linjc16/ctgov huggingface dataset:
A Novel ACT-based Video Game

Study Overview
=================
Brief Summary
-----------------
A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility.

Official Title
-----------------
A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol

Conditions
-----------------
Depression, Anxiety, Stress, Emotional, Quality of Life, Psychological Flexibility, Social Connecedness

Intervention / Treatment
-----------------
* Behavioral: Acceptance and commitment therapy video game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with some existing form of anxiety, depression or ongoing stress. Need ability to read and write English. Need internet access to plat the videogame. Exclusion Criteria: Those who are under 18, and do not have any existing forms of anxiety, stress or depression.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT video game<br> | Behavioral: Acceptance and commitment therapy video game<br>* The intervention is a videogame which teaches the participant about acceptance and commitment therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety Stress Scales (DASS21) | A measure of general psychological distress (assesses current depression, anxiety, and stress). | 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) with a focus on positive aspects of mental health. This measure has good internal consistency with a Cronbach's alpha coefficient of 0.89 (student sample) and 0.91 | A measure of mental well-being with a focus on positive aspects of mental health | 1 year | 
| University of California, Los Angeles (UCLA) Loneliness Scale | This measure involves two questions; (1) During these social interactions, I felt 'in tune' with the person/s around me, and (2) During these social interactions, I felt close to the person/s. | 1 Year | 
| EuroQol five dimensions (EQ5D). | A measure for health-related quality of life. | 1 year | 
| Acceptance and Action Questionnaire- second version (AAQ-II). | A measure psychological inflexibility, which involves the ability to accept and be open to difficult thoughts and feelings as well as to engage in valued behaviour in the presence of the difficult thoughts and feelings. | 1 year |
Flumazenil Reversal of Oral Triazolam

Study Overview
=================
Brief Summary
-----------------
An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the front line in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).

Official Title
-----------------
Flumazenil Rescue Strategy

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Drug: Flumazenil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I Exclusion Criteria: Use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study Body mass index (BMI) no less than 15 kg/m2 and no greater than 30 kg/m2 Pregnancy or not currently using pharmacologic methods of birth control Allergy or sensitivity to benzodiazepines History of a seizure disorder; AND Chronic tobacco use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Flumazenil 2mL | Drug: Flumazenil<br>* 2 mL, 0.2 mg SM<br>|
| Placebo Comparator: 2<br>Saline, 2mL SM | Drug: Placebo<br>* 2 mL sterile saline SM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer Assessment of Alertness/Sedation |  | 360 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS |  | 360 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conscious sedation, dental anxiety/drug therapy, behavior/drug effects
Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?

Study Overview
=================
Brief Summary
-----------------
The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia.

Detailed Description
-----------------
The survey will be administered preoperatively in the ENT clinic or the preoperative surgical unit. The following data will also be recorded: patient demographics (age, gender, BMI), surgical procedure, length of procedure and anesthetic, and smoking exposure. Based on differences in postoperative outcomes (e.g., supplemental oxygen requirement in the PACU) observed in the derivation cohort for the 6-item questionnaire, the study will enroll 1,000 patients to attain sufficient power for evaluating the 6-item questionnaire in the overall cohort and in demographically or clinically defined subgroups.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will include all who are presenting for surgery to the main operating room, ambulatory surgical center or procedure center at Nationwide Children's Hospital. Exclusion Criteria: Emergency surgery and any caregiver or patient refusal.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| Children undergoing surgery<br>Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp. | Other: Survey<br>* Completing a survey on RedCap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liters of Oxygen | The patient's oxygen requirement while in the PACU. | 1 hr post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic usage in mg | The patient's opiod requirement while in the PACU. | 1 hr post-op | 
| PACU length of stay |  | 1-2 hr post-op |
Eosinophilic Esophagitis Databank

Study Overview
=================
Brief Summary
-----------------
This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

Detailed Description
-----------------
Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE. The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis. The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies.

