linjc16/ctgov huggingface dataset:
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.

Official Title
-----------------
An Open-Label, Randomized, 3-Way Crossover, Single-Dose Study in Healthy Volunteers Comparing the Bioavailability of CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation and the Effect of Food on CMX001 Bioavailability

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: CMX001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and non-childbearing females 18-55 years old Exclusion Criteria: Use of an investigational drug and/or treatment within 30 days prior to enrollment. Positive HIV, Hepatitis B or Hepatitis C test result Tobacco user History of GI disease or disorder History of positive fecal occult blood test (FOBT) Body Mass Index (BMI) > 30 or < 18, or body weight < 50 kg Prior abdominal or pelvic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All subjects will receive three 40mg doses of CMX001 as 1)solution fasted, 2)tablet fasted and 3)tablet following a high-fat breakfast. The order in which each subject receives each of the doses will be determined by a randomization code. | Drug: CMX001<br>* CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC and Cmax of CMX001 and cidofovir |  | Each of 3 doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and laboratory endpoints and adverse events |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability
Capturing Parkinson's Disease Medication Side Effects During Daily Activities

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).

Official Title
-----------------
Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System

Conditions
-----------------
Parkinson's Disease, Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa Exclusion Criteria: Antipsychotic medications (including quetiapine and clozapine) Coexisting neurologic disease such as stroke or dementia Lacking capacity for informed consent Residing in a nursing home comorbid non-neurologic illnesses that impacts the ability to perform the study tasks Implantable defibrillators

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?
-----------------
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
-----------------
levodopa, tremor, bradykinesia, motion sensors
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.

Detailed Description
-----------------
Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.

Official Title
-----------------
A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

Conditions
-----------------
Choroidal Melanoma, Indeterminate Lesions

Intervention / Treatment
-----------------
* Other: Standard of Care
* Drug: AU-011


Participation Criteria
=================
Eligibility Criteria
-----------------
Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.

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 |
| --- | --- |
| Case Group<br>Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial | Drug: AU-011<br>* Previously received<br>* Other names: bel-sar;|
| Control Group<br>Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator | Other: Standard of Care<br>* Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Change from baseline in logMAR visual acuity score at 5 years. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AU-011, Belzupacap sarotalocan, Choroidal melanoma, Plaque radiotherapy, Matched case control, Visual acuity, bel-sar
A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)

Study Overview
=================
Brief Summary
-----------------
As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented. It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®

Official Title
-----------------
A Canadian, Multi-center, Prospective, Open-label, Observational, Pharmacovigilance Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced) in Patients Transitioning From Treatment With Currently Available Humate-P®

Conditions
-----------------
Von Willebrand Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients of any age; Patients who are suffering with von Willebrand disease previously treated with Humate-P®; Patients who are able to communicate well with the Investigator and his/her representatives; Patients who are able and agreeing to comply with all study requirements; Patients who have provided written signed and dated informed consent prior to any study procedures being performed. Exclusion Criteria: Patients who have received any investigational drug ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with von Willebrand disease treated with Humate P® ivr in Canada | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of Humate-P® (reported adverse events) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
von Willebrand disease, VWD, Humate-P®, Infusion volume reduced, ivr
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Official Title
-----------------
A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

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

Intervention / Treatment
-----------------
* Drug: muraglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening HbA1c >or = 7% and < or = 10% Fasting c-peptide > or = 1.0 umol Body Mass Index < or = 41 kg/m2 Mean serum triglycerides < or = 600 mg/dl

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: muraglitazar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline HbA1c after 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the pathogenic role of obesity on blinding eye diseases in a population of severely obese patients with no history of eye diseases, and to verify whether weight loss induced by bariatric surgery may have a protective effect.

Detailed Description
-----------------
This was a pilot, monocentric, prospective, and open label study conducted at First Affiliated Hospital of Jinan Universityreceived.Patients with body mass index ≥ 32.5Kg/m2; or patients with body mass index of 27.5-32.5Kg/m2 and metabolic diseases were consecutively recruited.All participants underwent complete ophthalmological evaluation， Keratograph 5M and optical coherence tomography.Patients who underwent bariatric surgery were evaluated also 3 months, 6 months and 1 year after surgery.

Official Title
-----------------
Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery:A Pilot, Monocentric, Prospective, Open-label Study

Conditions
-----------------
Eye Diseases, Obesity Associated Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with BMI≥32.5Kg/m2； patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases; Exclusion Criteria: Patients with pre-existing ocular diseases or visual alterations were excluded to avoid confounding factors related to pre-existing retinal pathology, independent from obesity per se. Patients with dementia, Parkinson's disease, Alzheimer's disease, multiple sclerosis or other severe neurological diseases were also excluded since ophthalmologic parameters may be altered in these conditions. Patients with lens opacities that made impossible the posterior segment examination, or with a refractive error > +5 or <-8 diopters spherical equivalent were also excluded.
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| optical coherence tomography |  | 12 months |
Outcome of Patients With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

Detailed Description
-----------------
Previous studies have shown that children and adults presenting with congenital heart disease are at increased risk of morbidity and mortality after non-cardiac interventions. This risk depends on the type of pathology, the age of the patient and the experience of the physicians in charge of these patients. We sought to determine the prevalence of children and adults with congenital heart disease presenting for non-cardiac interventions and to investigate their outcome.

Official Title
-----------------
Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Outcome research


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children and adults with congenital heart disease Exclusion Criteria: Parental or patient refusal Patients presenting for cardiac interventions
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Congenital Heart Disease<br>Undergoing evaluation at 30 days | Other: Outcome research<br>* patients will undergo an evaluation of their outcome at 30 days postoperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a single-centre tertiary hospital | To analyze the exact number of children and adults with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze morbidity after non-cardiac interventions in patients with congenital heart disease | Morbidity outcome after non-cardiac interventions | 30 days | 
| To analyze mortality after non-cardiac interventions in patients with congenital heart disease | Mortality outcome after non-cardiac interventions | 30 days |
Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-SR 50 mg
* Drug: DVS-SR 100 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of major depressive disorder Must be able to swallow tablets Must be at least 18 years of age. Exclusion Criteria: Clinical diagnosis of other psychiatric disorders Significant risk of suicide Unstable medical conditions.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-SR 50 mg|nan|
|Drug: DVS-SR 100 mg|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Adult, Outpatients
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Official Title
-----------------
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Device: RESTOR IOL Model SA60D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥21 years of either gender or any race Potential post-op VA 20/20 Pre-op astigmatism ≤ 1.0D Able to sign the informed consent Able to complete all required postoperative visits Planned cataract removal by phaco Clear intraocular media other than cataract Exclusion Criteria: Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture Any corneal pathology and previous corneal refractive surgery Patients with unrealistic expectations in anticipated post-op VA Happy to wear glasses Occupational night driver

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Acrysof ReSTOR IOL<br>AcrySof ReSTOR Intraocular lens (IOL) implanted | Device: RESTOR IOL Model SA60D3<br>* Implanted into the study eye following cataract extraction surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Uncorrected Visual Acuity(UCVA | Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity. | 6 months after surgery of 2nd eye | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Sensitivity |  | 6 months after sugery of the 2nd eye | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bilateral implantation, ReSTOR Aspheric IOL, uniocular unaided distance, binocular unaided distance, intermediate visual acuity, near visual acuity