linjc16/ctgov huggingface dataset:
Study Evaluating IMA-026 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026 administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Subjects

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

Intervention / Treatment
-----------------
* Biological: IMA-026


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy men and women ages 18 - 50 Body weight greater than or equal to 50 kilograms Nonsmoker or fewer than 10 cigarettes per day No serious infection, i.e., requiring hospitalization or IV antibiotics, or an upper respiratory infection within 1 month before dosing

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) analysis |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult
Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of a high calcium breakfast on substrate metabolism during exercise and appetite throughout the day.

Conditions
-----------------
Exercise Fat Oxidation

Intervention / Treatment
-----------------
* Dietary Supplement: High calcium milk
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Aged 18-45 years Physically active - able to run continuously for 1 h. Exclusion Criteria: Smokers Food Allergies Metabolic Disorders Consuming herbal/dietary supplements Gastric Problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Breakfast<br>Normal calcium breakfast. | Dietary Supplement: Control<br>* Regular Milk<br>|
| Experimental: High calcium breakfast<br>High calcium breakfast. | Dietary Supplement: High calcium milk<br>* High calcium milk (9 mg/kgBM)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fat oxidised during 60 min of exercise (g). | Assessed by indirect calorimetry | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentration | 2 h incremental area under the curve for blood glucose following breakfast consumption | 2 hour | 
| Serum Insulin Concentration | 2 h area under the curve for serum insulin following breakfast consumption | 2 hour | 
| Subjective appetite ratings | Subjective ratings of appetite assessed by visual analogue scales. | 3 hour |
HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Study Overview
=================
Brief Summary
-----------------
Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen s (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.

Official Title
-----------------
HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.

Conditions
-----------------
Chronic Hepatitis B (HBeAg-negative)

Intervention / Treatment
-----------------
* Drug: Pegylated interferon alfa-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis B (HBeAg-negative) Signed inform consent Aged > 18 Exclusion Criteria: Contraindications for Pegylated interferon (cirrhosis, pregnancy, others) Previous treatment with interferon or Pegylated interferon Previous HBsAg loss Treatment duration with Nucleos(t)ide analogues less than 2 years Poor adherence to Nucleos(t)ide analogues

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pegylated interferon alfa-2a<br>adding Pegylated interferon alfa-2a (180 microgs /week during 48 weeks) in HBeAg-negative patients receiving nucleos(t)ide analogues | Drug: Pegylated interferon alfa-2a<br> <br> |
| No Intervention: Control<br>HBeAg-negative patients receiving nucleos(t)ide analogues | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with HBsAg loss | HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients) | 1 year after treatment completion |
Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

Study Overview
=================
Brief Summary
-----------------
Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study

Official Title
-----------------
Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food, Consumed by Young Children Immediately After the Addition of the Enzyme Phytase. A Randomized Single Blind Study

Conditions
-----------------
Bioavailability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-24 month old Male of female Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards. No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study Exclusion Criteria: Body temperature ≥ 37.5°C Hemoglobin ≤ 7g/dL Positive RDT test Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract) Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 24 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional absorption of zinc | Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry. | 33 days |
Impact of Nimodipine on Sublingual Microcirculation in Patients With Hemorrhage - a Prospective Monocentric Observational Study

Study Overview
=================
Brief Summary
-----------------
Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine.

Detailed Description
-----------------
SAH group - in patients with SAH and documented vasospasms by digital subtraction angiography (DSA) of trans-cranial doppler imaging (TCD) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. The disfunction of cerebral microcirculation in rats with SAH has been documented [1-6]. Changes in sublingual microcirculation in patients with SAH with documented vasospasms with nimodipine has not been described.

Official Title
-----------------
Impact of Nimodipine on Sublingual Microcirculation in Patients With Subarachnoid Hemorrhage - a Prospective Monocentric Observational Study

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adulthood ICU admission diagnosis of non-traumatic subarachnoid hemorrhage Exclusion Criteria: inherited coagulation disorder rheumatic disease microangiopathy patient of representative refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| SAH patients with nimodipine<br>Patients with SAH receiving nimodipine as prevention of vasospasms and as a nootropic drug. | |
| SAH patients without nimodipine<br>Patients with SAH not receiving nimodipine as prevention of vasospasms and as a nootropic drug or in whom the drug has been temporarily discontinued. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capillary density (FCD) | Parameter describing the perfusion of the microcirculation | One week | 
| Proportion of perfused vessels (PPV) | Parameter describing the perfusion of the microcirculation | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasospasm occurence | Occurence of vasospasms on angiography and/or transcranial Doppler | One week | 
| Circulatory incoherence | Deranged microcirculation in patients on catecholamines | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nimodipine, sublingual microcirculation, Side-stream Dark Field imaging
Expanded Access for PSV Personalized Oncolytic Viruses

Study Overview
=================
Brief Summary
-----------------
A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.

