linjc16/ctgov huggingface dataset:
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Study Overview
=================
Brief Summary
-----------------
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism. Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.

Official Title
-----------------
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Conditions
-----------------
Hypertension, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: AF Suppression Pacing Algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age ≥ 65 years History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy). Recent (< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities. In pacemaker patients only the primary indication for pacing is sinus or AV node disease. Exclusion Criteria Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device) Geographic/social or psychiatric factor likely to interfere with follow-up Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: AF Suppression OFF<br> | |
| Experimental: AF Suppression ON<br> | Device: AF Suppression Pacing Algorithm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of ischemic stroke & Non-CNS systemic embolism |  | 3 years | 
| Symptomatic or Asymptomatic AT documented by ECG |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
Changes of Functional Connectivity After rTMS in Depression

Study Overview
=================
Brief Summary
-----------------
In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

Detailed Description
-----------------
Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache. We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS. All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.

Official Title
-----------------
Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: repetitive transcranial magnetic stimulation(rTMS)
* Device: Sham repetitive transcranial magnetic stimulation(rTMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV major depressive episode Failure of at least 3 different kind of antidepressant Exclusion Criteria: Organic brain disorder Other diagnosis of DMS-IV except nicotine dependence History of seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 19 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: transcranial magnetic stimluation<br> | Device: repetitive transcranial magnetic stimulation(rTMS)<br>* 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.<br>* Other names: MAGSTIM;|
| Sham Comparator: rTMS_sham<br> | Device: Sham repetitive transcranial magnetic stimulation(rTMS)<br>* Sham repetitive transcranial magnetic stimulation(rTMS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of functional connectivity between pre/post rTMS |  | 14 days |
Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Official Title
-----------------
A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: PF-3512676 + Erlotinib
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced, EGFR-positive NSCLC ECOG Performance Status 0, 1 or 2 Measurable disease Exclusion Criteria: Known CNS metastasis Pre-existing autoimmune or antibody mediated disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Standard of Care chemotherapy plus experimental intervention (PF-3512676) | Drug: PF-3512676 + Erlotinib<br>* PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity<br>|
| Active Comparator: B<br>Standard of Care chemotherapy | Drug: Erlotinib<br>* Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity<br>* Other names: Tarceva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | 50Events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety Profile |  | 28 days post treatment | 
| Time to Tumor Progression |  | End of treatment | 
| Overall Objective Response Rate |  | Time of disease progression | 
| Duration of Response |  | Time of disease progression | 
| Overall Survival |  | Time of death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator
A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed Description
-----------------
Patients receive intravenous DS-4152 by infusion once every 21 days; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Official Title
-----------------
A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Tecogalan sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Kaposi's sarcoma plus HIV infection OR metastatic solid tumor. Life expectancy of at least 12 weeks. NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks. Recovered from toxicity of any prior anticancer therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Leukemia or lymphoma. Current gastrointestinal bleeding by stool guaiac. Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. Acute intercurrent infection other than genital herpes. Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. Concurrent Medication: Excluded: Other anticancer therapy. Other investigational agents. Patients with the following prior conditions are excluded: History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. History of myocardial infarction within past 6 months. Prior Medication: Excluded: Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C). Investigational agents within the past 4 weeks.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tecogalan sodium|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
-----------------
Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Non-Malignant Pain

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain. Taking oral, transdermal, intravenous, or subcutaneous opioids. Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives. Exclusion Criteria: History of chronic constipation before the initiation of opioid therapy. Other GI disorders known to affect bowel transit. Women who are pregnant, breast-feeding, or plan to become pregnant.

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: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OIBD, OIC, Opioid, Constipation, Laxative
Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Detailed Description
-----------------
Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study. Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.

Official Title
-----------------
Ventriculostomy in SAH: ICP Open or Not?

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to Duke University NCCU Adult (18 years of age or older) Primary diagnosis is Subarachnoid Hemorrhage Intraventricular catheter in situ Exclusion Criteria: Glasgow Coma Score = 3 Hunt and Hess Score = 5 Prisoners Ventriculostomy > 72 hours

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 |
| --- | --- |
| Monitor then drain<br>Subjects who are treated with intermittent CSF drainage | |
| Drain then monitor<br>Subjects who are treated with continuous CSF drainage at set pressure thresholds | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral artery vasospasm |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasospasm, Cerebral Spinal Fluid, Ventriculostomy, Subarachnoid hemorrhage, Human Subjects
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.

Official Title
-----------------
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

Conditions
-----------------
Hypercholesterolemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: pitavastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females (18-75 years of age) At least two cardiovascular disease risk factors Must have been following a restrictive diet Diagnosis of primary hypercholesterolemia or combined dyslipidemia Exclusion Criteria: Homozygous familial hypercholesterolemia Conditions which may cause secondary dyslipidemia Uncontrolled diabetes mellitus Abnormal pancreatic, liver or renal function Abnormal serum creatine kinase (CK) above the pre-specified level

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 4 mg QD<br>Pitavastatin 4 mg once daily | Drug: pitavastatin<br> <br> |
| Active Comparator: Simvastatin 40 mg QD<br>Simvastatin 40 mg once daily | Drug: simvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in LDL-C | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin
Platelets for Acute Wound Healing

Study Overview
=================
Brief Summary
-----------------
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.

Detailed Description
-----------------
Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors. According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury. Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.

Official Title
-----------------
Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: autologous platelet gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal volunteers 18 years old or older Exclusion Criteria: Pregnant or lactating Diabetic, keloid former, collagen vascular disease Smoker Body mass index >30kg/m2 Known history of HIV/AIDS; Hepatitis A, B, or C Bleeding disorder Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user Cancer, or treatment for cancer, in past 5 years

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: autologous platelet gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of wound depth at each visit |  |  | 
| Measurement of residual scarring at 6 months post wounding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wounds, healing, Acute wounds healing by secondary intention
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.

Official Title
-----------------
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation

Conditions
-----------------
Cataract, Dry Eye

Intervention / Treatment
-----------------
* Drug: Topical Cyclosporine, Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Males or females > 50 years old Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL. Likely to complete all study visits and able to provide informed consent Visual potential of 20/25 or better Exclusion Criteria: · Prior use of topical cyclosporine Known contraindications to any study medication or ingredients Active ocular diseases or uncontrolled systemic disease Active ocular allergies

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical Cyclosporine, Tears|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |