linjc16/ctgov huggingface dataset:
Renal Denervation in Patients After Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure and left ventricle remodeling progression in patients after acute coronary syndrome.

Official Title
-----------------
Renal Denervation in Patients After Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Arterial Hypertension

Intervention / Treatment
-----------------
* Procedure: Renal denervation
* Drug: Metoprolol
* Drug: Lisinopril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute Q negative myocardium infarction (during first 14 days) non stable angina significant stenosis BP > 140/90 torr. during more than 1 year Exclusion Criteria: absence of arterial hypertension Thrombolysis during previous 24 hours indications for CABG

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI+Renal denervation<br> | Procedure: Renal denervation<br>* The treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.<br>Drug: Metoprolol<br>* Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.<br>Drug: Lisinopril<br>* ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.<br>|
| Active Comparator: PCI alone<br> | Drug: Metoprolol<br>* Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.<br>Drug: Lisinopril<br>* ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death |  | 1 year | 
| myocardium infarction |  | 1 year | 
| stroke |  | 1 year | 
| repeat revascularization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure changes |  | 1 year | 
| CCS and NYHA |  | 1 year | 
| heart rhythm disturbances |  | 1 year | 
| intima-media index |  | 1 year | 
| IVS thickness |  | 1 year | 
| restenosis |  | 1 year | 
| diastolic disfunction |  | 1 year |
Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical N0 Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of a PET/CT-based deep learning signature for predicting occult nodal metastasis of clinical stage N0 non-small cell lung cancer in a multicenter prospective cohort.

Official Title
-----------------
PET/CT-based Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical Stage N0 Non-Small Cell Lung Cancer: A Multicenter Prospective Diagnostic Trial

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PET/CT-based Deep Learning Signature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum short-axis diameter of N1 and N2 lymph nodes less than 1 cm on CT scan; (3) The SUVmax of N1 and N2 lymph nodes less than 2.5; (4) Pathological confirmation of primary NSCLC; (5) Age ranging from 20-75 years; (6) Obtained written informed consent. Exclusion Criteria: (1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants not receiving systematic lymph node dissection; (5) Participants who have received neoadjuvant therapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET/CT-based Deep Learning Signature|Deep Learning Signature Based on PET-CT for Predicting Occult Nodal Metastasis of Clinical N0 Non-small Cell Lung Cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic curve | Area under the receiver operating characteristic curve | 2022.1-2023.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity Sensitivity | Sensitivity | 2022.1-2023.12 | 
| Specificity | Specificity | 2022.1-2023.12 | 
| Positive predictive value | Positive predictive value | 2022.1-2023.12 | 
| Negative predictive value | Negative predictive value | 2022.1-2023.12 | 
| Accuracy | Accuracy | 2022.1-2023.12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Lymph node metastasis, Deep learning, PET-CT
Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.

Study Overview
=================
Brief Summary
-----------------
Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.

Official Title
-----------------
A Randomized, Open-Label, Methodology Trial To Investigate The Utility Of Echocardiography In Assessment Of Cardiac Valvular Regurgitation In Adult Subjects

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Device: cardiac echosonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >=18 years of age subjects with stable concomitant diseases with BMI >=30 kg/m2 Exclusion Criteria: Pregnant females Those with unstable/new onset diseases Those who are on agents known to be associated with cardiac valvular heart 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cardiac echosonography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.

Official Title
-----------------
Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy

Conditions
-----------------
Medication Adherence, Patient Compliance

Intervention / Treatment
-----------------
* Behavioral: Motivational interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with polypharmacy (5 or more medicines) That detects to them a problem of Therapeutic Adherence That agree to take part in the study Exclusion Criteria: Immobilized patients or with an index of Barthel lower than 60 points Incapable to fulfill ABVD Patients with cognitive deterioration Patients with diagnosis of ictus in the last 6 months That has been admitted to hospital 2 or more times in the last year Institutionalized patients

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational interview<br> | Behavioral: Motivational interview<br> <br> * Other names: Patient-centered method;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication errors in the patients | Medication errors before and after the intervention in each group | Baseline, 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adherence | To measure adherence to treatment will use a combination of direct methods (counting of medication) and indirect tests are passed or self-reported compliance test Haynes-Sackett and Morisky-Green test | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication errors, Patient Compliance, patient safety, polypharmacy
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)

Study Overview
=================
Brief Summary
-----------------
This observational, multicenter, retrospective/prospective study will evaluate the use of Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer. Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and Avastin will be followed for up to 15 months.

