linjc16/ctgov huggingface dataset:
Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes

Official Title
-----------------
Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules

Conditions
-----------------
Safety and Cosmetic Issues in Endoscopic Thyroidectomy

Intervention / Treatment
-----------------
* Procedure: Endoscopic thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign thyroid nodules unilateral or bilateral Normal thyroid function Exclusion Criteria: malignant Thyroid Nodules Recurrent goitre Toxic goitre

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Intervention group<br> | Procedure: Endoscopic thyroidectomy<br>* Endoscopic thyroidectomy in Thyroid Nodules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Endoscopic Thyroidectomy |  | 2020_2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome of Endoscopic Thyroidectomy |  | 2020_2023 |
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

Official Title
-----------------
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Stage 3 or 4 CKD Ability to give informed consent Exclusion Criteria: Serum Calcium > 10 g/dL Serum Phosphorous > 6 g/dL On > 400 units/d Vitamin D therapy Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar) Allergic to radiocontrast dye

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol<br>After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time. | Drug: Paricalcitol<br>* 2 mcg oral Paricalcitol once per day for 7 days<br>* Other names: Zemplar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Urine Creatinine Excretion Rate | We expect the 24 hour urine creatinine excretion rate to show no differences between groups. | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance | The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods. | 1 Week | 
| Serum Creatinine | We expect serum creatinine to confirm the results of creatinine clearance. | 1 Week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Vitamin D
Fournier's Gangrene in Patient With Uncontrolled Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Detailed Description
-----------------
Fournier's gangrene is a potentially fatal emergency condition, supported by an infection of perineal and perianal region, characterized by necrotizing fasciitis with a rapid spread to fascial planes. FG, usually due to compromised host, may be sustained by many microbial pathogens. A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Official Title
-----------------
Fournier's Gangrene as a Rare Complication in Patient With Uncontrolled Type 2 Diabetes Treated With Surgical Debridement: a Case Report and Literature Review

Conditions
-----------------
Fournier Gangrene

Intervention / Treatment
-----------------
* Procedure: surgical debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Fournier's Gangrene Insulin dependent diabetes (type 2) Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical debridement|The surgical team performed an extended surgical debridement to healthy tissue of external genital, as well as perineal, perianal, and infrapubic regions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants | Number of patients enrolled by the emergency room. | From 3 November 2020 at 23 November 2020 | 
| Fournier's gangrene evolution after treatment | Evolution of gangrene after surgical debridement of perineal and perianal regions. | 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fournier's gangrene, Type 2 diabetes, surgical debridement
Safety Profile of Nulojix in Home Infusion Settings

Study Overview
=================
Brief Summary
-----------------
The study is a retrospective cohort study that utilizes medical records from the BiologicTx. Data accrual starts upon initial home infusion nurse visit until the most recent home infusion nurse visit. Infusion related adverse events are quantified as number of patients with adverse event over the total number of patients and number of event over total number of home infusion visits.

Official Title
-----------------
Safety Profile of Nulojix in Home Infusion Settings

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

Intervention / Treatment
-----------------
* Drug: Nulojix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx home infusion service settings

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings |  | 24 hours after the date of a home infusion visit |
Radioimmunoimaging of AL Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed Description
-----------------
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Official Title
-----------------
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

Conditions
-----------------
AL Amyloidosis

Intervention / Treatment
-----------------
* Biological: 124I-labeled monoclonal antibody Mu 11-1F4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of AL Amyloidosis Exclusion Criteria: New York Heart Association class IV patient on renal dialysis serum antibodies to mouse protein

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I-124 Mu 11-1F4 sterile injection<br>Single arm study | Biological: 124I-labeled monoclonal antibody Mu 11-1F4<br>* Single infusion of radiolabeled antibody: 2mCi (1 mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioimmunoimaging of AL amyloid deposits |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging of amyloid deposits as determined by PET/CT |  | 10-14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radioimmunoimaging, AL Amyloidosis, PET/CT
Hepatitis C Testing in VA Community-Based Outpatient Clinics

Study Overview
=================
Brief Summary
-----------------
The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.

