linjc16/ctgov huggingface dataset:
Ability to Meet Enteral Nutritional Needs With a Peptide-based, High Protein Formula

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.

Detailed Description
-----------------
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.

Official Title
-----------------
Prospective Study Of Ability To Meet Nutritional Needs With A Peptide-based, High Protein Enteral Formula

Conditions
-----------------
Enteral Feeding

Intervention / Treatment
-----------------
* Other: Medical Food: Peptide-Based Enteral Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with established enteral access Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs Signed informed consent Exclusion Criteria: Condition which contraindicates enteral feeding (i.e. intestinal obstruction) Any condition that would contraindicate use of the study product Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment Judged to be at risk for poor compliance to the study protocol Participating in a conflicting clinical trial

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm, non-randomized, open-label observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enteral Tube-fed Adults<br>Adults being fed an enteral formula with a feeding tube | Other: Medical Food: Peptide-Based Enteral Formula<br>* Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calorie nutritional goals | Daily percentage of calorie nutritional goals met | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein nutritional goals | Daily percentage of protein nutritional goals met | 14 days | 
| Daily reports of gastrointestinal intolerance | Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting) | 14 days | 
| Adverse events | Daily adverse event reporting | 14 days |
Glycaemic Response Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

Official Title
-----------------
Glycaemic Response Testing

Conditions
-----------------
Glycaemic Index, Glycaemic Response

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (not less than 40% males or females Non-smoker Aged 18 to 55 years Have a body mass index between 18.5 to 29.99 kg/m2 Healthy, non-diabetic, no gastric bypass surgery Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L) Willing and able to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Test Drink<br>Control drink | Other: Dietary Intervention<br>* 300 ml of liquid food product<br>|
| Experimental: Experimental Test Drink 1<br>Control drink containing ingredient 1 | Other: Dietary Intervention<br>* 300 mL of liquid food product<br>|
| Experimental: Experimental Test Drink 2<br>Control drink containing ingredient 2 | Other: Dietary Intervention<br>* 300 ml of liquid food product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic index of experimental test food using capillary blood |  | 0-120 minutes |
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.

Official Title
-----------------
An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rasagiline mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic Parkinson's disease. eligible to Azilect® treatment as per Canadian product monograph Exclusion Criteria: exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph. investigational drug within 30 days prior to study use of Azilect® or selegiline within 60 days prior to study significant medical condition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azilect<br>Subjects with a diagnosis of idiopathic Parkinson's disease eligible to Azilect® treatment based on the investigator's clinical assessment and according to the Canadian product monograph. | Drug: Rasagiline mesylate<br>* Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily<br>* Other names: Rasagiline mesylate, Azilect;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS). |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS). |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rasagiline, Sleep, Sleepiness, Parkinson's Disease Sleep Scale, Epworth Sleepiness Scale
Genetesis Accelerated Registry

Study Overview
=================
Brief Summary
-----------------
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.

Official Title
-----------------
Genetesis Accelerated Registry

Conditions
-----------------
Acute Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: CardioFlux


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. ≥ 18 years of age at the time of enrollment. Exclusion Criteria: < 18 years of age Patients unable to fit into device Non-ambulatory patients Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners Patients with a language barrier/language difficulties

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 |
| --- | --- |
| GEAR cohort<br>This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease. | Device: CardioFlux<br>* Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Cardioflux diagnosis/screening of ACS | Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemia, acute myocardial injuries, CardioFlux, MCG, Cardiovascular disease
Blood Sampling for Neurochemical and Genetic Testing

Study Overview
=================
Brief Summary
-----------------
This study involves sampling blood from both normal volunteers and patients with diseases known or suspected to involve body chemicals called catecholamines. The blood will be used to establish normal values for plasma levels of catecholamines and related neurochemicals; to test for abnormal neurochemical patterns in patients; and to establish a bank of DNA from normal volunteers and from patients to be used in future studies about possible alterations of catecholamine-related genes. Study participants will report to NIH after fasting overnight except for water or noncaloric, noncaffeinated beverages. They must not have taken Tylenol for at least 5 days. Blood will then be drawn. DNA will be extracted and stored in the freezer for future studies.

Detailed Description
-----------------
This project is to allow blood sampling from normal volunteers and patients with dysautonomia, pheochromocytoma, hypertension, or neurogenetic diseases involving catecholaminergic systems. The blood is used to establish normal values for plasma levels of catechols and related neurochemicals; test for abnormal neurochemical patterns in patients; and establish a bank of DNA samples from normal volunteers and from patients, to be used in future studies about mutations or polymorphisms of catecholamine-related genes.

