linjc16/ctgov huggingface dataset:
Study Evaluating Enbrel (Etanercept) in Adult Patients With Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the incidences of adverse events for patients with plaque psoriasis treated with Enbrel under usual care settings.

Official Title
-----------------
Observational Study With Enbrel (Etanercept) in Adult Patients With Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven diagnosis of Plaque Psoriasis Exclusion Criteria: Contraindications according to SmPC of Enbrel

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 |
| --- | --- | --- |
Effects of Betaine Supplementation on Strength and Muscle Creatine Content

Study Overview
=================
Brief Summary
-----------------
It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.

Official Title
-----------------
Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: creatine
* Dietary Supplement: betaine
* Dietary Supplement: dextrose
* Dietary Supplement: creatine plus betaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physically inactive non-obese Exclusion Criteria: skeletal muscle disturbance cardiovascular disturbance use of dietary supplements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creatine<br>will receive creatine monohydrate (20g/d) throughout 10 days | Dietary Supplement: creatine<br>* 20g/d throughout 10 days<br>|
| Experimental: betaine<br>will receive betaine (2g/d) throughout 10 days | Dietary Supplement: betaine<br>* 2g/d throughout 10 days<br>|
| Placebo Comparator: placebo (dextrose)<br>will receive dextrose(20g/d)throughout 10 days. | Dietary Supplement: dextrose<br>* dextrose (placebo), 20 g/d throughout 10 days<br>|
| Active Comparator: creatine plus betaine<br>will receive creatine (20g/d) plus betaine (2g/d) throughout 10 days | Dietary Supplement: creatine plus betaine<br>* creatine (20g/d) plus betaine (2g/d) throughout 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength |  | after 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intramuscular creatine content |  | after 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
betaine, creatine, strength
Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy

Study Overview
=================
Brief Summary
-----------------
Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.

Detailed Description
-----------------
Nipple Sparing Mastectomy (NSM) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. The oncologic safety has been well established in multiple studies in appropriately selected individuals. Additionally, rates of wound complications and risk factors for wound problems are well documented. The intercostal perforating vessels (IPV) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. Thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. We propose that localization of these vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of NSM. Objectives Demonstrate that US is an effective means of localizing the IPV intraoperatively. Evaluate the frequency of IPV preservation with the use of US. Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV. Compare observed rate with historical controls.

Official Title
-----------------
Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Ultrasound for localizing intercostal perforating vessels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 18 years of age or older Planned nipple sparing mastectomy Exclusion Criteria: Contraindication to nipple sparing mastectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound for localizing intercostal perforating vessels|Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy. |  | At the time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nipple Sparing Mastectomy, Ultrasound
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
Hospital acquired chest Infections are common complications in hospitalized cirrhotic patients. Infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia Intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures

Detailed Description
-----------------
Aim of the work To estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients . To determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol. To define the impact of nosocomial chest infections on survival of our patients. To develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care . To motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals

Official Title
-----------------
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients

Conditions
-----------------
Nosocomial Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnosis of bacterial infections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cirrhotic patients , decompensated , child pug score B or C ,may have Hepatocellular carcinoma , other comorbidities may present as (Diabetius mellitus , Hypertension , Heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission Exclusion Criteria: Patients have any chronic chest disease Patients have severe immunosuppression (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and HIV-related disorders.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nosocomial infected cirrhotic patients<br> | Diagnostic Test: Diagnosis of bacterial infections<br>* Cultures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of nosocomial infection in patients with liver cirrhosis | nosocomial infection is one of predictors of bad outcome in liver cirrhosis | baseline |
A Study of 2 Doses of MAP0010 in Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)

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

Intervention / Treatment
-----------------
* Drug: 0.135mg MAP0010
* Drug: 0.25mg MAP0010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed 12 weeks of treatment in the MAP0010-CL-P301 study. Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate. Exclusion Criteria: Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 8 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 |
| --- | --- |
| Experimental: 0.135mg MAP0010<br>0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | Drug: 0.135mg MAP0010<br>* 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks<br>|
| Experimental: 0.25mg MAP0010<br>0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | Drug: 0.25mg MAP0010<br>* 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | 40 weeks | 
| Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthmatic children
Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Study Overview
=================
Brief Summary
-----------------
This study aims to compare biological communities in stool samples obtained from age, diet and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS) never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing spondylitis previously or currently treated with TNF inhibitors, subjects with non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with TNF inhibitors and healthy participants. The differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the University of Washington. The investigators predict that this study will confirm a significant difference between the fecal microbiota composition (FMC) of both AS and nrSpA patients and controls.