Detailed Description
-----------------
The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1) increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or other markers of social disparity influence completion of HCV testing and linkage to specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to treatment evaluation, management of comorbidities and contraindications, and subsequent initiation.

Official Title
-----------------
Hepatitis C Testing in VA Community-Based Outpatient Clinics (QUE 15-284)

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: quality improvement intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans Born in the period of 1945-1965 (birth cohort) With an outpatient visit in primary care at a VISN1 facility in FY 2016 Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quality improvement intervention<br>The intervention activities included: assessment, planning, stakeholder engagement, education, ongoing process monitoring, program adaptation, problem identification and problem solving, data audit/feedback, program marketing, network development, among others. | Other: quality improvement intervention<br>* The intervention activities included: assessment, planning, stakeholder engagement, education, ongoing process monitoring, program adaptation, problem identification and problem solving, data audit/feedback, program marketing, network development, among others.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV Antibody Test | Number of Participants with HCV Antibody Test | within 30 days of outpatient primary care visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C
Study Evaluating Etanercept in Moderate to Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma

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

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe persistent asthma for at least 1 year Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted Subjects must be on a high-dose inhaled corticosteroid (ICS) Exclusion Criteria: Previous treatment with etanercept Current use of cigarettes Significant concurrent medical conditions at the time of screening

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Anti-Asthmatic Agents, Receptors, Tumor Necrosis Factor
Lupus Cohort--Thrombotic Events and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).

Detailed Description
-----------------
BACKGROUND: The Johns Hopkins Lupus Cohort, begun by Dr. Petri in 1987, was a longitudinal study of the incidence and pathogenesis of thrombotic events and coronary artery disease in SLE. The usual natural history of thrombotic events and coronary artery disease is telescoped in SLE, so that patients present with these outcomes in their third and fourth decades. DESIGN NARRATIVE: Risk factors addressed in the study included: 1) the hypercoagulable state secondary to antiphospholipid antibodies (the lupus anticoagulant and anticardiolipin antibody); 2) premature atherosclerosis, accelerated by prednisone and hypertension; 3) underlying vascular damage from lupus vasculopathy and vasculitis; 4) co-morbid factors, including obesity, smoking, hyperlipidemia, hypertension, sedentary life style, and family history of coronary artery disease, and 5) other factors, including sex, age, race, immunogenetics, compliance with medication, and socioeconomic status. The Hopkins Cohort Study was uniquely able to focus on these issues, both because of its population, which reflected a broad racial, educational, and socioeconomic background, and because the four years of data accumulated showed promising preliminary results. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Thrombosis, Heart Diseases, Lupus Erythematosus, Systemic

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
* Drug: BSS Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply.

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 |
| --- | --- |
| Experimental: NGOIS<br> | Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|
| Active Comparator: BSS Plus<br> | Drug: BSS Plus<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in endothelial cell density |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected logMAR visual acuity |  |  |
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

Study Overview
=================
Brief Summary
-----------------
This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.

Official Title
-----------------
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial

Conditions
-----------------
Plaque Induced Gingivitis

Intervention / Treatment
-----------------
* Other: green tea mouthwash
* Other: green tea mouthwash
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH) Age from 18 - 35 years Generalized plaque-induced gingivitis (GBI > 85%) Exclusion Criteria: Patients with any systemic diseases Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy) Pregnant or breast-feeding patients Smokers Periodontitis patients Patients who received any form of periodontal therapy within the last 6 months Patients who were under antibiotic therapy the past month Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Other: green tea mouthwash<br>* green tea bags in 100 ml warm water for 5 min<br>|
| Experimental: Group B<br> | Other: green tea mouthwash<br>* , in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.<br>|
| Placebo Comparator: Group C<br> | Other: placebo<br>* Plain water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque control record |  | over 27 days | 
| gingival bleeding index |  | over 27 days |