linjc16/ctgov huggingface dataset:
Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL. This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study: EORTC QLQ C30 to assess global health and major health domains Brief Pain Inventory (BPI) Personal Health Questionnaire (PHQ9) to assess psychosocial distress Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire Peripheral Neuropathy Questionnaire The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.

Official Title
-----------------
A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously diagnosed with adult ALL or T-lymphoblastic lymphoma Age >/= 18 Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission Understand English and are able to fill out questionnaires

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 |
| --- | --- |
| Adult acute lymphoblastic leukemia patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01) |  | 9 months |
Postoperative Adjuvant TACE Treatment in CK18 Positive Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate and analyse the clinical effect and application value of postoperative adjuvant TACE treatment in patients with different expression levels of CK18 using randomized controlled study and provide evidence for the necessity of postoperative adjuvant TACE.

Official Title
-----------------
The Effect of Postoperative Adjuvant TACE Treatment in CK18 Positive Patients of Hepatocellular Carcinoma.

Conditions
-----------------
Postoperative Adjuvant TACE, Hepatocellular Carcinoma.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Via clinical diagnosis and confirm it is primary liver cancer Pathological evidence of HCC Estimate tumor can gain treatment of curing operation No evidence for extrahepatic metestasis liver function ：Child-Pugh A/B Exclusion Criteria: reject to attend； impossible to come to our hospital for physical examination regularly. cancer epitome、seed focus、lymph node or distant metastasis Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CK18 positive<br>HCC patients with CK18 high expression levels in tumor tissue. | |
| CK18 negative<br>HCC patients with CK18 high expression levels in tumor tissue. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cell keratin 18
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.

Official Title
-----------------
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Conditions
-----------------
Chronic Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Drug: Inspra (eplerenone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation . Written informed consent Exclusion Criteria: Persons with impaired decision-making ability. Pregnant women or who are actively trying to conceive. Additional eye disease affecting the macula or posterior retina. Creatinine clearance < 50 ml/min Hyperkalemia > 5 mmol/l Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women Treatment with potassium sparing agents or potassium Treatment with any other drugs known to cause interaction with eplerenone Microalbuminuria in patients with type 2 diabetes

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks. | Drug: Inspra (eplerenone)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of sub-retinal fluid measured by optical coherence tomography (OCT). |  | 6 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in macular volume at baseline, during and after the treatment with eplerenone. |  | 6 months | 
| Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone. |  | 6 months | 
| Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes. |  | 6 months |
Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients. Secondary aims are to clarify the pathogenesis and the clinical relevance of mitochondrial damage during sepsis.

Detailed Description
-----------------
The primary aim of the study is to demonstrate that mitochondrial dysfunction occurs in both skeletal muscle and circulating platelets of severely septic and septic shock ICU-admitted patients, as compared to otherwise healthy surgical ones. In order to better clarify the pathogenesis of mitochondrial dysfunction during sepsis, cardiogenic shock patients (suffering from systemic hypoperfusion) will act as additional controls. Markers of oxidative stress will be measured in tissue samples from septic patients. The clinical relevance of mitochondrial dysfunction during sepsis will be assessed in terms of both skeletal muscle and platelet function.

Official Title
-----------------
Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive ICU-admitted severely septic or septic shock patients. Exclusion Criteria: Severe thrombocytopenia. Severe coagulopathy. Pre-existing mitochondrial disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial respiratory chain enzyme activity |  | On day one and seven from admission to ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis. Shock, septic. Mitochondria.
Test Semiquantitative Prostate Specific Antigen (PSA)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Detailed Description
-----------------
Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE (Time Resolved Amplified Cryptate Emission) technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Official Title
-----------------
Validation of a Semiquantitative Screening Assay for PSA

Conditions
-----------------
Prostate Cancer, Prostatic Neoplasms, Prostatic Diseases

Intervention / Treatment
-----------------
* Other: PSA assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated. Patients must have given informed consent. Exclusion Criteria: Patients followed for a disease other than prostatic.

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

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

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

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: rapid PSA assay on whole blood<br> | Other: PSA assay<br>* rapid prostate specific antigen assay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay. |  | day of test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement. |  | at the last inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate-Specific Antigen, Prostate Cancer, Cancer, Assay
Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

Study Overview
=================
Brief Summary
-----------------
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.

Official Title
-----------------
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies

Conditions
-----------------
Down Syndrome, Aneuploidy

Intervention / Treatment
-----------------
* Other: Maternal blood draw of 30 to 50ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female Subject is 18 years or older Subject is no less than 8 and no more than 36 weeks gestation Subject provides a signed and dated informed consent Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21) Exclusion Criteria: Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy. | Other: Maternal blood draw of 30 to 50ml<br>* Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIPD result compared to standard test results | Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, aneuploidy, amniocentesis, chorionic villus sampling, Trisomy
Effects of Herbal Products on Metabolism and Hunger

Study Overview
=================
Brief Summary
-----------------
to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other blood)and hunger/caloric compensation on ephedra versus placebo

Official Title
-----------------
Effects of Herbal Products on Metabolism and Hunger

Conditions
-----------------
Obesity, Metabolism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-50, non-smoking, not pregnant (serum), Beck <15, physician permission Exclusion Criteria: pregnant, lactating, smoker, use of appetite-affecting medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DietPro|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic rate |  |  | 
| heart rate |  |  | 
| blood pressure |  |  | 
| TSH |  |  | 
| caloric compensation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  |  | 
| body composition |  |  |
IP3R Modulation by Cancer Genes in Mesothelioma

Study Overview
=================
Brief Summary
-----------------
Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction

Official Title
-----------------
IP3R Modulation by Cancer Genes Bcl-2 & PKM2 in Mesothelioma

Conditions
-----------------
Malignant Mesothelioma

Intervention / Treatment
-----------------
* Diagnostic Test: pleural biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of mesothelioma referral for diagnostic thoracoscopy Exclusion Criteria: contra-indication for thoracoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: pleural biopsy|diagnostic sampling|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pleural biopsy | Biopsy | 5 years |
Promoting Healthy Weight Gain During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy. It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.

Official Title
-----------------
Promoting Healthy Weight Gain During Pregnancy

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Lifestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-smoking, adults, < 16 weeks gestation Exclusion Criteria: medical comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: Intervention<br>Lifestyle intervention delivered during pregnancy | Behavioral: Lifestyle<br>* Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women above the Institute of Medicine Guidelines for gestational weight gain | Objective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral measures | The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior. | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Excessive gestational weight gain
Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

Study Overview
=================
Brief Summary
-----------------
This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.

Official Title
-----------------
Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects

Conditions
-----------------
Ascites, Cirrhosis

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Ascites Cirrhosis - Exclusion Criteria: Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eplerenone<br>oral daily treatment with doses 100 to 400 mg | Drug: Eplerenone<br> <br> |
| Active Comparator: Spironolactone<br>oral daily treatment with doses 100 to 400 mg | Drug: Eplerenone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascites |  | 6 months |