linjc16/ctgov huggingface dataset:
Does Gender Play a Role in Bone-mineral Density Measurement Precision?

Study Overview
=================
Brief Summary
-----------------
Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the current gold standard for osteoporosis diagnosis and therapy monitoring. Like all quantitative tests, there is some variability in BMD results obtained when scanning a person more than once. As such, it is current clinical practice, based on the recommendation of the International Society for Clinical Densitometry, that each technologist perform a precision assessment. This approach consists of scanning 30 people twice; the data from which allow determination of what constitutes a real difference in BMD with 95% confidence. A precision assessment typically evaluates a specific clinic's population, using the age range and genders seen at that clinic. However men generally have larger, but often more arthritic, bones than women which may impact the precision results. Therefore, it is possible that gender-specific precision values should be used in clinical practice, however this issue has never been investigated.

Official Title
-----------------
Does Gender Play a Role in Bone-mineral Density Measurement Precision?

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 65 years Able and willing to sign informed consent Exclusion Criteria: Inability to have DXA scans performed due to weight ≥ 450 pounds (exceeds densitometer table limit) Metallic hardware in, or overlaying, any of the measured skeletal sites

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Males<br> | |
| Females<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DXA Bone Mineral Density precision | The primary analysis will compare DXA BMD precision (mean square error/variance) in males and females, pooled across technicians, using the two-sample F-test for equality of variances. Separate analyses will also be performed for each technician. In addition, due to the sensitivity of the F-test to the normality assumption, a secondary analysis will perform the same comparisons using Levene's test. A nominal two-sided p-value of 0.05 will be regarded as statistically significant. | 1 day |
Patient Portal Use by Parents of Spanish-Speaking Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patient portal access is feasible and useful for Spanish-speaking parents. Participants will be given an electronic tablet and will be taught how to access their child's medical record and other electronic health resources using the tablet.

Official Title
-----------------
Patient Portal Use by Parents of Spanish-Speaking Children

Conditions
-----------------
Patient Engagement

Intervention / Treatment
-----------------
* Behavioral: Electronic tablet provision with teaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be parent/legal guardians of children receiving care in UNC's Children's Clinics Have Spanish as preferred language of individual identifying as primary caregiver Have never activated MyChart (patient portal) Have internet service at home OR ability to easily access internet service Have at least one child under age 13 Exclusion Criteria: Medically unstable at time of recruitment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic tablet<br>Spanish-speaking parents receive electronic tablet and teaching about use | Behavioral: Electronic tablet provision with teaching<br>* Spanish-speaking parents are provided with an electronic tablet and taught how to use it to access health information for their children.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Parents Activating Patient Portal | To determine patient portal use. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parent Attitudes Toward Health Information Technology | Parent attitudes and perceptions will be assessed by survey at enrollment and 1 month after intervention. Scale name: Reasons to use more health information technology. Range 3-12. Directionality: Higher scores indicate more favorable attitudes toward health information technology | Baseline, 1 month |
GLPG0259 Solid Formulation Bioavailability and Food Effect

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.

Official Title
-----------------
An Open Label Study to Compare the Oral Bioavailability of a Solid Dose Formulation of GLPG0259 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Solid Dose Formulation.

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

Intervention / Treatment
-----------------
* Drug: GLPG0259 solution
* Drug: GLPG0259


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

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

Sexes Eligible for Study
-----------------
Male

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: Single oral dose, solution<br> | Drug: GLPG0259 solution<br>* single oral dose, GLPG0259, 50 mg oral solution<br>|
| Experimental: Single oral dose, solid, fasted<br> | Drug: GLPG0259<br>* single oral dose, GLPG0259, 50 mg solid formulation<br>|
| Experimental: Single oral dose, solid, fed.<br> | Drug: GLPG0259<br>* single oral dose, GLPG0259, 50 mg solid formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of a solid dosage formulation of GLPG0259 (with/without food) compared to an oral solution of GLPG0259. |  | up to 96 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of GLPG0259 |  | up to 96 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. The incidence of cardiac arrest in Indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%. Cardiac arrest events urgently require CPR action that is useful to save lives in an emergency. The application of Code Blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. The Code Blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.

Official Title
-----------------
The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest at Sanglah General Hospital

Conditions
-----------------
Cardiac Arrest, Sudden, Cardiopulmonary Arrest, Cardiopulmonary Failure, In-hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Procedure: CPR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with in-hospital cardiac arrest that were treated at Sanglah General Hospital Exclusion Criteria: Patients who upon admission to the hospital already showing cardiac arrest rhythm Patients who were DOA (death-on-arrival)

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

| Intervention/Treatment |
| --- |
|Procedure: CPR|Cardiopulmonary resuscitation performed on patients with in-hospital cardiac arrest|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivors | The number of patients who were successfully converted to ROSC (return of spontaneous circulation) | 6-hours after CPR is stopped | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in-hospital, cardiac arrest, resuscitation, success rate
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Study Overview
=================
Brief Summary
-----------------
Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy. The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.

