linjc16/ctgov huggingface dataset:
Evaluation of Carbohydrates

Study Overview
=================
Brief Summary
-----------------
The study is open-label with a randomized, cross-over design using standard Gl methodology.

Official Title
-----------------
Evaluation of Carbohydrates

Conditions
-----------------
Glycemic Index

Intervention / Treatment
-----------------
* Other: CHO Control 1 and 2 Glucose
* Other: CHO Experimental 1 Slowly Digested
* Other: CHO Experimental 2 Digestion Resistant
* Other: CHO Experimental 3 Low Sugar
* Other: CHO Experimental 4 Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are males or non-pregnant females in good health. Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage. Exclusion Criteria: Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes or a heart condition. Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHO Control 1 Glucose<br>25 g glucose | Other: CHO Control 1 and 2 Glucose<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|
| Experimental: CHO Experimental 1 Slowly Digested<br>25 g slowly-digested carbohydrate blend | Other: CHO Experimental 1 Slowly Digested<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|
| Experimental: CHO Experimental 2 Digestion Resistant<br>25 g digestion-resistant carbohydrate blend | Other: CHO Experimental 2 Digestion Resistant<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|
| Experimental: CHO Experimental 3 Low Sugar<br>25 g low sugar carbohydrate blend | Other: CHO Experimental 3 Low Sugar<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|
| Experimental: CHO Experimental 4 Maltodextrin<br>25 g maltodextrin | Other: CHO Experimental 4 Maltodextrin<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|
| Active Comparator: CHO Control 2 Glucose<br>25 g glucose | Other: CHO Control 1 and 2 Glucose<br>* mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose response curve | area under the curve (AUG) | 0 to 120 minutes |
NIRS in PDA VLBW Infants

Study Overview
=================
Brief Summary
-----------------
Aim of study: To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population. Study population/inclusion criteria: VLBW newborn babies with hemodynamically significant PDA by echocardiography. Exclusion criteria: Major malformations Moribund patients

Detailed Description
-----------------
Aim of study: To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population. Study population/inclusion criteria: VLBW newborn babies with hemodynamically significant PDA by echocardiography. Exclusion criteria: Major malformations Moribund patients Protocol: Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.

Official Title
-----------------
Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants

Conditions
-----------------
PDA

Intervention / Treatment
-----------------
* Device: Near Infrared Red Spectroscopy (NIRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VLBW infants with hemodynamically significant PDA by echocardiography Exclusion Criteria: Major malformation Moribund

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Near Infrared Red Spectroscopy (NIRS)|NIRS using INVOS cerebral/somatic oximeter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oximetry |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal oximetry |  | 2 years |
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Official Title
-----------------
A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Extended-release carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for Bipolar I disorder Screening YMRS score =>16 Women of childbearing potential agree to take adequate precautions against contraception Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic Exclusion Criteria: Hospitalization required for treatment of psychiatric symptoms Patients who meet DSM-IV for ultra-rapid cycling History of serious suicide attempt requiring medical intervention Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-release carbamazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YMRS Scale |  |  | 
| Clinical Global Impressions Scale - Bipolar Version |  |  | 
| HAM-D and MADRS Scales for Depression |  |  |
Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

Study Overview
=================
Brief Summary
-----------------
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).

Official Title
-----------------
Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: AZT+3TC+IDV+RTV
* Drug: AZT+3TC+EFV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed HIV-1 infection. Age 18 years or over. No previous antiretroviral therapy. CD4 lymphocyte count of < 100 cells/mL. Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study. Exclusion Criteria: Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period. Currently undergoing treatment for an opportunistic infection (parenteral administration). Any formal contraindication to treatment with the study drugs

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

| Intervention/Treatment |
| --- |
|Drug: AZT+3TC+IDV+RTV|nan|
|Drug: AZT+3TC+EFV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months. |  |  | 
| Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive |  |  | 
| CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+) |  |  | 
| and levels of CD8 cells (CD28+ y CD38+) |  |  | 
| Incidence of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Naive
Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

Official Title
-----------------
A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting

Conditions
-----------------
Hemorrhagic Shock

Intervention / Treatment
-----------------
* Drug: Poly SFH-P Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients following trauma who have sustained blood loss and are in shock Exclusion Criteria: Patients who have sustained unsurvivable injuries Patients who have severe head injury Pregnant females Patients found in cardiac arrest Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).

