linjc16/ctgov huggingface dataset:
Estimating Average Vitamin A Requirements in Indonesian and American Women

Study Overview
=================
Brief Summary
-----------------
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.

Official Title
-----------------
Development of 13C-Retinol Isotope Dilution Techniques

Conditions
-----------------
Vitamin A Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin A supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal nutritional status (BMI 18.5-25) Exclusion Criteria: Significant clinical illness

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment to 0 or 525 micrograms supplemental vitamin A/day (Indonesia) or 0, 175 or 525 micrograms supplemental vitamin A/day (USA).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A supplement<br>Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily | Dietary Supplement: Vitamin A supplement<br> <br> |
| Placebo Comparator: Placebo<br>Subjects receive an oil placebo containing no vitamin A | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body vitamin A stores (micromoles of vitamin A) | Change in total body stores of vitamin A before and after intervention, measured by retinol isotope dilution | Baseline and after 42 to 60 days | 
| Total vitamin A liver reserves (micromoles vitamin A per gram liver) | Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution | Baseline and after 42 to 60 days |
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.

Detailed Description
-----------------
There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.

Official Title
-----------------
Limited Intervention in Low Risk(Tier 3) COPD Patients

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Behavioral: Educational brochures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC <70%. Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year -
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention<br>Subjects in this group will receive educational brochures about management of COPD | Behavioral: Educational brochures<br>* A locally developed educational brochure containing information about smoking cessation, influenza and pneumococcal vaccination, regular exercise, compliance with prescribed COPD therapy and recognition of symptoms, along with a goal setting questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined frequency of admissions and ED visits for COPD over 1 year. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient knowledge of COPD will be compared. |  | 1 year | 
| Use of respiratory medications will be compared |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the Glasgow Coma scale score with the building of a predictive score based on those findings taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.

Detailed Description
-----------------
Multicentre, prospective, observational study. All the consecutive blunt thoracic trauma patients consecutively admitted at the participating institutions' Emergency Department (ED) will be considered for enrolment. The primary outcome measure will be the need for orotracheal intubation for primary respiratory failure lasting at least 48 hours within 7 days after trauma. The secondary outcome measures related to analgesia are: the basal analgesia protocol received during the first 7 days from ED admission and the median cumulative dose of morphine-equivalents received as rescue therapy during the first 7 days after trauma. The secondary outcome measure related to the sonographic evolution of thoracic lesions is the global and regional LUS.

Official Title
-----------------
ThoRAciC Trauma IntubatiON Risk Score for Blunt Trauma

Conditions
-----------------
Trauma Chest

Intervention / Treatment
-----------------
* Procedure: oro tracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blunt thoracic trauma with a documentable lesion (T-AIS ≥ 2) Age ≥ 18 years GCS > 8 at ED admission Total body CT scan available performed within 6 hours from ED admission Exclusion Criteria: - Penetrating thoracic trauma Age < 18 years GCS <= 8 at ED admission Patients already intubated at ED arrival Do not intubate order, for any reason Intubation for Urgent/Emergent surgery within 24 hours from hospital 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intubated within day 7th<br>patients needing oro-tracheal intubation within day 7th from admission. | Procedure: oro tracheal intubation<br>* chest trauma requiring oro tracheal intubation<br>|
| non intubated within day 7th<br>patients not requiring intubation within day 7th from admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| needing for oro-tracheal intubation within day 7th from admission |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma; chest trauma
Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Study Overview
=================
Brief Summary
-----------------
Critically ill patients with body mass index (BMI) inferior to 20 kg/m2 have worse outcomes compared to normal and overweight patients. The impact nutrition therapy in this population is not yet stablished. There is a concern that too low caloric intake might worse their malnutrition; on the other hand, overfeeding is always a risk with serious consequences. The hypothesis of this study is that nutritional support, especially caloric and protein intake, can influence the outcome of underweight critically ill patients.

Official Title
-----------------
Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Conditions
-----------------
Underweight, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages eligible for study: 18 years and older Gender eligible: both Nutrition therapy: enteral, parenteral feeding, nothing by mouth Exclusion Criteria: Palliative care Exclusively oral nutrition Pregnancy Life expectancy inferior 24 hours ICU readmission

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Mortality | All patients will be followed until live hospital discharge or death | through study completion (up to a year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | patients will be followed until ICU discharge or death | through study completion (up to a year) | 
| Need and duration of mechanical ventilation | all patients for which mechanical ventilation is necessary will be followed until it is no longer necessary | through study completion (up to a year) |
Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT

Study Overview
=================
Brief Summary
-----------------
the investigators will follow up after patients with neuroendocrine tumors who undergo PRRT treatment and evaluate the response for treatment using PET/CT with different tracers

Detailed Description
-----------------
patients with suspected or biopsy proven NET will undergo imaging using a Combination of 18F- FDG , 18F-DOPA and 68Ga-DOTATATE PET/CT before the stat of PRRT . after two cycles of treatment another two PET/CT are done using 18F- FDG and 18F-DOPA and about 6-8 weeks from last treatment the patient will undergo PET/CT using 18F-DOPA .

