linjc16/ctgov huggingface dataset:
Effect of V0251 in Acute Vertigo

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

Conditions
-----------------
Acute Vertigo

Intervention / Treatment
-----------------
* Drug: V0251
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women Age 18 to 70 years Acute vertigo attack due to vestibular disorder Exclusion Criteria: Signs of brain, brainstem and/or cerebellar dysfunction Concomitant central neurological disorder Psychogenic vertigo Use of ototoxic drugs causing vertigo or dizziness within the last month Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V0251<br> | Drug: V0251<br>* single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo Symptoms Score (VSS) rated by patient using VAS |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant and Vegetative Symptoms Score (CVSS) rated by patients using VAS |  | 30 min, 2 hours and 4 hours post dose | 
| Number of patients with Adverse Events as a measure of safety and tolerability |  | 30 min, 2 hours and 4 hours post dose |
GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Study Overview
=================
Brief Summary
-----------------
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.

Official Title
-----------------
A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Conditions
-----------------
Cheek Augmentation

Intervention / Treatment
-----------------
* Device: GAL1704
* Device: Juvederm Voluma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface. Exclusion Criteria: - Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAL1704 (needle)<br>Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies. | Device: GAL1704<br>* new dermal filler<br>|
| Experimental: GAL1704 (cannula/needle)<br>GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle. | Device: GAL1704<br>* new dermal filler<br>|
| Active Comparator: Juvederm Voluma<br>Subjects randomized to control. | Device: Juvederm Voluma<br>* hyaluronic acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) | Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full. | 12 weeks |
Cognitive Stimulation in Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.

Official Title
-----------------
Cognitive Training in Adolescents During Treatment for Substance Use Disorders

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Computerized tasks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 14-21 Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse eligible for intensive outpatient treatment Exclusion Criteria: Untreated psychiatric disorder that might make participation hazardous Any condition associated with severe cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: computerized tasks- adaptive<br> | Behavioral: Computerized tasks<br>* The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.<br>|
| Active Comparator: computerized tasks - nonadaptive<br> | Behavioral: Computerized tasks<br>* The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| working memory (change from baseline) |  | expected within 2 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timeline follow back (change from baseline) |  | expected within 2 weeks after intervention | 
| delay discounting (change from baseline) |  | expected within 2 weeks after intervention | 
| Stroop (change from baseline) |  | expected within 2 weeks after intervention | 
| reading comprehension (change from baseline) |  | expected within 2 weeks after intervention | 
| emotion regulation (change from baseline) |  | expected within 2 weeks after intervention | 
| Go-No Go (change from baseline) |  | expected within 2 weeks after intervention | 
| Global Appraisal of Individual Needs (change from baseline) |  | expected within 2 weeks after intervention |
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.

Official Title
-----------------
A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: pramlintide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has completed the full dosing period in Protocol 137-150.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pramlintide Acetate<br>Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL. | Drug: pramlintide acetate<br>* Syringe vial and Pen-cartridge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150. |  | participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available | 
| To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight |  | participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150. |  | participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symlin, Diabetes, Amylin, pramlintide
Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube

Study Overview
=================
Brief Summary
-----------------
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.

Detailed Description
-----------------
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.

Official Title
-----------------
Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery

Conditions
-----------------
Endotracheal Intubation, Airway Management, One Lung Ventilation

Intervention / Treatment
-----------------
* Device: Standard double lumen tube
* Device: VivaSight double lumen tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing video assisted thoracoscopic lung lobectomy Exclusion Criteria: anticipated difficult intubation, patients who required rapid sequence induction patients with known tracheal pathology

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard double lumen tube<br>Intervention: Standard double lumen tube | Device: Standard double lumen tube<br>* Endotracheal left side double lumen tube<br>|
| Experimental: VivaSight double lumen tube<br>Intervention: VivaSight double lumen tube | Device: VivaSight double lumen tube<br>* VivaSight double lumen endotracheal intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for endotracheal intubation with visual confirmation of double lumen tube position position. |  | During induction of general anesthesia |
Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

