cyrilzakka/clinical-trials huggingface dataset:
SWITCH Diets Study: Self-monitoring with Internet Technology to Choose Healthy Diets

The goal of the Self-monitoring With Internet Technology to Choose Healthy Diets (SWITCH) study is to examine a 12-week remotely delivered program designed to help adults adopt a healthy dietary lifestyle and lose weight in a diverse cohort of adults with overweight/obesity.

The intervention uses a self-determination theory framework to provide a deeper understanding of the factors that influence dietary behavior within the context of tracking. This study incorporates autonomy-supportive strategies to encourage participants to feel more in control of their dietary choices and will provide information and resources to boost participant's competence in achieving their dietary goals. The intervention includes weekly learning modules to support healthy eating and weight loss and daily dietary tracking with visual feedback, all accessible within the SWITCH app.

The SWITCH study is a 12-week remotely delivered, randomized behavioral intervention. Participants will be randomized to one of two groups: 1) SWITCH tracking nutrients to decrease (n=50) or 2) SWITCH tracking nutrients to increase (n=50). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at baseline and 12 weeks.

Intervention Design:

Diet tracking. Participants in both groups will be asked to track all meals, snacks, and beverages via the SWITCH app and complete a weekly learning module. Both groups will receive the same intervention, but the targeted nutrient goals and the in-app display of daily intake will differ between groups. Participants will be given goals to either increase certain nutrients or to decrease certain nutrients.

Diet related education to support healthy eating and weight loss will be provided each week within the SWITCH app. Each module includes some or all (as applicable) of the following components: A brief educational video discussing the week's topic, a video sharing ideas for applying the educational content into daily life, "meal swap" examples, a weekly goal or challenge and example recipes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 64 years.
* BMI between 25 - 49.9 kg/m2
* Have 2 risk factors for T2DM in addition to having overweight or obesity (as defined by the NIDDK).
* Own and use a smartphone with a data plan.
* Must be willing and able to change dietary intake.
* Be free of major health or psychiatric diseases, drug, or alcohol dependency.
* Willing to sign informed consent.
* Own a digital body weight scale, have regular access, or be willing to purchase one

Exclusion Criteria:

* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months.
* Diagnosed with type 2 diabetes or currently using medications that may impact blood glucose.
* Pregnant (or have been pregnant in the last 6 months), anticipating becoming pregnant in the next 12 months, or currently breastfeeding.
* Having an eating disorder.
Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus

Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.

Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Little is known of how the esophagus heals after RFA treatment, and a better understanding of this healing process might provide insights into how to prevent Barrett's metaplasia from recurring after successful ablation.

The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus. Patients with Barrett's esophagus will undergo surveillance endoscopy with biopsy. This will be followed by RFA treatment of the BE and follow up endoscopy will be performed 1, 2, and 4 weeks after RFA. Healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. Stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. Protocol has been modified to provide a collaborative effort between the Dallas VAMC and Baylor Scott \& White Medical Center in Dallas, TX. Veteran participants electing to participate will receive initial screening and endoscopy at the Dallas VAMC and will continue with RFA and follow-up endoscopies at Baylor. An identical protocol has been approved at Baylor Scott \& White Medical center. Patients who are screened and enrolled at Baylor will receive all treatments at that location.

Eligibility Criteria:
Inclusion Criteria:

- Barrett's esophagus

Exclusion Criteria:

* inability to provide informed consent
* esophageal varices
* treatment with warfarin
* coagulopathy that precludes safe biopsy of the esophagus (including platelet count \<100,000/mm3, INR (international normalized ratio) \>1.5)
* allergy to fluorescein sodium
* comorbidity that precludes safe participation in the study
* pregnancy or breastfeeding status
Cognitive Stimulation and Strength Training in Older Adults With Cognitive Impairment

This program focuses on integrating cognitive exercises and strength training for older adults experiencing mild cognitive impairment (MCI). It aims to enhance cognitive functions such as memory, attention, and problem-solving skills through various stimulating activities. At the same time, it incorporates strength training exercises to improve muscle mass, balance, and overall physical mobility. By addressing both cognitive and physical aspects of health, the initiative seeks to provide comprehensive benefits that may lead to improved quality of life for older adults with MCI. The research contributes valuable insights into the importance of holistic interventions in mitigating the effects of cognitive decline and promoting physical well-being in this vulnerable population.


