linjc16/ctgov huggingface dataset:
Incidence of Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive disorder and factors correlation. Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive disorder and factors correlation.

Official Title
-----------------
Incidence and Prevalence of and Factors Associated With Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder, Metabolic Syndrome, Thyroid Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with major depressive disorder age over 18 years Exclusion Criteria: subject who cannot give information.

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
-----------------
Major depressive disorder, Metabolic syndrome, Thyroid dysfunction, incidence
Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?

Study Overview
=================
Brief Summary
-----------------
Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive dysfunction (POCD).

Official Title
-----------------
Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?

Conditions
-----------------
Delirium, Postoperative Cognitive Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60 or greater Open repair of the abdominal aorta Exclusion Criteria: refusal; planned endovascular repair; emergency surgery; previous diagnosis of dementia, Parkinson's disease, or psychiatric illness; active alcohol or substance abuse; and physical inability to complete neuropsychometric testing.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Open Aortic Repair<br>Patients 60 years of age and older undergoing open repair of the abdominal aorta | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium as assessed by the Confusion Assessment Method |  | 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCD as assessed by a battery of 9 neuropsychometric tests |  | 7 days postoperatively | 
| POCD as assessed by a battery of 9 neuropsychometric tests |  | 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium (MeSH Unique ID D003693), Cognition Disorders (MeSH Unique ID D003072), Postoperative Complications (MeSH Unique ID D011183), Apolipoproteins E (MeSH Unique ID D001057)
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Official Title
-----------------
CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: DEFINITY®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images. Exclusion criteria Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent. Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DEFINITY® (Perflutren Lipid Microsphere)<br>Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography | Drug: DEFINITY®<br>* DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert<br>* Other names: Perflutren Lipid Microsphere injectable suspension;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration |  | during or within 30 minutes of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration | Through 24 hours | 
| Adverse Events | Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration | Through 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DEFINITY, Safety, Survelliance
Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications

Study Overview
=================
Brief Summary
-----------------
Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?

Detailed Description
-----------------
Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.

Official Title
-----------------
The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications

Conditions
-----------------
Pregnancy, Fetal Aneuploidy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women at approximately 20 weeks ages 18-50 singleton pregnancy plans to deliver at North Shore University Hosp completed step-wise sequential screening Exclusion Criteria: multifetal gestation minors patients who have undergone diagnostic genetic testing incarcerated patients intention to deliver at a hospital other than North Shore University hosp

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| Correlation of geometric morphometric analysis of fetal brow to 10 soft markers | In patients who have undergone step-wise sequential screening, how often will the evaluation of 10 midtrimester sonographic soft markers of aneuploidy such that the recommendation regarding invasive diagnostic testing be changed? | completion of pregnancy |
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Study Overview
=================
Brief Summary
-----------------
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Official Title
-----------------
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Conditions
-----------------
Uncontrolled Hypertension

Intervention / Treatment
-----------------
* Device: Renal Denervation (Symplicity® Renal Denervation System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics); on 3 or more antihypertensive medications >= 18 and =< 85 years of age. Exclusion Criteria: renal artery abnormalities eGFR < 45mL/min MI, angina, CVA within 6 months Type 1 diabetes ICD or pacemaker, or any other metallic implant not compatible with MRI others

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal Denervation and maintenance of anti-hypertensive medications | Device: Renal Denervation (Symplicity® Renal Denervation System)<br>* Catheter-based renal denervation<br>|
| No Intervention: Control<br>Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office Systolic Blood Pressure Reduction | The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization. | Baseline to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, renal denervation, sympathetic nervous system, RDN
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies

Study Overview
=================
Brief Summary
-----------------
Meningitis are serious infections. Evidenced by high rates of mortality and sequelae. However, these diseases have a relatively small impact. Also physician services Home Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis. Indeed, it is only after this essential clinical milestone that will be carried out a lumbar puncture which will confirm the diagnosis and to quickly begin treatment. Unfortunately, if recent studies can improve the therapeutic management of patients with meningitis, no study was interested in yet fundamental step of diagnosis. It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a predictive clinical score of the presence or absence of meningitis.

