linjc16/ctgov huggingface dataset:
Vitamin D Replacement: The Effect on Statin-Related Myalgias

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.

Official Title
-----------------
Vitamin D Replacement: The Effect on Statin-Related Myalgias

Conditions
-----------------
HMG-CoA Reductase Inhibitors-related Myalgias

Intervention / Treatment
-----------------
* Drug: cholecalciferol/placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days) Patients aged 19-89 years old Men and women (not of childbearing potential) Patients receiving statins with concomitant ezetimibe Exclusion Criteria: history of alcoholism or malnutrition receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 89 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly | Drug: cholecalciferol/placebo<br>* 10,000 IU by mouth weekly for 6 months<br>* Other names: Vitamin D3/placebo;|
| Placebo Comparator: Placebo<br>Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly | Drug: cholecalciferol/placebo<br>* 10,000 IU by mouth weekly for 6 months<br>* Other names: Vitamin D3/placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
Burch Colposuspension and Mid-urethral Sling Operations

Study Overview
=================
Brief Summary
-----------------
Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons. Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension. The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.

Official Title
-----------------
Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence

Conditions
-----------------
Incontinence

Intervention / Treatment
-----------------
* Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A total laparoscopic hysterectomy was planned for benign causes, Patients scheduled for simultaneous operation for incontinence Exclusion Criteria: Patients previously operated for urinary incontinence Patients whose diagnosis of stress urinary incontinence is uncertain Patients with urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| laparoscopic burch colposuspension<br>who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing laparoscopic burch colposuspension | Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes<br>* total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence<br>|
| mid urethral sling operations<br>who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing mid-urethral sling operations | Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes<br>* total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | in patients who underwent total laparoscopic hysterectomy and simultaneous incontinence surgery for benign reasons; In the early postoperative period, relapse will be evaluated at 1 month, 6 months and 12 months. | 2 years |
Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.

Official Title
-----------------
The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.

Conditions
-----------------
Marfan Syndrome

Intervention / Treatment
-----------------
* Drug: Coversyl (perindopril)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40 Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria Exclusion Criteria: Age <18, >40 Women of child-bearing potential not on adequate contraception Serum creatinine of >0.11 A history of intolerance to ACEI Patients on angiotensin receptor blockers Blood pressure >140/90mmHg History of previous aortic surgery

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Coversyl (perindopril)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aortic root diameter |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial stiffness |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
marfan syndrome, aortic root diameter
Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Study Overview
=================
Brief Summary
-----------------
Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Detailed Description
-----------------
The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Official Title
-----------------
A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Darbepoetin alfa and Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance

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

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin alfa and Epoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced incidence of transfusions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin concentration |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-myeloid malignancy, Chemotherapy-induced anemia
Engaging School and Family in Navajo Gardening for Health

Study Overview
=================
Brief Summary
-----------------
This study builds on several years of working with Navajo communities to increase gardening and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the investigators propose to develop a school garden intervention to increase fruit and vegetable consumption and reduce risk for obesity among Navajo families. The intervention will integrate: an enhanced school garden plot; a curriculum for elementary school children on gardening and healthy eating; and family engagement in the curriculum and at community gardening fairs.

Official Title
-----------------
Engaging School and Family in Navajo Gardening for Health

Conditions
-----------------
Dietary Habits, Eating Behavior, Health Behavior

Intervention / Treatment
-----------------
* Behavioral: Gardening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending School Participating in Trial Parent able to Participate
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>Behavioral Gardening Exposure | Behavioral: Gardening<br>* Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child healthy eating behaviors assessment | Assess servings of vegetables and fruits eaten per week from the picture sort frequency method using the 5 a Day questions | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Gardening Participation Survey | Survey children to see if they have a garden at home, and if so how often they do gardening activities there | 1 year | 
| Child Gardening Self-efficacy Survey | Survey children to identify how confident they are in their abilities to perform gardening behaviors, utilizing six-item likert scale | 1 year |
Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure

Detailed Description
-----------------
The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure in Patients with Obesity

Official Title
-----------------
The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure in Patients With Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Glucerna


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age：14 60years BMI ≥ 28kg/m2 without liver, kidney, gastrointestinal and other major organic serious diseases,lactating women, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 14 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucerna,Meal Replacement<br>Glucerna 52g instead of night meal 5weeks | Dietary Supplement: Glucerna<br>* Glucerna 52g meal replacement<br>* Other names: Glucerna （Abbort，SR）;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual energy X-ray absorptiometry |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lab testing |  | 5weeks |
Gene Expression in Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.