Official Title
-----------------
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Conditions
-----------------
Tracheostomy

Intervention / Treatment
-----------------
* Device: Shiley™ phonate speaking valve
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brain injury (traumatic/non-traumatic). tracheostomy. unresponsive wakefulness syndrome or minimally conscious state. fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3. the legal guardian speaks Hebrew. Exclusion Criteria: airway stenosis / inflammation. oxygen saturation <90%.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: speaking valve<br>Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments). | Device: Shiley™ phonate speaking valve<br>* The device connects to the tracheostomy tube. Usually used to aid vocalization.<br>* Other names: speaking valve;|
| Other: control<br>Respiratory physical therapy treatments conducted without using a speaking valve . | Other: control<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline oxygen saturation | at physical therapy sessions | 15 minutes | 
| change from baseline breathing rate | at physical therapy sessions | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of swallowing | during a physical therapy session | 15 minutes | 
| percentage of participants presenting vocalization | occurrence of vocalization at the respiratory physical therapy sessions. | 2 weeks | 
| cough rate | the ratio of respiratory physical therapy sessions eliciting cough. | 2 weeks | 
| percentage of patients weaned from tracheostomy | whether or not decannulation was successfully performed during rehabilitation. | through study completion, an average of 6 months. |
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)

Study Overview
=================
Brief Summary
-----------------
This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Official Title
-----------------
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: TS-1 (S-1)
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 80 Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ULN Exclusion Criteria: Prior anticancer treatment

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TS-1 (S-1) | Drug: TS-1 (S-1)<br>* 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks<br>|
| Other: 2<br>Surgery alone | Procedure: Surgery<br>* Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival, adverse events |  | any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach cancer
Glucose Response From Antioxidant Rich Potato Chips

Study Overview
=================
Brief Summary
-----------------
Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.

Detailed Description
-----------------
Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest phenolic-rich potato extracts decrease intestinal glucose transport. The aim is to determine if these effects extend to the the an in vivo situation. Specifically, the glycemic response following consumption of phenolic rich pigmented potatoes compared to white potatoes with lower phenolic content will be measured. Gastric emptying will also be measured to show the effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport and not gastric emptying rate.

Official Title
-----------------
Glucose Response From Antioxidant Rich Potato Chips

Conditions
-----------------
Glycemic Response

Intervention / Treatment
-----------------
* Other: Purple Majesty potato chips
* Other: Mountain Rose potato chips
* Other: White potato chips
* Other: Crackers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-25 non-smoker Exclusion Criteria: BMI outside 18-25 smoker previous gastrointestinal disease or other disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Purple Majesty potato chips<br>Purple Majesty potato chips | Other: Purple Majesty potato chips<br>* Purple Majesty potato chips<br>|
| Experimental: Mountain Rose potato chips<br>Mountain Rose potato chips | Other: Mountain Rose potato chips<br>* Mountain Rose potato chips<br>|
| Experimental: White potato chips<br>White potato chips | Other: White potato chips<br>* White potato chips<br>|
| Experimental: Crackers<br>Crackers | Other: Crackers<br>* Crackers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose | blood taken at 10, 20, 30, 60, and 120 minutes by finger prick | up to 2 hours | 
| Gastric emptying | Breath Hydrogen concentrations will be measured every 15 minutes for 4 hours | up to 4 hours |
A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.

Official Title
-----------------
An Open, Single-centre, Controlled Trial to Investigate the Efficacy and Usability of Published Best Practice to Control Glycaemia in Hospitalised Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Insulin Aspart, Insulin Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Blood glucose in the range between 140 - 400 mg/dl Expected stay ≥ 48 hours Exclusion Criteria: Hyperglycemia without known history of type 2 diabetes mellitus Impaired renal function (serum creatinine ≥3.0mg/dL) Clinically relevant hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin titration protocol<br>Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes. | Drug: Insulin Aspart, Insulin Glargine<br>* The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).<br>|
| No Intervention: Standard care<br>Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood glucose | Mean blood glucose over 24 hours | duration of hospital stay (48 hours - maximum three weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of glucose measurements in hyperglycaemic ranges |  | duration of hospital stay (48 hours - maximum three weeks) |
Continuous Monitoring of Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage

Study Overview
=================
Brief Summary
-----------------
Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome

Official Title
-----------------
Observational Study of Continous Monitoring of Arterial Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage

Conditions
-----------------
Intraparenchimal Cerebral Haemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalization only for spontaneous intraparenchimal cerebral haemorrhage age over 18 years Exclusion Criteria: cerebral haemorrhage secondary to other causes

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 |
| --- | --- |
| Intraparenchimal cerebral haemorrhage<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of blood pressure varibility on clinical course in patients with cerebral haemorrhage |  | Day 7 |