linjc16/ctgov huggingface dataset:
MK0457 in Patients With Leukemia (0457-003)

Study Overview
=================
Brief Summary
-----------------
In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.

Official Title
-----------------
A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Conditions
-----------------
Chronic Myelogenous Leukemia in Blast Crisis, Lymphocytic Leukemia, B Cell, Acute, Myelodysplastic Syndromes, Myelogenous Leukemia, Chronic

Intervention / Treatment
-----------------
* Drug: MK0457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part 1: Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis Part 2: Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only At least 2 weeks since the last cytotoxic therapy Acceptable renal and hepatic function Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation Exclusion Criteria: Not fully recovered from previous anti-leukemia therapy Previous allogeneic bone marrow transplant Uncontrolled congestive heart failure Myocardial infarction within the last 3 months Active or uncontrolled infection Pregnancy or lactation Currently active second malignancy, other than non-melanoma skin cancer History of hepatitis B or C, known HIV positivity, or AIDS related illness

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: MK-0457<br>Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration | Drug: MK0457<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |  | Part 1: up to 5 days, Part 2: up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematological response rate to MK-0457 as a 5-day CIV infusion |  | At the end of each cycle (up to 18 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelodysplastic Syndrome[Refractory Anemia with, Excess Blasts-1 or 2 (WHO Classification)], Chronic Myelogenous Leukemia in blast crisis
Early Warning Systems, Risk of Early Clinical Deterioration

Study Overview
=================
Brief Summary
-----------------
Primary purpose of the study was to evaluate the relationship between NEWS and VIEWS scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.

Official Title
-----------------
If Early Warning Systems Were Used, Could the Risk of Early Clinical Deterioration be Predicted and Re-admission to Intensive Care Could be Prevented

Conditions
-----------------
Early Clinical Deterioration

Intervention / Treatment
-----------------
* Diagnostic Test: Vitalpac early warning score (VIEWS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years patients who were taken back to the intensive care unit in the first 24 hours Exclusion Criteria: under 18 years old, patients undergoing postoperative intensive care, pregnant 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Vitalpac early warning score (VIEWS)|The Vitalpac early warning score (ViEWS) is an early warning system aimed primarily at prediction of the first 24-hour mortality in emergency patients and has not been used to assess intensive care unit discharge.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who were taken back to intensive care unit due to early clinical deterioration | Number of patients who were taken back to intensive care unit due to early clinical deterioration | six month |
Evaluating Strategies to Control Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
To determine the cost-effectiveness of alternative strategies for cholesterol reduction.

Detailed Description
-----------------
BACKGROUND: The availability of effective treatment for hypercholesterolemia raised the hope that millions of Americans could avoid or postpone the development of heart disease. Because the interventions were potentially effective but were also costly, the cost-effectiveness of alternative approaches to detecting and treating hypercholesterolemia had become a critical issue for health policy. The study was part of a three-grant initiative, Cost-Effective Strategies of Cholesterol-Lowering, which was recommended by the Arteriosclerosis, Hypertension, and Lipid Metabolism Advisory Committee in January, 1988 and given concept clearance at the September, 1988 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in March, 1990 and awards made in April, 1991. DESIGN NARRATIVE: Assessments were made of: effects of treatment on health outcomes (symptomatic coronary heart disease, death from coronary heart disease, and mortality from all causes); costs and effectiveness of specific dietary and pharmacological interventions; effects of delays in instituting treatment; effects of changing the interval between blood cholesterol tests on the probability and duration of treatment delay; cost and health consequences of modifying screening and treatment recommendations for other risk factors, age, and gender; population implications of screening and treatment strategies. Data from the Framingham Heart Study were used to estimate the time pattern of cholesterol levels, which was fundamental to the evaluation of changing the interval between cholesterol tests. Framingham data were also used to estimate the relation of event rates to blood cholesterol levels. Several components of the analysis were validated by testing model predictions against data from the Multiple Risk Factor Intervention Trial. The cost estimates were based on several additional sources. Individual-level cost-effectiveness estimates for several different interventions were presented along with population-level projections of the consequences of alternative strategies. The significance of altering assumptions about uncertain values, such as the long-term risks and benefits of specific medications, was tested in sensitivity analyses.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

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 |
| --- | --- | --- |
Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.