Eligibility Criteria:
Inclusion Criteria:

* People over 60 years of age.
* Diagnosis of mild cognitive impairment (MCI) confirmed by neuropsychological evaluation or by a health professional.
* Ability to participate in moderate physical activities and perform strength exercises with supervision.
* Willingness and ability to regularly attend sessions of the cognitive stimulation and physical training program.
* Signed informed consent authorization, indicating that they understand and accept the objectives and activities of the program.

Exclusion Criteria:

* Diagnosis of moderate or severe dementia or other advanced cognitive impairment that prevents participation in the program.
* Severe or limiting physical conditions, such as heart disease, respiratory disease, or musculoskeletal injuries, that make it impossible to perform strength exercises.
* Psychiatric disorders (such as major depression or schizophrenia) or substance use that affect commitment or ability to follow the program activities.
* Participation in other cognitive stimulation or physical training programs or interventions in parallel, which may interfere with the evaluation of the effects of the program.
* Inability to understand and follow simple instructions, or lack of family or social support to attend the program if necessary.
The Effectiveness of Self-Management Education and Telephone Follow-up in Patient with COPD Exacerbation

According to the 2024 GOLD guidelines, Chronic Obstructive Pulmonary Disease (COPD) is defined as heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction. COPD is one of the leading causes of mortality and morbidity in Turkey and worldwide. Since COPD is an incurable and lifelong disease, it is important for patients to have high levels of self-management.

The main questions it aims to answer are:

1. Does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with COPD exacerbation?
2. Does self-management education effect self-care agency and symptom management in people with COPD exacerbation? This study will evaluate the effect of self-management education and telephone follow-up on self-care agency and symptom management. Patients hospitalized with COPD exacerbation will be trained in the hospital and will be followed up by phone call after discharge. During the study, 3 groups were planned; Group 1 will be educated and followed up by telephone Group 2 will only receive education and no telephone follow-up. Group 3 will not receive education and telephone follow-up, only standard care. It is planned to collect the data from the patients at the beginning of the study, at 1, 3 and 6 months.

Main outcomes:

* Level of self-care agency
* Level of symptom management The results obtained will be interpreted by comparing between 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD for the last 1 year
* Diagnosis of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III or IV COPD documented by pulmonary function testing
* Patients hospitalized for acute exacerbation of COPD;
* Hospitalized for at least 3 days
* Having a personal mobile phone and the ability to use it,
* Being enough conscious and oriented to answer the questions,
* Voluntary patients

Exclusion Criteria:

* Under 18 years old
* Withdrawal from the study at any phase
* Inability to be contacted by phone/mobile phone,
* Patient death
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject has been diagnosed with type 2 diabetes.
* HbA1c greater than or equal to 7.5% and less than or equal to 12%
* Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
* Subject owns a compatible smartphone
* Subject agrees to a 3-month period of no diabetes medication changes.
* Subject is willing to make diet and lifestyle changes in response to education and glucose data

Exclusion Criteria:

* Subject is currently on insulin therapy or sulfonylurea-based medications.
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
* Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes

This study will develop a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module will incorporate effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin.

The implementation of the module will ultimately be triggered by medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior. The study will involve provider workflow analysis based on observation, module user testing, and live usability testing with direct observation and semi-structure interviews.

The primary objective of this study is to develop a scalable, EHR customization toolkit that applies BE insights to promote appropriate diabetes care in older adults based on the American Geriatric Society's Choosing Wisely Guideline, as to assess the acceptability of the resulting module.

Eligibility Criteria:
Inclusion Criteria:

* Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes

Exclusion Criteria:

* None
Validation of a New Questionnaire Regarding Pain Management

The study includes operative as well as conservative patients using a questionnaire containing items of pain quality. After having completed the questionnaire, the patient is interviewed by an assistant. By this way the new questionnaire should be validated.

In addition the patient´s personal experiences are included and conservative patients can be compared to operative patients.

It is validated whether the questions are formulated comprehensively and the patient consequently is able to understand all the different interrogated aspects of the questionnaire.

