linjc16/ctgov huggingface dataset:
Rituximab in Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.

Official Title
-----------------
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease Exclusion Criteria: ECOG (Eastern Cooperative Oncology Group) performance status > 2 Ocular melanoma Immunodeficiency syndromes or hypogammaglobulinaemia Active autoimmune diseases Treatment with immunosuppressive agents other than steroids Depressed bone marrow function (Leukopenia <3000, platelet count <100.000) Cardiac insufficiency NYHA (New York Heart Association) IV active Hepatitis B,C, or HIV infection Pregnancy or lactation Interstitial pulmonary disease Former treatment with anti-CD20 antibody

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rituximab<br> | Drug: rituximab<br>* induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.<br>* Other names: rituxan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free interval |  | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 42 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system.

Detailed Description
-----------------
Standing position is a routine therapeutic tool for improving bone density in children with cerebral palsy. The autonomous immediate response for these children is defective. In recent years it has been shown that there is an association between bone density and autonomic function . In this paper the investigators will examine how the addition of movement to standing subjects contribute to changes in heart rate and blood pressure. The hypothesis is that the integration of movement while standing presents a change in the autonomic response and thus may improve bone density.

Official Title
-----------------
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Innowalk cycling system
* Device: APT cycling system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Motor ability of GMFCS IV-V Exclusion Criteria: Children with hip subluxation On Baclofen inhaler treatment Heart disease surgical procedures

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Supine position<br>Children tested while lying down | |
| No Intervention: Standing position<br>Children tested while standing | |
| Experimental: Cycling supine postion<br>Children lying down with APT cycling system | Device: APT cycling system<br>* APT is used as a rehabilitative device that cycles the feet automatically or by the individual<br>|
| Experimental: Cycling standing postion<br>Children standing with Innowalk cycling system | Device: Innowalk cycling system<br>* Innowalk is a unique, motorized medical device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | 10 minutes each position | 
| Blood pressure monitoring |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, passive cycling, autonomic control system
Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy

Conditions
-----------------
Familial Hypertrophic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: left ventricular maximal wall thickness ≥ 15mm on echocardiography hypertrophic cardiomyopathy patients' relatives Exclusion Criteria: other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease) who deny the study entrance, especially in patients' relatives

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| familial hypertrophic cardiomyopathy<br>familial hypertrophic cardiomyopathy patients and their relatives | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) DNA analysis | 1) Identify susceptible genes for familial hypertrophic cardiomyopathy in Korean | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2) Prognosis of familial hypertrophic cariomyopathy | 2) all-cause mortality, hospitalization for heart failure progression, stroke, heart transplantation | 1 year |
Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

Official Title
-----------------
Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery

Conditions
-----------------
Delirium in Old Age, Sleep Disturbance, Circadian Rhythm Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self identify as Hispanic/Latino or preferred language as Spanish Undergoing scheduled elective and urgent cardiothoracic surgery 50 years of age and older Exclusion Criteria: Inability to consent preferred language other than English, Spanish or Portuguese emergency surgery anticipated discharge < 48 hours Individuals < 50 years of age Pregnant women Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Hispanic/Latino patients undergoing cardiothoracic surgery<br>Observational study of patients scheduled for cardiothoracic surgery as part of standard of care. Patients will be followed up to 30 days prior to surgery and up to 7 days after surgery or hospital discharge, whichever is sooner. Patients preoperative sleep patterns and postoperative delirium will be followed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery | Delirium will be assessed using the Confusion Assessment Method. | Up to 7 days post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with preoperative sleep disturbance | Sleep disturbance as measured by actigraphy data using a wrist-actigraph | Up to 7 days before surgery | 
| Pittsburgh Sleep Quality Index (PSQI) score | Pittsburgh Sleep Quality Index (PSQI) score with overall score ranging from 0-21, where lower scores indicate a higher sleep quality. | baseline | 
| Insomnia Severity Index (ISI) score | Insomnia Severity Index (ISI) score has a total score ranging from 0 to 28, with higher scores signifying greater insomnia severity. | baseline | 
| Epsworth Sleepiness scale (ESS) score | Epsworth Sleepiness scale (ESS) score has a total score ranging from 0 to 24, with a higher score indicating greater daytime sleepiness. | baseline | 
| STOP-BANG Score | STOP-BANG Score has a total score ranging from 0 to 8, with higher scores indicating a higher risk of obstructive sleep apnea. | baseline | 
| Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism. | Assess from blood samples. | baseline |
Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to learn how accessible JEEVA is for patients during the perioperative period (the time after the pre-operative surgical appointment, and up to 30 days after surgery

Detailed Description
-----------------
Objectives: Demonstrate feasibility of use for a mobile device-based application to provide perioperative resources and support in a multimedia format to breast surgery patients Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)

Official Title
-----------------
Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients

Conditions
-----------------
Breast

Intervention / Treatment
-----------------
* Other: JEEVA (new digital health navigator app)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects eligible for this study include breast surgical patients 18 years of age and older evaluated at the Texas Medical Center campus in the Nellie B Connally breast center or in the Houston Area Locations (HALs). This includes patients undergoing excisional biopsy, segmental mastectomy, total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, sentinel lymphadenectomy, targeted axillary lymphadenectomy, axillary lymphadenectomy, and axillary reverse mapping. Exclusion Criteria: Patients who do not have a smartphone), which utilizes iOS or Android operating systems, Patients who have visual impairment or blindness, which precludes effective utilization of an app, will be excluded. Patients whose surgical planning is discussed by telephone outside of an in-person pre-operative visit, will be excluded from the study. Patients who have cognitive impairment will be exclude

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 |
| --- | --- |
| an application-based digital navigator<br>JEEVA is a new digital health navigator app. This app can be used on a mobile phone or tablet. JEEVA has all of the surgical teaching information from the traditional paper packet and also has additional resources like brief videos, checklists, and reference photos. | Other: JEEVA (new digital health navigator app)<br>* An app can be used on a mobile phone or tablet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ) |  | through study completion, an average of 1 year |
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

Detailed Description
-----------------
The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.

Official Title
-----------------
A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: OSI-461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. No previous therapy for CLL. Expected remaining life span greater than or equal to six months. 18 years or older. Willingness and ability to sign an informed consent. Exclusion Criteria: Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. History of other malignancy which could affect the diagnosis or assessment of OSI-461. Previous therapy for CLL. Use of an investigational medication or device within one month of initiating study therapy. Concurrent immunotherapy. Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). Any condition or any medication which may interfere with the conduct of the study. Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. Evidence of CNS involvement. Pregnant or nursing women.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OSI-461|nan|

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
-----------------
chronic leukemia, leukemia, CLL
A Study on the Intraject Instructions for Use

Study Overview
=================
Brief Summary
-----------------
This study is designed to create an instruction set simple enough to be understood by migraine subjects as they were experiencing miagraine attacks.

Official Title
-----------------
Zogenix Intraject Instructions for Use Pilot Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Written Informed Consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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
-----------------
Healthy volunteers
Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan

Study Overview
=================
Brief Summary
-----------------
The linkage between viral hepatitis and renal failure is complex. The current study aims to exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan

Detailed Description
-----------------
Patients are prospectively recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan. Patients who provided informed consents for blood tests including genetic study related to HCV spontaneous seroclearance are enrolled for analysis. All the eligible subjects are tested for both HCV antibodies (third-generation, enzyme immunoassay; Abbott Laboratories, North Chicago, IL) and hepatitis B surface antigen (HBsAg). HCV RNA is tested by polymerase chain reaction (Cobas Amplicor Hepatitis C Virus Test, V.2.0; Roche Diagnostics, Branchburg, New Jersey, USA; detection limit: 50 IU/ml) twice for at least 6 months apart if anti-HCV is positive to ensure chronicity of HCV infection. HBsAg is quantified with the use of a standard quantitative chemiluminescent microparticle immunoassay (ARCHITECT HBsAg, Abbott Diagnostics). The concentration of HBsAg in the specimen is determined using a previously generated Architect HBsAg calibration curve (range, 0.05-250 IU/mL). Samples with serum HBsAg titer >250 IU/mL were diluted at 1:20 and 1:500 with the Architect HBsAg diluent and retested to expand the upper limit of the dynamic range from 250 to 125,000 IU/mL. Serum HBV DNA is determined by a standardized automated quantitative PCR assay (Cobas Amplicor HBV Monitor; Roche Diagnostics; detection limit 200 copies/ml) if patients are seropositive for HBsAg.

Official Title
-----------------
Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan

Conditions
-----------------
Uremia, Viral Hepatitis

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uremic patients Exclusion Criteria: Nil
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uremic patients<br>blood sampling of viral hepatitis in uremic patients | Other: blood sampling<br>* blood sampling of viral hepatitis to determined seroprevalence in uremic patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprevalence of viral hepatitis in uremic patients |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors associated with HCV clearance or reappearance |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uremia, HBV, HCV, seroclearance
Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.

Official Title
-----------------
Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

Conditions
-----------------
Gestational Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women of self-identified African descent (black) and European (white) ancestry 18-40 years of age Regular menstrual cycles 5 or less years postpartum Have either a normal or a GDM index pregnancy history Are in good health free of thyroid, cardiac, or renal disease Exclusion Criteria: If you are pregnant If you are lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Black women with history of pregnancy/ies complicated by gestational diabetes mellitus | |
| 2<br>Black women with history of normal, uncomplicated pregnancy/ies | |
| 3<br>White women with a history of pregnancy/ies complicated by gestational diabetes. | |
| 4<br>White women with a history of normal, uncomplicated pregnancy/ies. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gestational diabetes mellitus, cardiovascular disease risk, heart disease risk