Official Title
-----------------
Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Metastatic colorectal cancer Having initiated first-line treatment with fluoropyrimidine-based chemotherapy plus Avastin between 1. September 2011 and 29. February 2012 Availability of test fro K-RAS genotyping Exclusion Criteria: Participation in a clinical trial during treatment with Avastin

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events |  | approximately 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with treatment discontinuation due to other causes |  | approximately 15 months | 
| Incidence of other causes for treatment discontinuation |  | approximately 15 months | 
| Second-line treatments initiated |  | approximately 15 months | 
| Progression-free survival (patients with treatment discontinuation due to disease progression or Avastin-related toxicity as compared to patients with treatment discontinuation due to other causes) |  | approximately 15 months |
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.

Detailed Description
-----------------
Subjects with idiopathic PD will be recruited to a 10-week dose escalation study. Each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. Information on safety and fasting blood/urine samples will be collected. Primary endpoint is plasma F2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. Serum phospholipase A2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.

Official Title
-----------------
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Dietary Supplement: coenzyme q10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic Parkinson disease age >21 years able to provide written informed consent Exclusion Criteria: diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking major psychiatric disorder or drug and/or alcohol abuse/dependence regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs

Ages Eligible for Study
-----------------
Minimum Age: 21 Months

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: Coenzyme Q10<br>400mg/day, 800mg/day, 1200/day and 2400mg/day | Dietary Supplement: coenzyme q10<br>* 400mg/day, 800mg/day, 1200/day and 2400mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of oxidative damage |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Unified Parkinson's Disease Rating Scale (UPDRS) |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coenzyme Q10, Parkinson disease, oxidative damage
Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior. Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

Detailed Description
-----------------
No more details required

Official Title
-----------------
Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older CRC diagnosis Upcoming colonic and/or rectal resection with/without anastomosis Individuals without diseases of the colon and rectum (healthy controls) Exclusion Criteria: Pregnancy Previous stoma Bowel surgery in the last 4 weeks prior to the surgery Secondary objectives, inclusion criteria are as follows: Age 18 years and older Rectal cancer diagnosis with histopathological confirmation Abdominoperineal resection with terminal colostomy Expectative non-surgical management (Watch and wait approach)

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 |
| --- | --- |
| Groupe 1<br>Patients with colorectal cancer undergoing resection with anastomosis | |
| Groupe 2<br>Patients with colorectal cancer undergoing resection without anastomosis (Abdominoperineal resection) | |
| Groupe 3<br>Patients with rectal cancer without surgery (Watch and wait) | |
| Groupe 4<br>Control group consisting of patients who do not have surgical pathologies of the colon and rectum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an anastomotic leak | Clinical and/or radiological anastomotic leak | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cancer reoccurence | Colorectal cancer local or distant reoccurence | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiota
Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

Study Overview
=================
Brief Summary
-----------------
An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796

Official Title
-----------------
An Open Label, 2-Period, Sequential Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Ketoconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of multiple oral doses of ketoconazole on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of HCV-796 and ketoconazole when coadministered to healthy subjects. |  |  |
Iron Supplementation Among Low-Income Postpartum Women

Study Overview
=================
Brief Summary
-----------------
Anemia is common among low-income women after they have given birth. Anemia, or low hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of this study is to evaluate three methods of giving iron to prevent anemia among low-income women after they have given birth.

Detailed Description
-----------------
Currently the Centers for Disease Control and Prevention recommendations to prevent iron deficiency advocate selective screening and treatment of anemia at about 6 weeks postpartum. However, among some groups, such as low income women, data suggest that anemia and iron deficiency are common. This study aims to evaluate the effectiveness of three stategies to prevent iron deficiency among low income postpartum women in Mississippi. Comparisons: Clinics will be randomized to one of three strategies: 1)Selective anemia screening and treatment of anemic women, 2)universal anemia screening and treatment of anemic women, or 3)universal iron supplementation of 65 mg a day for three months.

Official Title
-----------------
Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Behavioral: Daily iron supplements of 65 mg a day for 3 months
* Behavioral: Universal anemia screening and treatment
* Behavioral: Selective anemia screening and treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postpartum girls and women, 2-6 weeks after birth age 13 years or more WIC certified Exclusion Criteria: sickle cell anemia Hemoglobin < 7 g/dL

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Daily iron supplements of 65 mg a day for 3 months|nan|
|Behavioral: Universal anemia screening and treatment|nan|
|Behavioral: Selective anemia screening and treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anemia |  | 6 months postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Postpartum, iron, supplements