linjc16/ctgov huggingface dataset:
Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia

Official Title
-----------------
A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia

Conditions
-----------------
Hyperlipidemia, Hypertension

Intervention / Treatment
-----------------
* Drug: YH16410
* Drug: Rosuvastatin
* Drug: Telmisartan
* Drug: YH16410 placebo
* Drug: Rosuvastatin placebo
* Drug: Telmisartan placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Men and women ≥ 19 years of age Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent Exclusion Criteria: Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH16410<br>PO, Once Daily, 8 weeks | Drug: YH16410<br> <br> Drug: Rosuvastatin placebo<br> <br> Drug: Telmisartan placebo<br> <br> |
| Active Comparator: Rosuvastatin<br>PO, Once Daily, 8 weeks | Drug: Rosuvastatin<br> <br> Drug: YH16410 placebo<br> <br> Drug: Telmisartan placebo<br> <br> |
| Active Comparator: Telmisartan<br>PO, Once Daily, 8 weeks | Drug: Telmisartan<br> <br> Drug: YH16410 placebo<br> <br> Drug: Rosuvastatin placebo<br> <br> |
| Placebo Comparator: Placebo<br>PO, Once Daily, 8 weeks | Drug: YH16410 placebo<br> <br> Drug: Rosuvastatin placebo<br> <br> Drug: Telmisartan placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure, Change in LDL Cholesterol |  | Change from Baseline at 8 weeks |
Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity. IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.

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

Intervention / Treatment
-----------------
* Other: Low-glycemic-load and milk-free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild, moderate or severe acne (GAGS score 15-44) Age: 14-20 years old Presence of acne for at least 2 months Exclusion Criteria: Diabetes Polycystic ovary syndrome Use of hormonal contraceptives Previous use of oral retinoids Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months Use of medications known to cause or exacerbate acne including lithium, oral or injected retinoids, some anticonvulsant drugs, medications containing iodides or bromides Drug or alcohol abuse. Active smokers Anticipated difficulty attending visits or fear of blood draws

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Diet<br> | Other: Low-glycemic-load and milk-free diet<br> <br> |
| Placebo Comparator: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAGS Acne severity scale |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin like growth factor 1 (IGF-1) |  | 13 weeks | 
| Diet acceptability and adherence |  | 13 weeks | 
| p70S6K | A phosphorylated product of mTORC signaling pathway | 13 weeks |
Inflammatory Markers in Pregnant Women Destined to Develop Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the predictive role of serum inflammatory markers in pregnant women who subsequently develop preeclampsia.

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasian, nulliparous Exclusion Criteria: preexisting cardiovascular diseases, diabetes, hypertension, inflammatory bowel diseases, serious organ diseases, and development of separate gestational diabetes and/or hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 43 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prognostic marker
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass

Study Overview
=================
Brief Summary
-----------------
Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation

Conditions
-----------------
Coronary Artery Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent who isolated off-pump coronary artery bypass Exclusion Criteria: combined carotid procedures preoperative cerebral haemorrhage nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 88 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 |
| --- | --- |
| non epiaortic group<br>non epiaortic group ( n=1019) | |
| epiaortic group<br>epiaortic group ( n=1273) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Stroke After Off-pump Coronary Artery Bypass |  | number of incidence of early strok from surgery to discharge, an expected average of 5 weeks |
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Detailed Description
-----------------
An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus. To evaluate the safety of RTA 402.

Official Title
-----------------
A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Chronic Kidney Disease, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: RTA 402


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD patients with type 2 diabetes mellitus Patients whose eGFR levels are eligible for this study Patients being treated with stable dose of ACE inhibitors and/or ARB etc. Exclusion Criteria: Patients with Type 1 diabetes Patients with known non-diabetic renal disease Patients with a history of renal transplantation Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg Patients with HbA1C > 10% Patients with cardiovascular disease specified in the study protocol Patients for whom Inulead® injection is contraindicated etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: RTA 402<br> | Drug: RTA 402<br>* once a day, oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: glomerular filtration rate measured by inulin clearance | Individual subjects' change from baseline in GFR measured by inulin clearance will be evaluated. | Up to 16 weeks | 
| Adverse Event collection and assessment | Adverse Event collection | Up to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD patients with type 2 diabetes
Virological Response Study of the HCV Vaccine IC41

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41. Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.