Official Title
-----------------
Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

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

Intervention / Treatment
-----------------
* Genetic: n/a - observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years. First metastatic breast cancer relapse after treatment for early stage disease A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging Patient prescribed cytotoxic, endocrine or biological therapies Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring Written informed consent Exclusion Criteria: Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia Diagnosis of brain metastases. Contraindication to magnetic resonance MR imaging

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 |
| --- |
|Genetic: n/a - observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression rate of liver metastases | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression rate of skeletal metastases | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy | 3 months | 
| Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy | 3 months | 
| Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy | 3 months | 
| Comparison of patient acceptability to whole-body CT | Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy | 3 months |
NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

Study Overview
=================
Brief Summary
-----------------
Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90 ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual healthy food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

Detailed Description
-----------------
Dietary and physical exercise counseling.

Official Title
-----------------
NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Behavioral: diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of fatty liver Exclusion Criteria: type I or type II diabetes, no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAFLD<br>diet | Behavioral: diet<br>* diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of fatty liver appearance by ultrasound |  | 6 months |
Change of Immune Cell of ARDS Patients：an Observational Study

Study Overview
=================
Brief Summary
-----------------
To evaluate change of different immune cellsduring ARDS and its impact on prognosis.

Conditions
-----------------
Intensive Care Medicine, ARDS

Intervention / Treatment
-----------------
* Other: taking blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ①sign on the acknowledged ②Diagnosis with ARDS(The Berlin definition），onset within 48hours Exclusion Criteria: ①diagnosis of hematological or immunological disease ②treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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 |
| --- | --- |
| ARDS<br>Patients admitted to ICU with diagnosis of ARDS,which happened in 48hours. | Other: taking blood sample<br> <br> |
| Control<br>Heathy vonlunteers | Other: taking blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 28-day |
Probiotics in the Treatment of Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.

Official Title
-----------------
Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Lactol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 65 diagnosis of IBS based on the Rome III criteria willingness to participate Exclusion Criteria: receiving other probiotics compound during the study receiving antibiotics during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactol<br> | Drug: Lactol<br>* The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo pill was applied 3 times a day for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months. | Up to 3 months | 
| Constipation | Constipation was assessed by Rome III questionnaire at baseline and then after 3 months. | Up to 3 months | 
| Diarrhea | Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months. | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable bowel syndrome, Functional gastrointestinal disorders, Gut flora, Probiotics
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.

Detailed Description
-----------------
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.

Official Title
-----------------
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects on Biomarkers and Safety of Bugusan (BGS) in Postmenopausal Patients With Osteoporosis.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Bugusan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values < 20 pg/ml, serum FSH values ≧ 25 mIU/mL; Patients have bone mineral density <-2.5 SD of T score at the lumbar spine (L2-L4); All patients must sign the informed consent form (ICF) prior to the trial. Exclusion Criteria: Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis; Any X-ray film that documents bone fracture within 3 month prior to the trial. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial; Use of other Chinese medicine within 2 weeks prior to the trial; Patients with significant renal function impairment (Creatinine>2mg/dl) and liver function impairment (AST and ALT > 2 x the upper limit of normal range); Patients have laboratory test abnormality, which in the investigator's opinion might confound the study; Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV); Patients have life threatening disease; Patients are allergic to any of the composition of Chinese medicine; Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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: Bugusan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML. Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Gleevec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must meet all of the following criteria: Male or Female patients 18 years and older. Patient with a diagnosis of chronic myelogenous leukemia in chronic phase Within 6 months of initial diagnosis. Received any treatment for CML for less than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. Exclusion Criteria: Late chronic phase, accelerated phase or blastic phase Taking any other investigational agents within 28 days of starting the study If sibling donors have been identified and where allogeneic bone marrow transplantation will be the first line treatment. Another primary malignancy /cancer unless it is not considered clinically significant or does not require active intervention. If patients have heart problems or complications Pregnant or breast-feeding females Severe and/or uncontrolled disease such as diabetes, chronic renal disease, etc. Chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). Diagnosis of human immunodeficiency virus (HIV) infection. Received any treatment for CML for longer than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. Patient previously received radiotherapy to greater than 25% of the bone marrow. Patient had a major surgery within 4 weeks prior to study entry

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: Gleevec|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
-----------------
CML, Chronic Myelogenous Leukemia, RIGHT Trial, US177, CSTI571