linjc16/ctgov huggingface dataset:
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability

Official Title
-----------------
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.

Conditions
-----------------
Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
-----------------
* Drug: IMB-1018972


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Elevated HbA1c Elevated BMI Preserved left ventricular ejection fraction Diagnosis of HFpEF (Stage 2 only) Exclusion Criteria: Uncontrolled hypertension Contraindication to magnetic resonance scanning More than mild to moderate valvular heart disease Atrial fibrillation History of sustained ventricular tachycardia or cardiac arrest Inability to exercise (Stage 2 only) Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: IMB-1018972 200 mg<br> | Drug: IMB-1018972<br>* Modified release tablet for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972. |  | Baseline, End of Treatment (up to 16 weeks) | 
| Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972 |  | Baseline, End of Treatment (up to 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs |  | Baseline through End of Treatment (up to 16 weeks) |
Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus

Study Overview
=================
Brief Summary
-----------------
The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.

Conditions
-----------------
Amblyopia, Strabismus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with a status of strabismus or not strabismus made by a specialized ophthalmologist children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist signed consent of parents Exclusion Criteria: ocular pathology (except for isolated ametropia) evolutive paralytic strabismus antecedent of surgery for strabismus strabismus surgery in the past 6 months disease with possible impact on the child's answers, such as severe neurologic troubles) poor knowledge of French language

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validation of the questionnaire |  | immediate |
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

Study Overview
=================
Brief Summary
-----------------
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

Official Title
-----------------
Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Conditions
-----------------
Tinnitus, Hyperacusis

Intervention / Treatment
-----------------
* Device: Oasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age, TRQ of at least 17 or above, Able to pay for the treatment, Not using any other treatment for tinnitus, Access to computer and internet, Compliant patient Exclusion Criteria: Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale, Not willing to follow the protocol

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Oasis|Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post treatment scores on Tinnitus reaction questionnaire |  | 6, 12, 24, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, |  | 6, 12, 24, 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant, discomfort
Pain Relief by Platelet-rich Plasma (PRP) Treatment

Study Overview
=================
Brief Summary
-----------------
Past PRP therapy is not sufficient for some part of patients.In this clinical research, The integrated application of PRP with extracellurar matrix and some type of stem cell technique.

Conditions
-----------------
Sciatica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Injury by professional sports and non professional sports Exclusion Criteria: Other basic disease holder
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes of Amounts of Pain Killer Consumed for Scheduled Term Before and After PRP treatment. |  | 1 month |
West Virginia WISEWOMAN Project

Study Overview
=================
Brief Summary
-----------------
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Official Title
-----------------
West Virginia WISEWOMAN Project

Conditions
-----------------
Risk Reduction Behavior

Intervention / Treatment
-----------------
* Behavioral: West Virginia WISEWOMAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NBCCEDP Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle counseling<br>Women assigned to lifestyle change intervention arm for nutrition and physical activity with print-based tailored health communications and a computer-based interactive nutrition program targeting health behaviors of diet and physical activity. Women in a control group did not receive the intervention. | Behavioral: West Virginia WISEWOMAN<br>* Print-based tailored health communications and computer-based interactive nutrition program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical activity and nutrition lifestyle behaviors |  | baseline and one year |
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax. Planned registration period 4 years Planned surveillance period 5 years and 6 months

Official Title
-----------------
ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma

Conditions
-----------------
Lymphoma, T-Cell, Peripheral

Intervention / Treatment
-----------------
* Drug: Istodax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time. Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsed or Refractory T-Cell Lymphoma patients with Istodax<br>Among patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance | Drug: Istodax<br>* Istodax<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse event | Up to approximately 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Istodax, Survey, Relapsed or refractory, Peripheral T-Cell Lymphoma
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Low Strength IDP-107
* Drug: High Strength IDP-107
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of acne vulgaris on the face and neck/trunk Presence of inflammatory and non-inflammatory lesions on the face Exclusion Criteria: Presence of any skin condition on the face that could interfere with clinical evaluations Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Low Strength IDP-107<br> | Drug: Low Strength IDP-107<br>* Once a day for 16 weeks<br>|
| Experimental: High Strength IDP-107<br> | Drug: High Strength IDP-107<br>* Once a day for 16 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once a day for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of inflammatory lesions |  | Baseline and 22 weeks | 
| Percent of patients who achieve success for the acne global severity score |  | Baseline and 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of non-inflammatory lesions |  | Baseline and 22 weeks |
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression

Study Overview
=================
Brief Summary
-----------------
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.

