linjc16/ctgov huggingface dataset:
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Metformin
* Drug: Vildagliptin + Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes Diagnosis of T2DM for at least 4 weeks prior to study entry Age 18 - 78 years inclusive Body mass index (BMI) of 22 - 40 kg/m2 HbA1c: 7.5 - 11% inclusive FPG <270 mg/dL (15 mmol/L) Exclusion Criteria Pregnant or lactating female A history of type 1 diabetes Evidence of significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin + Metformin Dose 1<br> | Drug: Vildagliptin + Metformin<br> <br> |
| Experimental: Vildagliptin + Metformin Dose 2<br> | Drug: Vildagliptin + Metformin<br> <br> |
| Active Comparator: Vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Active Comparator: Metformin<br> | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | At week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | At week 24 | 
| Percent of patients with endpoint HbA1c <7% |  | At week 24 | 
| Percent of patients with reduction in HbA1c >/=0.7% |  | At week 24 | 
| Adverse event profile after treatment |  | At week 24 | 
| Change from baseline in body weight |  | At week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, metformin, hemoglobin A1c
Ostomy Belt Use Associated Quality of Life

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.

Official Title
-----------------
Ostomy Belt Use Associated Quality of Life

Conditions
-----------------
Stoma Ileostomy, Stoma Colostomy

Intervention / Treatment
-----------------
* Device: Ostomy belt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt 18 - 70 years old Willing and able to sign informed consent Exclusion Criteria: Patients without stoma or unwilling to wear ostomy belt. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ostomy belt group<br>Participants in this group will receive ostomy belts for eight weeks. | Device: Ostomy belt<br>* Stealth ostomy belt continuous for eight weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life as measured by SQOLS | Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction. | Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use |
Music in Urgent and Emergent Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED.

Detailed Description
-----------------
The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED. This study follows a prospective experimental design where patients will be assigned to two groups: one that receives the music intervention and one that does not receive music intervention.

Official Title
-----------------
Music in Urgent and Emergent Settings (MUES) Trial: Phase Three

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Other: Live Preferential Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥18 Chief complaint of musculoskeletal pain Gender: Male or Female Ethnicity: Any Physical ability: Any Language: English Cognitive skill/education: grade 2 reading level or above Physically and cognitively able to participate in study procedures Exclusion Criteria: Patients who are unable to participate in the informed consent process Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br> | |
| Experimental: Intervention Group<br>Music group | Other: Live Preferential Music<br>* Trained musicians will play live preferential music to ED patients who consent to participate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction |  | 60 to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of care |  | 20 weeks |
Screening Protocol for Adults With ADHD

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential adult subjects for appropriate ADHD clinical research studies

Detailed Description
-----------------
To address the needs of the large number of adults who contact the Adult ADHD Program at Massachusetts General Hospital annually, we have sought approval for several research studies aimed at evaluating critical components of the needs of this population. Potential participants for those studies present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we have potential subjects consent to undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program available to them.

Official Title
-----------------
A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
ADHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 18-55 Subjects must have a DSM-IV or DSM-V diagnosis of ADHD, as determined by a clinical evaluation based on DSM-IV or DSM-V criteria Exclusion Criteria: History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention. Any significant medical condition, in the judgment of the investigator Mental retardation Pregnancy of lactation Subjects with a known recent history (within the past 6 months) of illicit drug or alcohol dependence Sensory difficulties such as deafness or blindness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| A<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Protocol | This study is a prescreening for possible entry into other studies | Sreening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Adults
Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in the treatment of resistant major depression in an open study using two different H-coil designs.

Official Title
-----------------
Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: H1 and H2 deep TMS coils


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as suffering from treatment resistant major depression Exclusion Criteria: Other axis I diagnosis Risk factors for convulsions Electroconvulsive therapy (ECT) in the last 9 months History of drug abuse in the past year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Device: H1 and H2 deep TMS coils|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major depression, TMS
Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars

Study Overview
=================
Brief Summary
-----------------
This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.

