linjc16/ctgov huggingface dataset:
Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant

Conditions
-----------------
Cardiovascular Diseases, Statin Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Bempedoic acid 180 mg tablet
* Drug: Matching placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 85 years History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event Patient reported history of statin intolerance (inability to tolerate 2 or more statins, one at a low dose) Men and nonpregnant, nonlactating women Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening Exclusion Criteria: Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia History of severe heart failure Uncontrolled hypertension or uncontrolled diabetes

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bempedoic Acid 180 mg<br>Bempedoic acid 180 mg tablet taken orally, once daily. | Drug: Bempedoic acid 180 mg tablet<br>* Patients take bempedoic acid 180 mg tablet orally once daily<br>* Other names: ETC-1002;|
| Placebo Comparator: Placebo Comparator<br>Matching placebo tablet taken orally, once daily | Drug: Matching placebo tablet<br>* Patients take matching placebo tablet orally once daily<br>* Other names: placebo comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to first occurrence of one of the following adjudicated composite endpoints: CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. |  | 3.75 years (estimated average treatment duration) |
An Intermediate Size Expanded Access Protocol of Elamipretide

Study Overview
=================
Brief Summary
-----------------
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program. The treating physician must contact StealthBiotherapeutics using the Expanded Access Program Contacts provided. Elamipretide will only be made available after careful review of an individual request submitted by the treating physician. The initiation and conduct of the treatment with elamipretide for an individual patient, and compliance with this treatment guideline, will be under the full and sole responsibility of the treating physician.

Official Title
-----------------
An Intermediate Size Expanded Access Protocol of Elamipretide for Subcutaneous Injection in Patients With Genetically Confirmed Rare Diseases With Known Mitochondrial Dysfunction

Conditions
-----------------
Mitochondrial Diseases, Barth Syndrome

Intervention / Treatment
-----------------
* Drug: elamipretide


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: ≥1 year and ≤ 80 years of age or ≥12 years for Barth Syndrome in SPIES-007 Patients with genetically confirmed rare primary mitochondrial diseases including Barth Syndrome observed cardiomyopathy, renal impairment, neuropathic, or ophthalmic manifestation where such disease is serious or life-threatening and no comparable or satisfactory alternative therapy options available. Patients without genetic confirmation of a rare disease with known mitochondrial dysfunction but do exhibit serious or life-threatening clinical manifestations of mitochondrial dysfunction. Is self-able or has caregiver willing and able to administer SC injection. Would potentially benefit from treatment with elamipretide and cannot be treated satisfactorily with any approved medicinal product in the opinion of the treating physician. Key Exclusion Criteria: Known hypersensitivity to elamipretide or any excipients. Women who are pregnant, are planning on becoming pregnant, or are breast-feeding. Patients receiving any other investigational agent within 30 days of dosing. Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: elamipretide|Elamipretide is an aromatic-cationic tetrapeptide that readily penetrates cell membranes and transiently localizes to the inner mitochondrial membrane.|

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
-----------------
Barth
Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection

Study Overview
=================
Brief Summary
-----------------
Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.

Official Title
-----------------
Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: Hyaluronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing radical cystectomy and orthotopic neobladder reconstruction Exclusion Criteria: patients <18 years and unwilling to participate in this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyaluronic acid<br>intravesical instillation of 40 mg of hyaluronic acid at 6 specific time points: 1,2,3 and 4 weeks postoperatively 2 and 3 months postoperatively | Drug: Hyaluronic Acid<br>* intravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively<br>|
| No Intervention: retrospective control patients<br>retrospective control patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive urinary culture |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary tract infection |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthotopic neobladder, urinary tract infection, intravesical instillation, hyaluronic acid
Inappropriate Medications Associated With Anticholinesterase and/or Memantine Treatment in the Elderly

Study Overview
=================
Brief Summary
-----------------
In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.

Official Title
-----------------
Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 75 years and over identified as having Alzheimer disease and who have been treated for more than 3 months with anticholinesterase and/or memantine Exclusion Criteria: Patients with decompensated chronic condition or acute phase disease

Ages Eligible for Study
-----------------
Minimum Age: 75 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 evaluate the prevalence of PIM use in patients aged 75 years and over treated with anticholinesterase and/or memantine |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify factors associated with PIM use. To study the relationship between PIM exposure and adverse effects occurrence. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inappropriate Medications Associated, Alzheimer's disease
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Study Overview
=================
Brief Summary
-----------------
To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.

Detailed Description
-----------------
Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.

