linjc16/ctgov huggingface dataset:
Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study

Study Overview
=================
Brief Summary
-----------------
Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.

Official Title
-----------------
Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study

Conditions
-----------------
Thyroid Neoplasms, Thyroid Nodules

Intervention / Treatment
-----------------
* Device: Electrical Impedance Scanning (EIS) of the Thyroid gland


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 with thyroid nodules scheduled for surgery. Exclusion Criteria: Pregnant patients PAtients with electrical powered devices (cardiac pacemakers)

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 |
| --- | --- |
| A<br>This is a a single arm study evaluating the efficacy and accuracy of EIS in detecting malignant thyroid nodules. PAtients with thyroid nodules scheduled for surgery will undergo EIS examination. | Device: Electrical Impedance Scanning (EIS) of the Thyroid gland<br>* Patients will be examined in the supine position. A cylinder electrode conveying 2.5V electrical current will be held by the patient. The patient will be scanned by a probe (similar to an ultrasound probe. The examination takes 5 minutes and there is no risk or discomfort.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of EIS |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPV and PPV of EIS of the thyroid |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid neoplasms, thyroid nodules, electrical impedance scanning
Connection Between General Practitioner's (GP's) Estimation of Cardiovascular Risk and Theoretical Calculation in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.

Official Title
-----------------
Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France

Conditions
-----------------
Cardiovascular Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 50 years old and over, visiting their GPs

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Adults ≥ 50 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation (according to guidelines and validated scales (such as risk score profile in the Framingham Heart study or the SCORE risk estimation)) |  | At the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the number of cardiovascular risk patients, that have not been identified |  | At the end of the study | 
| To characterize those patients according to their theoretical cardiovascular risk (high, medium, low) |  | At the end of the study | 
| to reveal GP's estimation of cardiovascular risk is especially driven by LDL |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular risk, France, Observational, descriptive study
Study on Colonic Fermentation in Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.

Official Title
-----------------
Study on Colonic Fermentation in Chronic Kidney Disease Patients

Conditions
-----------------
Renal Insufficiency, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and ≤ 95 years Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months Written informed consent Exclusion Criteria: History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy) History of colonic surgery Recipient of a renal or other solid organ transplant Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Hemodialysis<br>Hemodialysis patients | |
| Control<br>Household contacts on the same diet Healthy unrelated controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in fecal metabolite profile (Chronic kidney disease vs. control) | difference in fecal metabolite profile between chronic kidney disease patients and control group | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in fecal metabolite profile depending on dialysis modality | difference in fecal metabolite profile between hemodialysis patients and peritoneal patients | baseline |
Body Composition in Systemic Amyloidosis

Study Overview
=================
Brief Summary
-----------------
Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the prognosis predominantly depend on the presence and severity of cardiac involvement, it was shown that malnutrition is an independent predictor of survival and quality of life. However, the assessment of nutritional status by common indices based on anthropometry is not always feasible and accurate due to reduced performance status and/or the presence of fluid imbalances (for example edema and ascites). Several recent studies have demonstrated the prognostic value of the phase angle. Moreover, the value is supported by its applicability to patients who are bedridden or present alterations in the state of hydration.

Official Title
-----------------
Prognostic Value of Phase Angle in Systemic Immunoglobulin Light-chain (AL) Amyloidosis

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Other: Dietary advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis Written informed consent Exclusion Criteria: Age <18 years Ongoing artificial nutrition Unavailability to planned measurements

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 |
| --- | --- |
| Amyloidosis<br>Consecutive adult patients affected by systemic immunoglobulin light-chain (AL) amyloidosis | Other: Dietary advice<br>* Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality at 12 months since baseline assessment | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Association between phase angle and quality of life at baseline and 6 months. Association between changes in phase angle and in quality of life at 6 months. | 6 months | 
| Mortality | Association between phase angle and its changes at 6 months and mortality at 12 months. | 12 months |
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

Detailed Description
-----------------
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: HCP1303 capsule 5/0.2mg
* Drug: HCP1303 capsule 5/0.4mg
* Drug: HGP1201
* Drug: HCP1303 capsule 5/0.2mg placebo
* Drug: HCP1303 capsule 5/0.4mg placebo
* Drug: HGP1201 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At Visit 1 ≥50 age BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13 Abnormal Erectile function ≥ at least 3months based on screening date At Visit 2 1. Total IPSS ≥ 13 Exclusion Criteria: History of hypersensitivity to Tamsulosin or Tadalafil History of allergy for Sulfonamide PSA (Prostate Specific Antigen) ≥4ng/mL

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo | Drug: HCP1303 capsule 5/0.2mg<br> <br> Drug: HCP1303 capsule 5/0.4mg placebo<br> <br> Drug: HGP1201 placebo<br> <br> |
| Experimental: Treatment 2<br>HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo | Drug: HCP1303 capsule 5/0.4mg<br> <br> Drug: HCP1303 capsule 5/0.2mg placebo<br> <br> Drug: HGP1201 placebo<br> <br> |
| Active Comparator: Active Comparator<br>HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201 | Drug: HGP1201<br> <br> Drug: HCP1303 capsule 5/0.2mg placebo<br> <br> Drug: HCP1303 capsule 5/0.4mg placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Total IPSS (International Prostate Symptom Score) |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Total IPSS |  | baseline and 4weeks, 8sweeks |
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Study Overview
=================
Brief Summary
-----------------
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Detailed Description
-----------------
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Official Title
-----------------
Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

Conditions
-----------------
Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: pitavastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed NK-104-304 (NCT 00309738) Hypercholesterolemia or combined dyslipidemia 2 or more risk factors for coronary heart disease (CHD) Exclusion Criteria: Withdrawn or terminated from NK-104-304 (00309738)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 4 mg<br>Pitavastatin 4 mg once daily | Drug: pitavastatin<br> <br> |
| Active Comparator: Simvastatin 40mg/80mg<br>Simvastatin 40 mg or 80 mg once daily | Drug: simvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Attaining NCEP LDL-C Target at Week 16 | Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL. | 16 weeks | 
| Number of Patients Attaining NCEP LDL-C Target at Week 44 | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL. | 44 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in LDL-C |  | Baseline to 44 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia
Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Study Overview
=================
Brief Summary
-----------------
Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.

Official Title
-----------------
The Guiding Value of Tumor Micronecrosis for Using Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Procedure: transcatheter arterial chemoembolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) pathologically confirmed HCC (2) achievement of R0 resection. Exclusion Criteria: (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| micronecrosis(+) group<br> | Procedure: transcatheter arterial chemoembolization<br>* transcatheter arterial chemoembolization after liver resection<br>|
| micronecrosis(-) group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the number of months from the date of surgery to the date of the last follow-up visit or time of death. | after liver resection until June 1, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | the number of months from the date of surgery to the date of first confirmable recurrence or death | after liver resection until June 1, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, TACE, tumor necrosis
Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.

Official Title
-----------------
Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Conditions
-----------------
Blood Loss in Myomectomy

Intervention / Treatment
-----------------
* Drug: Misoprostol 400 sublingual
* Drug: placebo 400 sublingual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging Age ≥ 18 years and ≤ 50 years Pre-operative hemoglobin >8 g/dl Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history Five or less symptomatic uterine myomas All myomas are subserous or intramural. Uterine size less than 24 weeks pregnancy Exclusion Criteria: Patients who have had a prior abdominal myomectomy Post-menopausal women Patients with known bleeding/clotting disorders Patients with a history of gynecologic malignancy Hypertension. Cardiac and Pulmonary diseases. Obesity (body mass index > 30 kg/m2). History of allergic reactions attributed to misoprostol Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>400 mg placebo | Drug: placebo 400 sublingual<br>* patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery<br>|
| Active Comparator: Group B<br>400 microgram misoprostol | Drug: Misoprostol 400 sublingual<br>* patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of intraoperative blood loss |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hemoglobin after surgery |  | 24 hours |
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: naveglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 Diabetes for at least 3 months. Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise. Diabetes therapy must be unchanged for at least 3 months prior to screening. Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening. Exclusion Criteria: Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin. Current use of metformin or a sulfonylurea agent in combination. History of liver disease. History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months. Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naveglitazar|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
-----------------
Type 2 diabetes