linjc16/ctgov huggingface dataset:
Hip Scope Fascia-iliaca (FI) Block Study

Study Overview
=================
Brief Summary
-----------------
Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.

Official Title
-----------------
Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block

Conditions
-----------------
Hip Dysplasia, Femoroacetabular Impingement, Acetabular Labrum Tear

Intervention / Treatment
-----------------
* Drug: ropivicaine
* Drug: clonidine
* Drug: Epinephrine
* Drug: Noropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for outpatient hip arthroscopy American Society of Anesthesiologists (ASA) 1-3 Exclusion Criteria: Prior surgery on ipsilateral hip ASA 4-6 Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes Allergy to amide local anesthetics Contraindication to regional anesthesia BMI > 40 Females who are pregnant or plan to get pregnant during the course of the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FI Block<br>Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) | Drug: ropivicaine<br> <br> Drug: clonidine<br> <br> Drug: Epinephrine<br> <br> |
| Active Comparator: Local Injection<br>Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin | Drug: Noropin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Arthroscopy
Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.

Official Title
-----------------
Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: rosiglitazone
* Drug: metformin
* Drug: Anti-diabetic medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently diagnosed type 2 diabetes No previous anti-diabetic medications Exclusion Criteria: Heart failure Renal disease Liver disease Life-threatening diseases

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin,lifestyle counselling<br> | Drug: rosiglitazone<br> <br> Drug: metformin<br> <br> Drug: Anti-diabetic medications<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel cardiovascular risk factors modification |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid and glucose regulation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metformin, rosiglitazone
Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction is registered with a validated questionaire (International Index of Erectile Function-15). Concentration, total number of sperm and motility is determined in freshly delivered ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly higher rate of retrograde ejaculation than healthy controls.

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 30-55 years of age Men registered in a Diabetic Biobank including 6000 diabetics and 6000 controls Exclusion Criteria: Men who do not understand Danish

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic men<br> | |
| Non-diabetic men<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrograde ejaculation (a minimum of a total of 1 million sperm in postejaculatory urine) |  | The examination program for each patient was finished within one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile dysfunction |  | The examination program (including a questionaire on erectile dysfunction) for each patient was finished within one day. |
ECG Belt for CRT Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

Detailed Description
-----------------
The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.

Official Title
-----------------
ECG Belt for CRT Response

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

Intervention / Treatment
-----------------
* Device: ECG Belt Research System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead. Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB LVEDD ≥ 55 mm, as determined by site Exclusion Criteria: Permanent/persistent AF or presenting with AF Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator Currently implanted with IPG or ICD with > 10% RV pacing Permanent complete AV block Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study. Less than 1 year life expectancy Vulnerable adults Younger than 18 years of age

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECG Belt<br>The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. | Device: ECG Belt Research System<br>* The ECG Belt Research System is used to identify the best vector and programming parameters.<br>|
| No Intervention: Control Arm<br>Standard CRT through 6 months follow-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. | Relative (%) change in LVESV from the baseline measurement to the 6 month measurement. | baseline to 6 months |
Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke

Study Overview
=================
Brief Summary
-----------------
In order to discover dysphagia scales, which shows meaningful predictability of aspiration and functional health status in patients with acute stroke, authors plan to find out more predictable indicators than existing penetration-aspiration scale (PAS) to validate their predictions and their internal and external validity over 6 months following stroke .

Detailed Description
-----------------
To determine the dysphagia scale with significant predictions of aspiration and functional health status in patients with acute stroke, video-fluoroscopic swallowing study (VFSS) will be performed to the patients who will be referred for VFSS among stroke patients who would be diagnosed by Brain MRI / CT. When any type of dysphagia is found, participant will be assigned to the test group (DYS), and when no dysphagia is found, they will be assigned to the control group (NOD). Numerous kinds of assessment will be conducted before and after VFSS, before discharge, and 3, 6, and 9 months after the stroke onset.

Official Title
-----------------
Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke: Prospective, Observational, Parallel Group, Case-control Trial

Conditions
-----------------
Acute Stroke, Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brain MRI / CT-based stroke patients who were referred for VFSS Exclusion Criteria: In case of a history of dysphagia Unstable patient in neurology 2 or higher of NIHSS 1a (level of consciousness) Patients with other neurological diseases Patients with decompression skull resection Refusal of participation

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Dysphagia group<br>Acute stroke patients who will be diagnosed dysphagia according to VFSS results. | |
| No dysphagia group<br>Acute stroke patient who showed no dysphagia according to VFSS results. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Body mass index (Kg/m2) | Body mass index (Kg/m2) | 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Check the Penetration/aspiration on PAS | Penetration/aspiration on PAS (DYS) | 1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset |
Bacteriuria and Indwelling Urinary Catheter.

Study Overview
=================
Brief Summary
-----------------
Investigation of 1. The incidence of symptomatic bacteriuria during four weeks after removal of an IUC in inpatients at a rehabilitation clinic for patients ≥ 65 years compared with the incidence of symptomatic bacteriuria among inpatients not treated with an IUC and 2. For how long does ABU persist in inpatients at a rehabilitation clinic for patients ≥ 65 years during a follow-up time of four weeks after IUC-removal?

