linjc16/ctgov huggingface dataset:
Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the reliability of computed tomography angiography (CTA) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

Detailed Description
-----------------
Critically ill patients, presenting Glasgow Coma Score 5 or lower, will be submitted to the Computed Tomography Angiography (CTA) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial Doppler would be applied as the gold standard for brain death. We will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the CTA.

Official Title
-----------------
Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Conditions
-----------------
Brain Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals of any age or sex with brain death suspicion raised, before clinical test. Comatose patients presenting Glasgow Coma Score as or under 5 points, under sedative agents or not. Exclusion Criteria: Brain dead patients clinically confirmed. Contraindications to the use of contrast medium (renal failure or allergy).
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 |
| --- | --- | --- |
| Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients. | After excluding confounding factors, we will submit comatose patients to CTA. Immediately after the exam, we will perform clinical evaluation for brain death and calculate CTA sensibility and specificity for this diagnosis. Time between these two interventions will be measured. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Death, Neurological Death, Cerebral circulatory arrest, Computed Tomography Angiography
Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.

Official Title
-----------------
A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of DT-216 in Adult Patients With Friedreich Ataxia

Conditions
-----------------
Friedreich Ataxia

Intervention / Treatment
-----------------
* Drug: DT-216
* Drug: DT-216 matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions Body mass index (BMI) between 17 and 32 kg/m2 Stage 5.5 or less on the Functional Staging for Ataxia (FSA) Exclusion Criteria: Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study Has clinically significant abnormal laboratory results Has significant cardiac disease Received an investigational drug within 3 months of screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose: DT-216<br>DT-216 will be administered once | Drug: DT-216<br>* DT-216 will be administered by intravenous (IV) injection<br>|
| Experimental: Single Dose: DT-216 matching placebo<br>Placebo will be administered once | Drug: DT-216 matching Placebo<br>* Placebo will be administered by intravenous (IV) injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment adverse events (TEAEs) | Frequency of treatment emergent adverse events (TEAEs) | Up to approximately 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of DT-216 | Maximum Plasma Concentration (Cmax) of DT-216 | Up to approximately 30 days | 
| Time to Maximum Plasma Concentration (Tmax) of DT-216 | Time to Maximum Plasma Concentration (Tmax) of DT-216 | Up to approximately 30 days | 
| Area Under the Concentration-time Curve (AUC) of DT-216 | Area Under the Concentration-time Curve (AUC) of DT-216 | Up to approximately 30 days |
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).

Detailed Description
-----------------
Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

Official Title
-----------------
A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures

Conditions
-----------------
Uterine Fibroids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months. HCPs have provided permission to share their responses in aggregate to Health Canada. Exclusion Criteria: HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study. HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of HCPs with correct responses to the knowledge level questions. | Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs. | 18 - 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure . | HCP's recall of receiving and reading the HCP Letter and HCP Brochure . | 18 - 24 months | 
| Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card | HCP's recall of distributing the Fibristal Patient Alert Card | 18 - 24 months | 
| Percentage of patients who recall counselling patients on information included in the Patient Alert Card | HCP's recall of counselling patients on information included in the Patient Alert Card | 18 - 24 months | 
| Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions | Composite score on the level of HCPs knowledge across all knowledge-related questions. | 18 - 24 months |
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Detailed Description
-----------------
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects 21-90 years of age subjects has urinary incontinence on 3 day bladder diary subject has severe incontinence urine dipstick or urine culture negative for urinary tract infection cystometrogram without stress urinary leakage must have failed at least one anti-cholinergic medication negative urine pregnancy test on day of administration of study medication Exclusion Criteria: history of carcinoma of the bladder presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance gross fecal incontinence known allergy to sulfa or ciprofloxacin or to lidocaine any medical condition that may put the subject at increased risk with exposure to Botox females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential known allergy to any of the components in the study medication prior documented resistance to Botox evidence of recent alcohol or drug abuse concurrent participation in another investigational drug or device study within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Injected<br>|
| Experimental: 2<br>Botox | Drug: Botox<br>* Injected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinent Episodes Per Day | The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point. | week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Incontinence Pads Used Per Day | The number of incontinence pads used per day per day was recorded by each participant in a diary. | week 13 |
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy

Study Overview
=================
Brief Summary
-----------------
It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.

