linjc16/ctgov huggingface dataset:
Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
A number of prognostic and/or predictive genomic signatures for breast cancer have been developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene signatures and compare them with conventional clinical prognosticators and predictors. As the investigators plan to use archival tumor samples that dates back to the 1990s, the aim of this pilot study is to first analyze 10 anonymized samples to determine the feasibility of running these assays on old archival blocks. The information generated will help us determine whether very old samples (diagnosed before 2000) may be selected for the actual study.

Detailed Description
-----------------
Up to 10 archival breast tumor blocks will be obtained from the Department of Pathology, NUH - half of these blocks will be from patients who were diagnosed before year 2000, and the other half of the blocks will be from patients diagnosed between year 2000-2005 (control specimens). Basic tumor and patient information will be collected without patient identifiers - grade, stage, ER/PR/HER2 status, treatment received, outcome data. 8-10 ten-micron sections will be cut from each tumor block. RNA will be extracted from the tumor sections using the Roche High Pure FFPE RNA Micro Kit. RNA will be profiled using the Illumina Veracode assay and the Affymetrix Quantigene assay. RNA extraction and gene expression profiling will be performed by collabroators at the Genome Institute of Singapore.

Conditions
-----------------
Breast Tumor

Intervention / Treatment
-----------------
* Other: Breast Tumor Blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Half of these blocks will be from breast cancer patients who were diagnosed before year 2000. Half of the blocks will be from breast cancer patients diagnosed between year 2000-2005 (control specimens). Exclusion Criteria: Breast cancer patients diagnosed after year 2005.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Tumor<br>Breast Tumor Blocks | Other: Breast Tumor Blocks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Conditions
-----------------
Anemia, Hemolytic, Autoimmune, Felty Syndrome, Purpura, Thrombocytopenic, Autoimmune Diseases

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants) Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3 --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Age: Not specified Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Ejection fraction at least 40% Pulmonary: FVC, FEV1, or DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Not preterminal or moribund
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: filgrastim|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
-----------------
Felty syndrome, autoimmune hemolytic anemia, autoimmune neutropenia, hematologic disorders, immune thrombocytopenic purpura, rare disease
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study. Comparisons are: Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy. Healthy controls. Exclusion Criteria: Nicotine usage Metastatic breast cancer Need for chemotherapy AI other than anastrazole Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months) Clinically significant abnormality of thyroid function Treatment with gonadal hormone replacement therapy within last 3 years Status post unilateral/bilateral surgical oophorectomy Having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease] Medication-dependent diabetes mellitus or hypercholesterolemia. Gastric surgery Weight loss medication (prescription or over the counter)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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 |
| --- | --- |
| Anastrazole<br>Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole. | |
| Control group - 2<br>Healthy controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatase Inhibitor, Anastrazole, Arimidex, Heart disease, Lipids, Body composition, Breast cancer.
CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.

Official Title
-----------------
Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection

Conditions
-----------------
Colorectal Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years; Histologically proven colorectal cancer All the lesion (s) has been R0 resected Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests More than 1 CTC has been detected (including 1) ECOG 0-1 Hematology tests suggest that they can tolerate chemotherapy Written informed consent for participation in the trial Exclusion Criteria: Have any radiological evidence of recurrence Other previous malignancy within 5 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC. | Drug: Chemotherapy<br>* Started chemotherapy or change the current adjuvant therapy<br>|
| No Intervention: Control Arm<br>Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from randomization to death | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free time from randomization to death or recurrence | 3 year | 
| Adverse event | CTCAE adverse event of chemotherapy | 1 year |
A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

Study Overview
=================
Brief Summary
-----------------
This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.