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

| Intervention/Treatment |
| --- |
|Drug: Poly SFH-P Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Analgesic Effects of Melatonin

Study Overview
=================
Brief Summary
-----------------
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.

Official Title
-----------------
The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers

Conditions
-----------------
Analgesia, Antihyperalgesia

Intervention / Treatment
-----------------
* Drug: Melatonin 10 mg
* Drug: Melatonin 100 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males aged between 20 and 40 years Exclusion Criteria: Under aged/minors Does not speak or understand danish Alcohol or abuse of medicines Prior QST-trial within the last 2 month Prior medical trail within the last month Serious comorbidity (ASA-class 3-4) Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>IV formulation | Drug: Placebo<br> <br> |
| Active Comparator: Melatonin 10 mg<br>IV formulation, Melatonin 10 mg | Drug: Melatonin 10 mg<br> <br> |
| Active Comparator: Melatonin 100 mg<br>IV formulation, Melatonin 100 mg | Drug: Melatonin 100 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS) |  | During burn injury. 1 hours following melatonin/placebo administration | 
| Change in areas of secondary hyperalgesia | Areas of secondary hyperalgesia will be assessed by quantitative sensory testing | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erythema/oedema assessed by ultrasound |  | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration | 
| Thermal thresholds assessed by quantitative sensory testing |  | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration | 
| Mechanical thresholds assessed quantitative sensory testing |  | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration |
Sepsis Assessment in Belgian Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

Detailed Description
-----------------
Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission. Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken. The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.

Official Title
-----------------
Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission

Conditions
-----------------
Sepsis, Shock, Septic, Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age, Suspected infection (temperature >38C or clinical evidence of infection), intention by clinician to start antibiotics Exclusion Criteria: None

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 |
| --- | --- | --- |
| Validation of use of HBP in evaluation of patients with suspected infection |  | 12 months |
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes

Study Overview
=================
Brief Summary
-----------------
To determine the associations among biometric data and previously reported medication changes in the original MAPS study

Detailed Description
-----------------
Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision. Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Official Title
-----------------
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Device: Arrhythmia Management System (AMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: those that completed the MAPS study and that had medication changes based wholly or in part on biometric information. Exclusion Criteria: Those patients from the MAPS study that did not have medication changes.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| MAPS Study Patients with Medication Change Reported<br>No intervention will be administered. This is a retrospective study of the patients who participating in the MAPS Protocol 90D0234 completed in 2021. Patients who had a medication change reported in that study are the focus of this study MAPS II 90D0255. | Device: Arrhythmia Management System (AMS)<br>* Retrospective collection of data related to subjects who participated in the MAPS 90D0234 study and had a medication change reported will wearing the AMS device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association Between Arrhythmia Biometric and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject-Reported Symptom Biometric and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject Wellness Biometric and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject Adverse Event and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject Status and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject Hospital Events and Medication Change | Clinical Case Report Form | 1 Day | 
| Association Between Subject Clinical Events and Medication Change | Clinical Case Report Form | 1 Day |
Validation of Thrombelastometry (ROTEM®)

Study Overview
=================
Brief Summary
-----------------
Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von: i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne, während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der Thrombozyten während der Lagerungszeit zu untersuchen. Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.

Conditions
-----------------
Coagulation

Intervention / Treatment
-----------------
* Procedure: ROTEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. Vorgesehen für einen elektiven Eingriff 2. Unterschriebene Einverständniserklärung Exclusion criteria: 1. bekannte Tumorerkrankung oder Immunosupression, 2. bekannte Gerinnungsstörung 3. Antikoagulation 4. Behandlung mit Heparin über 3000 UI im Sinne der Thrombose-Prophylaxe hinaus 5. Gebrauch von Acetylsalicylsäure innerhalb der letzten 5 Tage 6. Gebrauch von NSRA innerhalb der letzten 24 Stunden 7. bekannte Niereninsuffizienz oder eine Plasmakonzentration von Kreatinin grösser 120 Mm, oder Lebererkrankungen oder einer Plasmakonzentration von ASAT (> 50 U/l) oder ALAT (> 50 U/l). 8. Patienten / Patientinnen und Probanden / Probandinnen die der Deutschen Sprache nicht mächtig sind.

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: ROTEM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |