linjc16/ctgov huggingface dataset:
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

Study Overview
=================
Brief Summary
-----------------
The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.

Detailed Description
-----------------
Heart failure patients will be enrolled and randomized to cervical VNS implantation on either the left side or right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 6 months, with data collection at 3 months and 6 months.

Official Title
-----------------
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Vagus Nerve Stimulation (VNS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

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: Left Sided Stimulation<br>Left cervical Vagus Nerve Stimulation (VNS) | Device: Vagus Nerve Stimulation (VNS)<br>* Electrical Stimulation of the Vagus Nerve<br>|
| Experimental: Right Sided Stimulation<br>Right Cervical Vagus Nerve Stimulation (VNS) | Device: Vagus Nerve Stimulation (VNS)<br>* Electrical Stimulation of the Vagus Nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Function | Left ventricular end-systolic volume (LVESV) and ejection fraction (EF) | 6 months | 
| Adverse Events | Incidence of procedure and device-related complications | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status | 6-minute walk test | 6 months | 
| Quality of Life | Minnesota Living with Heart Failure Questionnaire | 6 months | 
| Functional Status | New York Heart Association Class | 6 months | 
| Autonomic Function | Heart Rate Variability (HRV) | 6 months | 
| Blood Biomarkers | Blood Levels of Heart Failure Biomarkers | 6 months | 
| Cardiac Function | Left ventricular end-systolic diameter (LVESD) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Vagus Nerve, VNS
Clinical Characteristics of Lip Hemangiomas

Study Overview
=================
Brief Summary
-----------------
Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas.

Detailed Description
-----------------
Hemangiomas involving lip are of special concern, since they occur in a prominent location on the face and can distort lip anatomy and lead to disfunction. Infantile hemangiomas in lip had significantly higher incidence than the others. It is often difficult to decide which patient with an lip hemangioma is at higher risk. The investigators are interested in conducting a study on the clinical features of lip hemangiomas. The investigators are collecting medical records and photos of lip hemangiomas, including demographic information, maternal process, birth, location, size and complication. Based on the data, sum up the main points of clinical characteristics and complication.

Official Title
-----------------
Clinical Characteristics and Complications of Infantile Hemangiomas Located in Lips

Conditions
-----------------
Hemangioma

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only lip hemangiomas visiting between June 1, 2010 and October 1, 2014 were included in this study, which was defined as any infantile hemangioma covering any part of vermilion. Exclusion Criteria: Perioral hemangiomas which did not involve vermilion were excluded.

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| lip hemangiomas<br> | Other: observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appearance time, location, size, complication of lip hemangiomas |  | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic information |  | up to 1 month | 
| maternal specific events |  | up to 1 month |
Safety of Lactobacillus Fermentum in Newborn Infants

Study Overview
=================
Brief Summary
-----------------
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

Official Title
-----------------
Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716

Conditions
-----------------
Tolerance

Intervention / Treatment
-----------------
* Other: Infant formula
* Other: Infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 1 month infants exclusively formula-fed Exclusion Criteria: gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux) gastrointestinal surgery cow's milk protein allergy metabolic disorders (diabetes, lactose intolerance) immune deficiency antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Ages Eligible for Study
-----------------
Minimum Age: 21 Days
Maximum Age: 30 Days

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No probiotics<br>Infant formula with no probiotics | Other: Infant formula<br>* Powder infant formula<br>|
| Experimental: Probiotic<br>Infant formula supplemented with probiotic | Other: Infant formula<br>* Powder infant formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average weight gain |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth and health of infants | average weight, length of infants. Incidence of infections. Incidence of allergic diseases | 2,4,6,12 and 36 months of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, infant nutrition, safety, infections
Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

Study Overview
=================
Brief Summary
-----------------
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.

Official Title
-----------------
Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC

Conditions
-----------------
Total Shoulder Arthroplasty

Intervention / Treatment
-----------------
* Device: reverse shoulder arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures Exclusion Criteria: patients with previous surgery patients with deltoid deficiency patients with acute infection
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
Interventional Model Description: randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glenosphere 42<br>patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch | Device: reverse shoulder arthroplasty<br>* prosthesis implantation<br>* Other names: Delta X-tend;|
| Active Comparator: glenosphere 38 ECC<br>patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch | Device: reverse shoulder arthroplasty<br>* prosthesis implantation<br>* Other names: Delta X-tend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scapular notch development | X-ray assessment of scapular notch development | two years |
Paracetamol Metabolism After Liver Surgery

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.

Detailed Description
-----------------
Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity. Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection. Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.

Official Title
-----------------
Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.

Conditions
-----------------
Liver Resection, Paracetamol Administration

Intervention / Treatment
-----------------
* Other: Paracetamol (observation of routine administration)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing liver surgery Exclusion Criteria: Contra-indication to paracetamol Inability to give written, informed consent. Jaundice (Bilirubin > 100 μmol/L). Liver resection combined with secondary surgical procedure. Age < 18 years. Pregnant women.

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 |
| --- | --- |
| Liver resection group<br>Patients undergoing liver resection and receiving paracetamol (observation of routine administration) | Other: Paracetamol (observation of routine administration)<br>* Normal administration of paracetamol as prescribed by operating surgeon<br>* Other names: Acetaminophen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary cysteine |  | Post operative days 1-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mercapturic acid |  | post operative days 1-4 | 
| Glutathione |  | day of surgery and post operative days 1 and 3 | 
| Paracetamol level |  | day of surgery and post operative days 1 and 3 |
Effect of Mental Stress on Platelet Function

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to study the acute and chronic effect of mental stress on platelet adhesion and aggregation in two population composed of normal subjects at different ages

Detailed Description
-----------------
Psychological stress is an important cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could be one of the mechanisms linking psychological stress and cardiovascular diseases. We plan to include 32 healthy subjects. (16 in every group). One group with subjects at age 20 - 49 and the other group with subjects at age 50 - 70 years. The aim of the study will be to assess the acute and chronic effect of a standard short mental stress (2-minute Bondet Test) on platelet function and of the level of endothelin-1, catecholamines and cortisol. We plan to evaluate if age may play a role in the effect of psychological stress on platelet function.

Official Title
-----------------
Effect of Mental Stress on Platelet Function in Healthy Subjects

Conditions
-----------------
Mental Stress

Intervention / Treatment
-----------------
* Behavioral: 2-minute Bondet test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects between 20 - 70 years of age written informed consent no evidence of diseases Exclusion Criteria: pregnancy oral contraceptives smoking use of aspirin or NSAIDs within the last week use of benzodiazepines within the last week Alcohol or drug abuse participation in another study within the last month

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young subjects<br> | Behavioral: 2-minute Bondet test<br>* 2-minute Bondet test<br>* Other names: 2-minute Bondet light test;|
| Experimental: Older subjects<br> | Behavioral: 2-minute Bondet test<br>* 2-minute Bondet test<br>* Other names: 2-minute Bondet light test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental stress, platelet adhesion, platelet function, catecholamines
Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: calories measured 5x following wound healing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >25% burn surface area Wounds present as 95% healed Admitted to Shriners Hospital Cincinnati within 7 days of injury Exclusion Criteria: <5years old <25% burn injury admitted greater than 7 days postburn

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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, observed<br>measure REE via indirect calorimetry at various time points post burn | Other: calories measured 5x following wound healing<br>* measure REE at various time points postburn<br>|

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
-----------------
nutrition assessment, pediatric
The Function of Gastrointestinal Tract During Pregnancy

Study Overview
=================
Brief Summary
-----------------
In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index).

Official Title
-----------------
The Function of Gastrointestinal Tract During Pregnancy and After Delivery

Conditions
-----------------
Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent obtained pregnancy, delivery female non pregnant Exclusion Criteria: no informed consent male

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| During pregnancy<br>Pregnant ladies filled bowel function questionnaires | |
| After delivery<br>ladies within three weeks of delivery filled bowel function questionnaires | |
| Controls<br>Non pregnant ladies filled bowel function questionnaires | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel function | participants filled bowel function questionnaires | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, pregnancy, delivery
Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

Detailed Description
-----------------
Cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (HE) and infections. Dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation. TIPS can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. Hence we summarize that TIPS may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.

Official Title
-----------------
Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients

Conditions
-----------------
Cirrhosis, Acquired Portal-systemic Shunt Due to Cirrhosis, Hepatic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients who received TIPS; Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation) Exclusion Criteria: Uncontrolled infection or sepsis; Hepatobiliary or pancreatic malignancy or biliary obstruction; Vital organ dysfunction; Administration of antibiotics (after TIPS and 2 weeks before TIPS); Cachexia; Pregnant or breeding women

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIPS group<br>patients who have transjugular intrahepatic portosystemic shunt | |
| Non-TIPS group<br>patients who have endoscopic variceal ligation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fecal microbiota |  | baseline and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic encephalopathy |  | 6 month | 
| Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α |  | baseline and 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis, gut microbiota, transjugular portosystemic shunt, hepatic encephalopathy