linjc16/ctgov huggingface dataset:
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.

Official Title
-----------------
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients

Conditions
-----------------
Hyperphosphatemia, Inflammation, Renal Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Multivitamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections Serum phosphorous level > 5 mg/dl Stable phosphate binder regimen for 2 week prior to enrollment Stable dose of Vitamin D for 4 weeks prior to enrollment Stable calcimimetic dose for 4 week prior to enrollment Exclusion Criteria: patients who are pregnant patients who have pre existing thrombocytopenia defined as a platelet count of <100 x 109/L abnormal LFTs baseline CRP > 15 g/dl known sensitivity to any of the active ingredients patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months are currently taking any immunosuppressive medications

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br> | Dietary Supplement: Oral Multivitamin<br>* Oral Multivitamin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease, Inflammation
Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

Study Overview
=================
Brief Summary
-----------------
Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. It is associated with an increased risk of blood clots. Until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. A new treatment called eculizumab is now standard for patients who require regular blood transfusions. It works in the majority of patients by preventing the breakdown of red blood cells. This can eliminate the need for blood transfusion and reduce the risk of blood clots. It is not well understood why patients with PNH are at high risk of blood clots. The investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. The investigators will compare these tests with standard tests of clotting.

Official Title
-----------------
A Pilot Study Investigating the Role of Thrombin Generation and Rotational Thromboelastometry in Assessing the Prothrombotic Phenotype of Paroxysmal Nocturnal Haemaglobinuria

Conditions
-----------------
Paroxysmal Nocturnal Haemoglobinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a PNH clone Exclusion Criteria: Longterm anticoagulation for previous venous thrombosis

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 |
| --- | --- | --- |
| To establish the role of thrombin generation in assessing the prothrombotic phenotype of PNH |  | After sample is obtained | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH |  | After sample is obtained | 
| To establish effects of eculizumab treatment on thrombin generation and thromboelastometry |  | 3-6 months |
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Official Title
-----------------
A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

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

Intervention / Treatment
-----------------
* Drug: Inhaled Insulin (Exubera)
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 2 Failing two or more oral anti-diabetic agents Exclusion Criteria: Asthma, COPD Smoking

Ages Eligible for Study
-----------------
Minimum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Insulin<br>Inhaled insulin plus oral therapy | Drug: Inhaled Insulin (Exubera)<br>* Addition of inhaled insulin to pre-existing oral diabetes therapy.<br>|
| Other: Standard of Care<br>Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators | Other: Standard of Care<br>* Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | [(week 24 value - baseline value)/baseline value]*100% | 4, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Glycemic Control by Visit | 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0% | 4, 12 and 24 weeks | 
| Change From Baseline in FEV1 at Week 24 LOCF |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes melllitus
Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Study Overview
=================
Brief Summary
-----------------
This is an enhanced safety surveillance study that will occur within the military Service Member population. Primary Objective: To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination. Secondary Objectives: To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination. To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.

Detailed Description
-----------------
The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.

Official Title
-----------------
A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel

Conditions
-----------------
Smallpox

Intervention / Treatment
-----------------
* Biological: ACAM2000® smallpox vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Male and female military personnel >= 17 years of age. Have received the ACAM2000® smallpox vaccine. Exclusion Criteria : Not applicable.

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| ACAM2000® vaccinia vaccine Cohort<br>Participants had received ACAM2000®, vaccinia virus Smallpox vaccine. | Biological: ACAM2000® smallpox vaccine<br>* Previous vaccination, no vaccine is administered in this study.<br>* Other names: ACAM2000®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine |  | Entire study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smallpox, Smallpox Vaccine, Vaccinia virus, Military
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients

Study Overview
=================
Brief Summary
-----------------
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females. Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa. Insertion success rate and oropharyngeal leak pressure were also measured.

