linjc16/ctgov huggingface dataset:
Effect of Prenatal Education on Perceptions of Epidural Acceptance

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if targeted prenatal educational program on womens' perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative to the control group.

Detailed Description
-----------------
Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia. The purpose of our study is to determine if culturally-sensitive educational program targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural use.

Official Title
-----------------
Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Behavioral: Prenatal education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with viable intrauterine gestation seeking prenatal care Candidates for Intrapartum epidural analgesia Exclusion Criteria: Intrapartum epidural analgesia is contraindicated Trial of labor is contraindicated. Patients planning an elective cesarean

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Prenatal education<br>These subjects will be randomized to receive routine prenatal epidural class (control group). | |
| Active Comparator: Receives Prenatal Education<br>Subjects randomized to this group will receive educational video addressing the cultural and perceptions regarding the myths on epidural in either English or Spanish (Keeping an Open Mind: choices in Labor Anaglesia: an educational produce of the Society for Obstetric Anesthesia and perinatology) | Behavioral: Prenatal education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey | All subjects will be asked to fill out the Perceptions on Epidural Questionnaire (PEQ) to elucidate their desire to receive intrapartum pain control & their attitude towards epidural to patients. Each survey will take approximately five to ten minutes to complete. The survey will be distributed in English and Spanish. | One year time period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrapartum pain management, epidural
Benefits of Standard ONS in Indian Adults

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.

Official Title
-----------------
An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults

Conditions
-----------------
Poor Nutrition

Intervention / Treatment
-----------------
* Other: Oral Nutritional Supplement (ONS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory adult patients >or equal to 45 years of age Patients at the risk of malnutrition (MST > or equal to 2) Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent. Exclusion Criteria: Subject using commercially available macronutrient food supplements or another ONS History or evidence of hypersensitivity to any component of study product History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Oral Nutritional Supplement (ONS)<br>2 servings per day ONS | Other: Oral Nutritional Supplement (ONS)<br>* Per standard of care (SOC)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured weight kg | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Grip | Dynamometer | Baseline to 12 weeks | 
| Quality of Life (QoL) | World Health Organization QOL-BREF Questionnaire; 4 Domain scores scaled in a positive direction (very dissatisfied - very satisfied) | Baseline to 12 weeks |
Decreased EEG Complexity in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.

Detailed Description
-----------------
Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system

Official Title
-----------------
Decreased EEG Complexity in Chronic Residual Schizophrenia

Conditions
-----------------
Electrophysiological Randomness, Entropy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| schizophrenia<br>patients with a diagnosis of schizohrenia | |
| control<br>healthy control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean of the average Logarithmic Energy Entropy values |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hurst Exponent value |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complexity, electroencephalogram, entropy, negative symptoms, schizophrenia.
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: K-312 100 mg
* Drug: K-312 100 ug C14 IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed. Subject is a healthy adult male between the ages of 25 and 45 years, inclusive. Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive. Exclusion Criteria: Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment. Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312. Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-312<br> | Drug: K-312 100 mg<br>* Single oral dose<br>Drug: K-312 100 ug C14 IV<br>* microtracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma-concentration time curve to last measured time point |  | 336 hours post-dose | 
| Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing |  | 336 hours post-dose |
Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals

Study Overview
=================
Brief Summary
-----------------
Makers of ionic foot baths claim that their machines can eliminate heavy metals from the body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the machine under controlled conditions. The machine will first be tested without feet under normal operating conditions and again after operation under normal conditions with foot immersion.

Official Title
-----------------
Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: IonCLeanse Footbath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adults Exclusion Criteria: A wearer of a pacemaker or any other battery operated or electrical implant Pregnant or nursing women On heartbeat regulating medication On blood thinners (anticoagulants) On any drug known to have chelating properties Have had an organ transplant or a metal joint implant On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Footbath<br>Participants in this arm of the study will receive 4 30 minutes ionic footbath sessions, one each week for 4 weeks. | Device: IonCLeanse Footbath<br>* Application of an ionic footbath for 30 minutes per week for 4 weeks<br>* Other names: IonCleanse SOLO machine manufactured by A Major Difference;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heavy metal content in the water after a 30 minute IonCleanse footbath | The footbath water will be assessed after each footbath session for each participant via a drinking water assessment performed by an accredited lab. Screening for heavy metals will be done via a 24 urine collection and Urine Toxic Metals assessment four times during the study - baseline, during 2nd and 4th footbath sessions and then at the 3 month mark post baseline. | 4 sessions, May 26 to June 17 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assess the ability of the IonCleanse machine to remove heavy metals through the feet
Diabetes and Metabolic Postprandial Responses

Study Overview
=================
Brief Summary
-----------------
The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.

Official Title
-----------------
Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects

Conditions
-----------------
Type 2 Diabetes, Overweight

Intervention / Treatment
-----------------
* Other: oral glucose load


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight or obese volunteers Healthy for one group nd type 2 diabetic for the second group Age between 30 and 65 years old Total cholesterol < or = 7 mmol/l and triglycerides < or = 4 mmol/l For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c < 6% Stable weight over last 3 months Informed consent Exclusion Criteria: No compliant subjects Participation in an other trial 2 months before starting this one Ward of court or under guardianship (sheltered adults) Person deprived of freedom by judicial or administrative decision Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose Existence of a previously diagnosed pathology (other than type 2 diabetes) Previous gastro-intestinal pathology Treated by corticoids, anorexigens, weight loss medicines Alcoholism or severe tobacco consumption

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: type 2 diabetic subjects<br> | Other: oral glucose load<br>* oral ingestion of 13C labeled glucose<br>|
| Experimental: overweight healthy subjects<br> | Other: oral glucose load<br>* oral ingestion of 13C labeled glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism |  | 6 hours postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides |  | 6 hours postprandially | 
| Carbohydrate and lipid oxidation |  | 6 hours postprandially | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetic subjects
Compartmental Overpressures Associated to Reamed Intramedullary Nails

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

Detailed Description
-----------------
Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.

Official Title
-----------------
Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study

Conditions
-----------------
Tibial Fractures

Intervention / Treatment
-----------------
* Device: Quick Pressure Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tibial shaft fractures treated with intramedullary reamed nails Exclusion Criteria: Tibial fractures treated with other types of fixation or nails not reamed.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pressure monitor<br>Tibial Fracture | Device: Quick Pressure Monitor<br>* The monitor measures actively the actual pressure inside the compartment affected.<br>* Other names: Slit catheter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracompartmental pressures |  | 0-2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intramedullary nails, Compartmental syndrome, Fractures
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients

Conditions
-----------------
Low Back Pain Due to Spinal Nerve Compression

Intervention / Treatment
-----------------
* Procedure: skin compression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection Exclusion Criteria: Local anesthetic allergy, coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: compression group<br>skin compression with an indicator for determination of needle entry point | Procedure: skin compression<br>* skin compression with an indicator for determination of needle entry point<br>|
| Active Comparator: non-compression group<br>non skin compression with an indicator for determination of needle entry point | Procedure: skin compression<br>* skin compression with an indicator for determination of needle entry point<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiation exposure time | Total radiation exposure time during whole epidural procedure. | immediately ≤1 sec after the confirmation of successful epidural injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of the needle readjustments | The number of the needle readjustments for successful epidural injection | immediately ≤1 sec after the confirmation of successful epidural injection |