linjc16/ctgov huggingface dataset:
PALS for Pap Smear Follow up

Study Overview
=================
Brief Summary
-----------------
In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.

Detailed Description
-----------------
The overall goal of this research is to develop and test an intervention designed to improve knowledge and follow up among underserved women with abnormal pap smears. The researchers will use a unique web-based platform, the Patient Activated Learning System (PALS), which provides engaging and informative video and text designed to improve patient knowledge specifically among underserved populations. Twenty diverse patients with abnormal pap smears will be recruited from the Women's Health colposcopy clinic for initial qualitative interviews. Forty patients from the same population will then be engaged in a pre-post pilot to examine feasibility, acceptability, and impact of modules on improving knowledge.

Official Title
-----------------
Utilization Of A Web-Based Platform (Patient Activated Learning System- PALS) To Improve Knowledge And Follow-Up Among Women With Abnormal Cervical Cancer Screening (PALS)

Conditions
-----------------
Health Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Other: PALS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC Access to a smartphone English or Spanish Speaking Exclusion Criteria: Pregnant women Non-English or Spanish speakers

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PALS intervention<br>This arm will influence the development of a patient-directed education module using the Patient Activated Learning System (PALS) | Other: PALS<br>* patient activated learning system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reusable knowledge objects (RKOs) | Knowledge of cervical cancer screening and treatment, and perceived barriers, as measured in qualitative interviews | Month 1-2 | 
| Knowledge change | Quantitative change in knowledge post-intervention, as measured by attendance rates at follow-up visits | Month 3-4 |
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

Study Overview
=================
Brief Summary
-----------------
This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying shoulder tendinitis in terms of: Reduction or removal of shoulder calcifications Functional improvements Pain improvements 10 subjects will be assessed prior and 1 and 2 months post intervention onset. The intervention will consist in the application of the ECA cream in the affected shoulder twice a day during 1 month.

Official Title
-----------------
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

Conditions
-----------------
Calcifying Shoulder Tendinitis

Intervention / Treatment
-----------------
* Other: ECA cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients >=18 years diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray with disease evolution of more than 3 months and less than 12 months that give their informed consent by writing Exclusion Criteria: Previous shoulder surgery patients Patients with shoulder affections treated with shockwaves or corticosteroid injections.

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 |
| --- | --- |
| Experimental: Intervention<br> | Other: ECA cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of shoulder calcifications | X-ray | 2 months | 
| Size of shoulder calcifications | Ultrasonography | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder functionality | Constant Scale | 1 and 2 months | 
| Shoulder pain | Pain VAS (Visual Analogue Scale ) | 1 and 2 months |
Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

Detailed Description
-----------------
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.

Official Title
-----------------
Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

Conditions
-----------------
Anal Fistula, Fecal Incontinence, Surgery

Intervention / Treatment
-----------------
* Procedure: Gore-BioA Fistula Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years, male or female High cryptoglandular perianal fistula Written approval for the study Sufficient co-operation for the study Localization of the fistula by ultrasound or MRI Exclusion Criteria: Crohns disease Immunosuppressive treatment Anovaginal fistula Radiation therapy 6 months before study Chemotherapy 6 months before study Low- or intersphincteric fistula

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fistula patients<br>Gore-BioA Fistula Plug | Procedure: Gore-BioA Fistula Plug<br>* Gore-BioA Fistula Plug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the fistula |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of fecal incontinence |  | 6 months |
Trauma Reception and Resuscitation Project

Study Overview
=================
Brief Summary
-----------------
Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients. Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.

Official Title
-----------------
Trauma Reception and Resuscitation Project - 'Time for a New Approach'

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Device: Real time computer prompted trauma algorithms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All injured patients > 15 years old who are brought or present to the The Alfred Trauma Centre during the study period. Exclusion Criteria: Stable Trauma patients (ie Pulse rate <100/minute, MAP >70mmHg, Hb >70, temperature >35 and <37.5, Spo2 >92%, GCS >13) undergoing secondary transfer from another hospital, where trauma occurred >6hrs prior to arrival.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Device: Real time computer prompted trauma algorithms|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Error rate per patient treated demonstrated by deviation from the algorithms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed injuries |  |  | 
| Time to decision |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Wounds, Injuries
Effects of Isotretinoin on CYP2D6 Activity

Study Overview
=================
Brief Summary
-----------------
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.