Detailed Description
-----------------
Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.

Official Title
-----------------
Expanded Access for PSV Personalized Oncolytic Viruses

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: PSV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand and sign a written informed consent form. Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection. Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening. Acceptable liver function at Screening, as evidenced by: Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has been diagnosed with Gilbert's Disease AST (SGOT) and ALT (SGPT) ≤ 5 X ULN. Serum creatinine < 3 x institution upper limit of normal. Patient has acceptable hematologic status at Screening, as evidenced by: Absolute neutrophil count ≥ 1,500 cells/mm3; and Platelet count ≥ 70,000/mm3; and Hemoglobin (HGB) ≥ 8.5 g/dL. Medically acceptable contraception. Willingness to comply with all protocol procedures, evaluations and rescue measures. Exclusion Criteria: Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder. An active bacterial, fungal, or viral infection.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PSV|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer
A Study to Compare Two Different Brain Imaging Techniques in Healthy Volunteers and in Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
A direct comparison of Positron Emission Tomography (PET) (11C-Raclopride) and Single Photon Emission Computed Tomography (SPECT) (123I-IBZM) D2 RO measurements would allow GSK to gain understanding on the SPECT results obtained with SB773812, and to accurately interpret future D2 RO results from either PET or SPECT studies with new compounds.

Official Title
-----------------
An Open-label, Cross-over Study, to Compare the PET and SPECT Measurement of Antipsychotic-induced D2 Receptor Occupancy, in a Group of Healthy Volunteers and in Another Group of Patients With Schizophrenia and Other Psychotic Disorders

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Procedure: pet/spect scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Not pregnant or becoming pregnant during the study. No abnormality in clinical examination, clinical laboratory test or ECG. Not taking drugs Patients with schizophrenia, schizophreniform disorder or schizoaffective disorders. Patients with at least 1 month antipsychotic monotherapy with either risperidone, olanzapine or clozapine. Healthy volunteers with no neurological or psychiatric illness. Exclusion criteria: Have received other antipsychotic during the last month or neuroleptics during the last year. If you have taken part in investigations you should not receive a radiation dose of more than 10 mSv over any 3 year period. History of bleeding disorder or are taking medication that affects blood clotting History of substance dependence (except nicotine) Claustrophobia Gross head deformity. Unable to lie still in the PET or SPECT camera for 1 hour and a half. The presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| pet/spect scan<br> | Procedure: pet/spect scan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET and SPECT striatal binding potential |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentrations at the time of scanning, |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bolus, 11C-Raclopride, Schizophrenia, 123I-IBZM, SPECT, Receptor Occupancy, PET, MRI, Antipsychotics, Bolus/Infusion
European Database on Catheter-directed Treatment of Pulmonary Embolism.

Study Overview
=================
Brief Summary
-----------------
The main goals of EuroPE-CDT is to assess the currently applied catheter-directed treatment (CTD) techniques and strategies in pulmonary embolism (PE) patients and to determine the short term efficacy and safety of this invasive procedure.

Detailed Description
-----------------
This is a prospective (and retrospective, if required data are available), non-interventional, multicenter study. We intend to obtain data on basic patients characteristics, pulmonary embolism severity, catheter-directed treatment procedures and short term outcome. We are planning to include approximately 150-200 patients suitable for analysis by the end of 2020. Anonymized data of consecutive PE patients treated with CTD in European centers will be collected in the database.

Official Title
-----------------
European Database on Catheter-directed Treatment of Pulmonary Embolism.

Conditions
-----------------
Acute Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute pulmonary embolism catheter-directed embolectomy Exclusion Criteria: appropriate data not available

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 |
| --- | --- |
| PE patients treated with CDT<br>Acute pulmonary embolism patients undergoing catheter-directed embolectomy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Short-time follow-up | 30 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Any procedure-related complications, such as: local hematoma, hemoptysis, pulmonary artery injury, contrast-induced nephropathy, renal replacement therapy. | During hospitalisation (estimated 10 days) |
Myocardial Perfusion, Risk Factors, and Coronary Calcium

Study Overview
=================
Brief Summary
-----------------
To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.

Detailed Description
-----------------
BACKGROUND: Impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (CHD). The impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown. DESIGN NARRATIVE: The cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (CHD) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for CHD. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), which is an NHLBI funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. In MESA new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. Myocardial perfusion reserve (MPR)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. An impaired MPR appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. Magnetic resonance imaging (MRI) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 MESA participants. The study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |