linjc16/ctgov huggingface dataset:
Chronic Lymphocytic Leukemia Responds to Dermal Chelation

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to identify 50 participants with Chronic Lymphocytic Leukemia (CLL) and follow their total white blood cell (WBC) counts and absolute lymphocyte counts after performing dermal chelation and administering nutritional therapy

Detailed Description
-----------------
The purpose of this clinical trial is to use dermal chelation and hair tissue analysis to identify 50 participants with CLL. The total wbc counts and absolute lymphocyte counts of these participants will be followed after serial dermal chelations and nutritional therapy.

Official Title
-----------------
Dermal Chelation Lowers White Blood Cell Count in Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Device: Dermal Chelation
* Dietary Supplement: Nutritional Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Chronic Lymphocytic Leukemia and has a toxic heavy metal load Toxic heavy metal load Exclusion Criteria: Pregnant Pacemaker implants Organ transplant recipients Psychotic episodes or epileptic seizures

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
Interventional Model Description: Clinical trials with a single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Group receiving dermal chelation and nutritional therapy | Device: Dermal Chelation<br>* Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.<br>Dietary Supplement: Nutritional Therapy<br>* Vitamins and minerals that will be taken one or more times a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial Total White Blood Cell Count | Total WBC counts taken on a regular interval. | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, Chronic Lymphocytic Leukemia, Dermal Chelation, Nutritional Therapy
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.

Detailed Description
-----------------
The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.

Official Title
-----------------
Specified Drug Use-Results Survey on Long-Term Treatment for Prograf® Capsules 0.5 mg, 1 mg Lupus Nephritis

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
patients receiving tacrolimus for the treatment of lupus nephritis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tacrolimus group<br>Oral | Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of renal events (renal failure and progression to dialysis) |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary protein |  | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year | 
| Urinary red blood cell (RBC) count |  | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year | 
| Serum creatinine |  | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term treatment, tacrolimus, renal failure
Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

Detailed Description
-----------------
BACKGROUND: As medical treatments for coronary heart disease have become more sophisticated, they have also become more costly. Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients' quality of life, including return to work and to normal levels of functioning, has been mixed. At the same time. recent data suggest that psychosocial factors, such as social isolation and depression, are important predictors of morbidity and mortality in coronary heart disease patients. These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients. To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients, the human and financial costs associated with coronary heart disease can be reduced. The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992. The initiative was given concept clearance by the October 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in September 1994. DESIGN NARRATIVE: The study design compared a psychosocial intervention group, in which patients were provided with social and psychological treatment designed to decrease social isolation and depression, with a standard medical care group. The combined endpoint was death and reinfarction, measured for up to 4.5 years following hospital discharge. Secondary endpoints included assessment of health quality of life (HQL). The protocol was approved in May 1996. Recruitment began in October 1996 and ended on October 31, 1999 with 2,481 patients enrolled.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Depression, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
-----------------
* Behavioral: social support


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented MI and who are depressed and/or have low social support. Patients must be enrolled with 28 days of the index MI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: social support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of a Polymorphism in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA. PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer. Secondary Determine the incidence of this polymorphism in African-American patients with prostate cancer. OUTLINE: This is a retrospective, multicenter study. DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern. PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.

Official Title
-----------------
Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: polymerase chain reaction
* Genetic: polymorphism analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of prostate cancer OR healthy participant Patient enrolled on an IRB-approved clinical trial at the National Cancer Institute or Northwestern University, including, but not limited to, any of the following: NCI-99-C-0052 NCI-95-C-0178 NCI-00-C-003 NCI-00-C-0080 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: polymorphism analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
OCS Liver Perfusion (OLP) Post-Approval Registry

Study Overview
=================
Brief Summary
-----------------
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

Detailed Description
-----------------
OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Official Title
-----------------
OCS Liver Perfusion (OLP) Post-Approval Registry

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Device: OCS Liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System Donor Exclusion Criteria: Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or Split donor liver; or DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or DCD donors age >55 years; or DCD donor liver with macrosteatosis of >15% Living donors Donors with positive serology for HIV, Hep B and C Donors with macrosteatosis of ≥40% Recipient Exclusion Criteria: Fulminant liver failure; or Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or Chronic renal dialysis at time of transplant; or Dependency on more than 1 inotropic agent to maintain hemodynamics; or Ventilator dependent at time of transplant.

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 |
| --- | --- |
| OLP Registry primary analysis population<br>Adult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria | Device: OCS Liver<br>* Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival | 1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant. | 1 year post-Liver transplant |
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Study Overview
=================
Brief Summary
-----------------
Study Design : - A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Detailed Description
-----------------
Primary Objective: - To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Official Title
-----------------
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Amlodipine plus Losartan
* Drug: Amlodipine, Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 years Healthy Caucasian volunteers Non smokers or mild smokers Exclusion criteria: Pregnancy and/or breast-feeding Participation in another clinical trial within 60 days prior to Period 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine plus Losartan<br> | Drug: Amlodipine plus Losartan<br>* Amlodipine/Losartan high dose<br>|
| Active Comparator: Amlodipine, Losartan<br> | Drug: Amlodipine, Losartan<br>* Amlodipine, Losartan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmax |  | 0-144hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amlodipine, Losartan
Influence of Rapydan on Clinical Chemistry and Hematology Measurements

Study Overview
=================
Brief Summary
-----------------
There is an increasing awareness of the importance of treating procedure-related pain. Patients undergoing vascular access procedures are often afraid of needles and the discomfort associated with injections. This type of pain and/or fear can be stressful to patients. [1] For prevention of the pain associated with these procedures, the hospital is using Rapydan plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan produces topical anesthesia after an application time of 30 minutes and is used in the Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood draining the anaesthetized skin contains a higher blood concentration of the local anesthetics than does venous blood in other parts of the body [2] Although the concentrations of the local anesthetics are low in patients with normal skin, the question is whether the presence of the local anesthetics which Rapydan contains might influence routine measurements in clinical chemistry and hematology.

Official Title
-----------------
Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Rapydan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers 20-60 years who are decision making competent Exclusion Criteria: Patients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rapydan<br>Internal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan. | Drug: Rapydan<br>* lidocaine / tetracaine 70/70 mg patch<br>* Other names: Lidocaine Tetracaine Patch;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine Clinical Chemistry measurements differences |  | 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer

Detailed Description
-----------------
This protocol is intended to provide access to bemarituzumab (FPA144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on FPA144-001. That study is closing and this expanded access protocol allows this single patient to continue receiving this agent.

Official Title
-----------------
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer

Conditions
-----------------
Recurrent Bladder Cancer

Intervention / Treatment
-----------------
* Drug: FPA144


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand and sign an Institutional Review Board-approved informed consent form prior to receiving bemarituzumab Previously enrolled on the FPA144-001 study, received bemarituzumab and obtained clinical benefit from the investigational product (IP) administration Exclusion Criteria: 1. Pregnancy and lactation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FPA144|Bemarituzumab administration every two weeks|

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
-----------------
Single patient
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions

Study Overview
=================
Brief Summary
-----------------
A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.

Official Title
-----------------
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions

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

Intervention / Treatment
-----------------
* Procedure: Molecular Breast Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size. Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound. Exclusion Criteria: Are unable to understand and sign the consent form Are pregnant or lactating Are physically unable to sit upright and still for 40 minutes Have undergone bilateral mastectomy Are not scheduled to undergo conventional ultrasound

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with lesion on MBI<br>Women with lesion on MBI | Procedure: Molecular Breast Imaging<br>* Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.<br>* Other names: MBI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality. | Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, molecular breast imaging, breast, breast lesion