linjc16/ctgov huggingface dataset:
Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.

Official Title
-----------------
An Open Label Positron Emission Tomography (PET) Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects (Non Nicotine Users)

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

Intervention / Treatment
-----------------
* Drug: AZD3480
* Radiation: 2-[18F]-F-A85380


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically Healthy volunteers Genotyped with regard to CYP2D6 Normal MRI scan at Visit 2 Exclusion Criteria: Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator. Participation in a PET examination as part of a scientific study during the past twelve months. Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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> | Drug: AZD3480<br>* single dose, oral<br>|
| Experimental: 2<br> | Radiation: 2-[18F]-F-A85380<br>* Single dose, IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration (AUC, Cmax, tmax) |  | During time period of the PET assessement | 
| The whole brain uptake and regional distribution of radioligand 2-[18F]-F-A85380 following single intravenous (iv) microdose will be assessed (using derived radioactivity measurements). |  | One on baseline day and one at the drug treatment day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SafetyAEs and vital signs. |  | During the whole study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, AZD3480, PET examination
Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
this study was conducted to assess the insulin resistance indices in the subjects undergoing Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days period.

Detailed Description
-----------------
Insulin resistance is a feature of a number of clinical disorders, including type 2 diabetes/glucose intolerance, obesity, dyslipidaemia and hypertension clustering in the so-called metabolic syndrome.The prevalence of the metabolic syndrome, as defined by the 2001 ATP III criteria, was 22 percent, with an age-dependent increase.Data demonstrates that the prevalence has continued to increase, particularly in women.Hyperinsulinemia occurring in response to insulin resistance may play an important role in the genesis of metabolic syndrome. Prevention or reduction of obesity, particularly abdominal obesity, is the main therapeutic goal in patients with the metabolic syndrome .Weight reduction is optimally achieved with a multimodality approach including diet, exercise, and possible pharmacologic therapy, as with orlistat .It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, by reducing insulin resistance may be effective in improving the metabolic syndrome .During the month of Ramadan (The ninth month of the Islamic calendar), Muslims fast every day from dawn to sunset. They refrain from drinking and eating for about 12h intervals. There are currently no reports on the effect of Ramadan fasting (only two meals per day) on metabolic syndrome. Therefore, this study was conducted to assess the insulin resistance indices in the subjects undergoing this type of fasting for a thirty days period.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Ramadan Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with metabolic syndrome Exclusion Criteria: Conditions with insulin resistance including: Type 2 diabetes mellitus Infections Stresses Uremia Acromegaly Glucocorticoid excess Hypertension Cirrhosis and; Any addiction or drug therapy
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Ramadan Fasting|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring insulin sensitivity in metabolic syndrome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, Ramadan Fasting, Insulin sensitivity, Iran
An Expanded Access Protocol for Sebelipase Alfa for Patients With Lysosomal Acid Lipase Deficiency

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multicenter expanded access protocol to allow patients with a confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US), access to sebelipase alfa (recombinant lysosomal acid lipase [rhLAL]) until commercial product is available. Patients enrolled in the expanded access protocol will receive 1 mg/kg intravenous infusions of sebelipase alfa every other week.

Official Title
-----------------
AN EXPANDED ACCESS PROTOCOL FOR SEBELIPASE ALFA FOR PATIENTS WITH LYSOSOMAL ACID LIPASE DEFICIENCY

Conditions
-----------------
Lysosomal Acid Lipase Deficiency

Intervention / Treatment
-----------------
* Drug: sebelipase alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥ 8 months of age at commencement of treatment with sebelipase alfa. Patient has a confirmed diagnosis of LAL Deficiency. Patient or patient's parent or legal guardian (if applicable) consents to participation in the study. If the patient is of minor age, he/she is willing to provide assent where required per local regulations, and if deemed able to do so. Male and female patients of childbearing potential must use a highly reliable method of birth control (expected failure rate less than 5% per year) from the time they commence treatment through 4 weeks after the last dose of sebelipase alfa. Women of childbearing potential must have a negative serum pregnancy test at commencement of treatment with sebelipase alfa. Exclusion Criteria: Women who are nursing or pregnant. Patients who received an investigational product within 30 days (for a small molecule) or 60 days (for a biologic) of commencing treatment, and which in the opinion of the investigator or Sponsor, may negatively impact patient safety. Patients who have received sebelipase alfa as part of a clinical trial that is currently active. Patients with known hypersensitivity to eggs.

Ages Eligible for Study
-----------------
Minimum Age: 8 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sebelipase alfa|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
-----------------
Cholesteryl Ester Storage Disease, Acid lipase disease, Cholesterol ester hydrolase deficiency, LIPA Deficiency, Wolman disease, Lysosomal Storage Disease
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis

Study Overview
=================
Brief Summary
-----------------
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed. The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa). In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis. The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.

