linjc16/ctgov huggingface dataset:
Bariatric Surgery Registry

Study Overview
=================
Brief Summary
-----------------
Periodic analyses of our extensive database with regards to different surgical procedures for severe obesity and different obesity co-morbidities will be of benefit to our severely obese patients as well as to others world-wide.

Official Title
-----------------
Analysis Bariatric Surgery Data

Conditions
-----------------
Obesity, Morbid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of morbid obesity Have undergone a bariatric surgical procedure at the VCU Medical Center

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| weight loss |  | 1 year, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical mortality |  | 90 day post-surgery | 
| surgical morbidity |  | 90 day post-surgery | 
| resolution of co-morbidities |  | 1 year, 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatrics
Gene - Exercise Research Study

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.

Official Title
-----------------
Impact of Common Genetic Polymorphisms on CV Disease Risk Factor Changes With Endurance Exercise Training

Conditions
-----------------
Cardiovascular Disease Risk Factors

Intervention / Treatment
-----------------
* Behavioral: Endurance exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: generally healthy free from CV disease ability to undergo exercise training Exclusion Criteria: previous history of CV disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Prevention
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurance Exercise Training<br> | Behavioral: Endurance exercise training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Disease Risk Factors |  |  9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma lipoprotein lipids, body composition, glucose tolerance, inflammation markers, insulin sensitivity, coagulation markers
IUD Insertion During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

Official Title
-----------------
Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: IUD during CS
* Device: IUD after puerperium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman aged between 18 to 40 years old. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks. Body mass index between 19-30 kg/m2 Seeking contraception after delivery. Exclusion Criteria: History of menorrhagia or severe dysmenorrhea. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis). Patients who have bleeding disorders. Anemia (Hb < 9 g %). Chronic depilating diseases reducing immunity such as Diabetes. Structural uterine anomaly or large uterine fibroids distorting anatomy. History of previous IUD expulsion or removal for complications. Unexplained uterine bleeding. Copper allergy or Wilson disease. Gestational trophoblastic disease with persistently elevated Beta HCG. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section). Complications during cesarean section e.g. postpartum hemorrhage. Cesarean section during placenta previa.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IUD during CS<br> | Device: IUD during CS<br>* IUD insertion during CS<br>|
| Active Comparator: IUD after puerperium<br> | Device: IUD after puerperium<br>* IUD after puerperium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD expulsion rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | number of pads changed per day | 6 weeks | 
| Degree of Pain | Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated) | 6 weeks | 
| dyspareunia | Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated) | 6 weeks | 
| patient satisfaction | Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction) | 6 weeks |
Basal Insulins - Pharmacodynamics

Study Overview
=================
Brief Summary
-----------------
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.

Detailed Description
-----------------
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).

Official Title
-----------------
No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans

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

Intervention / Treatment
-----------------
* Drug: Insulin detemir
* Drug: Insulin glargine
* Drug: Insulatard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male BMI 20 - 50 kg/m2 Blood pressure < 140/90 mmHg signed informed consent Caucasien Exclusion Criteria: Diabetes or other disease Alcohol or drug abuse Smoking Use of prescription drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Insulin detemir | Drug: Insulin detemir<br>* 0.4 U/kg bw insulin detemir injected s.c. in the thigh.<br>* Other names: Levemir;|
| Active Comparator: 2<br>Insulin glargine | Drug: Insulin glargine<br>* 0.4 U/kg bw insulin glargine injected s.c. in the thigh<br>* Other names: Lantus;|
| Active Comparator: 3<br>NPH insulin | Drug: Insulatard<br>* 0.4 U/kg bw NPH insulin injected s.c. in the thigh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
Determinants of Respiratory Health in Young Adults

Study Overview
=================
Brief Summary
-----------------
To measure lung function and respiratory symptom status in a large cohort of healthy, non-smoking 18-22 year old subjects, and relate these measurements to past histories of passive smoke and air pollution exposures.

