linjc16/ctgov huggingface dataset:
LMBA02 Protocol for Patients With a Burkitt Lymphoma

Study Overview
=================
Brief Summary
-----------------
To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.

Conditions
-----------------
Burkitt Lymphoma

Intervention / Treatment
-----------------
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 18 years or older Histologically or cytologically proven Burkitt lymphoma according to the WHO classification WHO performance < 3 Informed consent Exclusion Criteria: Known HIV positive infection Positive serology for HCV and HBV (except after vaccination) Patients previously treated for lymphoma cardiac disease that contradict anthracycline chemotherapy Psychological or psychiatric condition who contradict steroids therapy Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L) Cirrhosis or severe hepatic failure unrelated to the lymphoma Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Primary organ transplant or other immunosuppressive conditions Pregnancy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival from date of first randomization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete and partial response rate, overall survival, toxicity |  |  |
Vitamin B6 on Relieving Linezolid-associated Cytopenias

Study Overview
=================
Brief Summary
-----------------
Linezolid is the first approved synthetic oxazolidinone that is active against multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid is widely used in clinical treatment. However, the side effects of linezolid commonly lead to anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can relieve anemia and thrombocytopenia. The present study was designed to verify the effects of Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its mechanism.

Detailed Description
-----------------
Infected patients receiving linezolid therapy are divided into two groups, i.e. the linezolid group and the linezolid + vitamin B6 group, the line of division being whether vitamin B6 is to be applied or not in the course of treatment. The purpose is to evaluate the role that vitamin B6 plays, during the process of linezolid therapy, in the relief of erythropenia and cytopenias.

Official Title
-----------------
The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias

Conditions
-----------------
Cytopenias, Erythropenia (Diagnosis)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of linezolid is not less than 3 days Exclusion Criteria: Serious adverse reactions
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linezolid+vitamin B6<br> | |
| Linezolid<br> | |

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
-----------------
Linezolid, Vitamin B6, Linezolid-associated cytopenias
Cannabinoid Receptor Function & Alcoholism

Study Overview
=================
Brief Summary
-----------------
This study attempts to characterize the effects of tetrahydrocannabinol (THC). Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, ganja, or pot. This study will involve healthy volunteers who 1) have no history of alcoholism in their family or 2) have a family history of alcoholism. This study looks at individuals with or without a family history of alcoholism to determine if there is a difference between the two groups in the response to THC.

Official Title
-----------------
Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC

Conditions
-----------------
Alcoholism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposure to cannabis at least once Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking a full joint Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual)IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol.Equivalent to smoking 1/10 of a joint | Drug: THC<br>* High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking a full joint Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking 1/10 of a joint<br>|
| Placebo Comparator: Placebo<br>Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon). | Drug: Placebo<br>* Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale (High rating), Rey Auditory Verbal Learning Test |  | Baseline, +15, +25 (RAVLT only), +70, +240 |
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.

Conditions
-----------------
Pancreatic Tubular Adenocarcinoma

Intervention / Treatment
-----------------
* Biological: MIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG performance status 0-2 at the time of inclusion Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment Exclusion Criteria: Pregnancy Less than 3 mths expected survival Serious comorbidity Age above 70 yrs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell infusion<br> | Biological: MIS<br>* Cell infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROGRESSION FREE SURVIVAL |  | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic tubular adenocarcinoma adjuvant setting
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of nocturnal administration of Anti-hypertensive medications in Non-dippers. Efficacy variables. ECHO 24hr. horter IMT BUN/crea, urine analysis (microalbulinuria Cardio vascular event. 

Official Title
-----------------
Effect of Nocturnal Administration of Anti-hypertensive Medications in NoN-dippers

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Valsaltan, amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertension (stage 1-2) 24hr. holer : non-dipper Age 18  70. Exclusion Criteria: Any known malignant disease Renal failure , creatinine >2.0mg/dl Liver disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: morning administration group<br> | Drug: Valsaltan, amlodipine<br>* nti hypertensive medication time (nocturnal administration vs morning administration<br>|
| Experimental: nocturnal administration group<br> | Drug: Valsaltan, amlodipine<br>* nti hypertensive medication time (nocturnal administration vs morning administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMT(intima media thickness) Measure data(Sono) |  | baseline | 
| IMT(intima media thickness) Measure data(Sono) |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-dipper HTN patient
PET Respiratory Gating to Detect Hepatic Metastasis in Patients With Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant.