Official Title
-----------------
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Other: Immunohistochemistry
* Other: Proteomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper age to 18 years Amylose diagnosis establish by tissue sample, after Rouge Congo coloration All patient with amylose identified by the two laboratory of anatomopathology Sample necessary for realized proteomic analysis No opposition at the participation of the study Patient sign an informed consent for biology collection Exclusion Criteria: Tissue sample inadequate for apply immunohistochemistry or proteomic identification Patient trust, guardianship, under legal protection measure, deprived of freedom

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: proteomic<br> | Other: Immunohistochemistry<br> <br> Other: Proteomic analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification success of amylose by immunohistochemistry and proteomic analysis |  | Inclusion |
Anticoagulant and Antiplatelet Agents in Patients Undergoing Vitreoretinal Surgery

Study Overview
=================
Brief Summary
-----------------
Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.

Official Title
-----------------
Maintenance of Anticoagulant and Antiplatelet Agents for Patients Undergoing Vitreoretinal Surgery

Conditions
-----------------
Retinal Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Take or no anticoagulant treatment before surgery, Vitreoretinal surgery Exclusion Criteria:none No surgery Anesthetic complication

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 |
| --- | --- |
| group 1<br>patients with no anticoagulants used as the control group | |
| group 2<br>patients treated with anticoagulant therapy (warfarin, fluindone, acenocoumarol) | |
| group 3<br>patients treated with aspirin | |
| group 4<br>patients treated with clopidogrel therapy | |
| group 5<br>patients treated with both anticoagulant and aspirin medications | |
| group 6<br>patients treated with both anticoagulant and clopidogrel medications | |
| group 7<br>patients treated with both aspirin and clopidogrel medications | |

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
-----------------
anticoagulant agents, antiplatelet agents, vitreoretinal surgery, Patients suffered from retinal detachment
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults

Study Overview
=================
Brief Summary
-----------------
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.

Official Title
-----------------
A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults

Conditions
-----------------
Pneumococcal Disease

Intervention / Treatment
-----------------
* Biological: EuPCV15
* Biological: Prevenar13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged 19 to 50 years old Participants willing to give written informed consent to participate in the trial Exclusion Criteria: History of invasive pneumococcal infection within 5 years at screening Known hypersensitivity to any component of the study vaccine Immune deficiency or immunosuppressive disorder Immunized with any licensed vaccine within 4 weeks prior to screening Pregnant, lactating women or women of childbearing age not using a reliable method of contraception Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EuPCV15<br>Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. | Biological: EuPCV15<br>* 15-valent Pneumococcal conjugate vaccine<br>|
| Active Comparator: Prevenar13<br>Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. | Biological: Prevenar13<br>* 13-valent Pneumococcal conjugate vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Solicited AEs (Local and Systemic) |  | within 14 days after vaccination | 
| Incidence of Unsolicited AEs |  | within 28 days after vaccination | 
| Incidence of SAEs |  | within 180 days after vaccination |
Deep Brain Stimulation in Treating Patients With Dystonia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia. PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months. Patients are followed every 3 months as long as the brain stimulation system remains in place. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Device: implanted pulse generator


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --Prior/Concurrent Therapy-- All medical therapy must be stable within the past month Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior destructive neurosurgical procedure Other: At least 3 months since prior botulinum toxin injections --Patient Characteristics-- Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No demand cardiac pacemaker Other: No history of substance abuse

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: implanted pulse generator|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
-----------------
dystonia, neurologic and psychiatric disorders, rare disease
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)

Study Overview
=================
Brief Summary
-----------------
Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery

Official Title
-----------------
Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years old Elective lung cancer surgery (VATS) Exclusion Criteria: do not understand Danish cognitive reduction bilateral procedure planned previous thoracic surgery pregnant or nursing known nerve affection from other cause alcohol/substance abuse inability to cooperate to pain scoring/sensory examination > 5 mg methylprednisolone/day

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 |
| --- | --- |
| lung cancer surgery<br>Patients undergoing video-assisted thoracic surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent post surgical pain | Pain intensity (Numerical Rating Scale) | 3 months | 
| Analgesic use | type(s) and amount of analgesics used | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VATS, standardized surgery, persistent pain
Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.

Study Overview
=================
Brief Summary
-----------------
Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.

Official Title
-----------------
Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.

Conditions
-----------------
CMR, NAFLD/MAFLD, Liver Fibrosis

Intervention / Treatment
-----------------
* Diagnostic Test: CMR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for Cardiovascular Magnetic Resonance Imaging Exclusion Criteria: Non-compatible Devices
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CMR|CMR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of fluid status on liver elastography and T1-times |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFLD, CMR