Official Title
-----------------
Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Biological: IC41


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained prior to study entry Patients with chronic hepatitis C; genotype 1 Treatment naive patients Male and Female, 18 to 55 years Presence of HLA-A2 marker Mentally healthy No clinically relevant pathological findings in any of the investigations at screening Treatment naive patients with chronic Hepatitis C of genotype 1 Exclusion Criteria: Positive results in HIV, HBsAg and HAV-Ag (IgM) Other causes of chronic hepatitis History of autoimmune diseases Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study) Active or passive vaccination 4 weeks before and during the entire study period Decompensated liver disease History of severe hypersensitivity reactions and anaphylaxis Known allergic reactions to one of the components of the vaccine and Imiquimod cream Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance Malignancies Immunosuppressive therapy Pregnancy, lactation or breast-feeding Unwillingness to practice appropriate contraception Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC41<br>8 injections of 4 x 0.125mL | Biological: IC41<br>* injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV-RNA 2 weeks after end of treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological assays and Safety |  | until study end |
A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting

Study Overview
=================
Brief Summary
-----------------
The investigators are conducting a project to provide a new type of resource called hand lettering to patients receiving chemotherapy. This is a type of art therapy. The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.

Detailed Description
-----------------
This study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a person has before and after using hand-lettering.

Official Title
-----------------
A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Breathing and journaling exercise
* Other: Art-therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10. Able to read and speak English Has a minimum appointment time of 60 minutes Exclusion Criteria: -Individuals with visual impairment or blindness will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Hand Lettering<br>The participant will engage in art-therapy by tracing and coloring a detailed letter or word Participants will also be guided through a relaxation breathing and journaling exercise that can be incorporated into the art activity. | Behavioral: Breathing and journaling exercise<br>* May help reduce anxiety of receiving chemotherapy<br>Other: Art-therapy<br>* May help reduce anxiety of receiving chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting | Feasibility will be defined through enrollment and completion rates. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe patient self-reported anxiety before and after utilizing hand-lettering | Anxiety measured through the State Trait Anxiety Index. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.

Official Title
-----------------
A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Conditions
-----------------
Extravasations of Anthracycline Anti-cancer Agents

Intervention / Treatment
-----------------
* Drug: Dexrazoxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected to have been exposed to extravasation of anthracycline Exclusion Criteria: Patients reasonably suspected to have been exposed to extravasation by other compounds than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Dexrazoxane<br>Dexrazoxane should be given once daily for 3 consecutive days. The dose is: Day 1: 1000 mg/m2, Day 2: 1000 mg/m2, Day 3: 500 mg/m2 (body surface area) | Drug: Dexrazoxane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants experienced adverse events | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extravasation, Anthracyclines
Retinal Therapy Guided by 3D OCT Image Analysis

Study Overview
=================
Brief Summary
-----------------
The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.

Detailed Description
-----------------
The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.

Official Title
-----------------
Retinal Therapy Guided by 3D OCT Image Analysis

Conditions
-----------------
Age-Related Macular Degeneration, Choroidal Neovascularization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF Exclusion Criteria: Patients with a CNV due to other causes (OHS, trauma) eyes that have been previously treated for CNV

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Measure central retinal layer thickness in µms. |  | one year | 
| Measure amount of fluid in the retina in µms. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT, AMD, Retina
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function

Study Overview
=================
Brief Summary
-----------------
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.

Official Title
-----------------
Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: rPMS device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 21 and 65 years Voluntarily signed informed consent form Suffers from UI Sexually active FSFI Questionnaire score ≤ 26.55 points Exclusion Criteria: Suffers from other types of urinary incontinence other than SUI, UUI, MUI Currently lactating Cardiac pacemakers Implanted defibrillators and/or neurostimulators Electronic implants Metal implants, including copper IUD Drug pumps Hemorrhagic conditions Anticoagulation therapy Fever Pregnancy Following recent surgical procedures when muscle contraction may disrupt the healing process Application over areas of the skin which lack normal sensation

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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: Treatment Group<br>Treatment with the investigational device - rPMS | Device: rPMS device<br>* Pelvic floor muscle contractions will be induced by the device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life improvement using the ICIQ-UI questionnaire | Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement. | 18 months | 
| Evaluation of quality of life improvement using the FSFI questionnaire | Evaluation of change in FSFI score. Increase of the score will be considered as an improvement. | 18 months | 
| Evaluation of quality of life improvement using the PISQ-12 questionnaire | Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed. | Incidence of adverse events (AE) associated with study device will be followed. | 18 months |