linjc16/ctgov huggingface dataset:
Cryosurgery in Treating Women With Breast Lesions

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions. PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.

Detailed Description
-----------------
OBJECTIVES: Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions. Determine the safety of this procedure in these patients. OUTLINE: This is a multicenter study. Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy. Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Official Title
-----------------
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation

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

Intervention / Treatment
-----------------
* Procedure: conventional surgery
* Procedure: cryosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy Tumor no greater than 2.0 cm in diameter Eligible for lumpectomy or mastectomy No superficial breast lesions No prior open surgical biopsy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics No other surgery that would preclude study participation Other: No other medical treatment that would preclude study participation
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Procedure: cryosurgery|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
-----------------
stage I breast cancer, stage II breast cancer
Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.

Study Overview
=================
Brief Summary
-----------------
The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Detailed Description
-----------------
Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.

Official Title
-----------------
Phase3, Open-Label, Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.

Conditions
-----------------
Wilson's Disease

Intervention / Treatment
-----------------
* Drug: NPC-02


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wilson's disease(adult, infant, pregnant woman) Exclusion Criteria: Acute hepatitis Malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: NPC-02<br>zinc acetate | Drug: NPC-02<br>* zinc acetate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy | Number of patients who have at least one adverse events. ALT Change | During study period (up to 96W ) |
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis

Study Overview
=================
Brief Summary
-----------------
During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.

Detailed Description
-----------------
An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.

Official Title
-----------------
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis

Conditions
-----------------
Myocardial Infarction, Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Device: Manual Aspiration Thrombectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015. Large trials randomizing more than 1000 patients. Trials must have had at least 30 day follow up. Exclusion 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 |
| --- | --- |
| Manual Aspiration Thrombectomy with PCI<br>Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to Manual Aspiration Thrombectomy followed by percutaneous coronary intervention (PCI). | Device: Manual Aspiration Thrombectomy<br>* Thrombus aspiration<br>|
| PCI Alone<br>Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to percutaneous coronary intervention (PCI) alone without manual aspiration thrombectomy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Cardiovascular death | time to event analysis | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Cardiovascular death | time to event analysis | up to 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thrombectomy, acute coronary syndromes, percutaneous coronary intervention, STEMI
The Impact of Non-pulsatile Blood Flow on CO2-Reactivity

Study Overview
=================
Brief Summary
-----------------
The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.

Official Title
-----------------
The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation

Conditions
-----------------
Cerebrovascular Circulation

Intervention / Treatment
-----------------
* Procedure: alteration of PaCO2 level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Carotid artery stenosis (> 50%) Neurological pathologies COPD with CO2 retention Women of childbearing age

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each patient served as his own control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-pulsatile blood flow<br> | Procedure: alteration of PaCO2 level<br>* step changes between 30, 40 and 50 mmHg<br>|
| Experimental: pulsatile blood flow<br> | Procedure: alteration of PaCO2 level<br>* step changes between 30, 40 and 50 mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow | Relation between PaCO2 level and cerebral blood flow velocity will be assessed during non-pulsatile and pulsatile blood flow. Measurements will be performed using trancranial doppler to measure flow velocity of the middle cerebral artery. Further, NIRS will be used to measure oxygen saturation of the brain. Measurements will be performed during step changes of PaCO2 (at 30mmHg, 40mmHg and 50mmHg. | first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient |
Aortic Elongation and Dissection

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.

Detailed Description
-----------------
Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g. aneurysm) can lead to life-threatening complications such as dissection and/or rupture. In daily practice however (e.g. imaging reports), the investigators often encounter patients with elongation of the ascending aorta. Little is known about the length of the proximal aorta. Furthermore, the clinical implications of an elongated aorta are unknown.

Official Title
-----------------
Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection

Conditions
-----------------
Thoracic Aorta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent recent (<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry. Exclusion Criteria: Age <18 years old. Prior thoracic, cardiac or aortic surgery. Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease). Infectious disease of the aorta. Malignant disease with involvement of heart and/or aorta.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>Healthy control patients | |
| Type A dissection<br>Patients with proven type A dissection, | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the ascending aorta | Ascending aortic length as measured on computed tomography. | Up to 72 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ascending aorta, Elongation of the aorta, Type A dissection, Aortic rupture, Aortic length
Effects of Manualized Treatment in a Seamless System

Study Overview
=================
Brief Summary
-----------------
The specific aims of this project are: To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders; To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level; To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.

Official Title
-----------------
Effects of Manualized Treatment in a Seamless System of Care: Handling Probation

Conditions
-----------------
Substance Abuse, Offenders, Criminal Thinking, HIV Risk Behaviors

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Substance abusers men and women treatment Exclusion Criteria: Parolees Low threshold substance abuse violent offenders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships | Behavioral: Cognitive Behavioral Therapy<br>* 18 sessions of CBT, twice weekly<br>Behavioral: Cognitive Behavioral Therapy<br>* 18 sessions with goals groups drug testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrest |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug treatment, substance abuse, offenders, high risk
Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.

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

Intervention / Treatment
-----------------
* Procedure: intravenous anesthesia
* Procedure: inhalation anesthesia
* Drug: propofol-remifentanil
* Drug: sevoflurane-remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies surgery performed by the same surgical team Exclusion Criteria: ASA physical status Ⅳ hepatic and renal impairment diabetes or other endocrine disorders body mass index > 35 kg/m2 immune disorders or immunosuppressive therapy steroid treatment in the last 6 months inflammation

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous<br>the total intravenous anesthesia group | Procedure: intravenous anesthesia<br>* total intravenous anesthesia group: propofol-remifentanil<br>Drug: propofol-remifentanil<br> <br> |
| Active Comparator: inhalation<br>the inhalation anesthesia group | Procedure: inhalation anesthesia<br>* inhalation anesthesia group: sevoflurane-remifentanil<br>Drug: sevoflurane-remifentanil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of NK cell | comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity | at 24 hour after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Study Overview
=================
Brief Summary
-----------------
Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

Official Title
-----------------
A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy

Conditions
-----------------
Aneuploidy, Down Syndrome, Noninvasive Prenatal Screening

Intervention / Treatment
-----------------
* Device: SEQureDx Trisomy Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy is 10-22 weeks gestation Between 18-34 years of age inclusive at estimated date of delivery No prenatal screening indicators for high risk including serum biochemical and ultrasound screening No personal or family history of Down syndrome Willing to provide written informed consent Willing to provide a whole blood sample Willing to provide access to medical records supporting fetal outcome Exclusion Criteria: Fetal demise at the time of the blood draw Previous specimen donation under this protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 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 |
| --- | --- |
| low risk pregnancies<br> | Device: SEQureDx Trisomy Test<br>* Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the false positive rate of SEQureDx Trisomy 21 Test |  | pregnancy outcome |
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Observing how cocoa effects the cardiovascular and renal system.

Detailed Description
-----------------
Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.

Official Title
-----------------
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Cocoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure <165/105 Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cocoa|Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Measurements |  | Hourly measurements (5-6 hours total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | Hourly (5-6 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocoa, diabetes, polyphenols