Official Title
-----------------
The Risk of Symptomatic Bacteriuria and Persistence of Asymptomatic Bacteriuria After Removal of an Indwelling Urinary Catheter- a Prospective Observational Study Among Elderly Inpatients.

Conditions
-----------------
Bacteriuria Asymptomatic, Urinary Tract Infections

Intervention / Treatment
-----------------
* Device: Indwelling urinary catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to a rehabilitation clinic for patients ≥ 65 years in Stockholm County, Sweden Ability to understand oral and written instructions in Swedish Ability to produce a voided urine-sample Exclusion Criteria: Severe cognitive failure and/or disability to understand oral and written instructions in Swedish according to the healthcare-personnel's judgment at the ward End-of-life care Physical disability to produce voided urine-samples Ongoing antimicrobial treatment for symptomatic bacteriuria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Intervention group<br>Inpatients with an indwelling urinary catheter (IUC) at admission to a rehabilitation clinic for persons ≥65 years in Sweden. Intervention is removal of the IUC. | Device: Indwelling urinary catheter<br>* Removal of indwelling urinary catheter<br>|
| Control group<br>Inpatients without an IUC at admission to a rehabilitation clinic for persons ≥65 years in Sweden | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic bacteriuria (urinary tract infection) | Clinical diagnosis of urinary tract infection by a physician | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymptomatic bacteriuria (ABU) | Prevalence of ABU at the point of removal of an IUC compared with patients without IUC | One day | 
| Persistence of ABU | For how long does ABU persist after IUC-removal | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Catheter
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to proof and investigate the effectiveness and safety of the invented device named Human Lumbar Puncture Assist Device (LPat) as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation if the LP need to be done under fluoroscopy, and need to obtain none traumatic tap for better CSF analysis.

Detailed Description
-----------------
Human Lumbar Puncture Assist Device (LPat) was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation.

Official Title
-----------------
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)

Conditions
-----------------
Meningitis, Encephalitis, Guillain-Barré, Subarachnoid Hemorrhage, Intracranial Neoplasm, Intracranial CNS Disorder

Intervention / Treatment
-----------------
* Device: LPat Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 12 years and older who need lumbar puncture (LP) for diagnostic purposes or patients already underwent LP but failed to obtain Cerebrospinal Fluids i.e. Unsuccessful Tap Exclusion Criteria: Patients younger than 12 years of age

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| LPat Device<br>Performing Lumbar Puncture assisted by LPat | Device: LPat Device<br>* Performing Lumbar Puncture utilizing LPat device<br>* Other names: Lumbar Puncture Assisted by LPat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Lumbar Puncture | Obtain CSF | Immediate |
Busulfan Pharmacokinetic Analysis and GST Pharmacogenetic Profile in Adults Undergoing Hematological Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is only checking the GST gene and MDR-1 gene

Detailed Description
-----------------
BU levels are largely unpredictable, patients are often exposed to the toxic effects of inappropriate drug regimens before dose modifications can be made. Although the importance of TDM cannot be over emphasized, it entails trial and error and does not allow for pre- treatment dose optimization. This study, which provides an integration of genetic and pharmacokinetic data analysis of patients preconditioned for HSCT with high dose oral BU, aims to define biomarkers predictive of poor BU metabolism and clearance to prevent potential drug toxicity.This study is not an interventional study, only investigates the GST and MDR-1 genes in correlation with the routine Busulfan AUC done during the preparative regimen in HSCT for AML patients.

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myeloid Leukemia who are clinically selected for HSCT according to known protocols. Exclusion Criteria: Unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 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 |
| --- | --- | --- |
| If GST and ABCB1 genes modify busulfan pharmacokinetics in AML patients who will be transplanted | If individuals diagnosed with AML carrying the GSTP1 variant allele rs1695 (heterozygotes) are at risk of developing supra-therapeutic BU AUC due to lower BU clearance, and if combined polymorphisms in GSTM1 and ABCB1 (3435 or 2677) are associated with BU clearance rates and AUC. | end of BMT transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Busulfan, Polymorphism, GST, MDR-1(p-Glycoprotein), Acute Myeloid Leukemia adult patients
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

Study Overview
=================
Brief Summary
-----------------
A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps

Official Title
-----------------
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

Conditions
-----------------
Endoscopy

Intervention / Treatment
-----------------
* Device: hot clamps
* Device: normal clamps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Patients with no known hemorrhage risk, with an indication of endobronchial biopsy Patients with no contra-indication for bronchial endoscopy Patients with or without endobronchial tumors Patients who have provided written informed consent Patients with health insurance coverage Exclusion Criteria: Refusal to be examined Contraindication for electrocoagulation (Pacemaker or metallic endobronchial prosthesis) Pregnant women Patients unable to provide voluntary informed consent, under (tutelage) or guardianship, or unable to come to the center

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hot clamps<br>reusable hot biopsy forceps | Device: hot clamps<br>* reusable hot biopsy forceps<br>|
| Active Comparator: normal clamps<br>normal clamps | Device: normal clamps<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of reusable hot biopsy forceps | To show that the use of hot clamps (thermocoagulating) for endobronchial analysis does not affect the anatomopathologic interpretation of biopsies under certain conditions (with varying in intensity of current). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial biopsy