linjc16/ctgov huggingface dataset:
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: BIIB023
* Other: Placebo (sterile normal saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of adult onset RA (functional class I-III) for at least 6 months Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks Must have at least 4 swollen and tender joints due to rheumatoid arthritis Exclusion Criteria: History of recurrent infections requiring antibiotic treatment within 12 months Serious local infection or systemic infection within 3 months Suffering from rheumatic or autoimmune disease other than RA History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BIIB023 | Drug: BIIB023<br>* Single IV doses of BIIB023 in dose-escalating cohorts<br>* Other names: Human glycosylated IgG1 monoclonal antibody;|
| Placebo Comparator: 2<br> | Other: Placebo (sterile normal saline)<br>* Single IV dose of Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA. |  | Baseline through Day 70 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects |  | Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70 |
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria

Study Overview
=================
Brief Summary
-----------------
The present study aims to evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients.

Detailed Description
-----------------
Introduction: HEPATOCELLULAR CARCINOMA (HCC) is the second leading cause of cancer mortality worldwide. Living donor liver transplantation (LDLT) for HCC patients has emerged as a rewarding therapy for a cure and a successful alternative where a Deceased donor liver transplantation (DDLT) program is lacking. Therefore, trials for careful expansion to Milan criteria have been adopted. Aim of the study: To evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients

Official Title
-----------------
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria in High Prevalence Young HCC Patients Country.

Conditions
-----------------
Hcc

Intervention / Treatment
-----------------
* Procedure: living donor liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis) age>18y Exclusion Criteria: other etiology for liver transplant rather than HCC patient not fit for surgery age >70y

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 |
| --- | --- |
| Group I<br>175 patients who fall within the Milan criteria. | Procedure: living donor liver transplantation<br>* liver graft from a living donor<br>|
| Group II<br>36 patients who fall within up-to-7 criteria | Procedure: living donor liver transplantation<br>* liver graft from a living donor<br>|
| Group III<br>30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC). | Procedure: living donor liver transplantation<br>* liver graft from a living donor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC recurrence | Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplant, HCC, Extended milan, Living donor liver transplantation
Diagnosis of Superficial Lymphadenopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the application of CEUS and SMI technology in superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

Detailed Description
-----------------
CEUS and SMI technology were used to evaluated the superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

Official Title
-----------------
SMI and CEUS in the Diagnosis of Superficial Lymphadenopathy

Conditions
-----------------
Lymphadenopathy, ULTRASOUND

Intervention / Treatment
-----------------
* Diagnostic Test: SMI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old and ≤ 80 years old; Patients with enlarged lymph nodes detected by ultrasound; No contraindications such as hypersensitivity to contrast-enhanced ultrasound; Voluntarily enrolled in this research project Exclusion Criteria: The patient's position cannot be matched during ultrasound examination Treatment history of lesion area: operation, radiotherapy, intervention, etc ③ Patients without informed consent ④ Lack of clinical data (no effective images such as two-dimensional ultrasound, color Doppler, contrast-enhanced ultrasound, micro blood flow imaging, or poor image quality, unable to analyze, unknown pathological results, etc.) ⑤ Lack of follow up information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| disease free survival<br>disease free survival | Diagnostic Test: SMI<br>* ULTRASOUND<br>* Other names: CEUS;|
| non-disease free survival<br>non-disease free survival | Diagnostic Test: SMI<br>* ULTRASOUND<br>* Other names: CEUS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PATHOLOGY | BIOPSY/SURGERY | up to 3 months |
Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

Study Overview
=================
Brief Summary
-----------------
Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.

Detailed Description
-----------------
Intervention: Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion. Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.

Official Title
-----------------
Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization

Conditions
-----------------
Sarcoidosis, Cardiac Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven sarcoidosis Suspected cardiac sarcoidosis Exclusion Criteria: Ischemic heart disease Diabetes Cardiomyopathy

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 |
| --- | --- |
| Sarcoidosis patients<br>Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac sarcoidosis - Sensitivity | Ability to correctly identify patients with cardiac sarcoidosis | 01/01/2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial cardiac glucose uptake assessed by Cardiac SUV | Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml. | 01/01/2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoidosis, Cardiac sarcoidosis, 18-FDG PET, 68Ga-DOTANOC PET
Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method

Study Overview
=================
Brief Summary
-----------------
The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage consensus bundle to provide every United States birthing facility consistent, validated practice guidelines. To facilitate implementation of each element of this bundle at the participants large tertiary center, the investigators utilized the Delphi method to identify deficiencies, perceived barriers to implementation, and multidisciplinary consensus on changes with high feasibility and impact on patient care.