Detailed Description
-----------------
In this aim, we will conduct a drug-drug interaction study evaluating the effects of 13-cis-retinoic acid on non-induced CYP2D6 activity in adolescent patients. Secondary analysis will evaluate the relationship between retinoid concentrations and CYP2D6 activity in these special populations

Official Title
-----------------
Effects of Isotretinoin on CYP2D6 Activity

Conditions
-----------------
CYP2D6 Polymorphism

Intervention / Treatment
-----------------
* Drug: Isotretinoin
* Drug: dextromethorphan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant ≥ 12 years Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons Exclusion Criteria: Weight < 80 lbs Allergy or adverse reaction to dextromethorphan, vitamin A or isotretinoin Pregnant or planning to become pregnant Unable to follow isotretinoin risk evaluation and mitigation strategies (REMS) program (also known as iPLEDGE program) Chronic or persistent cough accompanying asthma, smoking or COPD, Productive cough, Fever, Known kidney disease, Known liver disease, Diabetes Obesity, BMI ≥ 30 kg/m2 Bipolar disease, Attention deficit disorder, Social phobia, Concurrent or use within 14 days of drugs known to interact with DM or CYP2D6 or drugs known to increase the risk of adverse effects from DM Concurrent use of any other product containing dextromethorphan Consuming foods, beverages or dietary supplements known to interact with DM or CYP2D6 Unable to give written informed consent/assent, Inability to fast for 4 hours prior to study. Wards of the State

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adolescents<br>dextromethorphan pre- and post isotretinoin | Drug: Isotretinoin<br>* Drug interaction study<br>* Other names: accutane;Drug: dextromethorphan<br>* Drug interaction study<br>* Other names: robitussin pediatric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CYP2D6 activity | DM/DX Metabolic Ratio | 1 week to 6 months |
An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.

Official Title
-----------------
A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician. Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude; Subjects with a hypersensitivity to NovoRapid or to any of the excipients. Subjects with conditions considered as contraindications.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin aspart<br>* Intravenous NovoRapid dose & frequency as decided by treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs (adverse event) |  | After 6 months | 
| Incidence of SAEs (serious adverse event) |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other safety & efficacy measures |  | After 6 months |
A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.

Official Title
-----------------
Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS Exclusion Criteria: Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Psoriasis (PsO) participants who initiate treatment with Deucravacitinib. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period |  | Up to 52 weeks | 
| Change from Baseline in Body Surface Area (BSA) during study period |  | Up to 52 weeks | 
| Proportion of participants achieving Global Improvement Score (GIS) during study period |  | Up to 52 weeks | 
| Distribution of demographic characteristics: Age |  | Up to 52 weeks | 
| Distribution of demographic characteristics: Sex |  | Up to 52 weeks | 
| Distribution of demographic characteristics: Height |  | Up to 52 weeks | 
| Distribution of demographic characteristics: Weight |  | Up to 52 weeks | 
| Distribution of demographic characteristics: Past history /complication |  | Up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Deucravacitinib
European Pathology Laboratories and COVID-19

Study Overview
=================
Brief Summary
-----------------
The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.

Official Title
-----------------
Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.

Conditions
-----------------
Clinical Practice During the COVID-19 Crisis

Intervention / Treatment
-----------------
* Other: Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laboratories following the COVID-19 crisis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Activity|The questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity | The activity of the pathology laboratories has been compared for a same period (from the 15th of March 15 to the 31th of May) in 2019 and in 2020 | 1 day |
A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.

Official Title
-----------------
A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children

Conditions
-----------------
Need for Central Venous Access

Intervention / Treatment
-----------------
* Procedure: central line placement
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia Exclusion Criteria: Preoperative proof of non-patency of central veins coagulopathy access site surgeon

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Active Comparator: landmark guided<br>central line placement | Procedure: central line placement<br>* central line placement<br>|
| Active Comparator: ultrasound guided<br>central line placement | Procedure: central line placement<br>* central line placement<br>Device: Ultrasound<br>* Ultrasound guided central venous access<br>* Other names: Aloka, Wallingford, CT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Central Venous Cannulation at First Attempt | The count (%) of patients with successful central venous cannulation at first attempt is reported. | Up to 410 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Central Venous Cannulation Within First Three Attempts | The count (%) of patients with successful central venous cannulation within the first three attempts is reported. | Up to 410 seconds | 
| Patients With Arterial Punctures | The count (%) of patients with arterial punctures is presented. | Up to 410 seconds | 
| Patients With Complications | The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented. | Up to 410 seconds | 
| Time to Successful Cannulation |  | Up to 410 seconds |