linjc16/ctgov huggingface dataset:
Analysis of Blood and Bone Marrow to Detect Residual Disease in Patients With Previously Treated Hairy Cell Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in patients who have hairy cell leukemia. PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow to detect residual disease in patients who have previously treated hairy cell leukemia.

Detailed Description
-----------------
OBJECTIVES: I. Compare the sensitivity of flow cytometry, immunohistochemistry, and polymerase chain reaction in detecting minimal residual disease following therapy with cladribine in patients with hairy cell leukemia. OUTLINE: Blood and bone marrow samples are obtained from patients at time of bone marrow biopsies to assess minimal residual disease using flow cytometry, immunohistochemistry, and polymerase chain reaction. Patients are followed for 2 years or until disease relapse. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study over 12-24 months.

Official Title
-----------------
Detection of Hairy Cell Leukemia Minimal Residual Disease: Detection by Flow Cytometry

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

Intervention / Treatment
-----------------
* Genetic: polymerase chain reaction
* Other: flow cytometry
* Other: immunohistochemistry staining method


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Clinically documented hairy cell leukemia Active or in remission Must have received prior cladribine and be undergoing bone marrow biopsies as follow up PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy following prior cladribine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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: polymerase chain reaction|nan|
|Other: flow cytometry|nan|
|Other: immunohistochemistry staining method|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
-----------------
progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer

Study Overview
=================
Brief Summary
-----------------
A 3-year, randomized, controlled trial comparing a traditional worksite health promotion program and an activated consumer program on health practices, health status and patient activation measures.

Detailed Description
-----------------
The design is a cluster, randomized controlled trial of two companies with three arms in each company. The arms include two control groups (one from each company), two intervention groups using a standard health promotion intervention, and two intervention groups that constitute using an activated consumer intervention. The standard intervention includes educational offerings to address health behaviors. The activated consumer intervention offers shorter education sessions and includes decision tools and skills development for working with heath care providers to better manage health and clinical conditions. Variables include health risk assessments, clinical measures such as lipids, blood pressure, body mass index, and tobacco use, perception of health care consumer practices, claims costs, and absenteeism analysis.

Official Title
-----------------
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer

Conditions
-----------------
Evidence of Improved Health Status

Intervention / Treatment
-----------------
* Behavioral: Counseling in use of health care
* Behavioral: Counseling in diet, exercise
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Airline and health care employees Exclusion Criteria: Minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Counseling in use of health care<br> | Behavioral: Counseling in use of health care<br> <br> |
| Active Comparator: Counseling in diet, exercise<br> | Behavioral: Counseling in diet, exercise<br> <br> |
| Placebo Comparator: Contol group<br> | Other: Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop and evaluate a worksite-based, activated consumer intervention |  | March 2005; March 2007 |
Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions

Study Overview
=================
Brief Summary
-----------------
The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. The reasons for this include advanced age of primigravida, a wide range of indications, patient requests, the frequency of women with previous cesareans, women's rejections to offers of sterilization, and the common usage of assisted reproductive techniques

Official Title
-----------------
Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Other: Assessment of adhesions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with at least previous one cesarean section. Women accepted to participate in the study. Exclusion Criteria: Previous abdominopelvic surgery other than cesarean section. History of Pelvic inflammatory disease. Women refuse to participate in the study. Intrauterine fetal death

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple repeat cesarean (four or more)<br> | Other: Assessment of adhesions<br>* Modified Nair scoring system<br>|
| Fewer repeat cesarean (two-three)<br> | Other: Assessment of adhesions<br>* Modified Nair scoring system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of abdominal adhesions |  | 30 minutes |
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

Study Overview
=================
Brief Summary
-----------------
Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy. Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.

Conditions
-----------------
Graves Disease

Intervention / Treatment
-----------------
* Drug: Methimazole
* Drug: Methimazole
* Drug: Methimazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 graves disease(TSH<0.1 &increased FT4 & positive TSI one or more bartlena criteria for radio-iodine therapy 24 hour RAIU>25% euthyroidism after methimazole treatment Exclusion Criteria: pregnancy or lactation moderate or severe graves ophthalmopathy CHF or coronary heart disease palpable thyroid nodule lithium or amiodarone or lugol or ipodate treatment recent imaging with contrast agent very large goiter(more than 150 gram)

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group one<br>This group will be advised to discontinue methimazole 24-48 hour before iodine therapy | Drug: Methimazole<br>* Methimazole was stopped 24-48 before radio-iodine therapy<br>|
| Active Comparator: group two<br>methimazole stopped 48-72 hour before radioiodine therapy | Drug: Methimazole<br>* methimazole discontinued 49-72 hours before radioiodine treatment<br>|
| Active Comparator: group three<br> | Drug: Methimazole<br>* methimazole discontinued 73-168 hours before radio-iodine treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thyroid function tests over one year after radioiodine therapy | thyroid function test may change over one year . In order to consider the patients as cured ,thyroid function tests should reveal hypothyroidism or euthyroidism . In order to rule out temporary hypothyroidism the tests should be repeated after 6 months of radioiodine therapy. | months 1 , 3 ,6,9,12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperthyroidism, radio-iodine, I-131, methimazole, graves disease
Burden, Mortality and Supply Costs in Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

