linjc16/ctgov huggingface dataset:
Tamoxifen in Treating Patients With Primary Liver Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether receiving tamoxifen is more effective than no further therapy in treating patients with primary liver cancer. PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed.

Detailed Description
-----------------
OBJECTIVES: I. Assess the therapeutic role of tamoxifen in patients with inoperable hepatocellular carcinoma in terms of overall survival and quality of life. OUTLINE: This is a randomized, double blind, placebo controlled study of tamoxifen. Patients are randomized to one of 3 treatment arms. Arm I: Patients receive placebo orally twice daily for one year. Arms II and III: Patients receive tamoxifen, at 1 of 2 different doses, orally twice daily for one year. Quality of life is assessed before treatment and then monthly thereafter. Patients are followed monthly until death. PROJECTED ACCRUAL: This study will accrue 300 patients.

Official Title
-----------------
Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Drug: tamoxifen citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or radiologically confirmed inoperable hepatocellular carcinoma Serum alfa-feto protein level at least 500 ug/L OR Positive lipiodol uptake PATIENT CHARACTERISTICS: Age: 10 to 90 Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.7 mg/dL Other: No encephalopathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemoembolization therapy for disease No prior systemic chemotherapy for disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgery for disease Other: No prior percutaneous injection

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tamoxifen citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.

Official Title
-----------------
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Conditions
-----------------
Ventricular Dysfunction, Left

Intervention / Treatment
-----------------
* Device: LVAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned HeartMate II LVAD implantation Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement Exclusion Criteria: Prior history of mechanical circulatory support; Body weight < 110 lbs; Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation; Severe aortic stenosis; Renal failure requiring dialysis; Hepatic dysfunction resulting in severe coagulopathies; Recent serious infection; Current need for prolonged ventilatory support; Prior organ transplantation; Blood transfusion within 14 days of the first planned study blood draw; Concomitant immunosuppressant or chemotherapeutic agents; Pregnant women; Decisionally challenged or prisoners; Unwilling to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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 |
| --- | --- |
| LVAD recipients<br> | Device: LVAD<br> <br> * Other names: HeartMate II;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative differences in plasma protein abundance |  | Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation |
Safer Use of Medication in Pediatric Patients at Home

Study Overview
=================
Brief Summary
-----------------
This study aims: to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients. to assess de user satisfaction and perceived usefulness of the system. Participants: Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study. Sample size: 62 participants Main outcome variable: overall satisfaction

Official Title
-----------------
Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website

Conditions
-----------------
Medication Errors and Other Product Use Errors and Issues

Intervention / Treatment
-----------------
* Other: Study group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To care children aged under 14 years who have required drug treatment in the last two months To have an Internet connection To agree to participate in the study. To be registered in the study web-based notification system Age > 17 years Exclusion Criteria: To be health provider To care children in residence for minors. To care children with a life expectancy of less than 2 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br> | Other: Study group<br>* The study group uses a web-based medication error notification system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the web-based medication error notification system | Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire | At one month after use of the website |
Aromatase Inhibitors in the Treatment of Male Infertility

Study Overview
=================
Brief Summary
-----------------
Obesity is associated with an increase in blood levels of estrogen. Estrogen or female hormone is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.

Official Title
-----------------
The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male

Conditions
-----------------
Obesity, Oligospermia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male partner of a couple presenting for infertility work up after one year of unprotected intercourse Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL) of at least two separate occasions spanning a minimum of two weeks Obese men BMI ≥ 30 FSH and LH levels < 10 mIU/mL Exclusion Criteria: Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia Age less than 18 or greater than 65 years Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen Cryptorchidism Vasectomy reversal Regular use of tobacco products BMI < 30 Use of anabolic steroids or testosterone replacement All patients with abnormal initial liver function tests AST or ALT will be excluded form the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group B<br>Placebo | Drug: Placebo<br>* Placebo Comparator<br>|
| Experimental: Group A<br>Anastrozole | Drug: Anastrozole<br>* 1 mg qd for 4 months<br>* Other names: Arimidex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Partner pregnancy rate during study participation | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Low sperm count, Male infertility
Attachment Style of Type 2 Diabetics, and Cognitive, Social and Emotional Variables as Explanatory Factors of Adherence to Self-care Behavior and Diabetes Control

Study Overview
=================
Brief Summary
-----------------
This study will expand the understanding of factors associated with adherence to self care and the diabetes control among diabetes type 2 patients. The theoretical framework of the study incorporates central variables from two theoretical models: a cognitive model of health behavior - Health Belief Model, and the Stress and Coping model. The study is innovative in its focus on the association between the patient's attachment style and adherence to self care and diabetes control, a topic less studied among diabetes patients, in addition to cognitive, social and emotional variables. Further emphasis is upon a comparison of the study model between males and females.

