linjc16/ctgov huggingface dataset:
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth

Study Overview
=================
Brief Summary
-----------------
Given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed. Programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid. BullyDown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.

Official Title
-----------------
Developing a Bullying Prevention Program That Transcends Physical Boundaries

Conditions
-----------------
Bullying

Intervention / Treatment
-----------------
* Behavioral: BullyDown
* Behavioral: Attention-matched control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7th or 8th grade English speaking Own their own cell phone Home internet Provide informed assent Exclusion Criteria: Non-English speakers Unable to read the screener Know someone else in the RCT Know they are not on an unlimited text messaging plan
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Youth will be randomized to either the intervention or control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BullyDown intervention<br> | Behavioral: BullyDown<br>* BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.<br>|
| Placebo Comparator: Healthy lifestyle control<br> | Behavioral: Attention-matched control<br>* The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Recruitment and enrollment rates | Through study completion, anticipated to be 1 year | 
| Acceptability of the intervention | Positive program appraisal | Intervention end, 8 weeks after program enrollment |
Comorbid Painful TMD Among Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

Detailed Description
-----------------
This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.

Official Title
-----------------
Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients

Conditions
-----------------
Myofascial Pain, Trigeminal Neuralgia, Temporomandibular Disorder, Trigeminal Neuropathy

Intervention / Treatment
-----------------
* Diagnostic Test: Clinical appointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients visited the three clinical sites for facial pain Patients diagnosed with trigeminal neuralgia Has active pain symptoms in the past 30 days Exclusion Criteria: Non-English speakers Patients with psychiatric disorders that might alter pain perception Adults lack the capacity to provide informed consent. Persons under the age of 18. All vulnerable populations.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TN cohort<br>The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days. | Diagnostic Test: Clinical appointment<br>* One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence | Prevalence of comorbid painful TMD among TN patient | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic questionnaire | The sensitivity, specificity of the diagnostic questionnaire for TN and TMD | 2 years |
Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions

Study Overview
=================
Brief Summary
-----------------
This research study will determine how a smart phone application (app) for total body photography outlier analysis compares to a dermatologist's decision to biopsy skin lesions.

Detailed Description
-----------------
Informed written consent will be obtained by all study subjects. Each participant will be asked to generate a unique identifier, so their demographic data, medical intake, and study assessments can be stored without any patient identifiers. The unique identifier is the participant's 2-digit day of birth, first 3 initials of their mother's maiden name, and the 4 digits of their birth year. All clinical data will be entered into a de- identified database. Demographic information including age, gender, ethnicity, collected via medical intake survey at the initial visit. Data from the survey will be associated only with the patient's unique identifiers.

Official Title
-----------------
Correlation of Dermatologist Made Biopsy Decisions With Artificial Intelligence (AI) Assisted Total Body Photography Detection of Outlier Lesions

Conditions
-----------------
Skin Lesion

Intervention / Treatment
-----------------
* Device: SkinIO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females participants in overall good health ages 18 to 85 who have skin lesions Exclusion Criteria: Those who are under 18 or over 85

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Comparison of outlier analysis with dermatologist made biopsy decisions<br>Skin lesions recommended for skin biopsy by the dermatologist will be compared to lesions highlighted by the application outlier analysis. | Device: SkinIO<br>* The device is simply an application that photographs skin lesions and identifies lesions that may require further examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatologist made biopsy decision compared to AI outlier lesions | Patient will undergo total body photography that marks outlier lesions. Without reviewing the photos, a dermatologist will make recommendations for which lesions should undergo skin biopsy. | Three months |
MOS Prebiotic Potential in Older Adults

Study Overview
=================
Brief Summary
-----------------
Mannooligosaccharides (MOS) derived from baker's yeast may have prebiotic properties such as improving gastrointestinal function. The aims of this study are to determine the effect of MOS on gastrointestinal function and symptoms and fecal microbiota in older adults.

Detailed Description
-----------------
Novel prebiotics with specific microbiome targets and without adverse gastrointestinal symptoms are needed for the exploration of health benefits. This is a 3-week, open-label pilot study designed to evaluate the effect of 15 g per day of yeast-derived mannooligosaccharides on gastrointestinal symptoms, stool frequency, fecal microbiome, and urinary metabolites.