Official Title
-----------------
Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

Conditions
-----------------
Esophagitis, Eosinophilic Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing; Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted). Exclusion Criteria: Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites; Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 65 Years

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 |
| --- | --- | --- |
| Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis | A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted. | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eosinophilic Esophagitis
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Study Overview
=================
Brief Summary
-----------------
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized. The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements. The primary objectives of the trial are to determine: Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test Creating database of glucose levels readings utilizing the Glucometer GM-205.

Official Title
-----------------
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus type one or type two. Patients that are using Insulin. Exclusion Criteria: Vascular diseases Pregnant and lactating women. Exclusive use of long term Insulin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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 |
| --- | --- | --- |
Comparative Study Between Three Different Methods for Stuttering Therapy in Children

Study Overview
=================
Brief Summary
-----------------
The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment

Official Title
-----------------
Comparative Study Between Three Different Methods for Stuttering Therapy in Children

Conditions
-----------------
Stuttering, Childhood

Intervention / Treatment
-----------------
* Behavioral: speech therapy only
* Device: hyperbaric oxygen therapy
* Drug: medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 5 to 15 years old with IQ above 80 Exclusion Criteria: 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>will be treated by speech therapy only (fluency shaping). | Behavioral: speech therapy only<br>* fluency shaping technique<br>|
| Active Comparator: Group B<br>will be treated by speech therapy (fluency shaping) plus Hyperbaric oxygen therapy. | Behavioral: speech therapy only<br>* fluency shaping technique<br>Device: hyperbaric oxygen therapy<br>* chamber system using oxygen with pressure<br>|
| Active Comparator: Group C<br>will be treated by speech therapy (fluency shaping) plus medical treatment (brain stimulant). | Behavioral: speech therapy only<br>* fluency shaping technique<br>Drug: medical treatment<br>* brain stimulant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stuttering severity instrument (SSI-3) | rating scale for stuttering severity | before therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stuttering severity instrument (SSI-3) | rating scale for stuttering severity | post therapy by 3 months |
Prevalence of Osteoporosis in Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease is the most common single-gene disease in the world. Its prevalence is increasing in France, with patients' life expectancy increasing into developed countries. It mainly affects populations originating from sub-Saharan Africa. Among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. A dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in France may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases. This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in France

Official Title
-----------------
Prevalence of Osteoporosis in Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Black-skinned men and women Aged 20 to 40 years old Sickle cell patients Non-opposition to participate in the study Exclusion Criteria: Refusal to participate in the study Hemoglobinopathy other than sickle cell disease Severe or End Stage Renal Failure Long-term corticosteroid therapy (>3 months) History of solid cancer or malignant haemopathy History of organ transplantation Pregnant or breastfeeding woman Psychiatric pathology seriously impeding understanding Difficulty understanding oral French

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| sickle cell disease patients<br>150 black patients with sickle cell disease living in France, 20 to 40 years old will be included in this study | Other: Questionnaire<br>* For each subject recruited, will be collected for the study a questionnaire looking for a history of low energy fracture, and the origins of the patient (or relatives), as well as medical history, lifestyle (alcohol and tobacco consumption), weight and height. This data will be used for the secondary outcomes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Bone mineral density is measured by systematic bone densitometry at 3 sites: lumbar spine, femoral neck and total hip. These data will be collected in the patient's medical record | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell disease
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Official Title
-----------------
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention / Treatment
-----------------
* Drug: Esomeprazole 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history of gastric and/or duodenal ulcer A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age Exclusion Criteria: Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification History of esophageal, gastric or duodenal surgery Having severe liver disease or chronic renal disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole 20 mg<br>Esomeprazole 20 mg once daily | Drug: Esomeprazole 20 mg<br>* Esomeprazole 20 mg once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period |  | up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment |  | up to 4 weeks after treatment | 
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment |  | up to 12 weeks after treatment | 
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment |  | up to 24 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer