linjc16/ctgov huggingface dataset:
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs

Official Title
-----------------
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Conditions
-----------------
Sudden Cardiac Death

Intervention / Treatment
-----------------
* Device: Ovatio DR and Ovatio VR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108). Exclusion Criteria: Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes Incessant tachyarrhythmia Implanted pacemaker Primary disorder of bradyarrhythmia or atrial tachyarrhythmia Of minor age Pregnant Participating in another clinical 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ovatio DR and Ovatio VR|implantable cardioverter defibrillator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients free from complications |  | 6 months | 
| Shock effectiveness for VT/VF |  | 6 months |
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.

Detailed Description
-----------------
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.

Conditions
-----------------
Ovarian Carcinoma

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation
* Biological: Cytokine-induced killer cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with FIGO stage II ovarian carcinoma; cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed; medical records maintain comprehensive data on treatment and follow-up; no history of previous malignancies. Exclusion Criteria: neoadjuvant chemotherapy applied; less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed; medical records maintain incomplete data on treatment or follow-up; history of previous malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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 |
| --- | --- |
| No Intervention: RFA alone<br>Patients undergo radiofrequency ablation alone. | |
| Experimental: RFA+CIK<br>Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation is performed percutaneously under CT/US guidance<br>* Other names: RFA;Biological: Cytokine-induced killer cells<br>* The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.<br>* Other names: CIK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events related to RFA and CIK treatments. | 4 weeks |
Fluid Intake in Kidney Failure

Study Overview
=================
Brief Summary
-----------------
Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.

Official Title
-----------------
The Effect of Increased Fluid Intake on Chronic Renal Failure

Conditions
-----------------
Chronic Renal Failure, Kidney Transplantation

Intervention / Treatment
-----------------
* Behavioral: high fluid intake
* Behavioral: normal fluid intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with native kidney disease or chronic kidney transplant failure An effective glomerular filtration rate (eGFR) according the MDRD formula between 20 and 75ml/min/1.73m2 Ejection fraction >20% Absence of liver cirrhosis or ascites No evidence of active glomerulonephritis or immunosuppressive therapy if native kidney disease Acute transplant rejection Urinary protein excretion below 3g/d Age between 18 and 70 years. Exclusion Criteria: Therapy resistant edema Severe pulmonary disease Mean arterial pressure (MAP) > 120 mm Hg Pregnancy Kidney transplantation within three months prior to randomization

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fluid intake<br>fluid intake of 4 litres per day | Behavioral: high fluid intake<br>* fluid intake of 4 litres per day<br>|
| Experimental: normal fluid intake<br>Fluid intake of 2 litres per day | Behavioral: normal fluid intake<br>* Fluid intake of 2 litres per day<br>|

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
-----------------
chronic kidney disease, transplantation, kidney function, fluid intake, osmolarity
Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Breeze Pocket BR.

Conditions
-----------------
Hygiene

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 60 years old; Phototype Skin II and III; Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation; Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection; Diseases which can cause immunity decrease, such as HIV, diabetes; Use of drug photosensitizer; History of sensitivity or irritation for topic products; Active cutaneous disease which can change the study results; History of photodermatosis active; Family or personal antecedent of cutaneous photoinduced neoplasias; Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; Intense solar exposure in the study area; Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid (Dermacyd Breeze) | Drug: Lactic Acid<br>* Lactic Acid (Dermacyd Breeze)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR. |  | Throughout the study |
Clinical Trial of Lupeol for Mild-moderate Acne

Study Overview
=================
Brief Summary
-----------------
For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Drug: Lupeol
* Drug: Control vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris Exclusion Criteria: ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Active Comparator: Lupeol<br>Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks | Drug: Lupeol<br>* Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.<br>* Other names: no brand name;|
| Placebo Comparator: Control vehicle<br>Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks | Drug: Control vehicle<br>* Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks<br>* Other names: No brand name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne lesion counts as a measure of efficacy | Both inflammatory & non-inflammatory acne lesions of both of their facial sides | 8 weeks after beginning of applications | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Among total patients enrolled in this study, number of patients either experiencing objective adverse events or subjective uncomfortableness were counted | 8 weeks after beggning of applications | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication
Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences into clinical treatment planning.

Detailed Description
-----------------
The following specific aims are proposed: Aim 1: Determine whether individual patients' preferences, characteristics, and treatment experiences affect the definition of treatment success. Aim 2: Determine how to best predict real-life patients' treatment choices based on patients' preferences of adverse events. Aim 3: Determine whether physicians are likely to change their oncologic clinical practice after receiving a detailed communication of their patients' preferences of adverse events.