Conditions
-----------------
Axial Spondyloarthritis, Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent Male or Female patients ≥18 years of age Additional Inclusion Criteria based on cohort Exclusion Criteria: Current use of any pain-relieving medications other than NSAIDs, APAP and/or opioids Corticosteroid therapy or probiotic exposure within the last two weeks Antibiotic exposure within the past two months History of psoriasis or inflammatory bowel disease or reactive arthritis or any other chronic rheumatologic disease Active infection History of hepatitis B or C or HIV Active cancer or history of colon cancer or any form of chemotherapy or radiation within the past year Celiac disease Use of proton pump inhibitors within the prior two months History of clostridium difficile Pregnancy Active diarrhea (defined as a decrease in fecal consistency lasting four or more weeks) Additional Exclusion Criteria based on cohort

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 |
| --- | --- |
| TNF blocker-naïve ankylosing spondylitis patients<br> | |
| TNF blocker-exposed ankylosing spondylitis patients<br> | |
| TNF blocker-naïve nrSpA patients<br> | |
| TNF blocker-exposed nrSpA patients<br> | |
| Healthy Participants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weighted and unweighted UniFrac distances between stool samples from the five study groups |  | Within 1 month of baseline visit |
Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy

Study Overview
=================
Brief Summary
-----------------
This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy.

Official Title
-----------------
Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy

Conditions
-----------------
Seroma

Intervention / Treatment
-----------------
* Procedure: Standard axillary lymphadenectomy
* Procedure: Collagen sponge coated with human coagulation factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with axillary lymphadenectomies performed for oncological conditions. Exclusion Criteria: Patients that did not want to participate in the study.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1<br>Standard axillary lymphadenectomy | Procedure: Standard axillary lymphadenectomy<br>* Standard axillary lymphadenectomy<br>|
| Experimental: 2<br>Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls | Procedure: Collagen sponge coated with human coagulation factors<br>* Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls<br>* Other names: TachoSil(R), Nycomed Pharma, AS.;|

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
-----------------
axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy
Observational Study to Assess Safety and Utility Pattern of Topical Steroids

Study Overview
=================
Brief Summary
-----------------
To assess incidence of adverse drug reactions and use pattern of topical steroids among patients who are prescribed or purchase over the counter (OTC) topical steroids for skin conditions in Korea

Detailed Description
-----------------
Active collection of safety data, systemic and local adverse events. In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call Causality of adverse events will be assessed by independent two professionals Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration) Collection of information related with adverse event management

Official Title
-----------------
Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea

Conditions
-----------------
Skin Diseases

Intervention / Treatment
-----------------
* Drug: Topical Steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients or guardian of child purchased topical steroids in Korea Informed consent to participate Willing to follow and abide by the protocol Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical Steroids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse drug reaction upon use of topical steroid |  | 4 week after time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse drug reaction upon use of topical steroid |  | 2 month after time of enrollment | 
| Rate of adverse drug reaction upon use of topical steroid |  | 6 month after time of enrollment | 
| Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter) |  | 1 month after time of enrollment | 
| Rate of misuse and overuse of topical steroids |  | 6 month after time of enrollment | 
| Impact of covariates on incidence of adverse drug reaction |  | 6 month after time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatologic Agent
The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. The effect of the intervention is examined in a randomized controlled trial.

Official Title
-----------------
The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients

Conditions
-----------------
Geriatric Disorder

Intervention / Treatment
-----------------
* Other: Assessment of functional ability in combination with follow-up at home


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to, Medical Visitation Section (MVA) Aarhus University Hospital aged 65+ resident in City of Aarhus. Exclusion Criteria: Patients admitted from a psychiatric institution or nursing home patients without walking ability patients who do not speak or read Danish terminally ill patients patients transferred to other hospital departments

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Functional assessment<br>Assessment of functional ability in combination with follow-up at home | Other: Assessment of functional ability in combination with follow-up at home<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-admission | *Primary outcome was originally set to readmissions within 26 weeks but due to clerical error it has been written as 30 days. The error has now been corrected. | Re-admission in 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 day mortality | 
| Functional ability | Functional ability measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0) and Barthel-20 | 4 and 26 weeks after intervention | 
| Re-admission |  | Re-admission within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional assessment, acute care, older medical patients