linjc16/ctgov huggingface dataset:
The Influence and Effects of the COVID-19 Pandemic on Orthopaedic Resident Training

Study Overview
=================
Brief Summary
-----------------
Orthopedic residents, like all other healthcare professionals, face unique challenges during the coronavirus disease 2019 (COVID-19). The rapid spread of COVID-19 has forced healthcare systems around the world to adapt. As in many other specialties, it has led to many changes in the training of orthopedic residents including restructuring of surgical training, a reduction in elective surgery cases, and re-assignment of residents to COVID-19-related clinical duties. As a result, the standard training curriculum has been interrupted and the number of surgical cases has decreased, limiting the ability of the residents to meet the range and number of patient follow-up and treatment requirements set by the Turkish Orthopedics and Traumatology Education Council (TOTEK). The already stressful work environment of orthopedic residents has become more stressful and anxious with the COVID-19 pandemic. There are no well-designed survey studies that have shown the impact of the COVID-19 pandemic on orthopedic resident education and well-being from the resident's perspective. Therefore, the purpose of this nationwide survey study was to document and analyze the effects of the COVID-19 pandemic on the real-life experiences of orthopedic residents in Turkey.

Official Title
-----------------
The Influence and Effects of the COVID-19 Pandemic on Orthopaedic Resident Training: a Nationwide Cross-sectional Survey in Turkey

Conditions
-----------------
Educational Problems, Covid19, Depression, Burnout, Student

Intervention / Treatment
-----------------
* Other: Questionnaire about impact of the COVID-19 pandemic on orthopaedic resident training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteering to answer survey questions Exclusion Criteria: Incomplete answers to survey questions or refusing to participate in the survey

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

| Intervention/Treatment |
| --- |
|Other: Questionnaire about impact of the COVID-19 pandemic on orthopaedic resident training|Answers were collected for the effects of the COVID-19 pandemic on the real-life experiences of orthopaedic residents|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the COVID-19 pandemic on orthopaedic resident training | Descriptive data on perceptions of current status of orthopaedic residency training during the pandemic and impact of the pandemic on orthopaedic residency training. | 30.12.2020 - 15.01.2021 |
Multicenter Trial For Patients With Acute Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: etiprednol dicloacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have active confirmed Crohn's disease with CDAI > 220 and < 400. Otherwise healthy.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etiprednol dicloacetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Identification of Ventricular Fibrillation and Optimization of Defibrillation During CPR

Study Overview
=================
Brief Summary
-----------------
It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Both the guidelines by American Heart Association and the guidelines by European Resuscitation Council emphasize the importance of minimizing interruptions in chest compressions, specifically, duration of the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF during chest compression, which has high sensitivity and specificity. And the investigators can identify VF and defibrillate earlier. The aim of this study is to verify that if Sherlock algorithm of Philips MRx monitor/defibrillator can identify shockable rhythms during chest compression accurately.

Official Title
-----------------
Identification of Ventricular Fibrillation and Optimization of Defibrillation During Chest Compression of CPR: A Multiple Study of Cardiac Arrest Patients in China.

Conditions
-----------------
Cardiac Arrest, Identify of Electrocadiac Rhythm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac arrest patients The length from cardia arrest to be rescued is less than 10 minutes age≥14 Complied with ethical requirements signing the informed consent form. Exclusion Criteria: DNR Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| defibrillation patients<br>shockable rhythm, defibrillated | |
| non defibrillation patients<br>non-shockable rhythm, non defibrillated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of Sherlock algorithm of Philips MRx monitor/defibrillator in identify ventricular fibrillation. |  | 04/10/2016-10/01/2017 | 
| How long it is advanced that the first time Sherlock algorithm identified VF than the true time VF was recognized. |  | 04/10/2016-10/01/2017 | 
| Comparasion of no-flue time between true scene and assumed scene that useing Sherlock algorithm. |  | 04/10/2016-10/01/2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, identify of electrocardiac rhythm, ventricuar fibrillation, defibrillation
Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

Study Overview
=================
Brief Summary
-----------------
Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac patients. This study thoughts to prospectively validate the prognostic value of PRD in post-infarction patients.

Detailed Description
-----------------
Periodic repolarization dynamics (PRD) reflect periodic changes of repolarization instability located in the low-frequency spectral range. Level of PRD can be assessed using a high resolution surface ECG recorded in the 12-leads of Frank leads configuration during resting conditions. Increased levels of PRD have been associated with sympathetic overactivity and increased risk of mortality in survivors of acute myocardial infarction and patients undergoing a clinically indicated exercise test.

Official Title
-----------------
Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients: Validation Study

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous myocardial infarction >4 weeks age >18 years Exclusion Criteria: life expectancy < 1 year due to non-cardiac causes unable to give informed 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total deaths |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiovascular deaths |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Repolarization instability, Ventricular fibrillation
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

Conditions
-----------------
Liver Transplantation, Hepatocellular Carcinoma, Tumor Recurrence and Metastasis, Survival, Adjuvant Chemotherapy

Intervention / Treatment
-----------------
* Drug: gemcitabine and oxaliplatin
* Drug: doxorubicin, 5-Fu and cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment. Exclusion Criteria: Age less than 18 years Treatment with other postoperative adjuvant chemotherapy Survival is less than 3 months after liver transplantation Inability to provide written informed consent prior to study entry

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gemcitabine and oxaliplatin<br> | Drug: gemcitabine and oxaliplatin<br>* Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.<br>|
| Active Comparator: doxorubicin, 5-Fu and cisplatin<br> | Drug: doxorubicin, 5-Fu and cisplatin<br>* Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence and metastasis | Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy | within the first year after liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative survival | Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death. | within the first year after liver transplantation |
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Study Overview
=================
Brief Summary
-----------------
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Detailed Description
-----------------
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Official Title
-----------------
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Conditions
-----------------
Magnetic Resonance Imaging, Magnetic Resonance Angiography

Intervention / Treatment
-----------------
* Drug: Gadobutrol (Gadovist, BAY86-4875)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist). Exclusion Criteria: There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Gadobutrol (Gadovist, BAY86-4875)<br>* Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. |  | 1 day |
Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.

Official Title
-----------------
An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: M518101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who are able and willing to give signed informed consent Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. Who have up to 20% of body surface area (BSA) afflicted with plaques Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity. Who are pregnant or lactating. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. Whose serum calcium levels exceed the upper limit of reference range Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment. Who have been treated with systemic therapy within 30days of treatment. Who have treated with biologics within 5 half-lives of the biologics before the day of treatment Who have been treated with topical therapy within 14days before the day of treatment.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M518101<br>Proper quantity twice daily | Drug: M518101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course change of Investigator Global Assessment |  | 4 weeks interval |
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Fluvoxamine+Methylphenidate hydrochloride
* Drug: Fluvoxamine+sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Met DSM-V criteria Y-BOCS ≥ 16 Course of illness ≥ 1year Age range between 18 40 years old Junior high school education level above Exclusion Criteria: Any other psychiatric axis-I or axis-II disorders History of epileptic seizures or any other neurological disorder Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluvoxamine+Methylphenidate Hydrochloride<br>Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks. | Drug: Fluvoxamine+Methylphenidate hydrochloride<br> <br> |
| Placebo Comparator: Fluvoxamine+sugar pill<br>Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks. | Drug: Fluvoxamine+sugar pill<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | 8 weeks |
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.

Detailed Description
-----------------
Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.

Official Title
-----------------
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Physical exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A = Active group<br>Patients will receive interactive exercise training session from an experienced multiple sclerosis | Other: Physical exercise training<br>* Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis<br>* Other names: Aerobic exercise;|
| No Intervention: B = Control group (Placebo Comparator)<br>Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Fatigue |  |  | 
| Quality of Life |  |  | 
| Injection site visual analog scale (0-10) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, b1b-interferon, Fatigue, Exercise