Official Title
-----------------
Attachment Style of Type 2 Diabetics, and Cognitive, Social and Emotional Variables as Explanatory Factors of Adherence to Self-care Behavior and Diabetes Control

Conditions
-----------------
Type 2 Diabetes Patients

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes 40-70 years of age Hebrew speaking members of maccabi healthcare services

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| diabetes type 2<br>type 2 diabetes patients 40-70 years of age hebrew speaking members of maccabi healthcare services | Other: questionnaire<br>* questionnaire only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
68Ga-PSMA PET in the Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial. To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.

Official Title
-----------------
Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial

Conditions
-----------------
Prostatic Neoplasms, Metastases, PSMA-PET

Intervention / Treatment
-----------------
* Diagnostic Test: PSMA PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND ISUP Gleason grade group ≥ 4 Exclusion Criteria: Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMAPET-MRI<br> | Diagnostic Test: PSMA PET<br>* 68Ga-PSMA PET<br>|
| Experimental: MRI-PSMAPET<br> | Diagnostic Test: PSMA PET<br>* 68Ga-PSMA PET<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT | To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PET/CT to that of the current standard multiparametric MRI, using histopathology as the gold standard. | 2 years |
Tobacco Cessation in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test. Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.

Official Title
-----------------
Tobacco Cessation in Postmenopausal Women - Part I & Part II

Conditions
-----------------
HRT, Non-HRT, Continued Smoking, Smoking Abstinence

Intervention / Treatment
-----------------
* Behavioral: Part 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40-79 years old Clinical Menopause > 15 cigarettes per day for at least one year Experienced nicotine withdrawal based on DSM IV Exclusion Criteria: Currently obtaining nicotine from other sources Abnormal vaginal bleeding unstable health history of stroke or embolism history of abnormal thyroid function significant skin disorders active psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Patch<br>Nicotine Patch for Smoking Cessation | Behavioral: Part 2<br>* Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.<br>|
| Placebo Comparator: Placebo Patch<br> | Behavioral: Part 2<br>* Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy? |  | Outcome was measured after 1 baseline week and a 2 week quit |
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors

Study Overview
=================
Brief Summary
-----------------
The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.

Official Title
-----------------
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition

Conditions
-----------------
Stress Disorders, Post-Traumatic, Tissue Donors, Tissue and Organ Procurement

Intervention / Treatment
-----------------
* Other: Questionnaires and interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased Exclusion Criteria: refusal to participate does not speak French deaf/mute adult, but under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Reference<br>Nearest relatives of brain-dead patients who donated organs | Other: Questionnaires and interview<br>* Questionnaires and interview<br>|
| Opposition<br>Nearest relatives of brain-dead patients opposed to organ donation | Other: Questionnaires and interview<br>* Questionnaires and interview<br>|
| Medical/Legal<br>Nearest relatives of brain-dead patients for whom organ donation was not an option because of medical or legal reasons | Other: Questionnaires and interview<br>* Questionnaires and interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with an IES score > 37 | The IES score follows Azoulay et al (2005). Am J Respir Crit Care Med. 171: 987-94. IES = Impact of Event Scale - revised, ranging from 0 to 88, with 88 being the greatest risk for post-traumatic stress | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The IES score | The Impact of Event Scale - revised, ranging from 0 to 88 | 2 hours | 
| Hospital Depression and Anxiety Score (HDAS) | score ranging from 0 (no symptoms) to 21 (max). HDAS scores >=8 indicate clinically significant depression or axiety | 2 hours |
Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)

Study Overview
=================
Brief Summary
-----------------
This is a Quasi-experimental research design. The subjects are limited in intensive care unit within north medical center hospital. All subjects depend on ventilator and receive weaning plans. Experimental group is weaning with the support of negative pressure ventilator .The investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea scale and arterial blood gas analysis and ventilator weaning index. Compare experimental group and control group data. Data will be Statistical analyzed by: descriptive statistics (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value <0.05 will consider to be statistically significant.

Official Title
-----------------
Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Behavioral: negative pressure ventilator use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute respiratory failure patients in medical ICUs Exclusion Criteria: Age<20 years old Malignancy Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Base on positive pressure ventilation with intubation and mechanical ventilator, weaning processes will undergo by Pulmonologists. | |
| Experimental: Experimental group<br>Experimental group is weaning with the support of negative pressure ventilator. | Behavioral: negative pressure ventilator use<br>* Body ventilators that assist ventilation by applying intermittent subatmospheric pressure around the thorax, abdomen, or airway and periodically expand the chest wall and inflate the lungs. They are relatively simple to operate and do not require tracheostomy. Chest cuirass is used in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator weaning rate |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory failure patients in medical ICUs.