linjc16/ctgov huggingface dataset:
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Detailed Description
-----------------
Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

Official Title
-----------------
Potential Interactions Between IV Cocaine and RPR 102681

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Cocaine-Related Disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Includes but is not limited to: Non-treatment seekers DSM-IV criteria for cocaine abuse or dependence Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements Exclusion Criteria: Please contact site for more information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cocaine-Related Disorders|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic response to cocaine and subjective response to cocaine |  | 3x / 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Syphilis Video Tool to Promote Knowledge and Testing in the ED

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether the Syphilis and Men educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.

Detailed Description
-----------------
A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.

Official Title
-----------------
Video Tool to Promote Syphilis Knowledge and Testing in the Emergency Department

Conditions
-----------------
Syphilis

Intervention / Treatment
-----------------
* Other: 'educational video'


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-55 years of age were eligible only if they spoke English or Spanish. Exclusion Criteria: Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pre test survey, educational video, post test survey | Other: 'educational video'<br>* 'educational video'<br>|
| No Intervention: 2<br>no intervention | |
| Experimental: 3<br>educational video and post test survey | Other: 'educational video'<br>* 'educational video'<br>|
| No Intervention: 4<br>post test survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video. |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome was the decision to be tested for syphilis. |  | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
syphilis, educational video, knowledge, black, Hispanic
COVID Screening Strategies in Homeless Shelters

Study Overview
=================
Brief Summary
-----------------
Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.

Official Title
-----------------
COVID Screening Strategies in Homeless Shelters

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 Able to provide oral consent Able to perform a self-collected swab if in the relevant intervention arm Exclusion Criteria: -

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized multi-center trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Daily active screening only<br> | Diagnostic Test: COVID-19 Swab<br>* Nasal, Oral-Nasal combined or Nasopharyngeal swab<br>|
| Experimental: Daily active screening and self-collected nasal swab<br> | Diagnostic Test: COVID-19 Swab<br>* Nasal, Oral-Nasal combined or Nasopharyngeal swab<br>|
| Experimental: Daily active screening and self-collected oral-nasal swab<br> | Diagnostic Test: COVID-19 Swab<br>* Nasal, Oral-Nasal combined or Nasopharyngeal swab<br>|
| Experimental: Daily active screening and nurse collected nasopharyngeal swab<br> | Diagnostic Test: COVID-19 Swab<br>* Nasal, Oral-Nasal combined or Nasopharyngeal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Detection Rate |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of outbreaks |  | 8 weeks | 
| Enrollment over time |  | 8 weeks |
The Impact of Colorectal Cancer Surgery on Localization of Ureters; Prospective Clinical Trail

Study Overview
=================
Brief Summary
-----------------
To investigate the changes in the anatomical location of ureters after colorectal surgery.

Conditions
-----------------
The Relocation of the Ureter After Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old Curative surgery for colorectal cancer diagnosis Exclusion Criteria: Abnormal renal function Not having the test in accordance with the cancer follow-up program Contrast allergy Any surgery for the ureters in history

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 |
| --- | --- |
| Colorectal cancer patients<br>Colorectal cancer patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relocation of ureters (milimeters) |  | 1/10/2016- 1/06/2017 |
Behavior of Cyclists in Response to Pain

Study Overview
=================
Brief Summary
-----------------
A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.

Official Title
-----------------
Behavior of Cyclists in Response to Pain: a Qualitative Study

Conditions
-----------------
Athletic Injuries, Pain, Sport Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have at least one year of cycling experience and will not compete in multi-sport events such as a triathlon. Have had an injury currently or in the recent past associated with biking and experiencing pain related to cycling injury(s). Must read and speak English. Exclusion Criteria: Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Self-reported experience of cycling-related pain | Key themes elicited from semi-structured interviews with participants. Themes will involve experiences related to cyclists' experience of pain and behavior related to pain, specifically the decision surrounding if and how to seek medical attention. | Up to 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cycling, Endurance, Pain, Injury
Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function

Study Overview
=================
Brief Summary
-----------------
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.

Detailed Description
-----------------
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.

Official Title
-----------------
Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation

Conditions
-----------------
Postoperative Graft Function

Intervention / Treatment
-----------------
* Other: NO internvention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique - Exclusion Criteria: TEE absolute contraindication patient refusal
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EAD<br>Early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L within the first 7 days. | Other: NO internvention<br>* NO internvention<br>|
| Non EAD<br>No EAD | Other: NO internvention<br>* NO internvention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EAD | Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L | within the first 7 days status post OLT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection |  | within 6-8 weeks post transplant | 
| Prolonged (> 7 days) time to normalize total bilirubin (TIME t-bil), prolonged (>7 days) time to normalize INR (TIME inr), and prolonged (>7 days) time to normalize platelet count (TIME plt). |  | > 7 days post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TEE, orthotopic liver transplant, EAD
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)

Study Overview
=================
Brief Summary
-----------------
The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.

Detailed Description
-----------------
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects. Referring to animal data, empirical studies, and pilot human trials, exercise should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with impaired glucose tolerance during a short term exercise program.

Official Title
-----------------
Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?

Conditions
-----------------
Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with impaired glucose tolerance 50-65 years old moderate to heavy weight (BMI 25-35) must be able to do exercise intervention Exclusion Criteria: diabetes younger than 50 years BMI < 25 psychiatric medication severe disease MMSE < 26 severe cardiovascular disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Behavioral: Exercise<br>* 6 months of aerobic exercise<br>|
| Placebo Comparator: Placebo<br> | Behavioral: Exercise<br>* 6 months of aerobic exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory Verbal Learning Task |  | Prior to intervention and after 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional/Structural brain changes |  | Prior to intervention and after 6 months of intervention | 
| Plasma biomarkers |  | Prior to intervention and after 6 months of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, elderly, cognition, prevention, cognitive decline, Lifestyle
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Study Overview
=================
Brief Summary
-----------------
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Official Title
-----------------
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Conditions
-----------------
Joint Disease

Intervention / Treatment
-----------------
* Device: PROFEMUR® L Revision Femoral Stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has undergone revision total hip arthroplasty Subject is implanted with the specified combination of components Subject is willing and able to complete required study visits or assessments Exclusion Criteria: Subjects currently enrolled in another clinical study Subjects unwilling to sign the Informed Consent document Subjects with substance abuse issues Subjects who are incarcerated or have pending incarceration

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Revision Total Hip Arthroplasty<br>Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem | Device: PROFEMUR® L Revision Femoral Stem<br>* Revision Total Hip Arthroplasty<br>* Other names: Hip Revision Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who require a revision | The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up. | 10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient functional score on the the Oxford Hip Score instrument | To characterize patient hip-related health status, as assessed by Oxford Hip Scores | Screening (First Available), 2-5 years, 5-7 years, and 10 years | 
| Patient functional score on the EQ-5D-3L instrument | To characterize patient general health status, as assessed by EQ-5D-3L scores | Screening (First Available), 2-5 years, 5-7 years, and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity, Revision procedures
Study in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective in the treatment of asthma compared to the control drug.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of asthma Exclusion Criteria: Current asthma exacerbation or recent asthma exacerbation, requiring hospitalization History of smoking Debilitating systemic and/or life-threatening diseases.

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable is the measure of lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes include change in lung function, as well as in vital signs. |  |  | 
| Physical exams, AE reporting, etc. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Formoterol, Fumarate
Vienna Near-Infrared Spectroscopy in Cardiac Arrest Study (VINIRSCA)

Study Overview
=================
Brief Summary
-----------------
Measurement of Near-Infrared Spectroscopy (NIRS) during and after out-of-hospital cardiac arrest (OHCA) in the city of Vienna and the tertiary university hospital of the Medical University of Vienna, Austria. NIRS will be evaluated as a tool for resuscitation quality assessment as well as a prognosticator for cardiac arrest outcomes. Already-existing literature will be taken into account, and already-existing cutoffs and prognosticating values will be assessed and - if eligible - validated in a real-life setting.

Detailed Description
-----------------
Patients suffering from out-of-hospital cardiac arrest (OHCA) and receiving cardiopulmonary resuscitation (CPR) in terms of advanced life support (ALS) in the city of Vienna, Austria, will be included. A special study team will be dispatched to the event sites by the ambulance service. Trained study fellows will include patients by placing NIRS optodes on the patients' forehead as soon as possible during and/or after CPR. Measurements will continue until 72h post return of spontaneous circulation (ROSC) or the patient's death.

Official Title
-----------------
Messung Der Cerebralen Sauerstoffsättigung Mitttels Near-Infrared Spectooxymetrie in Der Reanimation Und Postreanimationsbehandlung

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Near-Infrared-Spectroscopy (NIRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age out-of-hospital cardiac arrest Exclusion Criteria: <18 years of age

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Observational cohort study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NIRS diagnostics<br>NIRS measurement | Device: Near-Infrared-Spectroscopy (NIRS)<br>* Placement of 2 NIRS optodes on the patients' forehead, measurement of NIRS during cardiac arrest and up to 72h post return of spontaneous circulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| near-infrared-spectroscopy | rSO2 | minute 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIRS, cardiac arrest