factors is antibiotic prescribing. Inappropriate antibiotic use and overuse of broad-spectrum antibiotics can lead to the development of resistant strains. Since in Malta the vast majority of antibiotics are acquired through prescription, targeting providers' prescribing behavior is an important strategy needed to try to curb antibiotic overuse and resistance.

The aim of this study is to evaluate the effect of a multifaceted social marketing intervention in changing general practitioners' (GPs) antibiotic prescribing behavior for patients with acute respiratory tract complaints in Malta. This quasi-experimental intervention study using an interrupted time series design includes three phases; a formative pre-intervention phase, an intervention phase and post-intervention evaluation phase, and will last a total of four years.

During the pre-intervention phase, various stakeholders, including GPs, pharmacists and parents will be interviewed in order to get a better contextual understanding of antibiotic use in Malta. A 1-year baseline surveillance system will also be set up to collect actual diagnosis-specific antibiotic prescribing by GP. This data will, at a later stage, be used to measure the change in antibiotic prescribing behavior post-intervention stage. GPs stage of behavior change and intention to prescribe antibiotics will also be measure pre-intervention using questionnaires based on the theory of planned behavior and the transtheoretical model.

The intervention stage will last 6 months and will include multiple components, including, delayed prescription pads, educational sessions, educational materials for patients and distribution of antibiotic guidelines. The intervention will be monitored closely through numerous process indicators.

Following the intervention, GPs' stage of change and intention to prescribe antibiotics will be re-measured using the same questionnaire used pre-intervention. Surveillance data collection will be also be resumed and will provide data to measure the primary outcome as well as additional secondary outcomes.

The primary outcome of interest is the change in the rate of antibiotic prescribing for patients presenting with an acute respiratory tract complaint.


Eligibility Criteria:
Inclusion Criteria:

* All actively practicing general practitioners and trainees specializing within family medicine are eligible to participate regardless of whether they work on a part-time or full-time basis, or in the public and/or private sectors

Exclusion Criteria:

* General practitioners who are no longer actively working
Acunpuncture for Fibromyalgia Syndrome

patients suffering from fibromyalgia syndrome according to the criteria of the American College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will be identified, according to the Traditional Chinese Medicine rules, acupuncture will be planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy. Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28 days follow-up.


Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of Fibromyalgia

Exclusion Criteria:

coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator
GAit, MEmory, Dietary and Vitamin D

Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.

Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.

The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Woman aged 65 and over
* To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D \[25OHD\] concentration ≤ 30ng/mL)
* To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)
* Ability to walk a distance of 15 meters unaided
* Ability to eat 2 yogurts per day
* Memory complaint without cognitive decline
* To have given and signed an informed consent to participate in the trial
* To be affiliated to French Social Security
* To have no vitamin D supplementation during inclusion

Exclusion Criteria:

* Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale \> 5/15)
* Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body.
* Vitamin D supplementation during inclusion
* Contraindications to vitamin D
* Unstable medical condition
* Dairy allergy
* Taste of dairy products not supported
* Enrolment in another simultaneous clinical trial
* Civil defense measures underway
* Refusal to participate of the subject
RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department

This project is called "Falls Aren't Us" and aimed at evaluating the effectiveness of a customised falls prevention program for people aged 60 and over who were presented to the hospital Emergency Department following a fall and being discharged home. Recruitment for this randomized controlled trial has commenced in late December 2002 from several major public hospitals in the western, southern, and northern parts of Melbourne Metropolitan Region. Consented participants will receive a comprehensive falls risk assessment within one week of being discharged home from the Emergency Department and at twelve month following this initial assessment. Their falls risks will be monitored for twelve months through a falls diary. Following randomization, participants in the intervention group will receive a customised falls prevention program in addition to the usual care being put in place from the hospital Emergency Department.

Older people presenting to an Emergency Department (ED) following a fall have high injury and hospitalisation rates. They are also at high risk of further falls and other adverse outcomes. However, there is currently limited available evidence to inform best practice.

The primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an ED after a fall. It also aims to identify those within this high-risk population most likely to benefit from the intervention program.

Approximately 800 people aged 60 years and over will be invited to participate at the Emergency Department from the end of September 2002. Those who are eligible to participate will have a falls risk assessment in their own home and will be required to complete a falls diary for 12 months. There is a 50/50 chance (random allocation) that participants will receive an individualised falls prevention program.

The duration of a falls risk assessment is up to 2 hours and there is no cost involved. Participation in the research program will not affect routine management from the Emergency Department.

Becoming a participant may lessen the risk of having another fall and help others as well.

Eligibility Criteria:
Inclusion Criteria:

* presenting to the Emergency Department with the primary cause of presentation being a fall; aged 60 years or older;
* discharged directly home following emergency care; living in the community or a retirement village; willing to take part in the study;
* able to provide informed consent or has consent provided by a third party; able to comply with simple instructions;
* able to walk independently indoors with or without a gait aid.
Characterization of Influenza-like Illness in Mexico

A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1.

In March 2009, a new influenza A virus, novel H1N1 (commonly referred to as "swine flu"), began causing an increase in reports of influenza-like illness in North America. Although the virus subsequently spread rapidly around the world, the earliest reported outbreak of cases occurred in Mexico City, which is seen as the epicenter of the influenza pandemic, the world's first in 40 years.