Official Title
-----------------
The Prebiotic Potential of a Yeast Cell Wall Fraction Containing Mannooligosaccharides and β-glucans.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Mannooligosaccharides yeast extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 50-99 years of age. Able to provide written informed consent in English. Willingness to complete all study procedures Exclusion Criteria: Yeast allergy. Self-reported kidney disease. Elite athletes or long-distance runners. Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. Current use of laxatives or antidiarrheal medications. Use of other investigational products within 3 months of the screening visit. Previously or currently being treated for any intestinal disease or condition, including IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer (self-report). Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection) Current cancer treatment Currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannooligosaccharides<br>Mannooligosaccharides yeast extract | Dietary Supplement: Mannooligosaccharides yeast extract<br>* 15 g per day of mannooligosaccharide yeast extract.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily rating of gastrointestinal symptoms | Change from baseline mean sum of daily mean rating from 0 (no symptom) to 3 (severe symptoms) | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
Aschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt

Study Overview
=================
Brief Summary
-----------------
miRNAs have been detected in different bodily fluids, which suggests significant potential, such as their use as biomarkers in diagnostics and prognostics. Sha-mir-71a was abundantly found in the urine of patients with bladder cancer as compared to benign bladder cystitis associated with schistosomiasis . Additionally, this miRNA was more highly detected in urine samples from patients with bilharzial bladder cancer than bladder cancer not associated with bilharziasis (schistosomiasis), suggesting its specificity in the identification of bladder cancer associated with infection.

Official Title
-----------------
Role of Aschistosoma Haematobiumspecific microRNAas Atumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: urinary micro RNA detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: urinary symptoms (hematuria, urinary retention, dysuria… etc.), who were planned to undergo cystoscopy for suspicion of bladder cancer (BC) or benign bilharzial cystitis (Bil), will be selected. Exclusion Criteria: : In bladder cancer group Patients who have received chemotherapy, or with previously diagnosed other malignancy within the past 5 years.
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Active Comparator: chronicurinary schistosomiasis<br> | Diagnostic Test: urinary micro RNA detection<br>* Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR_71a gene expression analysis MAPK-3 gene expression analysis<br>|
| Active Comparator: bladder cancer diseased patients<br> | Diagnostic Test: urinary micro RNA detection<br>* Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR_71a gene expression analysis MAPK-3 gene expression analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer | Sha-mir-71a could be a biomarker with diagnostic and prognostic value | one year |
To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Test Drug(JW0302) or Reference Drug(C2206)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Subjects does not meet the Inclusion Criteria

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: Sequential Assignment
Interventional Model Description: A randomized, open, single-dose, 2x2 crossover-design clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Test Drug for Period I Reference Drug for Period II | Drug: Test Drug(JW0302) or Reference Drug(C2206)<br>* Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration<br>|
| Other: Group 2<br>Reference Drug for Period I Test Drug for Period II | Drug: Test Drug(JW0302) or Reference Drug(C2206)<br>* Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK for JW0302 and C2206 after multiple dose | up to 24 hours | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | Evaluation PD for ambulatory 24hr pH monitor | Baseline versus Multiple dose during 7 days |
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to determine effect of arginine and glutamine on outcome of COVID-19 patients. The main questions it aims to answer are: -to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome Dr. M. Djamil General Hospital Padang Participants will given ONS containing arginine and glutamine. Researchers will compare intervention group with control group to see if ONS affected outcome of COVID-19 patients

Official Title
-----------------
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Dietary Supplement: Neomune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients confirmed positive for COVID-19 Age over 17 years The patient can take food orally Exclusion Criteria: Patients with restricted fluid intake Patients who cannot take food orally suffering from diabetes mellitus and kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd | Dietary Supplement: Neomune<br>* Neomune containing 4.8 g arginine and 2 g glutamine<br>|
| Active Comparator: control group<br>the control was administered with a High-Calorie High-Protein diet + ONS hospital standard. | Dietary Supplement: Neomune<br>* Neomune containing 4.8 g arginine and 2 g glutamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | length of stay of patients in hospital | 3 months | 
| Outcome | Outcome Measures of patients (discharge or dead) | 3 months | 
| ICU Admission | A patient is likely to be admitted to ICU during intervention period | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Il-6 and CRP Levels | Il-6 and CRP Levels during hospitalization | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Oral Nutrition Supplement
Evaluation of Inflammatory Markers in LARC Patients

Study Overview
=================
Brief Summary
-----------------
Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis. Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.

Official Title
-----------------
Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients

Conditions
-----------------
Locally Advanced Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Inflammatory markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery Exclusion Criteria: evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or watch and wait approach and evidence of inflammatory or hematological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High levels of inflammatory scores<br> | Diagnostic Test: Inflammatory markers<br>* analysis of inflammatory scores<br>|
| Low levels of inflammatory scores<br> | Diagnostic Test: Inflammatory markers<br>* analysis of inflammatory scores<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival Disease-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response through Ryan Tumor Regression Grade | TRG 1-5; 1- no viable cancer cells; 5- no fibrosis, with extensive residual disease | at study completion, average of 5 years |