linjc16/ctgov huggingface dataset:
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

Study Overview
=================
Brief Summary
-----------------
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, novel cardiovascular risk factors and safety parameters will be also evaluated.

Official Title
-----------------
EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION

Conditions
-----------------
Hypertension, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25). no previous hypolipidemic medication ability to provide Informed Consent. Exclusion Criteria: pregnancy or lactation myocardial infarction or unstable angina within the past 6 months heart failure NYHA class III-IV renal disease (SCr>3 mg/dL or proteinuria>3g/d) liver disease history of malignancy history of drug or alcohol abuse treatment with corticosteroids any other condition with poor prognosis inability to provide Informed Consent.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br> | Drug: Atorvastatin<br>* 10 mg of atorvastatin once daily for six months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo once daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Albumin Excretion |  | Six months | 
| Insulin Sensitivity |  | Six months | 
| Arterial Stiffness |  | Six months | 
| Urinary levels of nephrin |  | Six months | 
| Urinary levels of podocalyxin |  | Six months | 
| Urinary levels of Endothelin-1 |  | Six months | 
| Urinary levels of Asymmetric Dimethylarginine |  | Six months | 
| Urinary levels of indices of oxidative stress |  | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential hypertension
A Cohort Analysis Study of Intestinal Flora in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.

Detailed Description
-----------------
The gastrointestinal microbiome is believed to be critically important for infant growth and development. As we all know, the gut microbiota can influence gut maturation, metabolic, immune and brain development in early life. Host genotype, gestational age, antibiotic use, mode of delivery, diet and the context in which the infant is born (rural vs urban, presence of siblings, pets and other factors) can influence the development of infant gut microbiota. In the early life stage, intestinal flora disorders may alter the host immune function and increase the susceptibility to immune or metabolic diseases. This research intends to establish a birth cohort of healthy newborns. The influence factors of gastrointestinal microbiome will be investigated by means of questionnaire survey, specimen collection and high throughput sequencing analysis. What's more, the correlation of gut microbiome, infant growth as well as related diseases will be explored either. The results will provide constructive suggestions for the establishment of infant normal intestinal flora and play an indispensable role in exploring the occurrence, development and prevention of related diseases.

Official Title
-----------------
An Observational Study of Intestinal Flora in Infants

Conditions
-----------------
Gastrointestinal Microbiome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborns Exclusion Criteria: Newborns with diseases such as congenital heart disease or congenital malformation and so on

Ages Eligible for Study
-----------------
Maximum Age: 3 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Flora Sequencing | Intestinal Flora Sequencing | Intestinal Flora Sequencing Change from Baseline to 12 months after Birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal Microbiome, Infants
ECM and Blood Components for Wound Healing

Study Overview
=================
Brief Summary
-----------------
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.

Official Title
-----------------
Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components

Conditions
-----------------
Ulcer, Venous Ulcer, Foot Ulcer, Diabetic

Intervention / Treatment
-----------------
* Device: ECM
* Biological: Blood Products
* Device: ECM in Blood Products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or Type 2 diabetes, and/or venous insufficiency to the affected leg Ulcer has been present between 12 and 52 weeks Ulcer is less than 40 cm2 in area Exclusion Criteria: Less than 18 years of age Pregnant or planning to become pregnant during the study period Simultaneously participating in another investigational drug or device study Unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen Patient or legal representative refuses to sign the EC-approved informed consent form Known allergy to pig or porcine products Additional criteria may apply

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: ECM in Saline<br> | Device: ECM<br>* ECM in saline applied to wound<br>|
| Active Comparator: Blood Products<br> | Biological: Blood Products<br>* Autologous blood product applied to wound, with saline cleanse on alternating weeks<br>|
| Experimental: ECM in Blood Products<br> | Device: ECM in Blood Products<br>* Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

Official Title
-----------------
Single-Dose Food In Vivo Bioequivalence Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers.

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

Intervention / Treatment
-----------------
* Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
* Drug: Macrobid® Capsules 100 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg | Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg<br> <br> |
| Active Comparator: 2<br>Macrobid® Capsules 100 mg | Drug: Macrobid® Capsules 100 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collection through 28 hours |
A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Study Overview
=================
Brief Summary
-----------------
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.

Detailed Description
-----------------
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.

