linjc16/ctgov huggingface dataset:
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).

Official Title
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Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

Conditions
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Opioid-use Disorder

Intervention / Treatment
-----------------
* Other: MORE-VR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older DSM-5 opioid use disorder diagnosis treated with medications for opioid use disorder (MOUD) Exclusion Criteria: Mindfulness intervention experience (MBSR, MBRP) Active psychosis or high risk of suicidality Cognitive impairment (per self-report or report by clinician) Unwilling or unable to remain in MOUD treatment for duration of study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE-VR<br>Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. | Other: MORE-VR<br>* Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events and/or Serious Adverse Events | Number of participants who reported adverse events and serious adverse events. | Baseline through week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement | Net Promoter Score (NPS) is a engagement and satisfaction measurement taken from asking participants how likely they were to recommend the MORE-VR intervention to others on a scale of 0-10. Net Promoter Score (NPS) is calculated by subtracting the percentage of customers who answer the NPS question with a 6 or lower (known as 'detractors') from the percentage of customers who answer with a 9 or 10 (known as 'promoters'). The summary Net Promoter Score is reflected as a percentage. | Baseline through week 8 | 
| Numeric Rating Scale of State Craving | Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving. | Baseline through week 8 | 
| Numeric Rating Scale of State Positive Affect | Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect. | Baseline through week 8 |
Summer Weight and Environmental Assessment Trial

Study Overview
=================
Brief Summary
-----------------
The consequences of childhood obesity are devastating, affecting the physical and mental health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI during the summer months and there is a dearth of information regarding the causal health behaviors and environmental factors. The overall objective of this application is to provide an in depth examination of key dietary and physical activity behaviors as well as the food, physical activity, and social environments of low-income, racial/ethnic school-age children. To achieve this goal, an observational study utilizing a multi-state prospective cohort design will be conducted with the goal of examining the weight gain trajectory among a racially and ethnically diverse convenience sample of disadvantaged school-age children who routinely attend structured programming during the summer months and those who don't participate in structured programming. In addition, a subset of these children will be evaluated to learn their daily health behaviors, as well as their food, physical activity, and social environments during the summer. Identification of determinants of program participation and factors that may enhance the beneficial effects of program participation will also occur. A social ecological framework approach will guide the research. This study can be expected to have a significant positive impact by providing information on the factors that protect disadvantaged children from unhealthy weight gain during the summer which can be used by stakeholders at the local, state, and federal level to reform current policy that will increase child participation in health promoting programming during the summer window of risk.

Official Title
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Summer Weight and Environmental Assessment Trial (SWEAT)

Conditions
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Childhood Obesity

Intervention / Treatment
-----------------
* Other: n/a - observational study


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Underserved school-aged children<br>Underserved school-aged children at risk for obesity | Other: n/a - observational study<br>* n/a - observational study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI |  | Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks) |
Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the efficacy of cryotherapy application on the success of inferior alveolar nerve block (IANB) in reducing pain during pulp therapy of the mandibular first permanent molars with irreversible pulpitis (IP) in children age from 7 to 16 years. The null hypothesis (H0) supposed no difference in pain intensity during pulp therapy of primary molars with IP anesthetized with IANB with and without cryotherapy application. The secondary aim was to evaluate the children's behavior before and after pulpectomy in the two groups.

Official Title
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Cryotherapy Efficacy in 9 to17-year-old Children During Endodontic Treatment of the Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Parallel Controlled Trial

Conditions
-----------------
Cryotherapy Effect, Irreversible Pulpitis, Pain

Intervention / Treatment
-----------------
* Other: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification. Cooperative children (rate 3 or 4 according to Frankl behavior rating scale) Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed. No radiographic changes with at least two-thirds of the root must be evident. Exclusion Criteria: Children with severe emotional, intellectual, and behavioral difficulties. Necrotic pulp of primary molars. Unrestorable crowns Positive history of gingival swelling, abnormal mobility, and fistulous tract. Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy<br> | Other: Cryotherapy<br>* Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration<br>|
| Active Comparator: Inferior alveolar nerve block<br> | Other: Cryotherapy<br>* Ice packs were applied in the buccal mucosa related to the tooth for 5 minutes after IANB administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain was assessed using Visual Analogue Scale (VAS) | up to 24 hours |
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Study Overview
=================
Brief Summary
-----------------
Evaluation of an artificial intelligence system for polyp detection (CADe)

Detailed Description
-----------------
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.

Official Title
-----------------
Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort

Conditions
-----------------
Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon, CADe

Intervention / Treatment
-----------------
* Device: ENDOMIND


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication CRC surveillance endoscopy indication post-polypectomy surveillance endoscopy positive fecal immunochemical test in patients >=50 years Exclusion Criteria: reasonable suspicion of inflammatory bowl disease reasonable suspicion of familiar polyposis Syndrome Patient after radiation/resection of colonic parts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surveillance endoscopy with CADe support<br>Endoscopy perfomed with CADe support. | Device: ENDOMIND<br>* CADe system for Polyp detection<br>|
| No Intervention: conventional surveillance endoscopy<br>Endoscopy perfomed without CADe support. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate | proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp detection rate | Exmainations with minimum one polyp detected. | 4 months | 
| withdrawal time | Time of withdrawal. | 4 months | 
| resection time | Time spent on polyp resections. | 4 months | 
| Boston Bowl Preparation Score | minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance | 4 months |
Ventricular Matrix Remodeling: Correlates and Prognosis

Study Overview
=================
Brief Summary
-----------------
To assess the diagnostic and prognostic usefulness of serum markers of left ventricular remodeling for predicting congestive heart failure.

