linjc16/ctgov huggingface dataset:
Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development

Study Overview
=================
Brief Summary
-----------------
This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Detailed Description
-----------------
Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk disease progression to cancer, but only reduce the probability of some ER and PR positive tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive breast cancer. In the first hospital of Jilin University, the preparations containing antler ingredients have been clinically proven to be able to treat breast hyperplasia, which has been proved to be able to prevent breast cancer in basic research, and antler ingredients have been proved to be non-toxic and side effects in the treatment dose. This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Official Title
-----------------
Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between the ages of 18 and 80 Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology Women with breast cancer in first degree relatives Patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent Exclusion Criteria: Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases Patients not suitable for this study judged by researchers

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antler plate group<br>Antler plate group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canceration by biopsy | Imaging suspected malignant, confirmed by pathology | 1 year |
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Detailed Description
-----------------
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Official Title
-----------------
A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: Zalutumumab
* Drug: Induction chemotherapy
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC stage IIIA-IIIB Performance status 0 or 1 (Zubrod or WHO Scale) Exclusion Criteria: Evidence of metastases either in a separate lobe of the lung, or extra thoracic Patients with high risk of radiation pneumonitis and or compromised lung function Estimated life expectancy of less than 3 months Prior chemotherapy for lung cancer Prior radiotherapy to the chest Prior surgery with curative intent for lung cancer

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: Zalutumumab 8 mg/kg<br> | Biological: Zalutumumab<br>* 8 mg/kg<br>Drug: Induction chemotherapy<br>* Combination of cisplatin and docetaxel administered as two cycles given every three weeks<br>Radiation: Radiotherapy<br>* 64 Gy in 32 fractions over 6.5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival Verified by Imaging Techniques. | Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16 | Until disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants reporting at least one adverse event | Up to 3 months |
Stalevo in Early Wearing-Off Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

Official Title
-----------------
Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off

Conditions
-----------------
Idiopathic Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Stalevo (levodopa/carbidopa/entacapone)
* Drug: Levodopa/carbidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day Unchanged antiparkinsonian medication for 6 weeks prior to baseline Exclusion Criteria: Secondary or atypical parkinsonism Patients with daily unpredictable OFF periods or painful dyskinesia

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stalevo (levodopa/carbidopa/entacapone) | Drug: Stalevo (levodopa/carbidopa/entacapone)<br>* Oral, 50-150 mg levodopa four times daily, for up to 2 years<br>|
| Active Comparator: 2<br>Levodopa/carbidopa | Drug: Levodopa/carbidopa<br>* Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms |  | Up to 2 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale |  | Up to 2 years of treatment | 
| Clinical Global Impression of Change (investigator) |  | Up to 2 years of treatment | 
| Parkinson's Disease Questionnaire (PDQ-39) |  | Up to 2 years of treatment | 
| Work Impairment Questionnaire |  | Up to 2 years of treatment |
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to examine the agreement between arterial, central venous, and peripheral venous lactate values in a population of medical Intensive Care Unit (ICU) patients.

Detailed Description
-----------------
This study is a single-center, prospective trial to assess the agreement between arterial, central venous, and peripheral venous lactate measurements. When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible. A maximum of 10 paired arterial and venous lactate samples will be obtained per patient to prevent a single patient from dominating the data set. Additional data collected on a standardized data collection form will include primary diagnosis, intubation status, use of inotropic agents, hypotension (defined as a systolic blood pressure < 90 mm Hg), ICU length of stay and mortality. The Bland-Altman method will be used to assess agreement between arterial (A), central venous(CV), and peripheral venous (PV) lactate measurements. Approximately 50 patients will be enrolled in this study.

Official Title
-----------------
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

Conditions
-----------------
Blood Lactate Analysis

Intervention / Treatment
-----------------
* Procedure: Blood Lactate Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18 years or older Admitted to the Intensive Care Unit (ICU) Determined by their treating clinicians to require both a central venous line and arterial line Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: Blood Lactate Analysis<br>* When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between peripheral venous, central venous, and arterial lactate values in a population of medical Intensive Care Unit (ICU) patients. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial Lactate, Central Venous Lactate, Peripheral Venous Lactate
Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting

Study Overview
=================
Brief Summary
-----------------
Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.