Official Title
-----------------
Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices

Conditions
-----------------
Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion, Airway Morbidity

Intervention / Treatment
-----------------
* Device: Laryngeal Mask Airway Supreme
* Device: i-Gel extraglottic airway device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I/II female age 19-65 years Exclusion Criteria: < 19 years had a known or predicted difficult airway a body mass index > 35 kg m-2, or were at risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal Mask Airway Supreme<br>Directly measured mucosal pressures | Device: Laryngeal Mask Airway Supreme<br>* Directly measured mucosal pressures<br>* Other names: Supreme;|
| Experimental: i-Gel<br>Directly measured mucosal pressures | Device: i-Gel extraglottic airway device<br>* Directly measured mucosal pressures<br>* Other names: i-Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal mucosal pressure |  | every 5 minutes during steady state anesthesia |
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium

Study Overview
=================
Brief Summary
-----------------
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer

Detailed Description
-----------------
A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.

Official Title
-----------------
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: fluorocholine PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : biological suspicion of relapse of prostate cancer or initial staging of prostate cancer positive PET/CT with fluororocholine Exclusion criteria : -none

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: test and retest in a single group of patient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluorocholine PET/CT<br>all patients will undergo a second PET/CT with fluorocholine | Diagnostic Test: fluorocholine PET/CT<br>* standard diagnostic PET/CT procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility of the results | Comparison of the number and location of identified lesions and comparison of lesion uptake | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
repeatability, positron emission tomography (PET), fluorocholine
Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

Study Overview
=================
Brief Summary
-----------------
Postoperative cognitive dysfunction is defined as a cognitive decline arising after surgery. In the present study, the authors evaluate the level of D-Amino Acid Oxidase, D-serine and Serine in blood as an indicator of postoperative cognitive dysfunction after cardiac surgery.

Official Title
-----------------
Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery

Conditions
-----------------
Postoperative Cognitive Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood
* Diagnostic Test: Neurocognitive test
* Diagnostic Test: Assessment of delirium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective cardiac surgery Exclusion Criteria: MMSE <24 History of psychological or neurological diseases Illiteracy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac surgical patients<br> | Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood<br>* Blood sampling is done before surgery and at 1, 2, and 7 day after surgery. The level of D-Amino Acid Oxidase, D-serine and Serine in blood are assessed.<br>Diagnostic Test: Neurocognitive test<br>* Neurocognitive test is performed before surgery and at 7 day after surgery<br>Diagnostic Test: Assessment of delirium<br>* Postoperative delirium is assessed daily during 7 days after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery | Blood level of D-Amino Acid Oxidase is assessed. | At 1, 2, and 7 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of D-serine in blood | Blood level of D-serine is assessed. | At 1, 2, and 7 day after surgery | 
| Concentration of Serine in blood | Blood level of Serine is assessed. | At 1, 2, and 7 day after surgery | 
| The incidence of postoperative cognitive dysfunction | The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery | At 7 day after surgery | 
| The incidence of postoperative delirium | The incidence of postoperative delirium is evaluated. | Daily for 7 days after surgery |
The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.

Detailed Description
-----------------
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .

Official Title
-----------------
The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients

Conditions
-----------------
Point-of-Care Systems

Intervention / Treatment
-----------------
* Device: HemaCue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: geriatric patients requiring intensive care treatment Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hb analysis with Hemacue<br>Hb analysis with Hemacue and with arterial blood gas analyser in geriatric ill patients requiring intensive care | Device: HemaCue<br>* comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.<br>* Other names: Blood gas analyser;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin levels | comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients. | 1 months |
Study to Create Potential Cell-Based Therapies to Treat Human Disease and Disability

Study Overview
=================
Brief Summary
-----------------
This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment.

Detailed Description
-----------------
It is thought that studies of genetic reprogramming and SCNT using human cells have the potential to give us new basic knowledge about human development. Current work will focus on developing this basic knowledge. In the future, human embryonic stem cell lines (hESC) derived from genetic reprogramming and SCNT may also have the potential to develop into cell types that are useful for cell-based therapies to treat human disease and disability.

Official Title
-----------------
Derivation of Primary Donor Cell Lines for Human Cell Reprogramming

Conditions
-----------------
Metabolic Diseases, Infertility

Intervention / Treatment
-----------------
* Procedure: Improving the scientific process of human cell reprogramming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Donors with a degenerative disease phenotype or genetic disorders such as Type I Diabetes, heart disease, or infertility (azoospermia and premature ovarian failure) Exclusion Criteria:1. Unable to read or understand English. 2. Unable to provide skin biopsy sample due to skin condition in the underarm area.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Improving the scientific process of human cell reprogramming|nan|

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

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