Official Title
-----------------
A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers

Conditions
-----------------
Weight-Gain Prevention

Intervention / Treatment
-----------------
* Drug: Mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers between 18 and 40 years of age BMI between ≥ 18 and ≤ 25 Able to provide written informed consent Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits Exclusion Criteria: History of Cushing's syndrome or Addison's disease Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing Have a history of an allergic reaction to either mifepristone or olanzapine Any clinically significant abnormality on screening laboratory tests QTc Bazzett's ≥ 450 msec Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk. Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight History of recent (within 6 months of screening) significant weight fluctuation

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers. |  |  |
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

Study Overview
=================
Brief Summary
-----------------
This study will compare blood collection from the forearm using an investigational device, TAP20-C to blood collection from the finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.

Official Title
-----------------
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System

Conditions
-----------------
Diabetes, Anemia

Intervention / Treatment
-----------------
* Device: TAP20-C
* Device: SAFE-T-FILL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subject Group Male and female volunteers 18 years of age or older. Voluntary written consent to participate in this study. Diabetic Subject Group Male and female volunteers 18 years of age or older. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report. Voluntary written consent to participate in this study. Exclusion Criteria: Subjects who are pregnant or nursing mothers by self-report. Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested. Subjects with a missing index or middle finger on either hand or a missing forearm Subjects who have known allergies to titanium.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP20-C<br>TAP20-C | Device: TAP20-C<br> <br> |
| Active Comparator: SAFE-T-FILL<br>SAFE-T-FILL | Device: SAFE-T-FILL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non Inferiority of Analyte Levels | The study will compare the concentrations of glucose, hemoglobin and hemoglobin A1c in blood samples collected with the two different blood collection methods in a single 2 1/2 hour session. | Day 1 |
A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery.

Detailed Description
-----------------
1. Objectives Assess the feasibility of performing MRI scans in the treatment position for accurate treatment planning and dose delivery in spinal stereotactic body radiation therapy (spinal SBRT). Characterize the improved accuracy of image fusion between MRI and CT and its dosimetric impact when performing MRI scans in treatment position in spinal SBRT. Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (>3 consecutive vertebral body levels) Optimize the workflow of using MRI simulation in treatment planning and dose delivery.

Official Title
-----------------
A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy

Conditions
-----------------
Spinal Metastases

Intervention / Treatment
-----------------
* Other: mask for immobilization
* Other: Elekta BodyFix


Participation Criteria
=================
Eligibility Criteria
-----------------
3.1. Inclusion Criteria Greater than or equal to 18 years of age Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary Signed informed consent Willing to undergo 2 MRI simulations in one or multiple sessions, one with immobilization device, and the other without. Patients undergoing spinal SBRT 3.2. Exclusion Criteria a. Patient with a relative or absolute contraindication to MRI (such as pacemaker, etc.) b. Patients with significant instrumentation or cement at the site of interest causing artifact c. Inability to tolerate with immobilization device for greater than 30 minutes

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 |
| --- | --- |
| group 1<br>patient using mask for immobilization | Other: mask for immobilization<br>* mask for immobilization<br>|
| group 2<br>patients using Elekta BodyFix | Other: Elekta BodyFix<br>* Elekta BodyFix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performing MRI scans in the treatment position for accurate treatment planning. |  | through study completion, an average of 1 year | 
| Performing MRI scans in the treatment position for dose delivery in spinal stereotactic body radiation therapy (spinal SBRT). |  | through study completion, an average of 1 year |
Pharmacokinetics of Ghrelin

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the half life of the hormone ghrelin in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

Detailed Description
-----------------
Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R). Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels. Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease. We investigate the changes in cardiac function during ghrelin infusion in healthy subjects. The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate this aspect further. Comparisons: In a double blind, placebo controlled, cross over study we investigate the effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler, stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.

Official Title
-----------------
Pharmacokinetics of Ghrelin in Normal Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Human acylated ghrelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male BMI < 25 kg/m2 Non-smoker Age < 40 yrs Exclusion Criteria: Any known disease Any medication (except OTCs) Former malignant disease Alcoholism Blood donation (with in 6 months) Allergy to test medication

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Human acylated ghrelin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human ghrelin half life in healthy subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular indices (stroke-velocity index, TEI-index) |  |  |