Official Title
-----------------
Blood Sampling for Neurochemical and Genetic Testing

Conditions
-----------------
Pheochromocytoma, Autonomic Nervous System Disease, Healthy, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: The subjects are healthy normal volunteers or patients with dysautonomia, pheochromocytoma, hypertension, or neurogenetic diseases involving catecholaminergic systems. Children of any age above 4 years may participate. In the case of minors, consent is obtained from an adult who is legally responsible for the subject. EXCLUSION CRITERIA: Subjects in whom anatomic or technical factors preclude insertion of an arm intravenous (i.v.) catheter are excluded. Normal volunteers taking any prescribed medication are excluded. Normal volunteers who smoke cigarettes or consume alcohol daily are excluded.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metanephrine, Dopamine, Norepinephrine, Epinephrine, Catecholamines, Tyrosine Hydroxylase, Monoamine Oxidase, Phenosulfotransferase, Sympathetic Nervous System, Normetanephrine
Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study

Study Overview
=================
Brief Summary
-----------------
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication. Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up. The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.

Conditions
-----------------
Bronchoscopy Biopsy

Intervention / Treatment
-----------------
* Drug: tranexamic acid
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient that are candidates to endobronchial or transcronchial biopsy Exclusion Criteria: S/P MI or CVA or PE or DVT . S/P thrombophilia. Patients under coagulation therpay Chronic Renal Failure Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid<br>tranexamic acid will be administrated using the bronchoscope | Drug: tranexamic acid<br> <br> |
| Placebo Comparator: saline<br>the saline will be administrated using an infusion during the biopsy. | Drug: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of bleeding | amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank. | participants will be followed for the duration of hospital stay, an expected average of one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of erythrocytes | amount of erythrocytes by multiplying the Hematocrit and blood volume | participants will be followed for the duration of hospital stay, an expected average of one day |
The ICU Care Knowledge Study

Study Overview
=================
Brief Summary
-----------------
Family members have poor overall understanding of ICU patients' prognosis, resuscitation status and care, defined a priori as less than 75% correct responses to the yes/no ICU care questions. Family members of all adult patients admitted to an intensive care of San Francisco General Hospital will be screened for enrollment and recruited sequentially over a period of nine months (August 1, 2005-March 31, 2006). We will determine the frequency of family members' correct responses to the survey questions about ICU care. Family member responses will be compared to the chart and real-time patient observation reality (gold standard). Hypothesis # 2 Poor English language comprehension and low education level (defined as not having completed high school) are risk factors for poor ICU care understanding and knowledge. During their surveys family members will be asked questions regarding their English language comprehension and education level. Association of these possible risk factors with low level of ICU care knowledge will be tested primarily using analysis of variance. Should our hypothesis #2 prove to be correct, our future goal will be to develop recommendations for interventions to increase understanding specific for these high risk groups. One of these interventions is described in Hypothesis #3 below. Hypothesis # 3 Provision of the results of family members' knowledge assessment to health care providers will result in improved ICU care knowledge on subsequent testing. Subjects will be randomized to two groups-one group's health care providers will be shown the results of family members' initial ICU knowledge assessment; the other group's providers will not be given these results. One to two days after providing this summary to providers, all randomized subjects will undergo a second interview assessing their ICU care knowledge. Changes in the frequency of correct responses between the two groups will be compared using mean differences in proportions with 95% confidence intervals.

Official Title
-----------------
The ICU Care Knowledge Study: A Prospective Study of Family Members' Knowledge of ICU Care and Prognosis

Conditions
-----------------
ICU Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: family member of ICU patient Exclusion Criteria: incarceration, unable to participate in interview
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 |
| --- | --- | --- |
Post Market Surveillance for Infanrix™

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the following questions through post-marketing surveillance: Unknown/Unexpected adverse events and the serious adverse events. The circumstances in which the adverse events occurred under the practical application. Factors considered to have influence on safety. Factors considered to have influence on efficacy. Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.

Official Title
-----------------
Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine

Conditions
-----------------
Diphtheria, Acellular Pertussis, Tetanus

Intervention / Treatment
-----------------
* Biological: GSK Biologicals' Infanrix™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children receiving Infanrix™ were eligible for this survey. Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infanrix Group<br>Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). | Biological: GSK Biologicals' Infanrix™<br>* Primary and booster vaccination according to vaccination schedule. Intramuscular injection<br>* Other names: DTPa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Serious Adverse Events | A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Since the beginning of the study and during the entire study period (up to 6 years) | 
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting. | During the 4-week follow-up period after each dose | 
| Number of Subjects Reporting Unsolicited Adverse Events | An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Within the 31-day (Day 0-30) following vaccination. |