Official Title
-----------------
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study

Conditions
-----------------
Meningitis

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: May be included in the study two groups of patients: *On the one hand, those in which will be carried out a lumbar puncture. Ideally, all patients in whom the examination is envisaged will be included. The logistics must allow inclusion rate as high as possible (see below). So, are included in this group, patients for which the following criteria are met: Over 15 years patient and 3 months, Admission to the emergency for less than 6 hours Realization of a proposed lumbar puncture, Information sheet given. *On the other hand, those in whom it is not intended to be carried by lumbar puncture, but for which the clinical picture present on admission makes relevant for clinical signs of meningitis. So, are included in this group, patients for which the following criteria are met: Over 15 years patient and 3 months, Admission to the emergency for less than 6 hours At least one of the following 5 clinical signs motivating consultation and / or present on admission: fever (measured temperature above 38 ° C) headache, vomiting, stiff neck, vigilance disorders, Information sheet given. Exclusion Criteria: Patient who underwent neurosurgery recent (within the month before admission).

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| meningitis (either viral or bacterial) or absence of meningitis |  | Until 2 days |
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

Official Title
-----------------
Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas

Conditions
-----------------
Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Tumor, Recurrent

Intervention / Treatment
-----------------
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age >18 years old Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme) Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging Karnofsky Performance Status scale >/=50 (due to brain pathology) Adequate hematological, renal and hepatic function Patients willing to participate in the study and signing the informed consent Exclusion Criteria: Karnofsky Performance Status scale <50 Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study Patients not suitable for follow-up

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Temozolomide<br>* 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity<br>* Other names: Temodar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival at 6-months |  | Until progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temozolomide, Brain Tumor, Recurrent, Chemotherapy
Opioid Compromise in Hypertension--Modulating Factors

Study Overview
=================
Brief Summary
-----------------
To confirm the preliminary findings of age, race, and hypertension chronicity effects on opioid and cardiovascular responses to stress and to determine the opioid mechanisms mediating these effects using an opioid receptor blockade strategy.

Detailed Description
-----------------
BACKGROUND: Opioids exert depressor effects on cardiovascular responses through sympathetic nervous system inhibition. Research suggests that opioid inhibition of sympathetic activity may be compromised in hypertension. Preliminary studies by the Principal Investigator suggest that the nature of this compromise may be influenced by age and race. Additionally, literature suggests that hypertension chronicity may modulate opioid sympathoinhibitory actions. The receptor mechanisms mediating the observed modulating effects of age, race, and hypertension chronicity on opioidergic inhibition and regulation of blood pressure remained to be determined. DESIGN NARRATIVE: Two double-blind, placebo-controlled cross-over studies were conducted to evaluate the effects of naltrexone hydrochloride, an oral opiate antagonist, on adrenergically-mediated cardiovascular responses in older and younger, Black and White normotensives and hypertensives with varying lengths of hypertension duration. Cardiovascular and opioid responses were measured in response to a stressor combined with either placebo or naltrexone pretreatment. Results from these studies assisted in (a) elucidating opioidergic mechanisms underlying the increased rates of hypertension morbidity and mortality among Blacks and the elderly, and (b) ultimately optimized the design of pharmacological interventions for the prevention and treatment of hypertension. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether expressions of adipokines can provide prognostic information concerning patients with chronic heart failure.

Official Title
-----------------
Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are giving open chest surgical treatment with a history of chronic heart failure (NYHA II   IV) more than 6 months. Patients from whom informed consent has been properly obtained in writing prior to start of the trial. Exclusion Criteria: Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy. Patients with a history of cardiomyopathy. Patients with Chronic arrhythmia. Pregnant women Severe hepatic dysfunction or End-stage renal failure. Uncontrolled hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 Years

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 |
| --- | --- | --- |
| All-cause mortality |  | Change from Baseline at 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) Classification |  | Week:4 | 
| re-hospitalization | Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay. | Change from Baseline at 3, 6 and 12 months | 
| plasma brain natriuretic peptide (BNP) concentration |  | Week:4 | 
| Cardiovascular death |  | Change from Baseline at 3, 6 and 12 months | 
| Cardiac transplantation |  | Change from Baseline at 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adipokines, Chronic Heart Failure, Prognosis
To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.

Official Title
-----------------
A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Schizophrenia or Schizoaffective disorder 18-55 years Exclusion Criteria: Subjects who are acutely psychotic Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia Subjects at significant risk of suicide Subjects with a seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bifeprunox|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
-----------------
Treatment interruption on reinitiation, Schizophrenia, Schizoaffective disorder