Official Title
-----------------
Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars

Conditions
-----------------
Dental Pulp Capping

Intervention / Treatment
-----------------
* Procedure: Indirect pulp therapy
* Procedure: Pulpotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with at least one primary molar with deep decay approaching the pulp.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indirect pulp therapy<br>Primary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus). | Procedure: Indirect pulp therapy<br>* Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)<br>|
| Active Comparator: Pulpotomy<br>Primary molars treated with MTA pulpotomy. | Procedure: Pulpotomy<br>* A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of pulp vitality | Pain, mobility, abscess as determined with clinical evaluation | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic assessment of pulp vitality | Signs of pulpal degeneration, including evaluation for presence or absence of internal/external root resorption, periodontal ligament widening, and intraradicular radiolucency as determined with radiographic evaluation | 10 years |
Single Site Robotic Cholecystectomy in Non Selected Patients

Study Overview
=================
Brief Summary
-----------------
This is a study of new technology to allow gallbladder removal through a single small surgical incision. A surgical robot is utilized to help navigate the small space. In this study, patient characteristics are broad to assess how applicable the procedure is to everyone.

Official Title
-----------------
Single Site Robotic Cholecystectomy in Non Selected Patients

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Procedure: Single site robotic chole
* Device: da Vinci Si Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of symptomatic gallstones Exclusion Criteria: significant previous open abdominal surgery

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 |
| --- | --- |
| Single site robotic chole<br>Cholecystectomy performed through a single incision with the robot. | Procedure: Single site robotic chole<br>* Cholecystectomy<br>Device: da Vinci Si Surgical System<br>* minimally invasive robotic surgical system designed to facilitate complex procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of procedure by SSRC |  | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events to study participants (e.g. bile duct injury, hemorrhage) |  | At time of procedure and in clinic up to 30 days after surgery |
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.

Official Title
-----------------
Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer

Conditions
-----------------
Non-muscle Invasive Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy. Exclusion Criteria: Patients younger than 18 years Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2 or greater) Patients who are unable or unwilling to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The recurrence status based on the pathology results |  | 1 year | 
| The Genomic Health bladder cancer assay results. |  | 1 year |
Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome

Study Overview
=================
Brief Summary
-----------------
Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome. Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for treating this disease. To test our hypothesis, we designed an experiment in which ex vivo peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome patient samples that are exposed DF-003.

Official Title
-----------------
A Phase 0 Study to Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cells (PBMC) From Subjects With Retinal Dystrophy, Optic Nerve Edema, Splenomegaly, Anhidrosis and Headache (ROSAH) Syndrome.

Conditions
-----------------
Unrecognized Condition

Intervention / Treatment
-----------------
* Other: Adult subjects with ROSAH syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged over 18 Patient with ROSAH syndrome with the confirm T237M mutation Exclusion Criteria: person under legal protection or under protectives measures person unable to express consent person in emergency situation (vital or not) person infected by Human Immunodeficiency Virus and/or Hepatitis B Virus and/or Hepatitis C Virus

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

| Intervention/Treatment |
| --- |
|Other: Adult subjects with ROSAH syndrome|The main objective is to evaluate the ex vivo inhibitory potential of DF-003 on alpha-1 kinase activity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine release assays | The Cytokine release assays will analyzed by ELISA in cells supernatants the Interleukin 8 (IL-8), Tumor Necrosis Factor (TNF) concentrations in the presence/absence of DF-003 and control. | At day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROSAH Syndrome.
Sleep Disturbances in Dermatology Patients

Study Overview
=================
Brief Summary
-----------------
This study is to investigate sleep disorders in patients with dermatologic diseases by taking into consideration dermatologic (itch, pain) and non- dermatologic (medication, depression) factors.

Official Title
-----------------
Sleep Disturbances in Dermatology Patients- a Survey

Conditions
-----------------
Sleep Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: survey on sleep disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients of the dermatologic university clinic Exclusion Criteria: Insufficient knowledge of German language Illiteracy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: survey on sleep disorders|self-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regensburg Insomnia Scale (RIS) | Self-rating scale: Five items cover quantitative and qualitative sleep parameters: Sleep latency (1), sleep duration (2), sleep continuity (3), early awakening (4) and sleep depth (5). Four items cover the psychological aspects of psychophysiological insomnia (PI), such as the experience of sleepless nights (6), focussing on sleep (7), fear of insomnia (8), and daytime fitness (9), one item covers sleep medication (10). A 5-step Likert scale was provided for response.The total score ranges from 0 to 40 points (score from 0-12 points considered as normal and a higher score as indicative of PI symptoms). | single time point assessment at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermatologic disease