linjc16/ctgov huggingface dataset:
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.

Official Title
-----------------
Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Conditions
-----------------
Tick-borne Encephalitis

Intervention / Treatment
-----------------
* Biological: Tick-borne Encephalitis Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children will be eligible for participation in this study if: they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old; they are clinically healthy; their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent; their legal representative agrees to keep a Volunteer Diary. Exclusion Criteria: Children will be excluded from participation in this study if they: have a history of any previous TBE vaccination; have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10); have a history of allergic reactions, in particular to one of the components of the vaccine; have received antipyretics within 4 hours prior to the first TBE vaccination; suffer from a disease that cannot be effectively treated or stabilized; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions; suffer from chronic, degenerative and / or inflammatory disease of the central nervous system; are known to be HIV positive (a special HIV test is not required for the purpose of the study); suffer from a febrile illness at study entry; have a history of vaccination against yellow fever and / or Japanese B-encephalitis; are participating simultaneously in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-borne Encephalitis Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

Study Overview
=================
Brief Summary
-----------------
There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

Detailed Description
-----------------
This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.

Official Title
-----------------
A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer

Conditions
-----------------
Carcinoid Neuroendocrine Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 years More than one ,member of a family with a history of biopsy confirmed carcinoid tumor English speaking Mentally and emotionally capable of answering questions Willing and available for study participation At least one other family member with carcinoid tumor Exclusion Criteria: If you are under the age of 18 years, If you are unable to understand or unable to provide informed consent, If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| 1<br>Families with carcinoid in multiple family members | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutations in MEN1 and SDHD genes |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoid, family members, familial, tumors, cancer
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

Study Overview
=================
Brief Summary
-----------------
This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

Detailed Description
-----------------
The objective of this study is to provide expanded access to MGAWN1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.

Official Title
-----------------
Expanded Access to MGAWN1 in Subjects With: Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection and a Compromised Immune System; or Substantial Accidental Exposure to West Nile Virus

Conditions
-----------------
West Nile Virus Infection

Intervention / Treatment
-----------------
* Biological: MGAWN1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis For immunocompromised subjects with suspected West Nile virus infection: Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident) Develop signs and/or symptoms within 14 days before study enrollment

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MGAWN1|Humanized monoclonal to West Nile virus. Dose=30mg/kg|

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
-----------------
West Nile virus, WNV, Encephalitis, Meningitis, Acute Flaccid Paralysis, Monoclonal Antibody, WNND, West Nile Neuroinvasive Disease, Accidental Exposure to West Nile Virus
Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.

Official Title
-----------------
A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Subjects treated with insulin for minimum 3 months Duration of diabetes for at least 12 months Body Mass Index (BMI) below 30 kg/m^2 HbA1c maximum 10% based on analysis from central laboratory Exclusion Criteria: Current treatment with insulin above 1.2 U/kg/day Current treatment with insulin glargine Current treatment with drugs known to interfere with glucose metabolism Current treatment with oral antidiabetic drugs

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin detemir<br> | Drug: insulin detemir<br>* Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)<br>|
| Active Comparator: insulin NPH<br> | Drug: insulin NPH<br>* Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate |  |  | 
| Time to maximum glucose |  |  | 
| Area under the curve |  |  | 
| Maximum concentration |  |  | 
| Time to maximum concentration |  |  | 
| Insulin clearance |  |  | 
| Mean residence time of insulin |  |  | 
| Terminal rate constant |  |  | 
| Terminal half-life |  |  |
Short Term Outcome After Meniscectomy

Study Overview
=================
Brief Summary
-----------------
Short term outcome after meniscectomy: a meniscectomy is a very frequent performed orthopedically procedure. The short term outcome is favourable, but some patients keep having residual lesions after surgery. This prospective study examens the clinical outcome after meniscectomy using questionnaires (KOOS, VAS, SF-36, Tegner) (before the surgery, 3, 6 & 12 months postoperative.) The investigators will also record the further treatment options for the people at risk.

