linjc16/ctgov huggingface dataset:
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.

Official Title
-----------------
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy

Conditions
-----------------
Prostatic Cancer

Intervention / Treatment
-----------------
* Drug: epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.) patients aged more than 65 years ASA physical status I or II absence of contraindications to epidural approach absence of a history of chronic pain or opioid medication Exclusion Criteria: contraindication to epidural catheterization

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: Diagnostic
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin |  | from preoperative baseline to postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients of prostatic cancer aged more than 65 years
A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair Of Pediatric Pectus Excavatum

Study Overview
=================
Brief Summary
-----------------
The main goal of the pectus multicenter outcomes study is to document the utility of PEx repair in improving health and quality of life and to test the prevailing belief that the two predominant surgical procedures currently in use for PEx repair are essentially equivalent in terms of long-term outcomes. We believe the uncertainty about the impact of PEx on cardiopulmonary function is due to part to the fact that the previous studies have not measured the physiological parameters mostly likely affected by the defect. A protocol to test this was developed. Thus, we propose to use these measures as well as conventional output of progressive exercise test to examine cardiopulmonary function before and after surgical repair of PEx within the context of the original study.

Official Title
-----------------
 A Multicenter Study Comparing the Clinical Outcomes of the Nuss and Ravitch Procedures for Repair of Pediatric Pectus Excavatum

Conditions
-----------------
Repair of Pectus Excavatum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Haller index by thoracic computed tomography (CT) scan of 3.2 or greater, has decided to have surgery to repair PEx, Written informed consent obtained from the parent or guardian of the subject,or, fro subjects 18-21 years, from the subject him(her)self, and assent of the child. - Exclusion Criteria:Pectus carinatum, Poland's syndrome or other comlex chest wall anomaly,Previous repair of PEx by any technique, Previous thoracic surgery, Congenital heart disease, Bleeding dyscrasia, History of major anesthetic risk factors such as malignant hyperthermia, Pregnancy, Surgical repair to be performed with bar other than stainless steel. -

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 21 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 |
| --- | --- | --- |
Improving Diabetes After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Detailed Description
-----------------
The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM. Funds are not available to pay for the surgery for patients, only to address research questions.

Official Title
-----------------
LABS-3 Diabetes: Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery

Conditions
-----------------
Obesity, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon. Enrollment in LABS-1 or LABS-2. Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group. Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group. Adequate IV access. Exclusion Criteria: Informed consent not obtained. Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL. Creatinine greater than 1.7. Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff. Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.

Official Title
-----------------
Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Conditions
-----------------
Wounds and Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements: Necrotizing fasciitis Compromised/failed skin grafts/flaps Chronic refractory osteomyelitis Soft tissue radiation necrosis Diabetic wounds, lower extremity Acute peripheral arterial insufficiency Crush injury Venous leg disease Pressure ulcer Other chronic, non-healing wounds Subjects must have signed the Informed Consent Forms. Exclusion Criteria Female subjects who are pregnant or nursing. Anyone who is unable to give written informed consent Subjects with end-stage renal disease or who require peritoneal or hemodialysis. Subjects with current malignancies.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Standard Care Group<br>Subjects who will undergo only standard wound care management. | |
| Hyperbaric Oxygen Therapy Group<br>Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity measurements | Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made. | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Wounds, Hyperbaric Oxygen, Laser Speckle Imaging, Hyperbaric Oxygenation
An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe COPD health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (COPD) population in real life in primary care during the last ten years.

Official Title
-----------------
A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD diagnosis according to medical records. Use of drugs prescribed for obstructive lung diseases
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>Primary care patients with COPD diagnosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the development of COPD health care structure in primary care. |  | Data will be extracted from the medical records on one occassion, covering a period of one decade. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the COPD population in primary care with special reference to treatment, co-morbidity and mortality during last decade. |  | Data will be extracted from the medical records on one occassion, covering a period of one decade. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiological, COPD health care, treatment in primary care
Left Ventricular Aneurysms in Children

Study Overview
=================
Brief Summary
-----------------
Collect data to support standard of care possibility of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.

Detailed Description
-----------------
Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists. We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following aneurysm categories: Mostly occur after: Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information: Procedures including the dates performed Medications Physical Exam Findings Weight Gestational Age Outcome

Official Title
-----------------
Left Ventricular Aneurysms in Children

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aneurysms between 6.30.2002 and 6.30.2004 Exclusion Criteria: those children who do no meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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
-----------------
pediatric, cardiac, aneurysms, left ventricular aneurysms, surgical repair for LV aneurysms
Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

Study Overview
=================
Brief Summary
-----------------
This study aimed to explore the effect of intravenous (IV) vitamin C on sequential organ failure assessment (SOFA) score among septic patients in intensive care unit (ICU).