Study Overview
=================
Brief Summary
-----------------
Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

Official Title
-----------------
Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Nexfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing elective cesarean delivery performed under spinal anesthesia Exclusion Criteria: patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb

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

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

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: Measurement of arterial pressure<br> | Device: Nexfin<br> <br> * Other names: Continuous measurement of arterial pressure using Nexfin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between Nexfin and intermittent measurements of blood pressure | Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve between both measurements | Analysis concerns data from intrathecal injection to childbirth | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Cesarean delivery
Understanding Allergies and Sensitizations in Healthy and Allergic Individuals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to strengthen our ability to accurately diagnose allergies and understand cellular, humoral, genetic components and physiological changes in allergic disease

Official Title
-----------------
Understanding Allergies

Conditions
-----------------
Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual with possible allergy Exclusion Criteria: Patients with special risks attendant to venipuncture will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 90 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 |
| --- | --- | --- |
| Skin testing to evaluate food allergen responses | Standardized skin testing performed to detect sensitivity to allergens of interest | 1 year |
Rehabilitation After Covid19-Clinical Results and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups: SARS-CoV-2-positive patients in the isolation ward Post-Covid-19 patients Control group; matched for gender, age and co-morbidity

Official Title
-----------------
Rehabilitation After Covid19-Clinical Results and Predictive Factors for Rehabilitation Outcomes

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients assigned to rehab Written informed consent Exclusion Criteria: not able to fill in questionnaires in German

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 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 |
| --- | --- |
| Isolation group with active Covid19<br>Patients assigned to rehab which had to be treated in isolation wards dur to active disease | Other: Rehabilitation<br>* Rehabilitative procedures in isolation ward<br>|
| Post-Covid-group<br>Patients assigned to rehab after active disease, still having restrictions in activity and particiaption | Other: Rehabilitation<br>* Rehabilitative procedures in isolation ward<br>|
| Control group<br>Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection | Other: Rehabilitation<br>* Rehabilitative procedures in isolation ward<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility | Timed Up and Go-Test TUG (Seconds; less=better, normal <10 Sec.) | Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks) | 
| Functional Independence Measurement-Level (FIM) | FIM at entry and discharge (min 18, max 126 points; higher level= better functioning; ) | Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks) | 
| Promis-10 (Promis= Patient reported outcome measurement information system) | Level of patient self rated functioning in daily activities (higher level= better self related functioning) | Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks) | 
| Quality of life | EQ5D- VAS (0-100; higher level = better quality of life) | Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Sars-CoV-2, Rehabilitation, Outcome, Predictive factors
Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

Study Overview
=================
Brief Summary
-----------------
The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2020 in under 50 year old patients.

Detailed Description
-----------------
The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency, MACE (secondary outcomes) after aortic valve replacement in under 50 year olds. We aim to compare those outcomes between mechanical valves and bioprostheses. Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2020.

Official Title
-----------------
Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: Aortic Valve Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated surgical aortic valve replacement in Austria Exclusion Criteria: below 18 years of age above 50 years of age concomitant heart surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Aortic valve replacement with mechanical valves<br> | Device: Aortic Valve Replacement<br>* Surgical replacement of aortic valves<br>|
| Aortic valve replacement with bioprostheses<br> | Device: Aortic Valve Replacement<br>* Surgical replacement of aortic valves<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | all cause mortality after aortic valve replacement | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reoperation | incidence of reoperation after aortic valve replacement | 10 years | 
| stroke | incidence of stroke after aortic valve replacement | 10 years | 
| heart attack | incidence of heart attack after aortic valve replacement | 10 years | 
| heart insufficiency | incidence of heart insufficiency after aortic valve replacement | 10 years | 
| MACE | incidence of MACE after aortic valve replacement | 10 years |