Official Title
-----------------
Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients

Conditions
-----------------
Gender, Comorbid Conditions, Age, Particularly Rural/Urban Residence, FACT-TOI Scores

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide consent Greater than or equal to 19 years of age Diagnosed with stage IV non-small cell lung cancer (NSCLC) Able to understand spoken English Eligible to undergo chemotherapy for stage IV NSCLC, to include, but not limited to, those who: have not yet started chemo are currently undergoing chemo for stage IV NSCLC have completed first line stage IV NSCLC chemo or progressed to maintenance for stage IV NSCLC within the last 30 days elect to have chemo elsewhere -- not at one of the study sites decline chemo Exclusion Criteria: Age <19 years Not willing and/or able to provide consent Not able to understand spoken English Not eligible to undergo chemotherapy for stage IV NSCLC

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Patient-defined treatment success | In advanced stage NSCLC patients does patient-defined treatment success differ when both survival and patient preferences of adverse events are accounted for, compared to when success is measured solely by survival? And does it also differ based on individual patient characteristics? | Baseline | 
| Patients' will to experience adverse events | Will the serious adverse events that an advanced stage NSCLC patient is willing to experience as part of his/her treatment differ after a real-life treatment experience, compared to before treatment? | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary score derived from patient preferences of adverse events | In advanced stage NSCLC patients, is a summary score derived from patient preferences of adverse events comparable to a real-life treatment scenario? | Up to three months |
Orthostatic Hypotension Among Veterans

Study Overview
=================
Brief Summary
-----------------
Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several different underlying diseases, conditions, or combinations of medicines may contribute to OH; therefore the cause of the condition varies among individuals. Some studies have shown that OH is associated with an increase in the rate of death, but it is not clear what role OH plays in increased morbidity. By studying what the prevalence of OH is in a generalized veteran population we expect increase clinical awareness of the degree of the problem so that patient care might be improved.

Official Title
-----------------
The Incidence of Orthostatic Hypotension Among Veterans

Conditions
-----------------
Hypotension, Orthostatic Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans Between the ages of 18 and 89 Exclusion Criteria: Current illness/infection Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Veterans<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure from supine to standing. | Change in blood pressure between Evaluation #1 and Evaluation #2. | Eval#1: 10min supine; Eval#2: 10min standing; | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Orthostatic Hypotension
Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid

Study Overview
=================
Brief Summary
-----------------
The research study aims to evaluate the synovial fluid to highlight the presence of possible micropolymers (micro/nanoplastics) in order to better understand the pathophysiology of joint degenerative processes. For patients with liquid under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physician. The investigators want to use this liquid for Microscopic and Spectrophotometric evaluation.

Official Title
-----------------
Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid

Conditions
-----------------
Osteoarthritis, Knee, Knee Arthritis, Gout Arthritis, Microcrystal Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Synovial fluid analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: arthritis of the knee with liquid aspiration recommendation age >18 years Exclusion Criteria: --refusal of the patient to participate -age<18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Synovial fluid analysis|For patients with knee under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physicians. After making the evacuation we will want to use this liquid for Microscopic and Spectrophotometric evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microplastics | evaluation with spectrophotometry and optic microscopy | immediately after liquid extraction | 
| nanoplastics | evaluation with spectrophotometry and optic microscopy | immediately after liquid extraction |
Swedish Ibrance Registries Insights (SIRI)

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.

Official Title
-----------------
Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)

Conditions
-----------------
Malignant Neoplasm of Breast

Intervention / Treatment
-----------------
* Drug: palbociclib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33) Age ≥18 years at index date Exclusion Criteria: There are no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)<br>Group Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33) | Drug: palbociclib<br>* patients on palbociclib combination treatment<br>|
| HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant<br>Group Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33) | Drug: palbociclib<br>* patients on palbociclib combination treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on treatment | Proportion of patients who have not discontinued treatment will be assessed at various timepoints (Time Frame: treatment start date through end of study [assessed up to 48 months]) | 01 January 2017 until 30 September 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients alive | Proportion of patients alive on palbociclib combination treatment at different points in time (Time Frame: treatment start date through end of study [assessed up to 48 months]) | 01 January 2017 until 30 September 2020 | 
| Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment |  | 01 January 2017 until 30 September 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic breast cancer (MBC)