linjc16/ctgov huggingface dataset:
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: DPP-IV Inhibitor
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 18-75 years of age; type 2 diabetes diagnosed >=1 month before screening; no previous treatment, or previous treatment with no more than 2 oral medications. Exclusion Criteria: type 1 diabetes; type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening; patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid or qd<br>|
| Experimental: 2<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid or qd<br>|
| Experimental: 3<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid or qd<br>|
| Experimental: 4<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid or qd<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* po bid or qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in HbAlc\n\n |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate |  | Week 12 | 
| AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n |  | Throughout study |
Feasibility Assessment of ACS Catheter

Study Overview
=================
Brief Summary
-----------------
This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK. The study will examine the safety and performance of a new urinary catheter, the Alternative Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which has been developed to reduce the morbidity of long-term catheterisation and the acknowledged deficiencies of the conventional Foley urinary catheter.

Official Title
-----------------
A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)

Conditions
-----------------
Urological

Intervention / Treatment
-----------------
* Device: ACS Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study. Capable of using a catheter valve to empty the bladder and able to communicate their experience with the system OR who has a carer able to fulfil these tasks. Fitted with a suprapubic catheter (at least 2 weeks post insertion). Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks. History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months. Exclusion Criteria: <18 years of age. Pregnant or lactating females. History of catheter associated septicaemia in the past month. Evidence of current systemic infection. Bladder pathology such as a tumour or stone >0.5cm as determined by cystoscopy. Flaccid bladder. BMI>35. Current participation in another device or drug study. Unwilling or unable to provide informed consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter placed<br> | Device: ACS Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of the ACS catheter |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary, Incontinence, Catheter
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Pexacerfont
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x). Patients whose current depressive episode is at least three months in duration at the Baseline Visit. Exclusion Criteria: Males Patients with treatment resistance to other antidepressants

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Pexacerfont<br>* Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation<br>* Other names: BMS-562086;|
| Active Comparator: A2<br> | Drug: Escitalopram<br>* Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.<br>|
| Placebo Comparator: A3<br> | Drug: Placebo<br>* Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests |  | every visit and endpoint | 
| Compare efficacy of escitalopram to placebo |  | at endpoint and at each visit |
The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique

Study Overview
=================
Brief Summary
-----------------
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

Conditions
-----------------
Lumbosacral Radicular Pain

Intervention / Treatment
-----------------
* Procedure: anteroposterior approach group
* Procedure: oblique approach group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic Exclusion Criteria: pregnancy coagulopathy systemic infection any active infection at the injection site history of allergy to contrast media, local anesthetics, corticosteroid patients unable to communicate or patients with cognitive dysfunction

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anteroposterior approach group<br>anteroposterior approach group | Procedure: anteroposterior approach group<br>* anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy<br>|
| Active Comparator: oblique approach group<br>oblique approach group | Procedure: oblique approach group<br>* oblique approach group (n=104): same as anteroposterior approach group except using oblique view<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of intravascular injection | the incidence of intravascular injection in the anteroposterior approach group and the oblique approach group | 5 seconds after injection of contrast media via block needle. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidural injections, intravascular injection
External Evaluation of Vancomycin Population Pharmacokinetic Models

Study Overview
=================
Brief Summary
-----------------
All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded. Seven pharmacokinetic models' predictive performance will be evaluated on this database. Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

Detailed Description
-----------------
Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.

Official Title
-----------------
External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations

Conditions
-----------------
Vancomycin Dosage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients hospitalized in Brest University Hospital, treated with vancomycin and receiving pharmacological monitoring between 1rst January 2019 and 1rst January 2021 Exclusion Criteria: Missing data on vancomycin administration Refusal to be included in this study Hospitalisation in ICU

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 |
| --- | --- | --- |
| Imprecision in Predictive performance of seven pharmacokinetic models | The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected | September 2021 | 
| Bias in Predictive performance of seven pharmacokinetic models | The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected | September 2021 |
Development of Molecular Diagnostic Platform for Tuberculosis

Study Overview
=================
Brief Summary
-----------------
This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

Official Title
-----------------
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: New technique vs Xpert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy Exclusion Criteria: Under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New technique group<br> | Diagnostic Test: New technique vs Xpert<br>* New technique vs Xpert<br>|
| Sham Comparator: Xpert group<br> | Diagnostic Test: New technique vs Xpert<br>* New technique vs Xpert<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of new diagnostic technique | sensitivity and specificity of new test | Time Frame: An average of 2 year |
Echocardiography Findings and Perioperative Outcomes in Children

Study Overview
=================
Brief Summary
-----------------
This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing surgery for congenital cardiac disease. Echocardiographic findings include the doppler patterns of hepatic vein, portal vein, renal artery, renal vein and splenic vein before and after cardiopulmonary bypass. Portal pulsatility index, renal resistive index, and respiratory variations in peak aortic blood flow velocity and diameter of inferior vena cava are measured.

Official Title
-----------------
Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study

Conditions
-----------------
Congenital Cardiac Defect

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients undergoing cardiac surgery Exclusion Criteria: Applying extracorporeal membrane oxygenator prior to surgery Trouble applying echocardiography

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with congenital cardiac disease<br>Children with congenital cardiac disease who undergoing surgery | Diagnostic Test: Echocardiography<br>* Echocardiographic examination before and after cardiopulmonary bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of Doppler values and its derived parameters of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography in children with congenital cardiac disease | To find the characteristics and standard values of Doppler findings measured by echocardiography before and after congenital cardiac surgery | after anesthetic induction until the end of surgery | 
| Association between Doppler values measured by echocardiography and clinical outcomes after pediatric cardiac surgery | To evaluate whether Doppler values of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography can predict major adverse outcomes after pediatric cardiac surgery | through study completion, an average 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major adverse outcomes after pediatric cardiac surgery |  | through study completion, an average 1-2 years |
Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.

Official Title
-----------------
Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

Conditions
-----------------
Pancreatitis, Acute, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Insulin
* Device: Aphesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged 18 to 80 years old; abdominal pain consistent with AP; serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit; abdominal imaging consistent with AP imaging changes. severe hyperlipidemia fasting serum TG> 1,000 mg/dL (11.2mmol/L); except for other AP causes, such as cholelithiasis, alcohol, drugs and so on. Exclusion Criteria: other etiologies other than hyperlipidemia leading to AP; fasting serum TG less than 1,000 mg / dL (11.2mmol / L); acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis. the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia. without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Insulin<br> | Drug: Insulin<br>* Insulin infusion for subjects in Group Insulin.<br>|
| Experimental: Group Aphesis<br> | Device: Aphesis<br>* Aphesis for subjects in Group Aphesis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum TG | Elimination of serum triglyceride. | every 4 hours in first 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment
Effects of Labetalol on Nicotine Administration in Humans - 14

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine

Detailed Description
-----------------
The purpose of this study is to determine whether labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine in humans. A total of 12 subjects will participate in the double blind placebo controlled, outpatient study. Subjects will have 3 separate experimental sessions 3-9 days apart. On each of the experimental sessions, a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered. Two hours after labetalol or placebo treatment, subjects will receive 15 variance grams nicotine base/kg intravenously. Several physiological endocrine and subjective measures will be obtained during the sessions. We propose that blockage of adrenergic receptors by labetalol will significantly block the physological and subjective effects of nicotine.

Official Title
-----------------
Effects of Labetalol on Nicotine Administration in Humans

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Labetalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Exclusion Criteria: History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Labetalol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective |  |  | 
| Physiologic measures |  |  |