Official Title
-----------------
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression

Conditions
-----------------
Anxiety, Depression

Intervention / Treatment
-----------------
* Drug: Sertraline
* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with an infant > 2 months and < 8 months of age Infant born after a full-term pregnancy Infant born with no congenital abnormalities Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). Exclusion Criteria: positive serum pregnancy test; concurrent psychiatric disorder (excepting co-morbid anxiety); recent history of antidepressant usage (within the last month); history of major allergy or drug allergy; history of substance abuse; prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs); predisposition to headache, migraine or nausea; tobacco habit in excess of 10 cigarettes per day; caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day; ongoing dental work; extreme levels of depression (psychotic); suicidal intent; participation in any medical trial within the previous three months;

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertraline<br> | Drug: Sertraline<br> <br> |
| Active Comparator: Cognitive Behavioural Therapy<br> | Behavioral: Cognitive Behavioural Therapy<br> <br> |
| Active Comparator: Combined Therapy<br> | Drug: Sertraline<br> <br> Behavioral: Cognitive Behavioural Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory |  | 24 weeks | 
| Parenting Stress Index |  | 24 weeks |
Cerebrotendinous Xanthomatosis (CTX) Prevalence Study

Study Overview
=================
Brief Summary
-----------------
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Official Title
-----------------
An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed With Early-Onset Idiopathic Bilateral Cataracts

Conditions
-----------------
Cerebrotendinous Xanthomatosis (CTX)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a diagnosis of idiopathic bilateral cataracts. Between the ages of 2 to 21 years at the time of diagnosis Exclusion Criteria: The patient has a diagnosis of cataracts with known etiology other than CTX. The patient has a diagnosis of CTX. The patient has cataracts caused by cataractogenic treatments. The patient has taken or is currently taking cholic acid or chenodeoxycholic acid. The patient has participated in an interventional clinical trial in the past 30 days. The patient and/or their parent/legal guardian, in the opinion of the Investigator, is unable to adhere to the requirements of the study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| To calculate the prevalence of Cerebrotendinous Xanthomatosis (CTX) in a patient population diagnosed up to age 21 with early-onset idiopathic bilateral cataracts | (by blood draw where plasma cholenstanol levels and/or urine bile alcohol results will be used to determine whether genetic testing is indicated. Genetic Testing, if indicated, will be used to determine the prevalence of CTX) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess other manifestations of CTX within patients presenting with idiopathic bilateral cataracts. | Based on a patient reported, CTX disease-specific medical history for the patients diagnosed with CTX, the manifestations and symptoms related to the disease will be presented by body system. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebrotendinous Xanthomatosis, CTX Prevalence Study, CTX, Idiopathic Bilateral Cataracts, Cataracts, Bilateral Cataracts, Early-Onset Idiopathic Bilateral Cataracts, Observational Study, Ophthalmology
An Analysis in the Use of Telecommunication Platform

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic becomes a global challenge. Beneficial to being an island country and having appropriate policies, there were only few imported cases in Taiwan. However, many locally acquired cases came out in the mid of this May. The hospital policy about containing infection changed accordingly. A real-time communication platform for the health care workers was designed and embedded in the hospital information system of the emergency department in 2018. The functions included sending messages to certain staff, pop-up reminders, and tracking messages. This study aims to evaluate the use of the communication platform during the COVID pandemic.

Detailed Description
-----------------
The COVID-19 pandemic becomes a global challenge. Beneficial to being an island country and having appropriate policies, there were only few imported cases in Taiwan. However, many locally acquired cases came out in the mid of this May. The hospital policy about containing infection changed accordingly. A real-time communication platform for the health care workers was designed and embedded in the hospital information system of the emergency department in 2018. The functions included sending messages to certain staff, pop-up reminders, and tracking messages. This study aims to evaluate the use of the communication platform during the COVID pandemic.

Official Title
-----------------
An Analysis of Changes in the Use of Telecommunication Platform in National Taiwan University Hospital During the Time of Global COVID-19 Pandemic

Conditions
-----------------
the Use of the Platform

Intervention / Treatment
-----------------
* Other: the use of the platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthcare workers with using the communication platform. Exclusion Criteria: healthcare workers without using the communication platform.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: the use of the platform|the use of the platform|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of the use of the communication platform during the COVID pandemic | the number of the use was divided by the visits | from 2018 to 2022 |