linjc16/ctgov huggingface dataset:
Compassionate Use Study of Pergolide in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.

Official Title
-----------------
Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease

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

Intervention / Treatment
-----------------
* Drug: Pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior Exclusion Criteria: History or current diagnosis of cardiac valvulopathy Inability to undergo echocardiograms every 6 months while receiving pergolide Hypersensitivity to pergolide or other ergot derivatives
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pergolide|Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.|

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
-----------------
Parkinson's disease, Antiparkinsonian, Compassionate use
Preoperative Cataract Pupillary Dilation: Inpatient At The Ambulatory Surgery Center vs Outpatient Dilation Prior To Arrival At The Ambulatory Surgery Center

Study Overview
=================
Brief Summary
-----------------
This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.

Official Title
-----------------
Preoperative Cataract Pupillary Dilation: Inpatient vs Outpatient

Conditions
-----------------
Pupil Dilation Prior to Cataract Surgery In-patient, Pupil Dilation Prior to Cataract Surgery Out-patient

Intervention / Treatment
-----------------
* Other: Pupil dilation with phenylephrine 10% vs cyclopentolate 2%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to self administer eye or have a helper for the task of administering eye drops. Ability to follow and eye drop administration schedule. No noted ocular abnormalities. Bilateral cataract surgery anticipated. Exclusion Criteria: Inability to self administer eye drops or have assistance with eye drop administration. Health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pupil dilation with phenylephrine 10% vs cyclopentolate 2%|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
-----------------
Cataract Surgery, Pupillary Dilation
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Study Overview
=================
Brief Summary
-----------------
Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

Detailed Description
-----------------
In non-focal congenital hyperinsulinism (CHI) the current doctrine warrants subtotal pancreatic resection in all children who do not respond to medication. However, the rate of diabetes after these extensive resections is very high. In this study investigators show that a less aggressive approach may suffice to wean many children from all medication or to get them manageable medically.

Official Title
-----------------
Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

Conditions
-----------------
Non-focal Congenital Hyperinsulinism

Intervention / Treatment
-----------------
* Procedure: restrictive pancreatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-focal congenital hyperinsulinism Exclusion Criteria: patients with focal congenital hyperinsulinism
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-focal congenital hyperinsulinism<br>13 children and one adult with non-focal congenital hyperinsulinism | Procedure: restrictive pancreatic resection<br>* Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necessity of medication after restrictive surgery in congenital hyperinsulinism |  | up to 3 years |
Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics

Study Overview
=================
Brief Summary
-----------------
chronic PDE5-Inhibition improves endothelial function in diabetics

Detailed Description
-----------------
Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes

Official Title
-----------------
Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes males Exclusion Criteria: females, nitrate use, PDE5-Inhibitors intolerance

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

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: sildenafil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function responders - Improvement in endothelial function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vascular inflammatory markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
function, inhibition
Health Assessment Study (0954-946)

Study Overview
=================
Brief Summary
-----------------
The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.

Official Title
-----------------
A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension

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

Intervention / Treatment
-----------------
* Drug: MK0954, /Duration of Treatment : 16 Weeks
* Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with mild to moderate hypertension\ Married male in stable heterosexual relationship No prior history of sexual dysfunction Satisfied with overall sex life Patient's spouse is in close proximity for the study Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start Patient able to visit doctor in the morning of each scheduled visit Able to complete the self administered health assessment questionnaire Exclusion Criteria: Hypertension due to cancer, history of heart or circulatory problems History of mental disorder that might impair sexual function History or presence of drug or alcohol abuse Prior surgery for erectile dysfunction or other urological procedure No penile implant or assist devices History of chronic liver disease, history of diabetes History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test Subjects with only 1 kidney Mental handicap or legal incapacity

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

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: MK0954, /Duration of Treatment : 16 Weeks|nan|
|Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sexual intercourse events in a 2-week period |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual functioning score and overall sexual satisfaction score after 16 weeks |  | 16 Weeks |
Evaluation of Introcan Safety 3 Closed IV Catheter

Study Overview
=================
Brief Summary
-----------------
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety

Official Title
-----------------
Evaluation of Introcan Safety 3 Closed IV Catheter

Conditions
-----------------
Patients in Need for Intravenous Access

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: need for intravenous access Exclusion Criteria: n. a.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Introcan Safety 3<br>Closed IV Catheter | |
| Introcan Safety<br>IV catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and time of occurence of blood leakage |  | Within one minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Problems during catheter insertion and fixation of Introcan Safety 3 |  | During insertion and fixation of catheter | 
| Necessity of disconnection of catheter |  | During catheter placement |
BOVAS: Bifurcation Optimal Viewing Angle Selection Study

Study Overview
=================
Brief Summary
-----------------
An optimal angiographic viewing angle is critical for correct diagnosis and intervention in coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve the selection of the best viewing angle.