Official Title
-----------------
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy

Conditions
-----------------
Recurrence

Intervention / Treatment
-----------------
* Drug: Steroid Drug
* Drug: No steroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urethral stricture with restricted urine flow of < 15 ml/min on uroflowmetry Exclusion Criteria: Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record), Patients with post-TURP strictures Patients with neurogenic bladder Patients with prior history of steroid use Patients with extravasation during optical internal urethrotomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Steroid<br>In this group oral steroids were given after Direct vision internal urethrotomy | Drug: Steroid Drug<br>* In this group Oral steroid medication after Direct Vision Internal Urethrotomy<br>* Other names: Oral steroid medication;|
| Placebo Comparator: No Oral Steroids<br>In this group no oral steroids were given after Direct vision internal urethrotomy | Drug: No steroid<br>* In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy<br>* Other names: Placebo Medication;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Urethral Stricture | Number of patients presenting with recurrence of urethral stricture after direct vision internal urethrotomy | 6 months post-operatively |
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

Detailed Description
-----------------
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated. Then, Phase II study started.

Official Title
-----------------
A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: combination of TLC D-99 and Ifosfamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy Age >/=18 yrs PS </=2 Disease detectable almost for 1 dimension Life expectancy >/=3 mos Minimum 4 wks from last radiotherapy Adequate medullary, liver, and renal functions Normal LVEF Written Informed Consent Exclusion Criteria: Pregnant or breast-feeding patients Serious concomitant disease or not controlled infections

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: combination of TLC D-99 and Ifosfamide|TLC D-99: 40 mg/m2 Day 1 every 3 weeks; Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide |  | Definition of TDL | 
| Phase II: Response rate (CR/PR or SD) |  | Tumor assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II: time to progression, duration of response, overall survival |  | Tumor assessment, follow-up |
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling

Study Overview
=================
Brief Summary
-----------------
The first year purpose: The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Detailed Description
-----------------
Our previous work is investigating the viral (Adv-BMP-2) administration for the development of a model to generate bones for possible use in clinical settings; the non-viral and viral administrations will be compared for best osteogenesis effects. The first year purpose: The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Official Title
-----------------
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling/Hydroxyapatite Nanoparticles--Comparisons Between Non-viral and Viral Administration in Tissue Engineered Bone Regeneration

Conditions
-----------------
Primary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 10 years old The patients require surgery ner iliac or abdomen areas Exclusion Criteria: age below 10 years old

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling/Hydroxyapatite Nanoparticles--Comparisons between Non-viral and Viral administration in Tissue Engineered Bone Regeneration | August 2011-July 2013 | 2 years |
Effect of Exenatide on Cortisol Secretion

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.

Detailed Description
-----------------
Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist. The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals. The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.

Official Title
-----------------
Effect of Exenatide on Cortisol Secretion

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

Intervention / Treatment
-----------------
* Drug: Exenatide Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 years Body weight >65 kg Exclusion Criteria: Presence of chronic illness daily use of any medicines pregnancy, lactation use of oral contraceptives during previous 2 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single-group, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>Single injection of 10 μg Exenatide subcutaneously. | Drug: Exenatide Injection<br>* Single injection of Exenatide 10μg subcutaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol peak | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenocorticotropin (ACTH) peak | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection | 
| Glucose | Glucose values' area under the curve | Glucose measured every 30 minutes during 2 hours after injection | 
| Growth hormone | Maximum concentration achieved after exenatide dose (any timepoint after injection) | every 30 minutes during 2 hours after injection |
Catechin Gargling for Influenza Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

Detailed Description
-----------------
In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.

Official Title
-----------------
A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection

Conditions
-----------------
Influenza Infection

Intervention / Treatment
-----------------
* Drug: catechin extracts (health food)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers aged 20 to 65 years old obtained written informed concent before participation inoculated with influenza vaccine before entering the study Exclusion Criteria: other gargling except water during the study possessing tea allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: catechin extracts (health food)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of influenza infection during the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of symptoms including complications and hospitalization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catechins, gargling, healthy volunteers