linjc16/ctgov huggingface dataset:
Psychological Impact of COVID-19 Pandemic in Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.

Detailed Description
-----------------
PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.

Official Title
-----------------
Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group

Conditions
-----------------
Covid19, Stress, Psychological, Work Related Stress, Epidemic Disease, SARS-CoV Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Psychological stress and adaptation at work score (PSAS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active healthcare workers in any private/public hospital > 18 years old Exclusion Criteria: Refusal to participate

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Psychological stress and adaptation at work score (PSAS)|completing a survey based on PSAS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSAS (Psychological Stress and Adaptation at work Score) during the crisis | evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers | during the pandemic (April 9, 2020 to April 19, 2020) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSAS (Psychological Stress and Adaptation at work Score) in basal conditions | evaluate the psychological stress in Spain in healthcare workers | After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year. |
Students and Trainers' Evaluations Correlation

Study Overview
=================
Brief Summary
-----------------
The delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing (students) (2) and to evaluate the correlation between the evaluation of this training carried out by students and the self-assessment conducted by the faculty (trainers).

Official Title
-----------------
Correlation Between Students' and Trainers' Evaluations While Learning Delegated Surgical Procedures: a Prospective Cohort Study

Conditions
-----------------
Surgical Procedure, Unspecified, Critical Thinking, Simulation, Evaluation

Intervention / Treatment
-----------------
* Other: Educational simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scrub nurses already in practice professional trainer, specialist in the field of the proposed course subject

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Student<br> | Other: Educational simulation<br> <br> |
| Trainers<br> | Other: Educational simulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SFDP26 questionnaire | This questionnaire is part of the System for Evaluation of Teaching Qualities (SETQ) which includes (1) a self-assessment by the trainer (2) an assessment by the student (3) then a feedback and (4) a follow-up to improve teaching. The SFDP26 questionnaire therefore exists in several versions for an evaluation of training by the students but also for a self-evaluation of by the trainers. Both versions share 25 basic items covering 7 dimensions of teaching quality | 2 weeks |
Clinical Application of Breast Blood-oxygen Functional Imaging Technology

Study Overview
=================
Brief Summary
-----------------
This trial is going to evaluate the value of blood-oxygen functional imaging technology in the diagnosis of breast diseases.

Official Title
-----------------
Clinical Application of Breast Blood-oxygen Functional Imaging Technology

Conditions
-----------------
Breast Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female older than 18 years breast lump received breast ultrasound and mammography Exclusion Criteria: After core-needle biopsy or resection After neoadjuvant chemotherapy, radiotherapy or endocrine therapy

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood-oxygen functional imaging technology, diagnosis
Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men

Study Overview
=================
Brief Summary
-----------------
The present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. The participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (Mondays, Wednesdays and Fridays, in the morning). Each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. The exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit Y deltoid fly, triceps pushdown. The exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, French triceps press, and high row. Eleven participants were included in the control group.

Official Title
-----------------
Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men

Conditions
-----------------
Effect of Different Exercise Programs on Body Composition

Intervention / Treatment
-----------------
* Other: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not having chronic disabling diseases not being bedridden institutionalized or hospitalized have their own mobility, without assistance from people, even if they have the aid of devices -without amputations. Exclusion Criteria: the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspension training group<br> | Other: Physical activity<br>* 12 weeks of exercise training<br>|
| Experimental: Free weight training group<br> | Other: Physical activity<br>* 12 weeks of exercise training<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Fat mass | 12 weeks |
Psoriatic Immune Response to Tildrakizumab

Study Overview
=================
Brief Summary
-----------------
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

Detailed Description
-----------------
This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Official Title
-----------------
Psoriatic Immune Response to Tildrakizumab

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Tildrakizumab Prefilled Syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patients with moderate-severe psoriasis or > 5% body surface area affected. Exclusion Criteria: taking systemic immunosuppressives in the last 4 weeks pregnancy severe immunodeficiency (either from genetic or infectious causes). tuberculosis or other active serious infection active systemic malignancy. breast-feeding Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tildrakizumab treatment<br>Biological/vaccine: tildrakizumab | Drug: Tildrakizumab Prefilled Syringe<br>* IL-23 inhibitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment | Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease. | Baseline, 3 months |
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Detailed Description
-----------------
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Official Title
-----------------
Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)

Conditions
-----------------
Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Niacin Extended Release/Lovastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old with CAD or risk factors for CAD under standard care at Family Medical Care of Tulsa not at LDL goal per ATP III guidelines Exclusion Criteria: pregnancy/lactating liver disease allergies to statin or niacin active peptic ulcer disease previous treatment with combination therapy for dyslipidemia

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: Niacin Extended Release/Lovastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid parameter change at 3 and 6 months |  |  | 
| Percent of patients achieving ATP III LDL goals at 3 and 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Niacin, Hyperlipidemia, Dyslipidemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin
Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules

Study Overview
=================
Brief Summary
-----------------
The detection and diagnosis of hepatocellular carcinoma is a public health issue. MRI is the most sensitive examination for diagnosis and especially hypervascularization in the arterial phase. Several studies have shown that MRI multiphase arterial sequences are superior to single phase to capture the arterial phase. The purpose of this study is to compare arterial enhancement sensibilities between multi and single phase sequences.

Official Title
-----------------
Comparison of Multiphase and Monophasic Arterial Hepatic MRI in the Detection of Arterial Enhancement of CHC Nodules in Cirrhotic Patients

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: non interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient included in CHIC study with histology of hepatocellular carcinoma Exclusion Criteria: nodules already treated by chimioembolization

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

| Intervention/Treatment |
| --- |
|Other: non interventional|non interventional, study on data|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial enhancement | significant arterial enhancement present in one of the three phases of multiphasic arterial time compared to all other arterial phases or single phase | 1 year |
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare and evaluate the diagnostic performance of scrape cytology using two different cytological staining techniques, and to evaluate additional touch imprint cytology with that of histopathology of superficial basal cell carcinoma and actinic keratosis.

Official Title
-----------------
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunvald-giemsa Stained Cutaneous Tissue Smear in Relation to Photodynamic Therapy

Conditions
-----------------
Carcinoma, Basal Cell, Porokeratosis, Disseminated Superficial Actinic

Intervention / Treatment
-----------------
* Procedure: Skin scrape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified basal call carcinoma and actinic keratosis Exclusion Criteria: Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 105 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 |
| --- | --- |
| skin scrape<br> | Procedure: Skin scrape<br>* scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis<br>|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytodiagnosis, Skin Scrape, Touch Imprint, Papanicolaou, May-Grunvald-Giemsa
A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

Study Overview
=================
Brief Summary
-----------------
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.

Official Title
-----------------
A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

Conditions
-----------------
Human Immunodeficiency Virus (HIV)

Intervention / Treatment
-----------------
* Drug: Open Label Treatment Access: Maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc. Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures. Exclusion Criteria: Subjects who discontinued in A4001050 study. Unable to provide consent.

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

| Intervention/Treatment |
| --- |
|Drug: Open Label Treatment Access: Maraviroc|Oral dosing twice daily. The dose will depend on the optimized background therapy.|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Label Access Program, Treatment experienced
Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide

Study Overview
=================
Brief Summary
-----------------
Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Bicalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cT2-T3a prostate cancer Exclusion Criteria: Men>75 years Men<18 years Prior hormonal therapy Prior radiation or chemotherapy Prior investigational agents Life expectancy > 10 years Prior malignancy within the last five years Any other serious medical or psychiatric condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicalutamide|nan|

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

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