Exemplarily the patient is asked to express his pain in an analogue scale in various situations and which type of pain they experience (for example headache).

Moreover, it is tested whether there is a relation between the pain and the treatment he receives, and whether the patient expressed the need for additional medication.

Besides, it is asked whether he already took medication before his hospitalisation.

With help of the interview, which is conducted subsequent to the questionnaire, it is verified if the patient understands the aspects. Some of the questions are interrogated in depth by additional questions, for example which type of pain he experiences in which situation.

One important aspect is to find out whether the patient is conscious about his medication.

In order to do so, schedules are used, which are based on the documented patient's history.

Eligibility Criteria:
Inclusion Criteria:

* Signing the consent form
* Patients with acute postoperative pain
* Patients with acute pain with conservative treatment
* Patients with ≥ 18 years of age

Exclusion Criteria:

* Lack of signature of the informed consent
* All physical and mental impairments which don´t allow the completion of the questionnaire or answering the interview
* Difficulties with the German language
* \<18 years of age
* Isolation of patient
Observational Study of the Preventive Trial With HIV-1 Tat Protein

The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune response. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.

All individuals (20) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, in addition to the hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation to the Phase I Clinical Trial ISS P-001
KT Tape for Pediatric Clavicle Fractures

Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling.

There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.


Eligibility Criteria:
Inclusion Criteria:

* Clavicle Fracture
* Injury date within 1 week of presentation

Exclusion Criteria:

* Underlying neuromuscular disorder (eg osteogenesis imperfecta)
* Inability or unwillingness to report pain score until healing
The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* patients with an appropriate indication for colonoscopy were considered eligible.

Exclusion Criteria:

* Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age \<18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.
Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a Randomized Controlled Trial

Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.

This is a randomized, double-blind study to study the analgesic effect of auricular pressure pill on persistent pain after hemorrhoidectiomy. Baseline pain intensity scores (VAS\>3) of the subjects will be collected 24 hours after the operation of the patients. Eligible subjects will be randomly assigned to receive auricular pressure pills or sham-auricular pressure pills. The treatment will last 5-7 days. Participants will receive auricular pressure once two days, and receive VAS, concomitant medication, PONV intensity scale and peripheral edema were recorded daily, and after the operation 24 hours, 3 days and 7 days the patients will receive anxiety and depression scale(HAD) , and VAS data will be collected by telephone at 3 and 6 months after the operation.

The statistical analysis results will be subject to the full analysis set (FAS) results, and a sensitivity analysis will be performed comparing the per-protocol (PP). The main indicators will be analyzed by covariance analysis, with VAS results as the dependent variable, grouping as the random factor, and age, course of disease, surgical method and baseline as the covariables to correct the P value. The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. Whether analgesic will be used as a dependent variable, grouping as a random factor, and age, course of disease, surgical method and evaluation time point will be analyzed as covariables. Other outcome indicators will be analyzed by covariance analysis, and the model will be the same as that of the main indicators. P\<0.05 considered as significant difference, and SPSS20.0 used for analysis.

The purpose of this study was to seek high quality evidence-based medical evidence for intervention of auricular pressure pills on postoperative pain of hemorrhoidectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions;
2. Age 18\~65;
3. External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia;
4. VAS score ≥3 points after the implementation of analgesia pump;
5. Improve clinical auxiliary examination and sign informed consent.

Exclusion Criteria:

1. Combined with inflammatory hemorrhoids, thrombotic hemorrhoids, perianal eczema, perianal abscess and other perianal diseases that affect the evaluation of curative effect;
2. Combined with intestinal infectious diseases, intestinal polyps, rectal malignant tumors, etc;
3. Combined with severe cardiovascular disease, immune deficiency, mental disorder, or severe liver and kidney dysfunction;
4. Auricle skin lesions or auricle skin allergy to tape is difficult to tolerate treatment;
5. Combined cognitive impairment could not complete the efficacy; evaluation;
6. Pregnancy or planned pregnancy.
Survival Analysis of Frail Patients With Localised Colorectal Cancer

The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment

Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.

Eligibility Criteria:
Inclusion Criteria:

* Localised colorectal cancer
* Positive frailty screening

Exclusion Criteria:

* None