linjc16/ctgov huggingface dataset:
Classification of Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).

Detailed Description
-----------------
Patients with HFpEF are a heterogeneous group with varying etiology and pathophysiology, which may play a large role in the difficulty in managing these patients and enrolling them in clinical trials. A major advance in the care of patients with HFpEF would be a classification system based on etiology, pathophysiology, and/or genetic factors as well as machine learning analyses. The ultimate goal of this study is to demonstrate that it is possible to better classify patients with HFpEF based on etiologic, pathophysiologic, and genetic differences between patients. If successful, this study could lead to: (1) novel risk estimation in patients with HFpEF and (2) more fruitful clinical trials based on targeting specific subsets of HFpEF.

Official Title
-----------------
Etiologic, Pathophysiologic, and Genetic Classification of Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Diastolic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 21 years Signs or symptoms of congestive heart failure Left ventricular ejection fraction > 50% Exclusion Criteria: Severe valvular heart disease History of cardiac transplantation Prior history of heart failure associated with left ventricular ejection fraction < 35%

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| HFpEF<br>HFpEF cohort (observational study) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure hospitalization |  | 1 year | 
| Cardiovascular hospitalization |  | 1 year | 
| Mortality - all cause and cardiovascular |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity (peak VO2) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Ejection fraction, Diastolic heart failure, Diastolic dysfunction, Ventricular-arterial coupling, Exercise testing, Echocardiography, Tissue Doppler imaging, Arterial tonometry, Genetics, Epidemiology
A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Official Title
-----------------
An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan + amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients (18 years) Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II) Exclusion Criteria: Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg) Pregnant or nursing women Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg) A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan + amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting diastolic blood pressure (analogously & explorative) |  |  | 
| Normalization (analogously & explorative) |  |  | 
| Responder rate. (analogously & explorative) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate essential hypertension (WHO grade II)
Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.

Official Title
-----------------
NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: NovoPen® 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician. A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations Exclusion Criteria: Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit Subjects with known or suspected allergy to any insulin or any of its excipients
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> | Device: NovoPen® 4<br>* Insulin administration by means of a NovoPen® 4 pen device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' device preference |  | 3 months | 
| Subjects' NovoPen® 4 evaluation |  | 3 months | 
| Number of clinical technical complaints |  | 3 months |
Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).

Detailed Description
-----------------
This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.

Official Title
-----------------
Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial

Conditions
-----------------
Bite Force, Botulinum Toxins, Type A

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume. Exclusion Criteria: Conditions or drugs affecting the central nervous system.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention with single botulinum neurotoxin injection into masseter. | Drug: Botulinum toxin type A<br>* Single intervention<br>* Other names: Xeomin;|
| No Intervention: Control<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of bite force | Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline. | Baseline, 4 weeks, 3 months, 6 months, 12 months. |
Clinical Effect of Rebamipide on Chronic Gastritis

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.

Official Title
-----------------
Clinical Effect of Rebamipide on Chronic Gastritis

Conditions
-----------------
Gastritis

Intervention / Treatment
-----------------
* Drug: Rebamipide
* Behavioral: optimization of life style


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on diagnosed as chronic gastritis with endoscopic and pathological methods agree to join in this clinical trail Exclusion Criteria: -
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 |
| --- | --- |
| Experimental: experimental<br>The experimental group were treated with rebamipide 0.1g tid and optimization of life style. | Drug: Rebamipide<br>* Rebamipide is a<br>* Other names: Mucosta;Behavioral: optimization of life style<br> <br> |
| Placebo Comparator: control<br>The control group were only optimized their life style. | Behavioral: optimization of life style<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Lanza score |  | 26 weeks | 
| visual Analog scale | to describe the inflamamtory of gastric mucosa pathologically | 26 weeks |
Cisplatin in Castration Resistant Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.

Official Title
-----------------
A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of prostate cancer Age 18 yrs or older Able to provide written, informed consent Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression Exclusion Criteria: Subjects with estimated glomerular filtration rate of less than 50 ml/min Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment. Subjects with grade 2 or greater neuropathy Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cisplatin<br> | Drug: Cisplatin<br>* Weekly IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to dosing differences of Cisplatin from lab and scan results | Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases. | 2 years | 
| Toxicity observed with dosing differences of Cisplatin | Blood samples and physical assessments will be conducted and reviewed to determine toxicity of treatment. Toxicity would be symptoms such as ringing in the ears (tinnitus) peripheral neuropathy or lab findings such as rise in creatinine, electrolyte abnormalities such as low magnesium. | 2 years |
Statin/Vitamin D & Migraine Study

Study Overview
=================
Brief Summary
-----------------
The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a sugar pill that looks like medication but does not have any active ingredients in it. The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.

Official Title
-----------------
Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Dietary Supplement: Vitamin D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Have had migraines for at least 3 years Have between 4 and 15 migraines a month Able to speak and read the English language Exclusion Criteria: Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes individuals at high risk for cardiovascular disease

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin and vitamin D<br>Participants in this arm will receive simvastatin + vitamin D. | Drug: Simvastatin<br>* simvastatin, 20 mg, twice daily for 6 months<br>Dietary Supplement: Vitamin D<br>* Vitamin D3, 1000 IU, twice daily for 6 months<br>|
| Placebo Comparator: Placebo Sugar Pill<br>Participants in this arm will take placebo pills, which look like the simvastatin and vitamin D. A placebo pill has no active medication in it, and is like taking a sugar pill. | Other: Placebo<br>* Two placebo pills, taken twice daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 |  | Weeks 1 to 12 | 
| Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 |  | Weeks 13 to 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine disorders, Headache, Simvastatin, Vitamin D
A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate

Study Overview
=================
Brief Summary
-----------------
This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.

Official Title
-----------------
A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults at least 18 years of age Histologically confirmed breast cancer with bone metastasis Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling Exclusion Criteria: Contraindication to ibandronate according to SmPC Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate

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 |
| --- | --- |
| Study population<br>Breast cancer patients with metastatic bone disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone pain according to Visual Analog Scale (VAS) score |  | From Baseline to the end of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire |  | Up to approximately 1 year | 
| Incidence of adverse events |  | Up to approximately 1 year |