Official Title
-----------------
the Use of 18F-FDG, 18F-DOPA and 68Ga-DOTATATE PET/CT in Patients With NETs That Are Potential Candidates for PRRT

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with neuroendocrine tumor eligible for PRRT Exclusion Criteria: younger than 18 years old 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 |
| --- | --- |
| PRRT positive<br>patients who have good response to prrt treatment - the tumor and/or the metastatic disease show no uptake/activity on PET-CT scans | |
| PRRT negative<br>no response to PRRT treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT) | patients who have clinical and radiological improvement (using RECIST CRITERIA ) | 7 months | 
| Number of participants with no response to Peptide Receptor Radionuclide Therapy (PRRT) treatment | patients who have no clinical and radiological improvement or worsening in clinical condition or radiologic findings (RECIST ) | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptide Receptor Radionuclide treatment
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.

Official Title
-----------------
A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis

Conditions
-----------------
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: ASP1585


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease patients on hemodialysis Hyperphosphatemia Written informed consent Exclusion Criteria: Patients with gastrointestinal surgery or enterectomy Severe cardiac disease patients Patients with severe constipation or diarrhea Patients with a complication of malignant tumors Patients with uncontrolled hypertension Patients treated with parathyroid intervention

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. ASP1585<br> | Drug: ASP1585<br>* oral<br>* Other names: AMG223;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum Phosphorus level |  | After 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of the patients meeting the target range of serum Phosphorus levels |  | During the treatment | 
| Changes in serum Calcium level |  | After 48 weeks | 
| Changes in serum Ca x P |  | After 48 weeks | 
| Changes in intact PTH level |  | After 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperphosphatemia, hemodialysis, CKD, ASP1585
Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

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

Intervention / Treatment
-----------------
* Drug: BI 638683 or placebo
* Drug: Placebo solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: healthy male subjects

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 638683<br>1 single dose per subject as oral solution | Drug: BI 638683 or placebo<br>* oral doses given to 6 subjects per dose group<br>|
| Placebo Comparator: Placebo solution<br>1 single dose per subject as oral solution | Drug: Placebo solution<br>* oral doses given to 2 subjects per dose group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of BI 638683 will be assessed in a descriptive way. |  | up to 14 days post treatment | 
| Tolerability of BI 638683 will be assessed in a descriptive way. |  | up to 14 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess pharmacodynamics of BI 638683. |  | up to 5 days post study drug administration | 
| To assess pharmacokinetics of BI 638683. |  | up to 5 days post study drug administration |
Siderophore-profile in Allergic and Non-allergic Subjects

Study Overview
=================
Brief Summary
-----------------
This study aims to profile the siderophore-content in the human gut from allergic and non-allergic subjects and to assess their contribution in iron homeostasis.

Detailed Description
-----------------
Iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete siderophores to liberate iron from their surroundings. In several studies, a misbalanced microbiota has been demonstrated in allergics suggesting that also their siderophore profile is severely attenuated. There are currently no data and very limited knowledge present on the composition of bacterial surviving factors in humans, or on their impact on the human immune system. As such, 1) the iron status, 2) the microbial biota composition and the 3) siderophore-profile in allergics and non-allergics will be assessed.

Official Title
-----------------
Linking Iron-deficiency With Allergy- the Role of Microbial Survival Components

Conditions
-----------------
Allergy, Healthy, Allergic Sensitisation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: allergic and non-allergic volunteers Exclusion Criteria: Patients will not be considered for the study if they have co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune or metabolic diseases and malignancy or if they use of medications (e.g. antibiotics, PPIs) that influence the iron, inflammatory or microbial status. Further exclusion criteria are pregnancy, lactation; veganism, zinc, and iron supplementation and smoking. Volunteers will be asked to cease blood donation for at least three months' before recruitment and to cease other supplements for at least two weeks, e.g. vitamins, fish oil or minerals (other than zinc and iron).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Allergic<br>Collection of blood, stool, urin samples | |
| Sensitized<br>Collection of blood, stool, urin samples | |
| Non-Allergic<br>Collection of blood, stool, urin samples | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status | Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in % | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Siderophore profile | Mass spectrometric analysis of siderophores | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron, siderophores, allergy, allergic sensitisation, trace elements
Evaluation of a Flexible Videoscope Training Simulator

Study Overview
=================
Brief Summary
-----------------
Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.

Detailed Description
-----------------
In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.

Official Title
-----------------
Evaluation of a Flexible Videoscope Training Simulator: a Randomized, Controlled, Simulation Teaching Study

Conditions
-----------------
Difficult Airway

Intervention / Treatment
-----------------
* Device: New training simulator
* Device: Traditional simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident or Medical student Willing to participate to the study Consent to evaluate the measured data Exclusion Criteria: experienced anesthetists

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New training simulator<br>Participants received training with new simulator | Device: New training simulator<br>* Participants receive training with new simulator<br>|
| Active Comparator: Traditional method<br>Participants received traditional training | Device: Traditional simulator<br>* Participants receive traditional training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time | time when participants perform flexible videoscope from incisor to carina | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | the rate of participants used flexible videoscope to view carina successfully | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, flexible bronchoscope, difficult airway