linjc16/ctgov huggingface dataset:
Wear-documentation and Orthodontic Appliance Compliance

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial aims to evaluate whether thermosensory wear-time documentation improves patient compliance of removable orthodontic appliances treated in a public health care clinic. The patients are children and adolescents.

Official Title
-----------------
Effect of Thermosensory Wear-documentation on Removable Orthodontic Appliance Compliance

Conditions
-----------------
Orthodontic Appliance Complication

Intervention / Treatment
-----------------
* Device: Wear-documentation microchip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orthodontic treatment with removable appliances planned Exclusion Criteria: non-compliance to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wear-documentation<br>Theramon | Device: Wear-documentation microchip<br>* Microchip embedded in the appliance<br>|
| No Intervention: controls<br>No microchip | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-time | months | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | qualitative self-evaluation | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthodontics
Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

Detailed Description
-----------------
Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded. Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation: Ringer-acetate solution 6% HES solution (Tetraspan®) During the 1 postoperative day we register hemodynamic changes, fluid balance, fluid extravasation, plasma ion concentration, modified thromboelastography, and kidney function.

Official Title
-----------------
Effect of Prime Solution on Fluid Balance After Open Heart Surgery

Conditions
-----------------
Valve Surgery, Coronary Artery Bypass Grafting

Intervention / Treatment
-----------------
* Drug: HES
* Drug: Ringer lactate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective combined cardiac surgery Exclusion Criteria: Liver failure Kidney failure

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ringer lactate<br>Crystalloid solution | Drug: Ringer lactate<br> <br> |
| Experimental: HES solution (Tetraspan®)<br>Balanced colloid solution | Drug: HES<br>* 20ml/kg as prime fluid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid balance |  | 1 postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aorta valve, mitral valve, coronary artery bypass grafting surgery, perfusion, priming
Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized open-label pilot study to investigate the effect of mycophenolate mofetil treatment in patients with abnormal urine protein excretion due to membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS). The change in urine protein excretion will be the primary outcome studied. The treatment regimen comprising prednisolone and mycophenolate mofetil will be compared with prednisolone and chlorambucil in MN, and compared with prednisolone in FSGS. The study duration will be 12 months for each patient.

Official Title
-----------------
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)

Conditions
-----------------
Glomerulonephritis, Membranous, Glomerulosclerosis, Focal

Intervention / Treatment
-----------------
* Drug: prednisolone and mycophenolate mofetil
* Drug: prednisolone and chlorambucil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal urine protein excretion and biopsy-proven idiopathic membranous nephropathy or focal segmental glomerulosclerosis

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

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

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

| Intervention/Treatment |
| --- |
|Drug: prednisolone and mycophenolate mofetil|nan|
|Drug: prednisolone and chlorambucil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteinuria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic membranous nephropathy or focal segmental glomerulosclerosis
Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Study Overview
=================
Brief Summary
-----------------
Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

Conditions
-----------------
Gastroduodenal Erosions

Intervention / Treatment
-----------------
* Drug: OXP005
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subject Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) H. pylori negative Exclusion Criteria: Clinically significant abnormal laboratory parameters Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXP005<br>1g naproxen | Drug: OXP005<br> <br> |
| Active Comparator: naproxen<br>1g naproxen | Drug: Naproxen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of GD irritation in the stomach and duodenum as measured by the Lanza score |  | Day 8 | 
| Total number of GD erosions overall |  | Day 8 |
A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The overall primary objective of this study is to test the hypothesis that, compared with placebo,administration of atomoxetine will result in an improved work productivity.

Official Title
-----------------
A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Atomoxetine Hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder (ADHD). Have a CGI-S-ADHD score of 4 (moderate symptoms) or greater at Visit 1 and Visit 2. Adult Men or Women, 18 years of age or older and not more than 50 years of age at Visit 1. Laboratory results must show no clinically significant abnormalities. Paid employees working 20 hours or more per week and who have been paid in their current place of employment for 6 months or more. Exclusion Criteria: Meet diagnostic criteria for current major depression, a current anxiety disorder and history of bipolar disorder or any history of a psychotic disorder will be excluded from the study. Are pregnant or are breastfeeding. Have organic brain disease. Have a history of any seizure disorder or patients who have taken or are currently taking anticonvulsants for seizure control. Are taking any psychotropic medication on a regular basis that has central nervous system activity. Must have a washout equal to a minimum of 5 half-lives of that medication prior to Visit 2. Are unstable in any way to participate in this study, in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine Hydrochloride|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the hypothesis that, compared with placebo, administration of atomoxetine for approximately 6 months will result in an improved work productivity,as measured on the Endicott Work Productivity Scale (EWPS) during Study Period II. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of atomoxetine in treating core symptoms in adults during Study Period II using the Conners'Adult Attention Deficit/Hyperactivity Disorder Rating Scale-Investigator rated. |  |  |
Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients

Study Overview
=================
Brief Summary
-----------------
A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis.