Detailed Description
-----------------
This study was approved by the Ethics and Research Committee of Universitas Indonesia. This study was a randomized clinical trial held from April to July 2019 in Cipto Mangunkusumo Hospital. 33 patients that met the inclusion criteria were included in the study. Subjects were divided into two groups: group A (intervention group, n = 18) received parenteral infusions of 1,5 g/6 hours of vitamin C and 200 mg thiamine, while group B (control group, n = 15) received 200 mg thiamine only. baseline demographic data was recorded on the first day. SOFA score was recorded at baseline, 24 hours, 48 hours, and 72 hours after treatment. Data were analyzed using SPSS (Statistical Package for Social Sciences) software.

Official Title
-----------------
Effect of Intravenous Vitamin C on Sequential Organ Failure Assessment (SOFA) Score Among Septic Patients: Randomized Controlled Trial

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: vitamin C, vitamin B1
* Drug: vitamin B1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with sepsis diagnosis based on sepsis-3 criteria in the ICU in between 6 hours to 24 hours post resuscitation after sepsis diagnosis Exclusion Criteria: patients with chronic kidney problems on haemodialysis, patients with kidney stones or kidney problem within the last 3 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin C and thiamine<br>patients who received intravenous vitamin C and thiamine | Drug: vitamin C, vitamin B1<br>* vitamin C 1,5 g/6 hours IV + thiamine 200 mg/12 hours for 3 days<br>* Other names: group A;|
| Active Comparator: thiamine<br>patients who received thiamine | Drug: vitamin B1<br>* thiamine 200 mg/12 hours for 3 days<br>* Other names: group B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment (SOFA) score | Sequential Organ Failure Assessment (SOFA) score score measured at several specified times. higher score indicates higher mortality in septic patients. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, intravenous vitamin C, SOFA score
Yoga Intervention Study on Episodic Tension Type Headache

Study Overview
=================
Brief Summary
-----------------
The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.

Official Title
-----------------
Effect of Yoga Intervention on Episodic Tension Type Headache: A Randomized Controlled Trial

Conditions
-----------------
Episodic Tension Type Headache

Intervention / Treatment
-----------------
* Behavioral: Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 to 60 years more than 5 but fewer than 15 headache episodes per month headache intensity moderate to severe Exclusion Criteria: Patients on anti-psychotic, antidepressant or any prophylactic medication pregnancy Taking psychotherapy or any other alternative medicine migraine headache more than 1 day a month pain disorder, psychiatric or medical disorder requiring immediate treatment, headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| No Intervention: Wait-list control group<br>The wait-list control group received no intervention, or instruction and they were observed with their usual care for 12-weeks intervention period. Upon completion of the study, this group received 12 weeks of yoga intervention. | |
| Experimental: Yoga Intervention Group<br>The yoga sessions developed specifically for study participant consisted of 12 weekly 60-minute designed to benefit in episodic tension type headache. | Behavioral: Yoga Therapy<br>* Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of headache |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Headache |  | 3 months | 
| Severity of headache |  | 3 Months | 
| Analgesic consumption |  | 3 Months | 
| Anxiety levels |  | 3 months | 
| Depression |  | 3 months | 
| Stress |  | 3 months |
Lipid-lowering Therapy for Secondary Prevention in Patients Undergoing Elective Percutaneous Coronary Intervention (PCI)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention.

Official Title
-----------------
LIPID-LOWERING THERAPY FOR SECONDARY PREVENTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) A 10-week, Open-label, Non-interventional Study of Total Cholesterol/LDL-cholesterol Management in Real Life in Coronary Patients Hospitalised for Elective PCI

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or nonpregnant female Coronary patient hospitalised for elective PCI Hypercholesterolaemia defined as LDL-C ≥ 2 mmol/L Exclusion Criteria: Any chronic inflammatory condition Chronic anti-inflammatory pharmacotherapy (except low-dose ASA)

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 |
| --- | --- | --- |
| Serum total cholesterol concentration |  | Week 0 | 
| Serum total cholesterol concentration |  | Once during the time period between Week 6 and Week 10 | 
| Serum LDL cholesterol concentration |  | Week 0 | 
| Serum LDL cholesterol concentration |  | Once during the time period between Week 6 and Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving LDL-C < 2 mmol/L |  | Once during the time period between Week 6 and Week 10 | 
| Proportion of patients achieving total cholesterol < 4 mmol/L |  | Once during the time period between Week 6 and Week 10 | 
| Change of hsCRP levels from baseline |  | Once during the time period between Week 6 and Week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood lipids, percutaneous coronary intervention, lipid lowering treatment
Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

Study Overview
=================
Brief Summary
-----------------
The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest. We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR >0.85

Official Title
-----------------
Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

Conditions
-----------------
Coronary Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with FFR> 0,80 between september 2012 till december 2016 Exclusion Criteria: refusal of participation

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 |
| --- | --- | --- |
| Composite outcome | cardiovascular mortality or acute coronary syndrom or revascularization or cardiovascular rehospitalisation | 3 years |