Detailed Description
-----------------
OBJECTIVES: To test whether the tumor suppressor candidate gene PDLIM2 is downregulated in human cancers such as T-cell acute lymphoblastic leukemia (T-ALL) and to use the human T-lymphotropic virus 1 (HTLV-1)-mediated in vitro transformation of human T cells as control. OUTLINE: Previously collected cancer and control tissues are analyzed for the expression patterns of PDLIM2 and other control genes. Human T-cells isolated from human blood are also co-cultured with HTLV-1-transformed T-cell lines.

Official Title
-----------------
Signaling in Tumorigenesis and Immunity

Conditions
-----------------
Leukemia, Lymphoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Specimens (e.g., tissue, blood, and bodily fluids) of various cancer cells and or tissues from de-identified patients such as T-cell acute lymphoblastic leukemia (T-ALL) Normal control tissue PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDLIM2 expression patterns in cancer and control tissues |  |  | 
| 8-week survival of human T-cell co-cultured with HTLV-1-transformed T-cell lines |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia, adult T-cell leukemia/lymphoma
Applications for Methotrexate Optimization in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to enable the study sponsor to assess the impact of a marketed or validated blood test has on physicians' clinical treatment decision making when treating RA patients who have been taking methotrexate. Ultimately, the blood test will allow treating physicians to modify current methotrexate therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an individualized basis, as a means of improving clinical outcomes. The study requires a blood sample from RA patients who have been on methotrexate therapy for a minimum of 3 months and are having an inadequate response to therapy. Physicians will then be provided with the results of the test indicating the methotrexate polyglutamate (active metabolites of methotrexate) levels in the patient's red blood cells as a means to help determine whether a patient's exposure to methotrexate has been optimized.

Detailed Description
-----------------
This study is currently enrolling individuals who have an established diagnosis of RA and are receiving methotrexate as part of their therapy. Patients are required to submit a blood sample. There is no cost to volunteers who participate.

Official Title
-----------------
Applications for Methotrexate Optimization in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Avise PG - Diagnostic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read, understand, and sign the informed consent form Able to read, write, and speak English ≥18 years of age Diagnosed with RA within past 24 months (waiver) Taking oral methotrexate therapy for a minimum of 3 months Considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing MTX dose or changing route of delivery, or adding or switching DMARDs (including but not limited to biologic DMARDs) Exclusion Criteria: Prior exposure of the study center, study physician or study patient to the Avise PG laboratory test Patients with known abnormal hepatic and or hematological parameters Use of prednisone >10mg/day (or its equivalent) Rheumatologic diagnosis other than primary RA

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 |
| --- |
|Other: Avise PG - Diagnostic test|Eligible patients will receive an Avise PG test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of the Avise PG test on physician's clinical treatment decision making process when assessing RA patients having an inadequate response to current MTX therapy. |  | Outcome is determined following the receipt of Avise PG test result |
Intra- and Inter-fraction Changes in Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor target volumes and surrounding normal organs in radiation therapy.

Detailed Description
-----------------
The accurate and detailed knowledge of the changes (e.g., anatomically/biologically intra- and inter-fraction changes) to be obtained from this study would allow the research team to determine how Adaptive Radiation Therapy (ART) should be performed for a given tumor site/type. Radiation oncologists then can choose a proper ART strategy for a given tumor type to account for the anatomic/biological intra- and inter-fraction changes, improving accuracy of radiation therapy delivery, and in turn reducing treatment related toxicities and/or improving tumor local control.

Official Title
-----------------
Intra- and Inter-fraction Changes in Radiation Therapy

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

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: °Completed radiation therapy Exclusion Criteria: °Subjects who refuse voluntary participation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiation Therapy|Radiation therapy plans for cancer patients who have completed treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of volumes from baseline of organs at risk during and after radiation therapy. | Changes of organs at risk volumes (cm^3) during and after radiation therapy. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of volumes from baseline or tumors during and after radiation therapy. | Changes of tumor volumes (cm^3) during and after radiation therapy. | 2 years |