Official Title
-----------------
Bifurcation Optimal Viewing Angle Selection Study

Conditions
-----------------
Coronary Bifurcation Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years of age Informed consent available Exclusion Criteria: Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support) Impaired renal function (serum creatinine > 2.0 mg/dl)

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bifurcation lesion, optimal viewing angle, automated software
the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.

Official Title
-----------------
The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Diane-35 pretreatment
* Drug: Diane-35 pretreatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed polycystic ovary syndrome patients according to Rotterdam criteria with hyperandrogenism and/or clinical hyperandrogenic manifestations no other oral contraceptives treatment for at least 3 months before this experiment no any other assisted reproductive therapy accompanied with fallopian tube and/or male factors normal hepato-/nephro- function Exclusion Criteria: oral contraceptive pills contraindications, eg.Deep Venous Thrombosis smoking, drunk exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: diane-35<br>Diane-35 pretreatment from the third day of menstrual cycle | Drug: Diane-35 pretreatment<br>* Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.<br>Drug: Diane-35 pretreatment<br> <br> |
| No Intervention: blank control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate |  | up to 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | up to 2years |
Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

Study Overview
=================
Brief Summary
-----------------
This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.

Official Title
-----------------
Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

Conditions
-----------------
Vision Disorders

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract surgery with an bilateral multifocal lens implant Restor Symptomatic patients : Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity Asymptomatic patients : No visual complaint for 3 months or more after the intervention Exclusion Criteria: Patients with ophthalmology disorders Contra indication for fMRI

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: asymptomatic patients<br>fMRI Asymptomatic patients | Other: fMRI<br>* functional magnetic resonance imaging<br>|
| Experimental: symptomatic patients<br>fMRI patients with visual difficulties | Other: fMRI<br>* functional magnetic resonance imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of neural activation in visual cortex measured by the number of voxels | compare the extent of neural activation in visual cortex between groups | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extent of neural activation in visual cortex measured by the number of voxels | compare the extent of neural activation in the different area visual cortex between groups | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional magnetic resonance imaging, Lens implantation, pseudophakia
Safety and Efficacy of Trastuzumab BS

Study Overview
=================
Brief Summary
-----------------
To confirm the safety and efficacy of this drug under the actual use

Official Title
-----------------
TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer)

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: TRASTUZUMAB BS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug* Patients who receive this drug* for the first time after this drug* is launched * Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug Exclusion Criteria: - not specified in this study

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| TRASTUZUMAB BS<br>Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS | Drug: TRASTUZUMAB BS<br>* Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-overexpressing unresectable advanced or recurrent gastric cancer in combination with other anti tumor agent(s). Regimen A: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 4 mg/kg (weight) at initial dose and 2 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every week. Regimen B: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 8 mg/kg (weight) at initial dose and 6 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every 3 weeks. If the initial dose is well tolerated, the dosing time after the second dose can be shortened up to 30 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions in this surveillance |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1. |  | 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent HER2-Overexpressing Gastric Cancer, TRASTUZUMAB BS
Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

Study Overview
=================
Brief Summary
-----------------
A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.

Official Title
-----------------
Zenith® LP AAA Endovascular Graft Post-Market Registry

Conditions
-----------------
Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm

Intervention / Treatment
-----------------
* Device: Zenith® Low Profile AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is implanted with Zenith® Low Profile AAA Endovascular Graft Exclusion Criteria: Patients for whom this device would not normally be considered standard of care.
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> | Device: Zenith® Low Profile AAA Endovascular Graft<br>* Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft patency and aneurysm exclusion |  | during (day 1) and after implantation through 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low profile, endovascular graft, endovascular procedure, aortic aneurysm, abdominal aortic aneurysm