linjc16/ctgov huggingface dataset:
Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients

Study Overview
=================
Brief Summary
-----------------
In this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. The aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. Expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.

Official Title
-----------------
Toxicological Analyses of Blood and Urine Samples in Pain Patients and Pre-surgical Control Patients to Investigate Incidences of Concealed and Feigned Substances

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: provided informed consent current pain Exclusion Criteria: no taking of blood sample possible no consent with toxicological analyzes insufficient comprehension of the German language

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pain patients<br>patients from a specific pain management department, patients with long duration of pain, mostly insufficiently treated pain | |
| pre-surgical patients<br>patients from a surgical outpatient department with current pain | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication compliance, adherence, toxicological analyzes, GC-MS, HPLC, pain patients, opioid misuse, patients with current pain
The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.

Official Title
-----------------
The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Drug: Lasofoxifene
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women over 50 years who have low bone mineral density. Exclusion Criteria: Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasofoxifene 0.25 mg/d<br> | Drug: Lasofoxifene<br>* Oral tablet, 0.25 mg, daily, 2 years<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Matching placebo tablet given once daily for 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density of the lumbar spine. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes are the levels of cells and proteins in the blood that provide information about the health of bone, along with change in bone mineral density of the hip and forearm. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, lasofoxifene, bone density, bone markers
Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?

Study Overview
=================
Brief Summary
-----------------
For victims of high velocity RTC, with no other Vittel criteria of gravity, normal clinical examination of the thorax, abdomen and pelvis and Glasgow Coma Scale (GCS) score of 15 : Study of clinically unsuspected injuries discovered on WBCT Description Predictive factors Diagnostic performances of kinetic elements of Vittel criteria, and results of examinations realised at the ED.

Official Title
-----------------
Is There a Benefit of Whole Body Computed Tomography (WBCT) for Patients With Only High Velocity Road Traffic Collision (RTC) Vittel Criteria?

Conditions
-----------------
High Velocity Transport Accidents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutives patients consulting the emergency department between August 1st 2016 and July 31th 2017 : Older than 18 y.o. WBCT performed, Victim of a high velocity RTC as defined by the presence of at least one criteria of the kinetics elements of the Vittel Criteria Normal physical exam of the chest, abdomen and pelvis, GCS score of 15 Exclusion Criteria: Opposition of the patient to the use of their CT-scan for research Patients who are under legal protection Patients who are incarcerated

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 |
| --- | --- | --- |
| Number of injuries diagnosed by Whole Body Computed Tomography (WBCT) that were not clinically suspected. | Number of injuries diagnosed by WBCT that were not clinically suspected. Classification in 3 categories according to their management : Potentially severe, that involve modification of patients management Injuries that could require further investigation according to the symptoms Minor injuries that require no further investigation or specific management | The day of inclusion |
Photoallergy Potential of Dapsone Gel in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: dapsone gel
* Drug: dapsone gel vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Healthy adults. Exclusion Criteria: Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application Sensitivity to adhesive bandages or tape.

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches twice a week for 21 days followed by a 10 to 17 day rest period then another application of dapsone gel and dapsone gel vehicle by patch. | Drug: dapsone gel<br>* Patches containing dapsone gel will be applied to the skin.<br>Drug: dapsone gel vehicle<br>* Patches containing dapsone gel vehicle will be applied to the skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoallergic (Sensitizing) Potential Using a Visual Scale |  | Week 6 |
Injectable Bulking Agent Needle Guide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.

Official Title
-----------------
Injectable Bulking Agent Needle Guide

Conditions
-----------------
Urinary Incontinence, Intrinsic Sphincter Deficiency

Intervention / Treatment
-----------------
* Device: Needle Guided Periurethral Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Individuals satisfying the Indications and Contraindications criteria in the Durasphere EXP Directions for Use may participate.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection with Needle Guide<br> | Device: Needle Guided Periurethral Injection<br>* Bulking Agent injection using a needle guide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the consistency of the location of the injection site and resulting location of bulking effect |  | at procedure | 
| Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique. |  | at procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Incontinence, ISD
Remdesivir Efficacy in Coronavirus Disease

Study Overview
=================
Brief Summary
-----------------
COVID 19 treatment using Remedesvir.

Detailed Description
-----------------
COVID 19 treatment using Remedesvir. Is this drug effective?