Detailed Description
-----------------
BACKGROUND: While the natural history of human lung function growth and decline has been studied intensively over the past 30 years, relatively few data have been collected during the period in which peak volumetric function is achieved, i.e., around the age of 20. As a result, very little is known about the factors, both demographic and environmental, which influence maximal attained lung function. DESIGN NARRATIVE: The longitudinal study collected information on the history of respiratory illness, residential history, parental smoking, socio-economic status and home characteristics via an initial questionnaire administered to cadets enrolling at West Point. A sequence of four annual measurements of lung function (by spirometry), and prior-year respiratory health status and activity patterns was obtained in the spring of each year. Pollution exposures were estimated by matching residential histories with historical pollution data stored at the Environmental Protection Agency. Data on meteorological variables (temperature, relative humidity, wind speed) and altitude were obtained for each residential location. The four annual lung function measurements provided precise estimates of individual mean levels of FVC, FEV1, FEF25-75, PEFR, and flow rates at 50 percent and 75 percent of expired FVC. Subject-specific lung function level was analyzed in relation to history of parental smoking and prior exposure to air pollution using analysis of variance methods, controlling for potential confounding variables. In addition to testing these hypotheses regarding the respiratory effects of passive smoking and air pollution exposure, the study also explored the effects of these exposures on the change in lung function between the ages of 18 and 22 and on respiratory illness and symptom experience while at West Point. Finally, the study established a cohort which could be followed in future years. 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
-----------------
Lung Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Epidural Analgesia Versus IV Meperidine for Labor Pain Control

Study Overview
=================
Brief Summary
-----------------
60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.

Detailed Description
-----------------
Population 60 female during second stage of delivery Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia. Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system. Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening). the parturient will be lying on her left side for that period. 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes. estimated duration of the procedure about one hour per woman.

Official Title
-----------------
Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Procedure: ECG recording
* Procedure: Epidural catheter insertion
* Drug: Intravenous meperidine injection
* Drug: Epidural Bupivacaine and fentanyl injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia. Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system. -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ECG recording|nan|
|Procedure: Epidural catheter insertion|nan|
|Drug: Intravenous meperidine injection|nan|
|Drug: Epidural Bupivacaine and fentanyl injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration. |  |  |
Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative than other traditional indices.

Official Title
-----------------
Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD II-III (FEV1<80 and >30%) Exclusion Criteria: Pregnancy Lung cancer Diabetes mellitus Primary exacerbation of COPD

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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
-----------------
copd, inspiratory muscle training, IF
Addressing Patients' Expectations of Total Hip Arthroplasty in a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.

Detailed Description
-----------------
The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Hip Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported hip symptoms with radiographic findings.

Official Title
-----------------
Addressing Patients Expectations of Total Hip Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial

Conditions
-----------------
Hip Osteoarthritis, Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Behavioral: Educational program to address patients' expectations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible for this study if they are 55 years of age or older and are scheduled for primary total hip arthroplasty at the Hospital for Special Surgery. Exclusion Criteria: Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative hip replacement class; if they are unable to complete the surveys; if they refuse to participate.

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Educational program to address patients' expectations|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Hip Replacement Expectations Survey. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity. |  |  | 
| The secondary outcome is to assess if patients' expectations after the class coincide with orthopedic surgeons expectations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip arthritis, total hip arthroplasty, expectations, education
Measurement of the Diaphragm Loading During the Training With a IMT Device

Study Overview
=================
Brief Summary
-----------------
It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.

Detailed Description
-----------------
This study has a quasi-experimental design. We will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form. After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).

Official Title
-----------------
Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device

Conditions
-----------------
Physical Therapy Modalities, Respiratory Muscles, Maximal Respiratory Pressures, Breathing Exercise

Intervention / Treatment
-----------------
* Device: Threshold IMT (Inspiratory muscle trainer) by Philips


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years, healthy subjects - Exclusion Criteria: without anticoagulation, without esophageal lesions,without airway lesions and without spirometry alterations -

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Threshold IMT (Inspiratory muscle trainer) by Philips|Apply a resistive load with the IMT device according the maximal inspiratory pressure of each subject.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm intervention during a certain percentage of resistive load with a IMT device | The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure | 1 year |