Detailed Description
-----------------
A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis. The study was conducted at Mansoura Fever Hospital in collaboration with the Chest Department and Clinical Pathology Department, Mansoura University, Egypt, from January 2015 to October 2016. Ethical approval had been obtained from Medical Research Ethics Committee of Faculty of Medicine, Mansoura University (code no: MD/138). Approval from Egyptian Ministry of Health was taken (No: 1-2016/18). Patients signed their written consents after detailed explanation of the study protocol.

Official Title
-----------------
Role of Detection of Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients; Egyptian Experience

Conditions
-----------------
TB - Tuberculosis HIV

Intervention / Treatment
-----------------
* Diagnostic Test: Urinary LAM ELISA:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study included seropositive HIV patients with a new diagnosis of either pulmonary or extra-pulmonary TB, and also included patients who were presented by symptoms suggestive for tuberculosis, changes in chest X ray that not improved by full course of antibiotics or positive tuberculin test ≥ 5 mm. Exclusion Criteria: Patients on anti-TB drugs or negative screening for sero-positive HIV patients were excluded from the study.

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TB group<br> | Diagnostic Test: Urinary LAM ELISA:<br> <br> |
| Placebo Comparator: Non TB group<br> | Diagnostic Test: Urinary LAM ELISA:<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive for TB | Concentration of urinary LAM was done in seropositive HIV patients | day 1 |
Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe

Study Overview
=================
Brief Summary
-----------------
The evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. The scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use. Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions questionnaire ( EQ-5D) were widely validated in various populations, of which the population of the diabetics patients. Both scales have validated versions in French. In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. One of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations. Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and Reunion Island, adapting and validating these scales according to an identical procedure in Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French versions of these scales in their populations of type II diabetics patients.

Official Title
-----------------
Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female ≥ 18 years of age type II diabetes diagnosed more than 1 year ago creole speaking living on the island for more than 5 years agreed and signed the informed consent form Exclusion Criteria: not able to understand and follow the instructions patients with proven cognitive issues which do not make possible to complete questionnaire patients with current acute and serious complications associated with diabetes medical history of stroke with physical or neurological damage patients already involved in the study

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal Consistency (IC) assessed as Cronbach's Alpha Value |  | 1 day (inclusion day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest Reliability |  | 3-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Validation of questionnaire, Quality of life
Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

Study Overview
=================
Brief Summary
-----------------
This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients

Official Title
-----------------
Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial

Conditions
-----------------
Tuberculosis, Pulmonary

Intervention / Treatment
-----------------
* Drug: Bupropion
* Behavioral: Behavioural Change Communication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pulmonary tuberculosis patients of age 18 years or above registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes Exclusion Criteria: Extra pulmonary tuberculosis drug resistant tuberculosis pregnancy positive history of epilepsy

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of three groups, two intervention and one control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion<br> | Drug: Bupropion<br>* This group received Bupropion 150 mg twice daily for 10 weeks<br>Behavioral: Behavioural Change Communication<br>* This group will receive Behavioural Change Communication<br>|
| Experimental: Behavioural Change Communication<br> | Behavioral: Behavioural Change Communication<br>* This group will receive Behavioural Change Communication<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients completing anti-tuberculosis treatment | Among both smear positive and smear negative TB patients, successful completion of ATT will be labeled at the end of 6 months period if the patients has been compliant with ATT through six months period.. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving abstinence from smoking | Abstinence is defined as staying away from smoking and it will be assessed at week 1, week 4, week 12 and week 24 will be assessed in following two ways: i. Self-reported abstinence using questionnaire ii. Expired carbon monoxide (eCO) levels using Micro Smokerlyzer (Bedfont Scientific) of less than 7 ppm. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation
Predictors of Early Chest Infection in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory of middle cerebral artery, insular infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related chest infection. The present study (PRECAST) aims to identify a small set out of these previously described risk factors that can predict stroke-related pneumonia with high sensitivity and specificity.

Official Title
-----------------
Predictors of Early Chest Infection in Acute Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke, Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ischemic stroke admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset clearly assessed brain lesion location Exclusion Criteria: previous large (non-lacunar) stroke chest infection present already on hospital admission mechanical ventilation already on day 1 or 2 after hospital admission treatment with immunosuppressive drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Acute ischemic stroke patients<br>Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset in whom ischemic brain lesion was clearly assessed on CT and/or MRI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of chest infection within 7 days after stroke |  | days 1-7 after stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute stroke, ischemic stroke, pneumonia, chest infection, brain lesion, lesion topology, dysphagia, sympathetic activation, immunosuppression