Official Title
-----------------
Remdesivir in COVID-19 Treatment: A Randomised Trial

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Remdesivir
* Other: Standard of care treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID 19 patients Exclusion Criteria: allergy or contraindication to the drug
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: Remdesivir<br>Remdesivir with standard of care treatment standard of care treatment | Drug: Remdesivir<br>* Remdesivir as antiviral drug<br>Other: Standard of care treatment<br>* Standard of care treatment<br>|
| Placebo Comparator: Standard of care<br>Standard of care treatment alone. | Other: Standard of care treatment<br>* Standard of care treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement or mortality | the estimated number of patients with improvement or mortality | 6 months |
Major Allergen in Wheat Anaphylaxis in Thai Population

Study Overview
=================
Brief Summary
-----------------
To study Major allergen in Wheat anaphylaxis in Thai population To study and compare demographic data between group of wheat anaphylaxis

Detailed Description
-----------------
Wheat is one of the most common causes in food-induced anaphylaxis and food dependent, exercised induced anaphylaxis. Gold standard for diagnose food allergy is double blind placebo control food challenge, but it is a high risk procedure. The accuracy of skin prick test and specific IgE assay showed unsatisfactory results. It might be explained by these tests may not detect all of the major allergens in wheat allergic patients. Previous studies showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5 gliadin, followed by high molecular weight glutenin. For IgE-mediated wheat allergy, the major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma gliadin, and the water-soluble part of wheat allergens. There is no study to direct compare the major allergen between patients who have low wheat specific IgE and very high wheat specific IgE. Also, there is no data about the major allergens of wheat anaphylaxis in Thai population.

Official Title
-----------------
Major Allergen in Wheat Anaphylaxis in Thai Population

Conditions
-----------------
Wheat Allergy, Anaphylaxis Food, Anaphylaxis Exercise

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of Pediatrics and Medicine, Siriraj Hospital from 2001 to 2016 Exclusion Criteria: Loss follow up No consent form Celiac disease, Autoimmune disease was diagnosed

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: specific IgE<br>Different level of specific IgE and immunoblot | Diagnostic Test: immunoblot<br>* immunoblot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major allergen sensitized by Thai Patients with Wheat anaphylaxis | To Identify major allergen (most component of protein that cause wheat allergy) between wheat anaphylaxis (low Specific IgE and high Specific IgE) and wheat dependent, exercise induced anaphylaxis by using immunoblot method (Electrophoresis). The results will be shown in electrophoresis gel and can identify in molecular weight (KDa) of protein which represent to major allergen of wheat protein. | 1 hour |
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.

Detailed Description
-----------------
Patient-reported outcomes (PRO's) are important to assess treatment progress in the field of pelvic floor disorders (PFDs), including urinary incontinence, pelvic organ prolapse, and fecal incontinence. The NIH has invested in the Patient-Reported Outcomes Measurement System (PROMIS) to revolutionize PRO measures. To date, PROMIS instruments and feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology has not been well explored in women with PFDs and warrant further investigation. In recruiting sixty women, the investigators will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration. The investigators will recruit 60 women with UI to participate in this study. Participants will be asked to complete both paper and CAT versions of PROMIS questionnaires covering the physical, social and mental health domains (Appendix 1). The time it takes to complete each version will be recorded. After completing the questionnaires, all participants will be interviewed, which will include a brief Usability and Satisfaction Questionnaire(Appendix 2), questions about technical problems, preferences, and the acceptability of each mode.

Official Title
-----------------
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Able to read English Diagnosis of urinary incontinence Age 18 or older Exclusion Criteria: Unable to read English or cognitive limitations making it difficult for study participants to complete PROMIS questionnaires

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

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

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 |
| --- | --- | --- |
| Primary Outcome Measure | To test the feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology in women with Urinary incontinence. In recruiting sixty women, we will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence
Study of A3309 in Patients With Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).

Official Title
-----------------
A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia

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

Intervention / Treatment
-----------------
* Drug: A3309
* Drug: A3309
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings Exclusion Criteria: Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A3309 low dose<br> | Drug: A3309<br>* A3309 in two different dosage levels<br>Drug: A3309<br>* A3309 in two different dosage levels for the duration of the study<br>|
| Experimental: A3309 high dose<br> | Drug: A3309<br>* A3309 in two different dosage levels<br>Drug: A3309<br>* A3309 in two different dosage levels for the duration of the study<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo comparator once daily for the duration of the trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low-density lipoprotein (LDL) cholesterol |  | eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyslipidemia, cholesterol, LDL
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

Official Title
-----------------
Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

Conditions
-----------------
Acquired Bleeding Disorder, Intracerebral Haemorrhage

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: Patients with secondary ICH Pre-existing disability Haemophilia

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

| Intervention/Treatment |
| --- |
|Drug: eptacog alfa (activated)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing disability and improving clinical outcome |  | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing mortality |  |  | 
| Reducing hematoma growth |  |  |
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate differences in risk prediction in female post-infarction patients.

Official Title
-----------------
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction; female gender Exclusion Criteria: -

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, risk, autonomic nervous system, Gender