Many questions remain about this emerging pandemic and the virus causing it, the answers to which could better inform patient management and policy decisions both in Mexico and internationally. Sparse reliable clinical research data have been collected on the natural history of the disease, on the risk factors associated with severe disease, or on the severity of this pandemic influenza as compared to seasonal influenzas. This study is an initial step to better characterize individuals in Mexico who develop influenza-like illness (including illness caused by novel H1N1), to describe the clinical management of those individuals, and to assess their short-term outcome. The planned data collection will provide timely information to inform policy and guidelines for the local populations and governments involved and may also be used to design future ancillary studies of this influenza virus and/or studies of other emerging infectious diseases.

The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and to describe clinical course over a period of at least 28 days after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by participant, or for pediatric participants, signed informed consent by parent/legal guardian and, where appropriate, signed assent by participant
* At least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough) and
* One of the following criteria:
* Fever (≥ 38 °C by any method: oral, axillary, etc.) on examination or participant-reported fever (≥ 38° C) or feverishness in the past 24 hours
* One or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain)
* Consenting to provide aspirate or naso-pharyngeal swab

Exclusion Criteria

* The onset of illness is more than 48 hours after hospitalization.
* Participants previously included in this study within the last 30 days.
Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction

Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the Rome IV criteria, functional dyspepsia (FD) symptoms included meal related fullness, early satiation, epigastric pain or burning which are unexpl ained after routine investigation. FD causes substantial psychophysical burden because of its unknown etiology and high prevalence. Although FD is currently associated with local inflammation of the gastrointestinal tract and microbiota alteration, current available treatments for FD are of limited effectiveness. In view of this, many studies have applied Chinese herbal medicine in FD and achieved some therapeutic benefit. The Jing Si Herbal Tea Liquid Packet composed of eight native Taiwanese herbs (wormwo od, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon,licorice, perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of Health and Welfare. The Jing Si Herbal Tea Liquid Packet also has been registered i n clinical trials as a complementary treatment for Coronavirus disease 2019(COVID-19). The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double blind randomized manner.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-70 years old.
2. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
3. Those who meet the definition of irritable bowel syndrome (IBS). (Irritable bowel syndrome (IBS) is chronic (once a week, lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) .
4. Be conscious and willing to sign the subject's consent form.

Exclusion Criteria:

1. Abnormal liver and kidney function;
2. Abnormal blood tests and thyroid abnormalities;
3. Have received surgery on the digestive tract;
4. Abnormal upper gastrointestinal endoscopy;
5. Abnormal colonoscopy;
6. Antibiotics are being used for infectious diseases;
7. Pregnant or breastfeeding women;
8. Suffering from heart, liver, or kidney failure;
9. Physical weakness, allergies, asthenia and cold constitution and chronic diseases.
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.

The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* One or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure.
* Severity of the symptom(s) warrants invasive treatment
* Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
* Willing to sign a consent form

Exclusion Criteria:

* Active pelvic inflammatory disease or infection
* Any malignancy of the pelvic region
* Endometrial neoplasia or hyperplasia
* Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity
* Presence of pedunculated serosal fibroid as the dominant fibroid(s)
* Fibroids with significant collateral feeding by vessels other than the uterine arteries
* Presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres
* Coagulopathy
* Atypical anatomy that will not allow for bilateral UFE
* Subject with known severe contrast allergy
* Subjects with known moderate to severe renal disease
Evaluation of Validity and Reliability of the Turkish Translation of the Digital Health Readiness Questionaire in Different Chronic Diseases

The World Health Organization (WHO) defines digital health as the field of knowledge and application related to any aspect of the adoption of digital technology in the stages of improvement. The combination of digital health with technology brings about a new transformation in digital media. This transformation allows for the development of communication and information in health services, the ability to conduct health-related research on digital media and the evaluation of this data. The ease of access to information and the provision of a timely feedback mechanism in the face of problems have enabled the spread of digital health systems, and have also enabled chronic disease management and epidemic disease monitoring.

It is recommended that the term digital readiness be used to cover the combination of digital access and use, digital literacy and digital health literacy. Digital health readiness is also defined as the main determinant of health and is thought to contribute to the improvement of health processes with the development of digital health literacy and to be a useful solution against health problems that may arise in the follow-up of chronic diseases.

Although there are tools in the literature that evaluate digital health readiness, there is no Turkish assessment tool that facilitates the follow-up of non-communicable chronic diseases. Therefore, the aim of our study is to evaluate the translation, validity, and reliability of the Digital Health Readiness Questionaire into Turkish in individuals with chronic non-infectious diseases.


Eligibility Criteria:
Inclusion Criteria:

* The study will include people over the age of 18, native Turkish speakers, literate, obese, diabetic, cardiovascular and respiratory patients.

Exclusion Criteria:

* Individuals with insufficient cooperation (Mini Mental Test score \&lt;24) and any cognitive problems that may prevent the administration of the survey will be excluded from the study.
Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.

30 untreated GD hyperthyroid patients will be randomized into two groups (A and B). Group A patients will be treated with an anti-thyroid drug (methimazole) at the dose aimed to control hyperthyroidism. Group B patients will be treated with methimazole plus selenium (160 mg daily). Patients will be evaluated at time 0, 45 and 90 days for symptoms of hyperthyroidism (by a specific questionnaire), clinical status (weight, heart rate), laboratory (thyroid function tests, TSHR autoantibodies, serum selenium, index of oxidative stress-MDA, cholesterol, SHBG) and EKG. The aim of the study is to evaluate if the combined treatment (methimazole plus selenium) is more effective than methimazole alone in controlling GD hyperthyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

* Hyperthyroid treated Graves' disease patients