linjc16/ctgov huggingface dataset:
Natural History Study of Azathioprine Adherence

Study Overview
=================
Brief Summary
-----------------
This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.

Detailed Description
-----------------
The study is complete. Patient recruitment is closed and active patient involvement in the study has ended. Statistical analysis of monitor records and new patient outcome data continues

Official Title
-----------------
Measurement of Compliance in Renal Transplant Recipients

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipient Discharged from hospital with functioning graft,not on dialysis Prescribed azathioprine Exclusion Criteria: Unable to give informed consent Non English speaking Previous or concurrent organ transplant other than kidney Taking liquid form of azathioprine Followed outside of the United states

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Renal transplant recipient<br>Recipients of successful renal transplant | Other: observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute transplant rejection |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft loss |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

Study Overview
=================
Brief Summary
-----------------
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.

Official Title
-----------------
Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide

Conditions
-----------------
Emesis

Intervention / Treatment
-----------------
* Drug: olanzapine
* Drug: metoclopramide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS signed IC Exclusion Criteria: psychiatric disorders drug abuse pregnancy high dose chemotherapy treatment with other antiemetic drugs

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olanzapine<br> | Drug: olanzapine<br>* 1x10mg per day for three days<br>* Other names: Zyprexa;|
| Active Comparator: metoclopramide<br> | Drug: metoclopramide<br>* 3x10mg per day for three days<br>* Other names: Paspertin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate | no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50% | three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | according to NCI-CTC-AE version4.0 | five days | 
| Quality of life | using EORTC-QLQ-C30 | 5 days | 
| change in urinary excretion of 5 hydroxy indole acetic acid | measurement in 24 hours urine samples | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
break-through, emesis, break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant
Uncovering Potential Breast Cancer Biomarkers Amp; Possible Drug Targets Using Advanced Quantitative Mass Spectrometry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to compare the protein profile between different subtypes of breast cancer (ER positive, HER2 positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2 positive, and triple negative tumors. Samples will be analyzed using advanced Mass Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that may be important in cancer. DNA and RNA will also be extracted from tumor samples for correlative analysis with the proteomics data. Genomics and proteomics data will be correlated with clinical data including treatment response and survival data. Importance of proposed research to science or medicine:Identification of tumor biomarkers may allow better prognostication, follow-up, and selection of treatment for cancer patients in the future. Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is minimal as there is no direct patient contact, and analysis is done on previously donated tumor samples. Patients have previously provided consent to donate their samples for research into the NUHS Tissue Repository. Novel tumor biomarkers that determine tumor biology, including prognosis and treatment sensitivity, may be detectable using the novel advanced quantitative mass spectromy method (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles analyzed using super SILAC.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer
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 |
| --- | --- | --- |
| Evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor | SILAC is a method of advanced quantitative mass spectometry that allows whole proteome analysis as comprehensively as transcriptome analysis. It allows quantification of whole-proteome, measure post-translational modifications and map complete interactome of a protein. Super-SILAC, an improvement of the SILAC method, enables the comparison of the amounts of hundreds or thousands of proteins from a particular tissue between different patients. This technology may enable the discovery of novel tumor protein markers that may be important in tumor progression and treatment response. |  |
Home Parenteral Nutrition in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.

Detailed Description
-----------------
This is a prospective descriptive non-randomized clinical study to examine quality of life outcomes and use of pain and anti-emetic therapy for patients receiving HPN support. The EORTC QLQ-C30 will be used to evaluate quality of life. All subjects will be monitored monthly throughout the course of treatment for a minimum of 3 months and a maximum of 1 year.

Official Title
-----------------
An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Home Parenteral Nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a cancer diagnosis who have been receiving parenteral nutrition in the hospital or have started on HPN while at Cancer Treatment Centers of America and meet the criteria for home parenteral nutrition. Patient expected to have a life expectancy of greater than 90 days post discharge. Exclusion Criteria: Patients less than 18 years of age HPN patients who do not receive nutrition assessment and follow-up by the Coram Healthcare nutrition support team Refuse to participate

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 |
| --- | --- |
| Home Parenteral Nutrition<br>Patients receiving home parenteral nutrition | Dietary Supplement: Home Parenteral Nutrition<br>* Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage<br>* Other names: Intravenous nutrition;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30 | Monthly for a minimum of 3 months to a maximum of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and nausea medication usage | To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally. | Monthly for a minumum of 3 months to a maximum of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parenteral Nutrition, Quality of Life
Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

Study Overview
=================
Brief Summary
-----------------
The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries. Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from  random  flaps to  propeller  flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension. The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.

Official Title
-----------------
A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Procedure: Flap covering for pressure ulcer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major Patient Patient with trochanteric, ischiatic or sacral pressure ulcer Patient who undergone flap surgery for pressure ulcer between January 1st, 2015 and December 31st, 2019 Exclusion criteria: Other loss of substance than pressure ulcer Combined covering with a random flap and a propeller flap Surgical revision of a flap without a new flap

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Propeller flaps<br>Patients who undergone propeller flap surgery | Procedure: Flap covering for pressure ulcer<br>* Flap covering for pressure ulcer<br>|
| Random flaps<br>Patients who undergone random flap surgery | Procedure: Flap covering for pressure ulcer<br>* Flap covering for pressure ulcer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate | Comparing failure rates between the two surgical techniques | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | Comparing complications rate between the two surgical techniques | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcer, Flap, Random, Propeller, Paraplegic, Surgery
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia

Official Title
-----------------
A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Simvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of managed care plan for hypercholesterolemia Fasting blood lipid levels as defined by the protocol Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Blood lipid levels above the limits defined in the protocol. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Simvastatin | Drug: Simvastatin<br> <br> * Other names: Zocor;|
| Active Comparator: 3<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin |  | 6 & 12 weeks | 
| Safety: adverse events & abnormal laboratory markers |  | 6 & 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, Zocor, simvastatin
Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),

Detailed Description
-----------------
The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Official Title
-----------------
Prospective Bone Metastases Database

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Procedure: intramedullary fixation or endoprosthetic reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction Exclusion Criteria: Patients with bone metastases of the spine
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intramedullary fixation or endoprosthetic reconstruction|Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction | The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in patients undergoing surgery for metastatic bone disease | Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests | 24 months |
Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing cardiovascular events in combination with statin therapy.

Official Title
-----------------
Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22)

Conditions
-----------------
Actue Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: PRAVASTATIN SODIUM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization for MI or high risk unstable angina within the last 10 days. Total cholesterol 240 mg/dl or greater. Stabilized post ACS Exclusion Criteria: Co-morbidity with life expectations no more than 2 years. Current lipid lowering therapy Corrected QT interval Need for Class IA or III antiarrhythmic agent

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRAVASTATIN SODIUM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the clinical equivalence of pravastatin 40 mg and atorvastatin 80 mg in reducing death or major cardiovascular event after 2 years |  |  | 
| To demonstrate in subjects with ACS that Gatifloxacin is effective in reducing death or major cardiovascular event after 2 years, compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the risk of nonfatal MI or coronary heart disease death between pravastatin and atorvastatin, and gatifloxacin and placebo. |  |  |