linjc16/ctgov huggingface dataset:
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

Study Overview
=================
Brief Summary
-----------------
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Official Title
-----------------
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Avagard
* Drug: Purell Surgical Scrub


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female age 25 - 55 Subject agrees not to use any hand wash products on their hands other than what has been provided in the study. Subject agrees not to use any moisturizers or any skin products on their hands during the study Subject agrees to use gloves to protect hands from activities such as dish washing Subject is willing to sign the Informed Consent and HIPAA Subject agrees to comply with the study requirement Exclusion Criteria: Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands Subject has scaly skin on hands based on Visual Scoring Scale at Day 1 Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves) Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study Subject is pregnant Study coordinator believes the subject is unsuitable for inclusion in the study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avagard<br>3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers | Drug: Avagard<br>* Topical solution, 6 mL, 6 applications/day for 14 days.<br>|
| Active Comparator: Purell<br>Purell Surgical Scrub with Moisturizers | Drug: Purell Surgical Scrub<br>* Topical solution, 4 mL, 6 applications/day for 14 days.<br>* Other names: Purell Surgical Scrub with Moisturizers;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly). | Baseline and 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin health
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.

Detailed Description
-----------------
The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC. FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.

Official Title
-----------------
Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC

Conditions
-----------------
Papillary Thyroid Carcinoma

Intervention / Treatment
-----------------
* Other: BRAF detection on fine needle aspiration biopsy (FNAB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm) Undergoing thyroid surgery (histology of index nodule) Exclusion Criteria: Not undergoing thyroid surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRAF immunohistochemistry (IHC)<br> | Other: BRAF detection on fine needle aspiration biopsy (FNAB)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB) | Mutations status correlated to histological diagnoses and mutation status on histological samples | 1 day |
Epidemiology of Body Mass Index Rebound

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.

Detailed Description
-----------------
BACKGROUND: Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound. DESIGN NARRATIVE: The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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 |
| --- | --- | --- |
Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

Study Overview
=================
Brief Summary
-----------------
Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses , will be a prospective observational cohort study looking at the epidemiology of bleeding in the pediatric ICU population at MSK.

Official Title
-----------------
Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

Conditions
-----------------
Cancer, Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children (≥28 days old through 18 years of age) with an oncologic diagnosis admitted to the PICU at Memorial Sloan Kettering Cancer Center An oncologic diagnosis will include those with a cancer diagnosis or those being treated at MSK for blood disorders, immunodeficiencies and complications of transplant. Exclusion Criteria: Preterm infants (<44 weeks gestation at age of enrollment) as in these patients most bleeding etiologies are specific to the neonatal period and the bleeding assessment tool is not calibrated for this population Known limitation of care at enrollment (standing Do Not Resuscitate order), as the interventions and clinical outcome would be biased Pre-existing bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum 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 |
| --- | --- | --- |
| the incidence of severity of bleeding |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critically Ill Children, 19-407
Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device. Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm

Official Title
-----------------
Blood Pressure Monitor（Model：KD-595） Clinical Test

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal blood pressure and hypertensive patients over 12 years old Exclusion Criteria: Patients with serious arrhythmias or a high frequency of arrhythmias pregnant woman Other investigators believe that it is not suitable to participate in this clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Subject use both KD-595 Arm Automatic Electronic BPM and mercury sphygmomanometers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure monitor accuracy | All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control | 30minutes |
Antimalarial and Covid 19 in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus. These compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately active rheumatoid arthritis (RA).

Detailed Description
-----------------
The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus.(1) . These compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately active rheumatoid arthritis (RA). It is difficult to carefully evaluate the onslaught of information that has emerged regarding potential COVID-19 therapies within a few months' time in early 2020. A brief but detailed approach regarding how to evaluate resulting evidence of a study has been presented by F. Perry Wilson, MD, MSCE. By using the example of a case series of patients given hydroxychloroquine plus azithromycin, he provides clinicians with a quick review of critical analyses.

Official Title
-----------------
Antimalarial and Covid 19 in Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rheumatoid arthritis recieving hydroxychloroquine chest infection Exclusion Criteria: patients not used hydroxychloroquine

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Rheumatoid patients receiving hydroxychloroquine<br>immunoglobulin analyses of covid 19 virus in patients already on hydroxychloroquine and relation to clinical presentation and genetics | Drug: Hydroxychloroquine<br>* assess its role in the coarse of covid 19 virus infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunoglobulin mesurement | serum level | 1 month |
Sucrosomial Iron in Patients With Celiac Disease and IDA

Study Overview
=================
Brief Summary
-----------------
Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which shows a high gastrointestinal absorption and high bioavailability with a low incidence of side effects due to lack of any direct contact with intestinal mucosa. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in CD patients.

Official Title
-----------------
Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate

Conditions
-----------------
Celiac Disease, Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Dietary Supplement: sucrosomial iron
* Drug: Sulphate iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven celiac disease iron deficiency anemia Exclusion Criteria: other autoimmne diseases pregnancy psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sulphate iron<br>patients administered with sulphate iron | Drug: Sulphate iron<br>* administration of sulphate iron<br>|
| Experimental: sucrosomial iron<br>patients administered with sucrosomial iron | Dietary Supplement: sucrosomial iron<br>* administration of sucrosomial iron<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | 3 months |
Drains and Surgical Site Infections

Study Overview
=================
Brief Summary
-----------------
This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Detailed Description
-----------------
Surgical site infections (SSI) represent the most common type of nosocomial infection amongst surgical patients. They cause morbidity and mortality. Surgical Drains are commonly inserted at the end of many surgical procedures. In contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of SSI. Patterns of use of drains vary widely across surgical disciplines and individual practices. There are no uniform guidelines and standards are often rather based on tradition than on evidence. The aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of SSI in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Official Title
-----------------
The Association of Surgical Drains With the Risk of Surgical Site Infection - a Prospective Observational Study

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Procedure: Insertion of drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients Age 18 years or older General, orthopedic trauma and vascular procedures Surgical antimicrobial prophylaxis Exclusion Criteria: outpatient surgery Presence of a contraindication for cefuroxime and/or metronidazole preexisting antibiotic therapy within 14 days prior to surgery cognitive impairment combined operations including other than the above specified surgical divisions Emergency procedures with planned incision within 2 hours after indicating the procedure.

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 |
| --- | --- |
| No drainage<br>Those patients that underwent surgery and no drain was inserted at the end of the procedure | |
| Drainage<br>Those patients that underwent surgery and one or several drains were inserted at the end of the procedure. | Procedure: Insertion of drainage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | The occurrence of surgical site infection according to CDC criteria | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Site Infection, Surgical drains
An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in Patients with Major Depressive Disorder (MDD)

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects With Major Depressive Disorder for a Treatment Period of Eight Weeks

Conditions
-----------------
Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Radafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) Duration of current depressive episode 12 weeks - 24 months Patients can read and write at a level sufficient to provide a signed consent If female, patients must be practicing an acceptable method of birth control Exclusion Criteria: Patients have other psychiatric disorders that would affect patient's response to treatment Patients have not responded to two or more adequate courses of antidepressant therapy Patients cannot be currently abusing illicit drugs or alcohol Patients are not currently receiving psychotherapy Patients have received electroconvulsive therapy within 6 months prior to screening Patients are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Radafaxine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study. |  | 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW353162, Major Depressive Disorder, MDD