Official Title
-----------------
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Vesnarinone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and herpes simplex. Patients must have: Asymptomatic HIV infection. CD4 count > 300 cells/mm3. No prior AIDS-defining illness or current constitutional symptoms of HIV disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening. Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix. Concurrent Medication: Excluded: Antiretroviral agents, including ddI, ddC, and AZT. Immunosuppressive agents. Investigational HIV drugs/therapies including vaccines. Interferon. Steroids (other than topical). Hematopoietins. Megestrol acetate. Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: Prior history of cardiac disease. History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function. Prior Medication: Excluded: AZT, ddI, and ddC within 14 days prior to study entry. Prior cytotoxic chemotherapy. Prior Treatment: Excluded: Radiation therapy (including electron beam irradiation) within 30 days prior to study entry. Active illicit drug abuse.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vesnarinone|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
-----------------
vesnarinone
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol

Study Overview
=================
Brief Summary
-----------------
According to the requirements of the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.

Official Title
-----------------
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold)

Conditions
-----------------
Peritoneal Dialysis-associated Peritonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required. Exclusion Criteria: Patients who have been treated with antibiotics for peritonitis before taking the sample. Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date. The sample size is insufficient. Repeated cases. The samples whose permeate is red in visual inspection.
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 |
| --- | --- | --- |
| Assessment reagent test results and clinical reference standard statistics | The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated. | 8 months | 
| Statistical analysis of non-professional self-testing test | There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities. | 8 months |
X-Ray Verified Accuracy of the proGAV Verification Instrument

Study Overview
=================
Brief Summary
-----------------
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.

Official Title
-----------------
X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument

Conditions
-----------------
Hydrocephalus Shunt (proGAV) Requiring Adjustment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted with proGAV Requiring adjustment Implant must be palpable under the skin Exclusion Criteria: Unwilling to consent Implanted within 7 days of inclusion visit
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 |
| --- | --- | --- |
| Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements. |  | 1day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus shunt, proGAV
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation

Study Overview
=================
Brief Summary
-----------------
All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.

Official Title
-----------------
Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation

Conditions
-----------------
Neuropathic Pain Rebel

Intervention / Treatment
-----------------
* Device: implantation of stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of pain caused by lesion of central or peripheral nervous system Pain persistent since one year at least Pain untreated with 3 different antalgic treatments Exclusion Criteria Pain linked t a malignant affection patient < 18 years-old

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: implantation of stimulator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of treatment of this pathology |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pain when the electric stimulation is off or on (during one month for each one). Using Visual Analogic Scale. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropathic pain, Electric cortical stimulation, Economic Medical evaluation
Multi-center Clinical Application of Hangzhou Criteria in Liver Transplantation for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Liver transplantation is an optimal radical therapy for selected patients with hepatocellular carcinoma. Hangzhou criteria could safely and effectively expand Milan criteria with expanded population and comparable survival. The purpose of this study was to evaluate the Hangzhou criteria in a multi-center cohort.

Detailed Description
-----------------
Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer-related deaths worldwide. Among all the liver cancer cases, hepatocellular carcinoma (HCC) constitutes 75-85%. Liver transplantation is the most effective treatment for HCC and is in high demand in China. The advent of Milan criteria has helped to select the recipients reasonably. However, the organ allocation system driven by the Milan criteria seemed to be too strict so that many centers worldwide have expanded the criteria in the aspects of morphological features, histopathology and biomarkers. Hangzhou criteria introduce the covariables of histopathologic grading and α-fetoprotein (AFP) into the selection of recipients for the first time. Based on the multi-center HCC patient cohort undergoing transplantation, this study aims to characterize an ideal candidate selecting system beyond the Milan criteria.

Official Title
-----------------
Multi-center Clinical Application of Hangzhou Criteria in Liver Transplant Candidate Selection for Hepatocellular Carcinoma

Conditions
-----------------
HCC, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥18 years and <=75 with HCC confirmed by histopathology; Undergoing a primary whole or split liver transplant from a deceased donor; Exclusion Criteria: Incomplete follow-up; Missing essential data for analysis (tumor size, number, differentiation grade, α-fetoprotein (AFP)) ; Vascular invasion according to radiological criteria; Perioperative mortality (<30 days) ;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Fulfilling Hangzhou criteria<br>Patients flfilling Hangzhou critieria: Without macrovascular invasion Tumor burden <=8 cm Preoperative AFP level <=400 ng/mL Histopathologic grades I, II | |
| Exceeding Hangzhou criteria<br>Patients exceeding Hangzhou critieria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence rate | 5 years |