Official Title
-----------------
Implementation of the National Partnership for Maternal Safety Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method

Conditions
-----------------
Pregnancy Hemorrhage, Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ five years of experience on the L&D unit current employment on the L&D unit > 20h per week prior involvement in clinical obstetric hemorrhage situations Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anesthesiologists<br>Total: 11 Intervention: Survey | Other: Survey<br> <br> |
| Active Comparator: Obstetricians<br>Total: 11 Intervention: Survey | Other: Survey<br> <br> |
| Active Comparator: Registered Nurses<br>Total: 10 Intervention: Survey | Other: Survey<br> <br> |
| Active Comparator: Surgical Technicians<br>Total: 6 Intervention: Survey | Other: Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components |  | 4 weeks | 
| Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components |  | 6 months | 
| Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care |  | 6 months |
PDRI Rates Among CAPD Patients at a Tertiary University Hospital: A 5-Year Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection rates, causative pathogens, appropriation of antibiotic use, treatment outcomes and trend in antimicrobial resistance of causative pathogens.

Official Title
-----------------
Peritoneal Dialysis-Related Infection Rates and Outcomes of Antibiotic Treatments Among Continuous Ambulatory Peritoneal Dialysis Patients at a Tertiary University Hospital: A 5-Year Retrospective Study

Conditions
-----------------
Peritoneal Dialysis-related Infection

Intervention / Treatment
-----------------
* Other: PDRI patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were at least 18 years old. Patients who were diagnosed with stage 5 chronic kidney disease (eGFR < 15 ml/min/1.73m^2). Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital during January 1, 2016 to December 31, 2020. Exclusion Criteria: Patients with incomplete data records that invalid to include in the process of data analysis Patients who were not treated and started their first CAPD at CAPD clinic, Phramongkutklao Hospital.

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: PDRI patients|The study was conducted by retrospective data collection from medical records of 135 continuous ambulatory peritoneal dialysis (CAPD) patients at Phramongkutklao Hospital from January 1, 2016 to December 31, 2020.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of peritoneal dialysis-related infection | Retrospective data collection from patients' medical records | January 1, 2016 to December 31, 2020 | 
| Treatment outcomes of peritoneal dialysis-related infection | Retrospective data collection from patients' medical records | January 1, 2016 to December 31, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causative pathogens of peritoneal dialysis-related infection | Retrospective data collection from patients' medical records | January 1, 2016 to December 31, 2020 | 
| Appropriation of antibiotic use in the treatments of peritoneal dialysis-related infection | Retrospective data collection from patients' medical records | January 1, 2016 to December 31, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Tunnel infection, Infection rate
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.

Official Title
-----------------
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

Conditions
-----------------
Is an Only Child

Intervention / Treatment
-----------------
* Drug: Clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 2 - 12 Years. Need for tonsillectomy / adenotonsillectomy. Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3. Anestesia geral com sevoflurano. Use of Intraoperative dipyrone, 30-50mg/Kg, IV. Exclusion Criteria: Changes in consciousness. Neurological Deficit. Use of another drug as medication before anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clonidine<br>Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative. | Drug: Clonidine<br>* 1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.<br>|
| No Intervention: No Clonidine<br>Usual care of Instituto de Medicina Integral Prof. Fernando Figueira. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative agitation | Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED). | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative agitation | Time in minutes. | 6 hours | 
| Need for post-anesthetic drugs for treatment of agitation | Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation. | 6 hours | 
| Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters | If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries. | 6 hours | 
| Drowsiness | Clinical evaluation: patient awake, awake, alert or patient under hypnosis. | 6 hours | 
| Parental satisfaction. | As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clonidine, Psychomotor agitation, Anesthesia recovery period, Tonsillectomy, Child, preschool
Race, Ethnicity, and Diffuse Parenchymal Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify factors that contribute to higher mortality rates among blacks and Hispanics with diffuse parenchymal lung disease.

Detailed Description
-----------------
It is well known that both socioeconomic and biological factors may contribute to race- and ethnicity-based health disparities. Black and Hispanic Americans have worse access to healthcare services and tend to receive care from physicians who cannot themselves access the same services for their patients that physicians who care for white patients can. These factors may play important roles in the development and maintenance of health disparities. In addition, biological differences may contribute to disparities. We propose to identify factors that explain survival disparities in a group of lung diseases called diffuse parenchymal lung diseases (DPLDs), including a severe form of DPLD called idiopathic pulmonary fibrosis (IPF). We will follow patients with DPLD at our center and measure both social and biological factors to try to identify the factors that lead to survival disparities between races. Results of this study will be used to design clinical trials aimed at reducing these disparities.

Official Title
-----------------
Determinants of Outcome in Diffuse Parenchymal Lung Disease

Conditions
-----------------
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Diffuse Parenchymal Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPF or other DPLD according to ATS criteria Signed informed consent Exclusion Criteria: None

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic pulmonary fibrosis, Interstitial lung disease, Diffuse parenchymal lung disease, Health disparities