Official Title
-----------------
A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Conditions
-----------------
Colorectal Cancer, Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Re-laparotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis Exclusion Criteria: under 18 years of age Pregnancy

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 |
| --- | --- |
| T drain<br>Patients treated with a T drain approach | Procedure: Re-laparotomy<br> <br> |
| Stoma<br>Patients treated with a stoma | Procedure: Re-laparotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring severity of complications with the Dindo Clavien complications scale | By using the Dindo Clavien complications scale assessment of recuperation and complications rate and severity following re-laparotomy and assessing if another surgery was avoided. | 30 day post operation |
Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population.

Detailed Description
-----------------
We submitted the Quality of Life in spina bifid Questionnaire to subjects who participated in the study and the Spinal Cord Independence Measure to the parents of subjects.

Official Title
-----------------
Assessment of Functional Independence and Quality of Life in Italian Population of Adolescents With Spina Bifid

Conditions
-----------------
Spinal Dysraphism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrence of clinic control in Unit for Spina Bifid in Parma 14-21 years old Exclusion Criteria: subjects unable to understand the items of the questionnaire (mental retardation and need for help at school ) subjects without any caregiver

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 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 |
| --- | --- |
| subjects with spina bifid<br>subjects with spina bifid between 14 and 21 years old referred to Unit for Care of Spina Bifid Hospital of Parma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between functional level of independence and motor level of neurological lesion |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, functional independence, spina bifid
Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.

Detailed Description
-----------------
The type of patient sampling used was consecutive patient sampling

Official Title
-----------------
PRAGMATIC (This is the True Official Title of the Protocol for This Study)

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: INEGY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man or woman aged over 18; patient suffering from primary hypercholesterolemia; patient justifying treatment with INEGY® (2nd intention); patient currently treated with INEGY® for at least 4 weeks; patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy; patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment. Exclusion Criteria: patient not previously treated with a statin; patient previously treated with a combination of hypolipemics; patient treated with INEGY® as first intention; patient treated with INEGY® for less than 4 weeks; patient already included in this study.

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 |
| --- | --- |
| Subjects treated with INEGY<br>Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY | Drug: INEGY<br>* Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks<br>* Other names: SCH 465981;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reaching the Targeted LDL-C Levels | A subject was considered to have met targeted LDL-C levels (been controlled) if: subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L, subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L, subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L, subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L, subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L. | 1 to 3 months after starting treatment |
Probiotics and Hospital Outcome in the Elderly

Study Overview
=================
Brief Summary
-----------------
Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of this study was to investigate if probiotics could improve outcome of hospitalized orthopedic elderly patients.

Detailed Description
-----------------
The patients were divided into two groups. One received probiotics for 45 days and the second received placebo. The patients had a clinical and epidemiological as well as nutritional assessment. They were followed-up as for their bowel movements, abdominal pain and nosocomial infections and for the incidence of helicobacter pylori and clostridiume difficille diarrhea.

Official Title
-----------------
Effects of Commercially Available Probiotics on Hospital Outcome

Conditions
-----------------
Diarrhea, Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: VSL#3
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent. Exclusion Criteria: Known or suspected allergy to any probiotics Neutropenia Inability to sign an informed consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics, VSL#3<br>Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. | Dietary Supplement: VSL#3<br>* one sachet per day, for 45 consecutive days<br>* Other names: VSL phrma,USA;|
| Placebo Comparator: Placebo<br>Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. | Dietary Supplement: VSL#3<br>* one sachet per day, for 45 consecutive days<br>* Other names: VSL phrma,USA;Dietary Supplement: placebo<br>* one sachet per day, for 45 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea. | 45 days of measuring the outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Nutritional and Immunological Measurements |  | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, motility, diarrhea, probiotics
Prevention of Akute Kidney Injury, Hearttransplant, ANP

Study Overview
=================
Brief Summary
-----------------
Prospective, blinded, placebo-controlled trial. Patients: Adult patients (>18 years of age) undergoing de novo Htx, with a preoperative GFR > 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of > 6 hours. A donor age > 70 years is an exclusion criteria. Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia. Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.

Official Title
-----------------
Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: ANP
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo Htx. Preoperative GFR > 30ml/min/1,73m2. >18 years old. Written consent. Exclusion Criteria: Multi organ transplantation or previous heart transplant. ECMO Donor age > 70 years. Dialysis. ABO-incompatible organ. Donor heart ischemia time > 6 tim. Known kidney disease. Other planed study within 2 mounth.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANP<br>Infusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia. | Drug: ANP<br> <br> |
| Placebo Comparator: Placebo<br>Infusion of NaCl at the same volyme as for ANP for 5 days. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR 4-5 days after Htx |  | 4-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR 1 year after Htx |  | 1 year |