Detailed Description
-----------------
This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs). The 3 endpoints and 3 respective risk groups (high, intermediate, low) are Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4 Endpoint mortality due to severity of disease regarding Simplified Acute Physiology Score (SAPS) II score values high SAPS II > 70, suspected mortality > 40% intermediate SAPS II > 40 - 70, suspected mortality 10 - 40% low SAPS II ≤ 40, suspected mortality < 10% Endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

Official Title
-----------------
Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.

Conditions
-----------------
Burden, Dependency, Mortality, End-of-life Care, Intensive Care Unit, Critically Ill Patient, Frailty, Multiple Organ Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients dying on the ICU and all patients staying for at least 72 hours on the ICU Exclusion Criteria: No
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive care unit patient<br>All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of care | Organ dysfunctions supported or replaced in numbers | 18 months | 
| Mortality | Dying patients in numbers | 18 months | 
| Supply costs | Costs in sum of Simplified Acute Physiology Score (SAPS) II score points over ICU stay; Costs in sum of points of organ support over ICU stay; Costs in Euro reimbursed for the ICU stay | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burden, mortality, end-of-life care, intensive care unit, critically ill patient, frailty, Multiple Organ Failure
Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.

Official Title
-----------------
A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly Senior PAMI

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Thrombolytic therapy
* Procedure: Percutaneous coronary intervention (PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 70 Clinical symptoms > 30 minutes Symptom onset <= 12 hours ST segment elevation >= 1 mm in 2 or more leads Exclusion Criteria: Prior thrombolytics Cardiogenic shock Cerebrovascular accident (CVA) Prolonged cardiopulmonary resuscitation (CPR) Blood pressure (BP) > 180/100 mm Hg Active bleeding International Normalized Ratio (INR) > 1.4 Acetylsalicylic acid [aspirin] (ASA) or heparin allergy History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency Peripheral vascular disease (PVD)

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- |
|Drug: Thrombolytic therapy|nan|
|Procedure: Percutaneous coronary intervention (PCI)|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
-----------------
AMI, MI, Acute myocardial infarction (AMI), (MI)
In Vitro Maturation of Immature Oocytes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure.

Conditions
-----------------
Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Procedure: In Vitro Maturation of immature oocytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS Women with previous Hyperstimulation or with risk of developing hyperstimulation during IVF Treatment Women diagnosed with cancer who are interested in fertility preservation Women with repeated IVF failure Exclusion Criteria: Severe cases of endometriosis Large myomas Hydrosalpinxs Technical problem with previous oocytes pick-up

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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 |
| --- |
|Procedure: In Vitro Maturation of immature oocytes|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
-----------------
PCOS, Fertility Preservation, Repeated IVF Failure, S/P Hyperstimulation
Validity Study of a Nasal Valve Implant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.

Official Title
-----------------
Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.

Conditions
-----------------
Nasal Valve Collapse

Intervention / Treatment
-----------------
* Procedure: nasal valve implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has nasal valve collapse Exclusion Criteria: Pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: nasal valve implant|Injectable implantation of a biodegradable material for support of the Nasal valve.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal obstruction symptom scale |  | 1 year |
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

Official Title
-----------------
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol

Conditions
-----------------
Hypercholesterolaemia

Intervention / Treatment
-----------------
* Dietary Supplement: commercially available nutrition supplement
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome according to ATPIII criteria 3 of the following: waist circumference >88cm (in females) or >102cm (in males) triglycerides >150mg/dl HDL <40 (50)mg/dl in males (females) blood pressure>130/85 or treatment for AHT glucose >110mg/dl Exclusion Criteria: pregnancy treatment with cholesterol lowering drugs

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: commercially available nutrition supplement<br>this group receives a commercially available nutritional supplement for a period of 2 months | Dietary Supplement: commercially available nutrition supplement<br>* the food supplement contains red rice yeast and olive extract<br>|
| Placebo Comparator: control group<br>this group receives a placebo for a period of 2 months | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL level |  | 2 months | 
| total cholesterol level |  | 2 months | 
| triglyceride level |  | 2 months | 
| HDL level |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OxLDL |  | 2 months | 
| BMI |  | 2 months | 
| malondialdehyde (MDA) |  | 2 months | 
| 8-OH-deoxyguanosine (8-OHdG) |  | 2 months | 
| side effects |  | 2 months | 
| waist circumference |  | 2 months |