linjc16/ctgov huggingface dataset:
Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis

Study Overview
=================
Brief Summary
-----------------
Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc.

Official Title
-----------------
Observational Study to Procure Human Specimens for Use in the Diagnosis and Management of Sepsis and Other Related Conditions

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs of age or older For women of child bearing years: not known to be pregnant Blood culture ordered as part of the ED, ICU (or equivalent) or hospital floor stay. Exclusion Criteria: Previously enrolled in this study Vulnerable individual Unable to speak and/or understand English

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 |
| --- | --- | --- |
| Progression of infection to severe sepsis | Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency Department, Infection, Sepsis
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patients with hypothyroidism

Official Title
-----------------
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Drug: Levothyroxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent must be of legal age and competent Age > 18 years presently diagnosed with hypothyroidism Exclusion Criteria: alcohol consumption >21 units per week Malignant disease pregnancy magnetic implants or material in the body BMI > 30 Heart disease (NYHA >2) Uncontrolled hypertension Manifest diabetes mellitus Changes in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic - intramyocellular lipids in 12 adult patients, recently diagnosed with hypothyroidism | Drug: Levothyroxin<br>* Dosage regulation will follow the local recommendations of treatment<br>* Other names: Eltroxin (Levothyroxin, GlaxoSmithKline Pharma);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracellular lipid content in liver and muscle |  | before and after 3 months treatment with growth hormone | 
| intraabdominal lipid content |  | before and after treatment | 
| insulin sensitivity |  | before and after treatment | 
| substrate metabolism |  | before and after treatment | 
| intracellular signaling in the basal state and during insulin stimulation |  | before and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin sensitivity, Substrate metabolism, Fatty liver, intramyocellular lipid, intracellular signaling
Allergy to Almond in Children

Study Overview
=================
Brief Summary
-----------------
Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.

Detailed Description
-----------------
Secondary objectives are description of allergic reactions to almond (symptoms, severity) modelisation of eliciting dose to almond in our population evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization

Official Title
-----------------
Allergy to Almond in Children: Diagnostic Values and Severity

Conditions
-----------------
Food Allergy in Children

Intervention / Treatment
-----------------
* Diagnostic Test: skin prick-test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020 Exclusion Criteria: doubtful or incomplete oral food challenge to almond

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: skin prick-test|retrospective study on data already collected|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic values of skin prick-test and sIgE to almond |  | BASELINE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic reactions during oral food challenge | symptoms and severity | BASELINE | 
| eliciting doses to almond | ED05, ED10 and ED50 | BASELINE | 
| atopic comorbidities | respiratory allergies, other food allergies, asthma | BASELINE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tree nuts, almond, atopy, allergy, children
Correlation of Hospital Stay Length With the Glucose Levels After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.

Detailed Description
-----------------
The stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not. This study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.

Official Title
-----------------
Correlation of Hospital Stay Length With the Glucose Measured Continuously Levels After Cardiac Surgery

Conditions
-----------------
Stress Hyperglycemia

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical status classification of the American Society of Anesthesiologists (ASA) II-IV Patients programmed for cardiac surgery Any body mass index Exclusion Criteria: Pregnant women Chronic Kidney Disease (CKD) Stage 2 or higher

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Patients<br>The glucose of 48 patients will be measured during 5 days after cardiac surgery. | Procedure: Cardiac surgery<br>* Glucose level will be measured after cardiac surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Glucose will be continuously monitored for 5 days | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | The days that the patient remains in the hospital after the surgery. | [Days] Within the first 20 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperglycemia
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.

Official Title
-----------------
A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: PF-00299804


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant solid tumor with no currently approved treatment Adequate functions Bone Marrow, Renal, Liver and Cardiac Exclusion Criteria: Any surgery, radiotherapy within 4 weeks of baseline disease assessments Clinically significant abnormalities of the cornea Patients with symptomatic brain/central nerve system metastases Any clinically significant gastrointestinal abnormalities Uncontrolled or significant cardiovascular disease Patients with significant interstitial pneumonia or pulmonary fibrosis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: 1<br>Open label single arm trial | Drug: PF-00299804<br>* Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore PD markers |  | End of study | 
| To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing |  | End of study | 
| To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumor
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Multiple Ascending Dose Study

Official Title
-----------------
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD7268
* Drug: AZD7268
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Informed Consent Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture Exclusion Criteria: Inability to understand or cooperate with given information Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test History of seizure (including infancy febrile seizures) or family history of seizure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD7268<br> | Drug: AZD7268<br>* Capsule, Oral, QD<br>Drug: AZD7268<br>* Capsule, Oral, BID<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsule, Oral BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential. |  | Safety assessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD7268 in plasma. |  | Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, Healthy Volunteer
Effectiveness of Point of Care Blood Analysis Obtained From Skin Puncture Blood

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood.