Official Title
-----------------
Short Term Outcome After Meniscectomy

Conditions
-----------------
Meniscectomy

Intervention / Treatment
-----------------
* Procedure: Meniscectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: all the meniscectomy patients (male & female, all ages) Exclusion Criteria:None

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

| Intervention/Treatment |
| --- |
|Procedure: Meniscectomy|patients undergoing meniscectomy will be asked to complete the KOOS-scale,Vas-scale, Tegner questionnaire, SF-36 questionnaire pre-operatively and at 3, 6 and 12 months post-operatively|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical outcome (residual lesions) after a meniscectomy | KOOS-scale, Vas-scale, Tegner questionnaire, SF-36 questionnaire | 12 months post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meniscectomy
Improving Defibrillation Pad Position

Study Overview
=================
Brief Summary
-----------------
Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy. We will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. We will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.

Detailed Description
-----------------
As above

Official Title
-----------------
Accuracy of Instructional Diagrams for Automated External Defibrillator (AED) Pad Positioning

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Pad positioning according to a manufacturer's diagram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 16 yrs age and willing to participate. Exclusion Criteria: Previous BLS training Previous AED training Clinical staff (doctor, nurse, HCA, paramedic etc)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pad positioning according to a manufacturer's diagram|Placement of defibrillation pads according to the diagram|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad position | Position of the pad (vertical and horizontal) in relation to optimal position as recommended by the resuscitation guidelines. | 6 months |
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism

Study Overview
=================
Brief Summary
-----------------
Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

Detailed Description
-----------------
Analysis about 50 genes in glutamate synapse

Official Title
-----------------
Autism and Glutamatergic Synapse : Research of Genetic Mutations and Identification of Clinical and Neurophysiological Markers.

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Genetic: analysis of the glutamate synapse in autism
* Genetic: DNA collection
* Other: Auditory evoked potentials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a Pervasive Developmental Disorder Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autism<br>Analysis of the glutamate synapse in autism | Genetic: analysis of the glutamate synapse in autism<br>* Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism<br>Genetic: DNA collection<br>* DNA collection<br>Other: Auditory evoked potentials<br>* auditory evoked potentials<br>|
| Other: Relative<br>Analysis of the glutamate synapse in autism | Genetic: analysis of the glutamate synapse in autism<br>* Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism<br>Genetic: DNA collection<br>* DNA collection<br>Other: Auditory evoked potentials<br>* auditory evoked potentials<br>|
| Other: Major control<br>DNA collection | Genetic: analysis of the glutamate synapse in autism<br>* Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism<br>Genetic: DNA collection<br>* DNA collection<br>Other: Auditory evoked potentials<br>* auditory evoked potentials<br>|
| Other: Minor control<br>auditory evoked potentials | Other: Auditory evoked potentials<br>* auditory evoked potentials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening of about 50 genes encoding proteins of the NMDA receptor complex, chosen according to their chromosomal localisation located in hotspots depicted by genome-wide screens in large population of autistic patients |  | two years |
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.

Conditions
-----------------
Acute Pain From Ankle Sprain or Strain

Intervention / Treatment
-----------------
* Drug: K-103-IP
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must provide informed consent before any study specific evaluation is performed. Subject is male or female aged 18 to 70 years, inclusive. Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit. Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing. Exclusion Criteria: Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain. Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit. Subject has received topical analgesic medication within 24 hours before the Screening visit. Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo patch: 0% indomethacin | Drug: Placebo<br>* Placebo comparator<br>|
| Experimental: K-103-IP<br>K-103-IP: 0.5% indomethacin | Drug: K-103-IP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity Difference(SPID) 0-72 |  | 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in pain intensity difference (PID) |  | 168 Hours |
Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.

Official Title
-----------------
Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

Conditions
-----------------
Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV, hemodynamic stability prior consent spontaneous ventilation social security coverage. Exclusion Criteria: Under-18 patients complex cardiac surgery pregnancy pre-existing chronic obstructive respiratory disease (COPD > stage II) legal guardianship incarceration

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 |
| --- | --- | --- |
| Quantitative evaluation by thoracic CT scan | Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive ventilation, cardiac surgery
Randomized Comparison of Curved Cutter Stapler and Linear Stapler

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.

Conditions
-----------------
Rectal Neoplasm, Surgical Stapler

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven adenocarcinoma of rectum. Preoperative stage I-III Patient who is expected to undergo low anterior resection at Samsung Medical Center. Age > 19 years old Exclusion Criteria: Patient with complicated rectal cancers(obstruction, perforation, abscess) Patient who needs to undergo emergency operation. Patient who can not undergo general anesthesia. Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .

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