linjc16/ctgov huggingface dataset:
Brain Blood Flow Studies of Language and Memory

Study Overview
=================
Brief Summary
-----------------
Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow. This study is designed to use positron emission tomography (PET) with radioactive water (H215O) to determine the areas of the brain associated with memory and language. Patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).

Detailed Description
-----------------
This protocol will use positron emission tomography (PET) with H2015 and functional MRI to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.

Official Title
-----------------
Cerebral Blood Flow Studies of Language and Memory

Conditions
-----------------
Cerebrovascular Disorder, Epilepsy

Intervention / Treatment
-----------------
* Drug: 15 O Water
* Drug: FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Normal Volunteers: The desired age range is 18 to 55 years. Subjects will have no history of head injury or other neurological disease and must not be taking any medication. Female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans. All volunteers will read and sign the consent form. Patients: Patients will be selected from among those referred to the Clinical Epilepsy Section, NINDS for evaluation. EXCLUSION CRITERIA: Patients with evidence of a progressive intracranial process, who are taking any drugs (except AEDs) that might affect the results, or active systemic disease will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 15 O Water|nan|
|Drug: FDG|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
-----------------
Epilepsy, Positron Emission Tomography, Stroke
Clinical Investigation of Infections Due to Leishmanial Parasites

Study Overview
=================
Brief Summary
-----------------
Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. Both non-specific and antigen-specific humoral and cellular immune responses will be assessed. Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

Detailed Description
-----------------
The main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the Peace Corps, Smithsonian Institution, tourists, etc.). In the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. We also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. In addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Official Title
-----------------
Clinical Investigation of Infections Due to Leishmanial Parasites

Conditions
-----------------
Leishmaniasis, Leishmaniasis, Visceral

Participation Criteria
=================
Eligibility Criteria
-----------------
Must be between the ages of 1 and 65 years.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy, Cytokines, Immunology, Kala-Azar, Leishmaniasis
Cohort Study of Respiratory Illness in Early Childhood

Study Overview
=================
Brief Summary
-----------------
To analyze previously collected data on respiratory illness in early childhood.

Detailed Description
-----------------
BACKGROUND: The study built on a previous study funded by the Health Effects Institute, a non-profit foundation jointly supported by the U.S. Environmental Protection Agency and vehicle manufacturers. The previous study was a prospective cohort study of nitrogen dioxide (NO2) exposure and respiratory symptoms and illnesses during the first 18 months of life. Between January, 1988 and June, 1990, 1,315 infants were enrolled and then followed with collection of daily respiratory symptom data and serial monitoring of NO2 concentrations in their homes. The full protocol was completed by 823 subjects and a total follow-up experience of over one-half million days was accumulated. Follow-up ended in December, 1991 and analyses related to the study's principal focus, the health effects of NO2, was completed during the fall of 1992. DESIGN NARRATIVE: The analyses were directed at the following: 1) Time spent in day-care and the incidence and severity of respiratory illnesses; 2) Breast-feeding and the incidence and severity of respiratory illnesses during the first six months of life; 3) Determinants of wheezing and wheezing illnesses; 4) Determinants of a physician-diagnosis of asthma; 5) Exposure to woodsmoke and incidence and severity of respiratory illnesses; 6) Household demographics, including ethnicity, and incidence and severity of respiratory illnesses; 7) Determinants of the duration of respiratory illnesses; 8) The validity of retrospective parental reports of respiratory illness; 9) Parental perceptions of the risks of indoor and outdoor air pollution; 10) Clinical findings on assessment of ill children in the community.

Conditions
-----------------
Lung Diseases

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

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

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

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 |
| --- | --- | --- |
TransplantLines: the Transplantation Biobank

Study Overview
=================
Brief Summary
-----------------
TransplantLines is an observational cohort study in all solid transplant recipients, i.e. kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical capacity. Moreover, we will collect multiple urine and blood samples for analysis. Additionally, we will store hair, nails and faeces from the transplant recipients. Next to this, we will perform physical capacity tests and cognitive tests.

