linjc16/ctgov huggingface dataset:
Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia. Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays. OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.

Official Title
-----------------
Implications of s-SHIP Expression and SHIP Alterations in AML

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: mutation analysis
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Relapse rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies
Vaccine Therapy for Patients With Stage IV Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Official Title
-----------------
A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: CancerVax vaccine (CANVAXIN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have Stage IV melanoma Must have had all clinically-detectable disease surgically removed Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy) Cannot have HIV or Hepatitis A, B, or C

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CancerVax vaccine (CANVAXIN)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Wheelchair Handling Skills of Caregivers: Comparison Between Anti-tip Devices and a New Design

Study Overview
=================
Brief Summary
-----------------
Currently available wheelchairs are often fitted with conventional rear anti-tip devices (C-RADs) to prevent wheelchair rear tips. The limitations of C-RADs have provided an incentive for the design of rear anti-tip devices that permit more rear tip without compromising safety (Arc-RADs). The purpose of this study is to test the hypothesis that caregivers handling occupied wheelchairs equipped with Arc-RADs have higher success rates on RAD-relevant skills than caregivers handling wheelchairs equipped with C-RADs.

Official Title
-----------------
Wheelchair Handling Skills of Caregivers: Comparison Between Conventional Rear Anti-tip Devices and a New Design

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

Intervention / Treatment
-----------------
* Device: wheelchair rear anti-tip device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older alert, able and willing to follow instructions wheelchair users: patients at the Nova Scotia Rehabilitation Centre wheelchair users:permission of physician to participate in the study caregiver:must provide at least part-time wheelchair-handling care for the wheelchair user in this study, a minimum of one hour per week on average Exclusion Criteria: wheelchair users:suffer from any unstable medical, emotional, or physiological conditions that may interfere with participation caregivers:medical condition of their upper limbs, heart or lungs that might cause them discomfort or endanger them when pushing or pulling an occupied wheelchair

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: wheelchair rear anti-tip device|assistive device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair Skills Test |  | day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheelchairs, caregivers, skills
Retrospective Study of Ovarian Cancer Patients With Brain Metastasis

Study Overview
=================
Brief Summary
-----------------
Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. In the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.

Detailed Description
-----------------
The ovarian cancer patient treated at the Department of Obstetrics and Gynecology of the National Taiwan University Hospital were retrospectively collected. The cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. The medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. Patients with other synchronous primary brain tumor were excluded. The initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. The intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (CT) and magnetic resonance imaging (MRI) scans. Therapeutic strategies for the metastatic lesions in the brain were also reviewed. All statistical analyses were performed using the SPSS 13.0 statistical software for Windows. P<0.05 was defined as statistical significance. Survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by Kaplan-Meier curves.

Official Title
-----------------
Retrospective Study of Ovarian Cancer Patients With Brain Metastasis

Conditions
-----------------
Ovarian Cancer, Brain Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ovarian cancer and brain metastasis Patients ovarian cancer from National Taiwan University Hospital Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
Micardis® in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals

Official Title
-----------------
Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential hypertension Minimum age of 18 years Exclusion Criteria: Not applicable

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 |
| --- | --- |
| Patients with normotension at baseline<br> | Drug: Telmisartan tablets<br>* All patients were treated with different doses of telmisartan for 14 days<br>* Other names: Micardis®;|
| Patients with essential hypertension at baseline<br> | Drug: Telmisartan tablets<br>* All patients were treated with different doses of telmisartan for 14 days<br>* Other names: Micardis®;|
| Patients with isolated hypertension at baseline<br> | Drug: Telmisartan tablets<br>* All patients were treated with different doses of telmisartan for 14 days<br>* Other names: Micardis®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in blood pressure | Evaluation was performed separately for three patient groups depending on their hypertension status at baseline (normotension, essential hypertension and isolated hypertension) | Up to 14 days | 
| Number of patients with adverse events |  | Up to 14 days |
Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff

Study Overview
=================
Brief Summary
-----------------
The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

Detailed Description
-----------------
Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

Official Title
-----------------
Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff

Conditions
-----------------
Premature Neonate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates wherein their parents have expressed consent to participate in trail neonates with parents who are able to understand and fill in questioners neonates with no chromosomal deficiencies and no genetic deficiency Exclusion Criteria: neonates with parents who are unable to understand and fill in questioners neonates with intraventricular bleeding IVH/PVH neonates with periventricular hemorrhage neonates with known chromosomal deficiencies or genetic deficiency

Ages Eligible for Study
-----------------
Maximum Age: 4 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premature neonate<br>premature neonate | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ◦Developmental assessment - a composite of several measures |  | ◦Time Frame: 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental assessment - a composite of several measures | Safety Issue?: No | ◦◦Time Frame: 18 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clown, neonate, premature
Role of Vitamin C to Augment Iron Chelation With DFP or DFX

Study Overview
=================
Brief Summary
-----------------
role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Detailed Description
-----------------
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Official Title
-----------------
Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation

Conditions
-----------------
Vitamin c, Thalassemia Major, Iron Chelation

Intervention / Treatment
-----------------
* Drug: Vitamin C, Defriprone, deferisarox
* Drug: deferiprone , deferesarox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subjects with overload secondary to thalassemia major Exclusion Criteria: • with HIV positive or have active HCV. A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema. Participation in a previous investigational drug study within the 30 days preceding screening. A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding. An inability to adhere to the designated procedures and restrictions of this protocol.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin c<br>25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator. | Drug: Vitamin C, Defriprone, deferisarox<br>* adjuvant vitamin c with iron chelator.<br>* Other names: DFX;|
| Other: iron chelator<br>Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator. | Drug: deferiprone , deferesarox<br>* iron chelator<br>* Other names: DFX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vit C to Augment iron chelation | assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients. | 12 months | 
| vitamin c augmenting effect of iron chelator | better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse related events | safety and occurrence of AEs in both studied groups | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin c, thalassemia major, iron chelation
Effects of Individual Intervention for Men in Focused Deterrence Program

Study Overview
=================
Brief Summary
-----------------
This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be randomized to receive an additional individual intervention based on the cognitive-behavioral Reasoning and Rehabilitation program.

Official Title
-----------------
Reducing Violence Among High Risk African American Men in Focused Deterrence Program Through Individual Support

Conditions
-----------------
Violence

Intervention / Treatment
-----------------
* Behavioral: Individual intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American male identified as at high risk for violence by the Birmingham Violence Reduction Initiative Exclusion Criteria: Mental retardation, serious mental illness (eg, psychosis)

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

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

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: Individual intervention<br>Individual intervention using cognitive-behavioral principles | Behavioral: Individual intervention<br>* Individual intervention based on a cognitive-behavioral program Reasoning & Rehabilitation<br>|
| No Intervention: Control<br>No additional intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Violence | involvement in violent incidents based on police records and self-report | 6 months |
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma

Official Title
-----------------
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Combination Product: TAI combine lenvatinib
* Drug: Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent Exclusion Criteria: cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAI+lenvatinib group<br>TAI combine lenvatinib | Combination Product: TAI combine lenvatinib<br>* TAI combine lenvatinib<br>|
| Active Comparator: lenvatinib group<br>lenvatinib only | Drug: Lenvatinib<br>* lenvatinib only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | From date of randomization until the date of death from any cause, assessed up to 60 months | 
| PFS | progression-free survival | From date of randomization until the date of progress from any cause, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | object response rate | From date of randomization until the date of death from any cause, assessed up to 60 months | 
| DCR | disease control rate | From date of randomization until the date of death from any cause, assessed up to 60 months |