Official Title
-----------------
Effects of Respiratory Gating on FDG/PET Detection of Hepatic Metastasis in Patients With Colon Cancer

Conditions
-----------------
Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with colon cancer 18 years or older Signed Informed Consent Form Blood Glucose of 200 or less prior to scan Exclusion Criteria: Patients with known hepatic metastasis

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

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

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 |
| --- | --- | --- |
| Detecting | To exam if there is an improved sensitivity in detecting hepatic lesions using respiratory gating and if there is improvement in confidence defining lesions as benign or malignant | Jan 2011 - Nov 2011 |
Celsius TCS Hyperthermia System PMCF Trial

Study Overview
=================
Brief Summary
-----------------
Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.

Detailed Description
-----------------
During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters.

Official Title
-----------------
Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry

Conditions
-----------------
Solid Neoplasms

Intervention / Treatment
-----------------
* Device: Hyperthermia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment performed with the Celsius TCS Hyperthermia System Exclusion Criteria: not applicable -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Hyperthermia<br>treatment with the Celsius42 Hyperthermia System | Device: Hyperthermia<br>* treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy<br>* Other names: treatment with the Celsius42 Hyperthermia System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failures of the device as well as failure of persons using the device during treatment | Based on the risk analysis the failures occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe). | one month after treatment | 
| any injury, harm or medically relevant discomfort occurring for the patients or the staff | Based on the risk analysis the injuries occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe). | one month after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplasms, hyperthermia
Drug Eluting Stent Registry of Thrombosis

Study Overview
=================
Brief Summary
-----------------
Multicenter, case-control study, to collect data regarding incidences of late and very late drug-eluting stent thrombosis with the aim of identifying trends and possible correlates of stent thrombosis.

Official Title
-----------------
Drug Eluting Stent Registry of Thrombosis

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Case Subjects: patients who have experienced definite late or very late drug-eluting stent thrombosis Control Subjects: patients who underwent drug-eluting stent implantation at the same facility and in the same time period as a matched Case Subject, and have not experienced drug-eluting stent thrombosis. Exclusion Criteria: Patients not meeting the above Inclusion Criteria

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 |
| --- | --- |
| Case<br>Late or very late drug-eluting stent thrombosis | |
| Control<br>No drug-eluting stent thrombosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis |  | Baseline |
Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women.

Official Title
-----------------
Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer

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

Intervention / Treatment
-----------------
* Other: Blood test
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible for the study if they are over 18 years of age, identify their ancestry as Jewish (both Sephardic and Ashkenazi Jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent. Relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific BRCA1 or BRCA2 mutation if they are able to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: Blood test<br>* subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.<br>Other: Questionnaire<br>* A questionnaire encompassing medical, environmental exposure, and reproductive history.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Jewish, BRCA1, BRCA2, 97-029
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

Official Title
-----------------
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <Renal impairment patient> age: 20-65 years eGFR: < 30ml/min/1.73m^2 not on dialysis body weight: greater than 55kg written informed consent <Healthy volunteer> age: 20-65 years body weight: greater than 55kg written informed consent Exclusion Criteria: AST, ALT > 1.5 times of upper normal range positive drug or alcohol screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal impairment patients<br>renal impairment patients who eGFR is lower than 30 ml/min/1.73m^2 without hemodialysis | Drug: fimasartan<br>* single administration of fimasartan 120mg<br>|
| Active Comparator: healthy volunteers<br>healthy volunteers group | Drug: fimasartan<br>* single administration of fimasartan 120mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic characteristic of fimasartan | AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fimasartan, renal impairment, hypertension