Official Title
-----------------
Correlation Between the Point of Care Blood Analysis Obtained From Skin Puncture Blood and Conventional Blood Analysis Obtained From Venous and Arterial Blood

Conditions
-----------------
Cardiovascular Diseases, Acute Abdomen, Respiratory Disease, Renal Disease, Cerebrovascular Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who simultaneously require the venous blood test, skin puncture blood test and arterial blood gas analysis Exclusion Criteria: Unstable patients Patients receiving the medications affecting the results of blood analysis.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Blood test group<br>All patients receive the three types of blood test (venous blood test, skin puncture blood (capillary blood) test and arterial blood gas analysis | Diagnostic Test: blood test<br>* Point of care blood analysis obtained from skin puncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood analysis between capillary blood, venous blood and arterial blood | Primary outcome Correlation of blood concentration between skin puncture blood and venous blood variables Na+ (mmol/L) K+ (mmol/L) Ca++ (mmol/L) Hct (%) Glucose (mg/dl) Creatinine (mg/dl) Cl- (mmol/L) Correlation of blood concentration between skin puncture blood and arterial blood variables pH pCO2 (mmHg) pO2 (mmHg) HCO3 (mmol/L) Lactate (mmol/L) Spearman correlation rank test will be performed to show the agreement of two methods in each value. We will show the correlation coefficient for all values. Ex) The correlation coefficient of Na+, K+, Ca2+, Hct, glucose, creatinine and Cl- are ___, ___, ___, ___, ___, ___, ___, respectively. | within 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous blood, arterial blood, capillary blood
Heart Failure With Mildly Reduced Ejection Fraction Registry

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) affects about 1% of patients younger than 55 years, whereas the prevalence of HF increases > 10% in patients with at least 70 years of age. Despite HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF), the clinical significance of HF with mildly reduced ejection fraction (HFmrEF) has gained more importance within the past years. Those patients are characterized by a left ventricular ejection fraction (LVEF) of 41-49%. However, within the current European guidelines, limited treatment recommendations in this subgroup of HF are yet available as a consequence of the limited number of studies in this field. The Heart Failure With Mildly Reduced Ejection Fraction Registry aims to characterize patients with HFmrEF and investigated the prognostic impact of interventional and pharmacological therapies in this subgroup of HF patients.

Official Title
-----------------
Heart Failure With Mildly Reduced Ejection Fraction Registry (HARMER)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HFmrEF (i.e., LVEF 41-49%) Patients with at least 18 years of age Exclusion Criteria: Patients younger than 18 years of age

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 |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LVEF | Change of LVEF | 2 years. | 
| Change of NT-pro BNP | Change of NT-pro BNP | 2 years. | 
| Heart-failure related hospitalization | Heart-failure related hospitalization | 2 years. |
Optimal Length of Pre-inserted ETT for Nasal Fiber Optic Intubation

Study Overview
=================
Brief Summary
-----------------
This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic intubation and the equation to predict it.

Official Title
-----------------
Optimal Length of the Pre-inserted Endotracheal Tube for Obtaining Good View of Laryngeal Opening for Nasal Fibreoptic Intubation

Conditions
-----------------
Nasal Fiberoptic Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II aged 20-65 yr (adults) Exclusion Criteria: rhinitis bleeding diatheses requirement of awake intubation a previous major oral and maxillofacial surgery history anatomical deformity of the face, neck and upper airway

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| optimal length of pre-inserted ETT for nasal fiberoptic intubation |  | during endotracheal intubation for general anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway management; Fiber optic technology; Intubation
Glycemic Index and CVD: a Crossover Feeding Study

Study Overview
=================
Brief Summary
-----------------
This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.

Detailed Description
-----------------
This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese male adults in a 10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic effect of food.

Official Title
-----------------
Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: low vs high glycemic index diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 35 years male BMI ≥ 27 ≤45 kg/m2 willingness to refrain from alcohol and caffeinated beverage consumption for duration of study Exclusion Criteria: major medical illness an abnormal screening laboratory test taking any prescription medications that might affect body weight current smoking (1 cigarette during any of the last 7 days) consuming special diets

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: low vs high glycemic index diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity as measured by FS-IVGTT |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVD risk factors |  |  | 
| Postprandial studies of oxidative stress |  |  | 
| Thermic effect of food |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, glycemic index, insulin resistance, cardiovascular disease, diabetes