linjc16/ctgov huggingface dataset:
Expert Learning in Musculoskeletal Ultrasound

Study Overview
=================
Brief Summary
-----------------
Musculoskeletal ultrasound (MSUS) is a complex procedure and requires lifelong theoretical and practical training to ensure continued professional development. Currently, the teaching approach for experts in MSUS is theoretical preparation first and then hands-on training, the Tell-Then-Do approach. The existing literature on optimizing training for experts is sparse, and it is unknown if the training intervention Discovery Learning could be a more effective teaching method for this group of learners.

Official Title
-----------------
Expert Learning in Musculoskeletal Ultrasound - the Effect of Discovery Learning

Conditions
-----------------
Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Other: Discovery learning (DL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experts in MSUS, defined as physicians who have performed more than 1000 MSUS examinations Exclusion Criteria: Physicians who have not performed 1000 MSUS examinations.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MSUS experts<br>Physicians with extensive experience with MSUS (performed more than 1000 examinations). | Other: Discovery learning (DL)<br>* DL makes the trainee practice before giving them instruction, Do-Then-Tell, thereby promoting their ability to use and build upon their existing knowledge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How do experts in MSUS approach a new and unfamiliar MSUS task? | All performances will be analyzed to examine how the experts solve the MSUS case, e.g., do they use the available material etc? More specifically, how much time (in seconds) do they use on different problem-solving methods such as information seeking, trial and error, and systematic evaluation. | January 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How do the experts respond to DL? | i.e., are they comfortable changing the learning situation from Tell-Then-Do to Do-Then-Tell? The participants will fill out a post-course questionnaire. 10 questions to be answered on a 5 point Likert scale from (range 1-5). | January 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical education, Ultrasound
Intraoperative Findings and Complications in Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single Institution. The objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. All operative information was collected prospectively and aimed to describe any of the previous situations. Secondarily, a morbidity analysis was performed, correlating intraoperative complications with postoperative complications and length of stay.

Official Title
-----------------
Unexpected Intraoperative Findings and Complications in Bariatric Surgery

Conditions
-----------------
Bariatric Surgery, Complication of Surgical Procedure, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient submitted to bariatric surgery All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity Exclusion Criteria: Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bariatric surgery|The gastric bypass (simplified technique) was performed in an antecolic fashion, with a calibrated 2 cm gastro-jejunal anastomosis (linear stapler); biliary and alimentary limbs measured 70 and 150 cm respectively [17] . Mesenteric defects were closed and the omentum divided. The sleeve gastrectomy was performed at 5-6 cm from the pylorus over a 36 Fr. bougie, with oversuture of the staple line (2-0 polypropylene). Methylene blue test and the use of drains were done routinely.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Complications | yes/no | During surgical time | 
| Intraoperative unexpected findings, change in surgical technique, surgery interruption | yes/no | During surgical time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | (yes/no) (minor/major) | 0-30 days | 
| Length of Hospital Stay | Days | 0-30 days |
Antiproteinuric Agents and Fabry Disease

Study Overview
=================
Brief Summary
-----------------
Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Detailed Description
-----------------
Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Official Title
-----------------
Observational Study of Antiproteinuric Agents in Patients With Fabry Disease Treated With Enzyme Replacement Therapy

Conditions
-----------------
Fabry Disease, Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetically confirmed Fabry disease institution of commercially available agalsidase-beta Exclusion Criteria: s/p kidney transplant

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 95 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proteinuria, ARBs, agalsidase-beta, MDRD estimated GFR, Chronic kidney disease
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.

Official Title
-----------------
Multicenter, Observational, Retrospective Study to Assess the Therapeutic Effectiveness of a Strategy of Induction With Enfuvirtide Within an Optimized Regimen of Antiretroviral Drugs (ARV) in Patients Infected With HIV-1 in Routine Clinical Practice

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age HIV-1+ infection Patients with a viral load > 50 copies/ml who have received induction treatment with Fuzeon in combination with antiretroviral treatment Naïve for Fuzeon at initiation of induction treatment Antiretroviral treatment of at least 12 months duration Exclusion Criteria: Patients who did not receive Fuzeon 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml |  | approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment with Fuzeon |  | approximately 24 months | 
| Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml |  | approximately 24 months | 
| Safety: Incidence of adverse events |  | approximately 24 months | 
| Treatment regimen: Antiretroviral drugs used |  | approximately 24 months |
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections

Study Overview
=================
Brief Summary
-----------------
Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;

Official Title
-----------------
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections

Conditions
-----------------
Surgical Site Infections

Intervention / Treatment
-----------------
* Other: laboratory-based data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient being treated in the Department and Clinic of Orthopaedic and Trauma Surgery, St. Barbara Specialised Regional Hospital No. 5, Sosnowiec patients undergoing surgery in studied unit Exclusion Criteria: under 18 years of age surgery of a different type than orthopedics non-surgical treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infected, with SSI<br>patients with SSI | Other: laboratory-based data collection<br>* laboratory-based surveillance of SSI<br>|
| non-infected<br>patients without SSI | Other: laboratory-based data collection<br>* laboratory-based surveillance of SSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection incidence rate | the cumulative incidence of surgical site infection (SSI) was calculated by dividing the number of SSI cases by the number of patients undergoing surgery and multiplying by 100 | The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties |
A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.

Official Title
-----------------
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions

Conditions
-----------------
Therapeutic Equivalency

Intervention / Treatment
-----------------
* Drug: methylprednisolone
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs). Exclusion Criteria: Any condition possible affecting drug absorption (eg, gastectomy). A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone suspension<br> | Drug: methylprednisolone<br>* constituted powder for oral suspension 4 mg/mL single dose at 32 mg<br>|
| Active Comparator: methylprednisolone tablets<br> | Drug: methylprednisolone<br>* tablets 32 mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf (area under the concentration time curve to infinity) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Cmax (maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast (area under the concentration time curve to last time point) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Tmax (time at maximum concentration) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 
| Half-life |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalence study, methylprednisolone, suspension, tablets, fed
A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative dental pain in male patients. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: MK0719


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction Exclusion Criteria : Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0719|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Dental Pain
Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica

Study Overview
=================
Brief Summary
-----------------
Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

Detailed Description
-----------------
Comparison of PMR patients and matched control subjects.

Official Title
-----------------
Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab

Conditions
-----------------
Polymyalgia Rheumatica

Intervention / Treatment
-----------------
* Drug: tocilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PMR patient included in the TENOR study with samples available Exclusion Criteria: Patient not included in the TENOR study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| PMR patients<br>Patients included in the clinical trial TENOR (prospective open-labeled study of tocilizumab in treatment-naïve PMR patients) | Drug: tocilizumab<br>* 3 monthly IV infusions in PMR patients<br>* Other names: anti-IL-6 receptor monoclonal antibody;|
| Healthy controls<br>Matched to PMR patients for sex and age, exclusion of any autoimmune, inflammatory, neoplastic and chronic infectious disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of blood lymphocyte populations (T cells, B cells, NK cells) | Lymphocyte subset analysis by flow cytometry | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cytokine concentration measurement | Cytokine level measurements using an array and ELISAs | 6 months |
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China

Detailed Description
-----------------
A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)

Official Title
-----------------
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer: a Population Study of the US Database and a Chinese Multi-institutional Registry

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: lymph node number


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible Exclusion Criteria: Patients with missing values on lymph node count and clinical features were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: lymph node number|Lymph nodes were harvested during surgical resection of rectal cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymph node number | lymph nodes were harvested during surgical resection of rectal cancer | during the surgery |