linjc16/ctgov huggingface dataset:
Diaphragmatic Echography After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).

Official Title
-----------------
Evaluation of Diaphragmatic Displacement With Echography in Patients Undergoing Thoracic Surgery

Conditions
-----------------
Surgery, Thoracic, Respiratory Diaphragm, Complication, Postoperative

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery for lung cancer Age > 18 ASA 2-3 Exclusion Criteria: BMI > 35 Contraindications for epidural catheter positioning History of neurodegenerative pathology Previous thoracic surgery Need for mechanical ventilation after surgery

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 |
| --- | --- |
| Lung cancer surgery<br>All patients undergoing thoracic surgery for lung cancer either with thoracoscopy or thoracotomy will receive diaphragmatic Ultrasonography 2 and 24 hours after surgery | Diagnostic Test: Ultrasonography<br>* Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic dysfunction | Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications | Postoperative pulmonary complications include hypoxemia, severe hypoxemia, bronchospasm, suspected pulmonary infection, new pulmonary infiltrates, atelectasis, pleural effusion | 7 days after surgery |
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Study Overview
=================
Brief Summary
-----------------
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission. Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.

Detailed Description
-----------------
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies. HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.

Official Title
-----------------
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Conditions
-----------------
HIV Infections, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Prior Medication: Required: At least 6 months of prior AZT, including continuously during the current pregnancy. Patients must have: HIV seropositivity. CD4 count <= 300 cells/mm3. Gestational age of 20-36 weeks, with intention to carry pregnancy to term. At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome. Concurrent Medication: Excluded: Antiretrovirals other than AZT.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort

Study Overview
=================
Brief Summary
-----------------
National guidelines about post-operative fasting after general anesthesia are missing. Current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period. The aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.

Official Title
-----------------
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.

Conditions
-----------------
Scheduled General Anaesthesia With Airway Control

Intervention / Treatment
-----------------
* Procedure: Early oral fluid recovery.
* Procedure: Delayed oral fluid recovery.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled surgery General anaesthesia with laryngeal mask or endotracheal intubation. Length of surgery < 4 hours Exclusion Criteria: Emergency surgery Intra-cranial, cervical or Ear, Nose and Throat surgery Guts surgery with guts anastomosis. Glottic topical anesthesia Patient with nasogastric tube Aspiration during surgery or during PACU stay

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oral fluid recovery.<br> | Procedure: Early oral fluid recovery.<br> <br> |
| Active Comparator: Delayed oral fluid recovery.<br> | Procedure: Delayed oral fluid recovery.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if early oral fluid recovery after an elective surgery under general anaesthesia with endotracheal intubation or laryngeal mask increasethe incidence of cough during swallowing, ie aspiration. | During first swallowing, patients will be observed to establish if cough occurs during this first swallowing. | 1min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if early oral fluid recovery (i.e patient discharged of PACU) after general anaesthesia increases post-operative vomiting during first hour and patient comfort rated on a 10 points scale. | During a one-hour period after first swallowing, patients will be looked after for any vomiting. At the end of day, patients will be asked to rate their postoperative comfort on a 10 points scale. | 1 hour |
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults

Study Overview
=================
Brief Summary
-----------------
This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.

Official Title
-----------------
Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults

Conditions
-----------------
Mobility Limitation

Intervention / Treatment
-----------------
* Dietary Supplement: Whey protein
* Dietary Supplement: Maltodextrin placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Females 70-85 yrs Community dwelling Short Physical Performance Battery score < 10 BMI = 21-32.5 Exclusion Criteria: Acute or terminal illness Mini Mental State Exam < 23 Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure Upper or lower extremity fracture in previous 6 months Uncontrolled hypertension (>150/90 mm Hg). Neuromuscular diseases and drugs which affect neuromuscular function. Hormone replacement therapy eGFR <30 mL/min/1.73m2 Types I and II Diabetes Mellitus Dietary protein intake < 0.8 g.kg-1.day-1 Disorders of nutrient absorption Milk, or whey allergy Sulfa drugs and allergy to PABA-containing sunscreens

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A, 1<br> | Dietary Supplement: Whey protein<br>* powdered, 46g supplement dissolved in fluids, twice daily<br>|
| Placebo Comparator: A, 2<br> | Dietary Supplement: Maltodextrin placebo<br>* powdered, 46g supplement dissolved in fluids, twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press | The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment. | Baseline and follow up (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean Mass | Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry. | Baseline and follow up (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whey protein, Resistance exercise, Physical activity, Mobility disability, Physical function, Muscle mass, Muscle strength, Older Adults, Mobility-Limited
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.