Detailed Description
-----------------
The last decades, the acute period after transplantation has markedly improved due to improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the major aim after transplantation is the long-term patient and graft survival which are still poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are setting up an extensive biobank to improve the long-term survival after transplantation. Moreover, we are one of the few studies to collect across transplant specialities. Like mentioned in the brief summary, extensive questionnaires will be send to participants prior to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the visit, we will collect multiple blood samples who will be taken during the regularly visit to the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces, hair and nails will be stored. Finally, physical tests and cognitive tests will be performed with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).

Official Title
-----------------
TransplantLines: the Transplantation Biobank

Conditions
-----------------
Solid Organ Tranplant Recipients, 18+ Years

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid organ transplant recipients Exclusion Criteria: Age younger than 18 years old Cognitive dysfunction

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 |
| --- | --- |
| Transplant recipients<br>Renal, heart, lung, liver, small bowel, pancreas or combined transplant recipients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft failure / mortality | Development of graft failure or mortality in the transplant recipients | Untill 2020 |
Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

Study Overview
=================
Brief Summary
-----------------
Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI). To investigate the influence of hyperemia on iFR. To test reproducibility of iFR and FFR.

Official Title
-----------------
Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice

Conditions
-----------------
Coronary Artery Disease, Plaque, Atherosclerotic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients undergoing FFR assessment for standard clinical indications. Exclusion Criteria: prior CABG extremely tortuous, calcified lesions coronary artery occlusion acute MI within 5 days
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FFR; iFR<br>Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice | In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iFR at rest vs iFr during hyperemia | iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia. | 30 days | 
| Repeatability of iFr and FFR | To test repeatability of iFR and FFR | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerotic lesion assessment
Positron Emission Tomography (PET) Study

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.

Official Title
-----------------
An Open-label Positron Emission Tomography (PET) Study Using 2 [18F] F A85380 to Determine α4β2 Neuronal Nicotinic Receptor (NNR) Occupancy of AZD1446 After Oral Administration to Male and Non-fertile Female (Non-nicotine Users) Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: AZD1446
* Radiation: 2-[18F]-F-A85380


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically healthy volunteers Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2 Exclusion Criteria: History of any clinically significant disease or disorder History of severe allergy/hypersensitivity reactions Participation in a PET examination as part of a scientific study during the past twelve months

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

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-[18F]-F-A85380<br>Single microdose | Radiation: 2-[18F]-F-A85380<br>* iv, single dose<br>|
| Experimental: AZD1446<br>Single oral administration | Drug: AZD1446<br>* Solution, oral, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs. |  | One PET assessment on baseline day and one PET assessment at the drug treatment day | 
| Plasma concentration (Cmax, tmax, AUC) |  | During time period of the PET assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (AEs, vital signs, lab) |  | During the whole study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1446, PET examination
Nebivolol in Patients With Systolic Stage 2 Hypertension

Study Overview
=================
Brief Summary
-----------------
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension

Conditions
-----------------
Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male of female, 18 to 64 years of age at screening mean seated heart rate at least 60 bpm diagnosed systolic stage 2 hypertension unremarkable physical exam findings Exclusion Criteria: high risk due to secondary hypertension or former stage 3 hypertension by JNC6 concurrent conditions (reno, cardiovascular, obesity, thyroid, etc) currently taking medication that cannot be stopped during the course of the study participating other clinical trials member of the study center personnel documented drug abuse contra indication to beta blocker abnormal lab finding poor compliance other conditions judged by investigator that is not suitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Nebivolol<br>* 5 mg, titrated to 20 mg, once daily oral administration<br>* Other names: Bystolic;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 5 mg or 20 mg once daily, oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6) | 
| Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Change from Baseline (Week 0) to Visit 4 (Week 6) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Bystolic TM, Hypertension, Stage 2 Hypertension
Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Study Overview
=================
Brief Summary
-----------------
The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.

Detailed Description
-----------------
IC = informed consent The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.

Official Title
-----------------
Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Conditions
-----------------
Children

Intervention / Treatment
-----------------
* Behavioral: video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For children admitted, age limits listed. Youth-parent pairs were admitted into the study. Had to be undergoing pediatric endoscopy. English speaking Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure. | |
| Active Comparator: intervention<br>Subjects in this arm viewed a video detailing key elements of informed consent. Subjects in this arm also received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure. | Behavioral: video<br>* Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Comprehension of Informed Consent Process via a scored scale | Structured Interview | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopy