linjc16/ctgov huggingface dataset:
Novel Laboratory Methods in Nutrition Studies

Study Overview
=================
Brief Summary
-----------------
This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.

Official Title
-----------------
Feasibility of Novel Laboratory Methods for Use in Nutrition Studies

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

Intervention / Treatment
-----------------
* Other: Nutrition Products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must agree to refrain from taking supplements other than study product. Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study. Exclusion Criteria: Body Mass Index (BMI) > or equal to 35 kg/m2 Has planned elective surgery requiring 2 or more days of hospitalization during the entire study Has stated active malignant disease Has a known history of chronic renal parenchymal disease Has a known history of severe liver disease/liver failure Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures Known allergy or intolerance to any study product ingredient Participation in another study that has not been approved as a concomitant study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Products<br>Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day | Other: Nutrition Products<br>* a sachet containing AN777and amino acids; a carotenoid capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of lab values from venipuncture and DBS methods | Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AN777 |  | Baseline to Day 60 | 
| Change in carotenoids |  | Baseline to Day 60 | 
| Compliance of study product consumption | Subject Questionnaire | Baseline to Day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Novel laboratory methods
Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.

Detailed Description
-----------------
Blood samples and data will be collected from subjects with atrial fibrillation and normal controls. The primary aim of future research using these samples is to identify mechanisms and pathogenesis of atrial fibrillation. Through this information, we hope to identify targets for new therapies and improve knowledge and understanding of atrial fibrillation. Identification of disease genes could improve strategies that prevent progression of atrial fibrillation to more persistent disease.

Official Title
-----------------
Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Atrial Fibrillation group: Male or female at least 18 years old Subjects with a history of or current Atrial Fibrillation Subjects able to give informed consent Exclusion Criteria for Atrial Fibrillation group: no history of atrial fibrillation Inclusion Criteria for Controls: Male or female at least 18 years old Subjects with no history of Atrial Fibrillation Subjects able to give informed consent Exclusion Criteria for controls: History of atrial fibrillation

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 |
| --- | --- |
| atrial fibrillation<br>Atrial fibrillation | |
| Control<br>Control subjects with no atrial fibrillation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variants associated with atrial fibrillation | Genome-wide association study of atrial fibrillation | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Genetics
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.

Detailed Description
-----------------
Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating patients to prevent development of first episode of hepatic encephalopathy is classified as primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary prophylaxis of hepatic encephalopathy

Official Title
-----------------
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: Lactulose
* Drug: Lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhotic patients(18-70yrs) who never had encephalopathy Exclusion Criteria: history of taking lactulose in the past 6 weeks alcohol intake during the past 6 weeks hepatocellular carcinoma previous TIPS or shunt surgery significant co morbid illness such as heart, respiratory, or renal failure neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies. patients on psychoactive drugs such as antidepressants or sedatives who restarted alcohol during follow up

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactulose<br> | Drug: Lactulose<br>* In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day<br>Drug: Lactulose<br>* lactulose will be used in 30-60ml/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of first episode of hepatic encephalopathy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects to lactulose and mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic encephalopathy, Lactulose
A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment

Study Overview
=================
Brief Summary
-----------------
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.

Official Title
-----------------
An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Tacrolimus from EMS
* Drug: Prograf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 year old Patient is receiving kidney from live or death donor Kidney donor younger than 65 years old PRA ≤ 30% Negative pregnancy test for women Patient agreement to practice birth control Patient has been fully informed and has given written informed consent Exclusion Criteria: HLA identical Patient multi-organ transplant recipient Any pathology or past medical condition that can interfere with this protocol Allergy or intolerance of any study medication

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus from EMS<br>Group 1: Tacrolimus from EMS + Myfortic® + Steroids | Drug: Tacrolimus from EMS<br>* Tacrolimus initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.<br>|
| Active Comparator: Prograf<br>Group 2: Prograf® + Myfortic® + Steroids | Drug: Prograf<br>* Prograf initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Incidence of biopsy confirmed acute rejection | day 1 to day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Patient and graft survival Renal function control by Estimated Glomerular Filtration Rate Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation. | day 1 to day 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Immunosuppressive Agents, Kidney transplantation
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description
-----------------
A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Official Title
-----------------
A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Paclitaxel, Carboplatin
* Drug: Paclitaxel, Epirubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks. Exclusion Criteria: Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel, Carboplatin，injection<br>Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment. | Drug: Paclitaxel, Carboplatin<br>* Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.<br>|
| Active Comparator: Paclitaxel, Epirubicin，injection<br>Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment. | Drug: Paclitaxel, Epirubicin<br>* Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST 1.1 |  | -7 days |
Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.

Detailed Description
-----------------
19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted. These patients reached 6 months follow-up and the original study had to be interrupted. This observational study prolonges follow-up to 36 months

Official Title
-----------------
Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery

Conditions
-----------------
Glaucoma, Open-Angle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655 Exclusion Criteria: if cannot assist to all future follow-up visits

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess post-op IOP reduction | Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% | 12, 24 and 36 months |
THYME AND CARVACROLL Nanoparticle Effect on Fungi

Study Overview
=================
Brief Summary
-----------------
Invasive Aspergillosis (IA) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the ICU, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%.

Official Title
-----------------
Effect of Thyme and Carvacroll Nanoparticles on Aspergillus Fumigatus Isolate From Intensive Care Patients

Conditions
-----------------
Aspergillosis

Intervention / Treatment
-----------------
* Other: silver nanoparticle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intensive care patients Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: silver nanoparticle|fungicidal effect of silver nanoparticles on aspergillus isolates|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fungicidal effect of silver nanoparticles on aspergillus fumigatus |  | 24 hours |
A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers

Study Overview
=================
Brief Summary
-----------------
The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a day will prevent upper respiratory infections in otherwise healthy adults working in child day care centers.

Conditions
-----------------
Upper Respiratory Infections

Intervention / Treatment
-----------------
* Other: PrevinC
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must provide written informed consent prior to the conduct of any study Male or female 18-65 years of age Inclusive Employed by one of seven selected Day Care Centers Exclusion Criteria: Recent symptoms of upper respiratory infection, respiratory disease Received medication for colds or allergies within 3 weeks of enrolling Had nasal surgery within 2 months of enrolling Had a pierced nose or wore nose jewelry

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

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

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

Design Details

Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrevinC<br>PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil. | Other: PrevinC<br> <br> |
| Placebo Comparator: Control solution<br>The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC. | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinitis | The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries. | weekly from February 2005 to May 2005, up to 3 months |
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: SGM-1019
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 18 to 75 years, inclusive Elevated ALT F1-F3 NASH BMI ≥ 25 Exclusion Criteria: Use of prohibited medication/supplements Poorly controlled type 2 diabetes Hepatic decompensation Chronic liver disease Planned surgeries/procedures

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose SGM-1019<br> | Drug: SGM-1019<br>* Active<br>|
| Experimental: Low-dose SGM-1019<br> | Drug: SGM-1019<br>* Active<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Inactive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events | Summary of treatment emergent adverse events coded using MedDRA | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pharmacokinetics - PK | Peak plasma concentration of SGM-1019 as measured by Cmax | 12 weeks | 
| Evaluation of Pharmacodynamics - Labs | Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin. | 12 weeks | 
| Evaluation of Phamacodynamics - MRI | Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness. | 12 weeks |