Official Title
-----------------
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,

Conditions
-----------------
Muscle Composition, Sarcopenia, Hypertrophy, Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary Protein Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women between the ages of 55-80 Body Mass Index between 27-35 Non Diabetic Normal liver, kidney and heart functions within 10% of clinical normalcy Not currently following a weight loss or other special /non balanced diets weight stable Exclusion Criteria: fasting glucose > 110 mg/dl blood pressure > 160/110 mm Hg plasma total cholesterol > 260 mg/dl LDL-cholesterol >160mg/dl triacylglycerol>400 mg/dl >than 1 hour/week of habitual aerobic and /or resistance exercise Currently taking prescribed blood thinners

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High or Normal Dietary Protein Intake<br> | Dietary Supplement: Dietary Protein Intake<br>* Dietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults | Anticipated subject recruitment completion | December 31, 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skeletal muscle lipid content, whole muscle volume, fasting glucose, insulin, blood urea nitrogen
PVI for TVC Response

Study Overview
=================
Brief Summary
-----------------
Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness

Detailed Description
-----------------
The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor. To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness. We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.

Official Title
-----------------
The Effectiveness of Tidal Volume Challenge Incorporating Plethysmographic Variability Index in Predicting Fluid Responsiveness

Conditions
-----------------
Validation of PVI in Tidal Volume Challenge Test

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position Exclusion: BMI < 18.5 or >30 kg/m2 Pregnant patient Allergy to starch solution estimated glomerular filtration rate< 60

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness | The change in value of Plethysmographic Variability Index after increasing VTE from 6 ml/kg to 8 ml/kg. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least significant change for Massimo PVI and Philips PPV | Calculate the least significant change for Massimo PVI and Philips PPV using data acquired from our electronic system | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tidal volume challenge,Plethysmography variability index,Fluid responsiveness
Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts

Study Overview
=================
Brief Summary
-----------------
Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.

Official Title
-----------------
Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Behavioral: text message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = 18 years of age at least one visit to the AIM clinic during previous 6 months a cell phone number in the registration system fluent in English or Spanish Exclusion Criteria: - Receipt of influenza vaccination during the 2014-2015 influenza season prior to randomization

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: text message<br>Receipt of series of text messages regarding influenza vaccination | Behavioral: text message<br>* series of text messages regarding influenza vaccination<br>|
| No Intervention: usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza vaccination | receipt of influenza vaccine | up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza vaccination | receipt of influenza vaccine | up to 2 months | 
| captured opportunity | receipt of influenza vaccination during a visit | up to 5 months |
Sayana-Uniject Volumetric Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the volumetric delivery of the Uniject.

Detailed Description
-----------------
Observe subjects deliver the drug None used

Official Title
-----------------
Quantitative Determination of the Volume of Suspension Delivered Via the Uniject Delivery System Following Simulated Subcutaneous Injection by Healthcare Professionals Into a Synthetic Subcutaneous Injection Training Device

Conditions
-----------------
Volume Delivery

Intervention / Treatment
-----------------
* Other: Uniject


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses Exclusion Criteria: Non-nurses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>All subjects | Other: Uniject<br>* single use container<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system). |  | Visit 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volume delivery
Single Ascending Dose Study of MYK-461 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.

Official Title
-----------------
Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: MYK-461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal body mass index (BMI) Normal LVEF Normal electrocardiogram (ECG) Females must not be breastfeeding and must be permanently sterilized or are postmenopausal. Exclusion Criteria: Any structural abnormalities on echocardiography Positive results of HIV test and/or seropositive for HCV or HBV.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MYK-461<br>single-dose, tablet formulation | Drug: MYK-461<br> <br> |
| Placebo Comparator: Placebo<br>single-dose, tablet formulation | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pharmacokinetics parameters | maximum concentration (Cmax) | 28 Days | 
| Determination of pharmacokinetics parameters | time of the maximum measured concentration (Tmax) | 28 Days | 
| Determination of pharmacokinetics parameters | area under the concentrationtime curve (AUC) | 28 Days | 
| Determination of pharmacokinetics parameters | half-life (t1/2) | 28 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertrophic Cardiomyopathy