Official Title
-----------------
Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania

Conditions
-----------------
Fetal Monitoring

Intervention / Treatment
-----------------
* Device: Moyo strap-on
* Device: Hand-held fetoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women admitted in labor Exclusion Criteria: Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission
Sexes Eligible for Study
-----------------
All

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

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: Moyo strap-on<br>Continous fetal heart rate monitoring | Device: Moyo strap-on<br>* Continous measurements<br>|
| Active Comparator: Hand-held fetoscope<br>Intermittent fetal heart rate monitoring | Device: Hand-held fetoscope<br>* Intermittent measurements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of abnormal fetal heart rate detection |  | Up to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery: vaginal versus operative |  | Up to delivery | 
| Neonatal outcome: dead versus alive |  | Up to 24 hours | 
| Time from abnormal fetal heart rate detection to delivery in minutes |  | Up to delivery |
Parent-Adolescent Interactions and Adolescent Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe parent-adolescent interactions and to examine the parenting behaviors and adolescent emotional and physiological responses that are associated with youth's substance use.

Detailed Description
-----------------
The study examines parenting behaviors and adolescent emotional responses during parent-adolescent interactions and whether these predict youth's current and future substance use over a 3 year follow-up.

Official Title
-----------------
Responses During Parent-child Interactions and Alcohol Use Behavior in Adolescents.

Conditions
-----------------
Substance Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent between ages 12-14 years Exclusion Criteria: For adolescent, Intelligence Quotient (IQ) < 70 on standardized test, for parent, evidence of inability to read or write. Evidence of a psychotic disorder for parent or adolescent Diagnosis of autism or pervasive developmental disorder for adolescent, as determined by parent report in the screening. For adolescent, current need for acute treatment of a psychiatric disorder, as determined by parent report in the study screening. For adolescent and parent, inadequate English proficiency to comprehend task instructions

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 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 |
| --- | --- |
| 12-14 year olds<br>No intervention administered. This is a longitudinal observational study including observation of behaviors and physiological responses. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use | Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results. | Baseline | 
| Substance Use | Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results. | 6 month follow-up | 
| Substance Use | Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results. | 1 year follow-up | 
| Substance Use | Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results. | 2 year follow-up | 
| Substance Use | Measured by a combination of self-report on the Youth Risk Behavior Survey and the Teen Addiction Severity Index and urine toxicology and alcohol breathalyzer results. | 3 year follow-up |
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.

Detailed Description
-----------------
In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.

Official Title
-----------------
Study of Treatment of Dyslipidemia for Hemodialysis

Conditions
-----------------
Complication of Hemodialysis

Intervention / Treatment
-----------------
* Drug: L-carnitine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration >200 mg/dl or serum HDL concentration >40 mg/dl in the beginning of the study. Exclusion Criteria: taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: placebo<br>it is as like as L-carnitine in shape | Drug: placebo<br>* 500 mg,twice daily, 16 weeks.<br>|
| Other: L-carnitine<br>it is kind of supplement | Drug: L-carnitine<br>* 500 mg,twice daily, 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile |  | at sixteen weeks after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anemia |  | at sixteen weeks after admission | 
| quality of life |  | at sixteen weeks after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal failure, hemodialysis, dyslipidemia, L-carnitine.
The Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.

Detailed Description
-----------------
Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.

Official Title
-----------------
To Investigate the Coexistence of Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms

Conditions
-----------------
Atherosclerotic Intracranial Arterial Stenosis With Intracranial Aneurysms

Intervention / Treatment
-----------------
* Drug: conservative treatment
* Procedure: Aneurysms clipping
* Procedure: Interventional embolization forAneurysms
* Procedure: stenting for stenosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms Stenosis caused by atherosclerosis Exclusion Criteria: patients do not agree Stenosis caused by no atherosclerosis disease

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: conservative treatment|nan|
|Procedure: Aneurysms clipping|nan|
|Procedure: Interventional embolization forAneurysms|nan|
|Procedure: stenting for stenosis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new stroke events during perioperative period |  | perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke events during follow up |  | 6 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerotic Intracranial Arterial Stenosis, Intracranial Aneurysms