Detailed Description
-----------------
BACKGROUND: Recent studies have established that cardiac extracellular matrix (ECM) remodeling is a major determinant of pathologic left ventricular hypertrophy (LVH) and progressive left ventricular dilatation, and as a result, contributes to the development of left ventricular dysfunction and overt congestive heart failure (CHF). The recent development of reliable serologic assays for procollagen peptides, metalloproteinases (MMP) and their tissue inhibitors (TIMP), and cytokines permits the in vivo assessment of LV ECM remodeling, and raises the possibility of expanding the utility of these markers 'from the bench to the bedside.' Prior studies of ECM biomarkers in congestive heart failure have been limited to cross-sectional investigations of small samples of highly selected patients with advanced disease. The fundamental question whether serum markers of ECM remodeling are important correlates of left ventricular dilatation or left ventricular hypertrophy, or are independent predictors of incident congestive heart failure in the community remains unanswered. DESIGN NARRATIVE: The aims of the study are to: determine the relationships between serum markers of ECM remodeling and traditional congestive heart failure risk factors; analyze the cross-sectional relations between markers of ECM remodeling and echocardiographic left ventricular hypertrophy and left ventricular dilatation, Doppler indices of left ventricular filling and serum natriuretic peptides; investigate prospectively the relationships between ECM remodeling markers and progressive left ventricular dilatation and left ventricular hypertrophy and congestive heart failure incidence, adjusting for standard risk factors. Stored samples from the Framingham Offspring and Omni cohorts will be used. Participants at the extremes of the joint distributions of left ventricular wall thickness and left ventricular internal dimension from echocardiograms performed at earlier Framingham exams will be sampled.

Conditions
-----------------
Heart Diseases, Heart Failure, Congestive, Cardiovascular Diseases, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Leucine Supplementation in Elderly Men

Study Overview
=================
Brief Summary
-----------------
In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men

Official Title
-----------------
The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly

Conditions
-----------------
Sarcopenia, Atrophy, Aging

Intervention / Treatment
-----------------
* Dietary Supplement: placebo
* Dietary Supplement: leucine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living independently Exclusion Criteria: Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>daily leucine supplementation | Dietary Supplement: leucine<br>* daily leucine capsules with each main meal<br>|
| Placebo Comparator: 2<br>daily placebo supplementation | Dietary Supplement: placebo<br>* wheat meal capsules with each main meal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass and body composition |  | before and after 12 wk intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | before and after 12 wk intervention |
Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry

Study Overview
=================
Brief Summary
-----------------
Background Cancer and cardiovascular diseases combined account for more than 50% of the overall mortality burden in the USA. Accumulating evidence indicates that saturated fat intake is related to an increase, while unsaturated fat intake is related to a decrease in all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to unsaturated fat. Objective The aim of the present study was to estimate the mortality risk reduction related to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat intake. Design The American National health and nutrition examination surveys conducted between 1999 and 2010 were linked to the 2011 national US death registry resulting in an observational prospective mortality study. Proportional hazards Cox models were used to evaluate the association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric substitution of 10% of the energy from dietary fat intake applied to the substitution of saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.

Official Title
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Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry

Conditions
-----------------
Diet Modification

Intervention / Treatment
-----------------
* Other: fat intake


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Included NHANES 1999-2010 age >= 30 years old Exclusion Criteria: Record not reported in the mortality linked file Cancer, type-II diabetes, cardiovascular disease at baseline Missing data on covariates used in the model

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: fat intake|Observational study on fat intake and mortality|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all causes and specific cause mortality | specific cause mortality = cancer and cardiovascular disease | up to 9 years of observatinal time |
Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Detailed Description
-----------------
By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Official Title
-----------------
Effects of Propofol and Sevoflurane on Early Postoperative Cognitive Dysfunction in Elderly Patients With Metabolic Syndrome

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Other: metabolic syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥60 years; ASAⅡor Ⅲ noncardiac surgery and nonneural surgery Exclusion Criteria: Mini Mental State Examination [MMSE] score too low chronic alcoho and drug abuse disturbed renal and liver function history of a cerebrovascular accident permanent ventricular pacing preoperative cognitive deficits lack of cooperation

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>Patients with metabolic syndrome were randomly assigned to receive propofol anesthesia | Other: metabolic syndrome<br>* metabolic syndrome<br>|
| Active Comparator: sevoflurane group<br>Patients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia | Other: metabolic syndrome<br>* metabolic syndrome<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group |  | up to 7days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative cognitive dysfunction, metabolic syndrome, propofol, sevoflurane