linjc16/ctgov huggingface dataset:
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis

Study Overview
=================
Brief Summary
-----------------
This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).

Official Title
-----------------
An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP)

Conditions
-----------------
Parkinson Disease Psychosis

Intervention / Treatment
-----------------
* Drug: Iloperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide consent and willing to complete all aspects of the study. Male or female patients greater or equal to 65 years of age. Clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year Psychotic symptoms for at least one month and actively experiencing psychotic symptoms each week during the month prior to screening Exclusion Criteria: History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder Current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloperidone (Cohort 1)<br> | Drug: Iloperidone<br>* oral tablet<br>* Other names: FANAPT;|
| Experimental: Iloperidone (Cohort 2)<br> | Drug: Iloperidone<br>* oral tablet<br>* Other names: FANAPT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis. | As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs. | 8 days and 5 weeks | 
| Reduction in positive symptoms of Parkinson's disease psychosis. | As measured by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD). | 8 days and 5 weeks | 
| Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone. | As measured by plasma concentrations. | 8 days and 5 weeks |
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment

Study Overview
=================
Brief Summary
-----------------
Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament. This prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences

Official Title
-----------------
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences

Conditions
-----------------
Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Solid Tumor, Hematologic Malignancy

Intervention / Treatment
-----------------
* Device: central venous catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients older than 18 years, with solid cancer or hematological malignancy receiving anticancer treatment in the outpatient medical department of Alpes Leman Hospital and having a central venous catheter been placed between the 11th of July 2022, and the 1st of January 2023.

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

| Intervention/Treatment |
| --- |
|Device: central venous catheter|collection and descriptionof central venous catheter-related complications|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of severe central venous catheter-related complications |  | 6 months |
Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System for Minimizing Severe Drug-Drug Interactions

Study Overview
=================
Brief Summary
-----------------
Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+. the investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).

Conditions
-----------------
Healthcare

Intervention / Treatment
-----------------
* Other: DDI+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Number of chronic concomitant drugs ≥5 Exclusion Criteria: Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C.

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDI+<br>DDI+ Incorporated in routine ambulatory practice | Other: DDI+<br> <br> |
| No Intervention: Control<br>Standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions |  | up to 12 months post initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health care expenditure, drug drug interactions, electronic decision support systems, Potential reduction
Stent Geometry in Sutureless Bioprosthetic Valves

Study Overview
=================
Brief Summary
-----------------
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Official Title
-----------------
Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves

Conditions
-----------------
Aortic Valve Stenosis, Heart Valve Diseases

Intervention / Treatment
-----------------
* Radiation: 4-dimensional volume-rendered computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016 Provide written informed consent Exclusion Criteria: •Contraindication for CT with intravenous contrast injection

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: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac CT imaging<br> | Radiation: 4-dimensional volume-rendered computed tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional expansion of valve prosthesis | Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement | 
| Overall expansion of valve prosthesis | Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eccentricity of valve prosthesis | Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100 | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement |
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation

Study Overview
=================
Brief Summary
-----------------
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. visually guided ablation (VGA) using the EAS-AC and radiofrequency ablation

Detailed Description
-----------------
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.

Official Title
-----------------
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Endoscopically guided PVI Ablation
* Device: RF PVI Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Symptomatic, Paroxysmal Atrial Fibrillation (AF) 18 to 75 Years of age Generally good overall health as determined by multiple criteria Willing to participate in a study Others

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency Ablation<br>PVI using RF ablation | Device: RF PVI Ablation<br>* Radiofrequency ablation<br>|
| Experimental: Visually Guided Ablation<br>PVI using visually guided ablation with an endoscopic ablation system | Device: Endoscopically guided PVI Ablation<br>* Endoscopically Guided Ablation using the EAS-AC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation | Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs). | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation
Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.

Official Title
-----------------
The Effect of Accumulated Versus Traditional Exercise Training on Metabolic Control and Heart Function in Individuals With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: accumulated exercise
* Behavioral: traditional exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes Exclusion Criteria: insulin treatment severe chronic diabetic complications liver dysfunction kidney dysfunction inflammatory diseases heart failure myocardial ischemia major cardiovascular event history physical exercise more than current guidelines for type 2 diabetes inability to exercise

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: accumulated exercise<br>12 exercise sessions of 10 minutes each week, 2 per day, 1 day rest | Behavioral: accumulated exercise<br> <br> |
| Active Comparator: traditional exercise<br>4 exercise sessions of 30 minutes each week, 3 in the training laboratory, 1 at home. | Behavioral: traditional exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosylated hemoglobin (HbA1c) | The measured HbA1c level consists of average blood glucose by 50% from the last month, 25% from the previous month, and 25% by the two first previous months. Analysis: standard procedure of St Olavs Hospital. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, Time factors
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.

Official Title
-----------------
An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection

Conditions
-----------------
Post-transplant Hepatitis C

Intervention / Treatment
-----------------
* Drug: Sofosbuvir
* Drug: Ribavirin
* Drug: Pegylated Interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C) Life expectancy of < 12 months if the HCV is left untreated Exclusion Criteria: History of clinically significant drug allergy to nucleoside/nucleotide analogs Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject Unable or unwilling to follow the contraception requirements

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sofosbuvir|nan|
|Drug: Ribavirin|nan|
|Drug: Pegylated Interferon|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
-----------------
HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, Pegylated interferon, Ribavirin, Open Label, Sofosbuvir, Liver transplant, Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action
Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. Little is known about the impact of epidural injection in such patients. The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: intra-articular infiltration
* Drug: epidural infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes stable for more than ten days no contraindication for steroids lumbar stenosis articular pain Exclusion Criteria: unstable diabetes renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylprednisolone,infiltration<br> | Drug: intra-articular infiltration<br>* intra articular infiltration<br>|
| Active Comparator: epidural injection<br> | Drug: epidural infiltration<br>* epidural infiltration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic values, |  | day 0 to day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary excretion rate |  | day 0 to day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methylprednisolone, intra articular infiltration, glycemia, epidural infiltration, diabetes
Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease

Detailed Description
-----------------
The study is primarily designed to follow a virtual model, in which Screening will take place over a telephone/video call. The study will comprise a single home health visit, either on the same day as Screening or within 30 days of enrollment. A safety follow-up may occur up to 5 days after Day 1 assessments are completed.

Official Title
-----------------
Observational Clinical Study of Anti-AAV Seroprevalence in Subjects With Ornithine Transcarbamylase Deficiency, Glycogen Storage Disorder Type Ia, and Wilson Disease

Conditions
-----------------
Ornithine Transcarbamylase Deficiency, Wilson Disease, Glycogen Storage Disease Type IA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of OTC deficiency, GSDIa, or Wilson Disease. Provide informed consent after the nature of the study has been explained, and prior to any research-related procedures. Exclusion Criteria: Prior exposure to an AAV-based gene therapy. Concurrent or previous participation in another Ultragenyx clinical study. Recipient of a liver transplant. Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of Anti-AAV8 Antibodies in Subjects with OTC Deficiency or GSDIa |  | Up to 35 days | 
| Prevalence of Anti-AAV9 Antibodies in Subjects with Wilson Disease |  | Up to 35 days |