linjc16/ctgov huggingface dataset:
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Official Title
-----------------
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Other: Road-tracking test
* Other: Car-following test
* Other: Harsh-braking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥18.5 and <25.0 kg/m2 at screening inspection No visual impairment (enable to correct the vision with eyeglasses or contact lens) Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study Exclusion Criteria: History of drug and food allergy Routinely drink alcohol before bedtime Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Driving test<br> | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lateral Position (SDLP) |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Coefficient of Variation (DCV) |  | 5 min | 
| Brake Reaction Time (BRT) |  | 5 min |
The Role of Mid-Life Adiposity in Functional Brain Connectivity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.

Detailed Description
-----------------
Participants will have one visit for: Blood draw Body composition scan Cognitive screen Neurological exam MRI scan The visit will take approximately 3 hours.

Official Title
-----------------
The Role of Mid-Life Adiposity in Functional Brain Connectivity

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45-65 years of age Normal memory Right-handed General good physical health Exclusion Criteria: History of stroke or neurological disease Seizures or head injury with loss of consciousness within the last five years Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner) Claustrophobia More detailed inclusion/exclusion criteria must be met in order to qualify for the study. The study coordinator will determine eligibility.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 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 |
| --- | --- | --- |
| Brain connectivity measured by fMRI |  | One visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fMRI, Dementia, Alzheimer's disease, functional neuroimaging, Memory
Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

Study Overview
=================
Brief Summary
-----------------
This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired within a short time interval from slightly different posterior projections. The image data are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules present in the thoracic cavity are detected by examining the geometrical correlation of the detected signals in the two views. The data are alos viewed stereoscopically for visual diagnosis. The expected high sensitivity/specificity of the method has the potential to change the current state of practice, perhaps leading to a preventive lung cancer screening program for high-risk populations, similar to the mammography screening program currently in place for breast cancer.

Official Title
-----------------
Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

Conditions
-----------------
Lung Cancer, Metastatic Cancer in the Lungs

Intervention / Treatment
-----------------
* Device: bi-plane chest radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal individuals Individuals with CT-confirmed subtle lung nodules. Exclusion Criteria: Individuals with acute pulmonary abnormalities or those in poor health conditions will be excluded due to the potential impact on the results as well as difficulty of acquiring the images. Pregnant women will also be excluded to avoid the exposure of the fetus to radiation.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: bi-plane chest radiography<br>* Bi-plane radiography of the thorax<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The technique is effective in diagnosing early lung tumors. |  | end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative performance of BCI with respect to chest radiography and CT for lung cancer detection. |  | end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nodules, lung cancer, radiography, CT, Stereoscopy
Collagen Injections for the Treatment of Acne Scars and Wrinkles

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.

Official Title
-----------------
Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet

Conditions
-----------------
Acne Scars, Wrinkles

Intervention / Treatment
-----------------
* Drug: Fibroblast Treatment
* Procedure: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or over Bilateral acne scars or have moderate to severe wrinkles Subjects in good health Subjects has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator Exclusion Criteria: Under 18 years of age Pregnancy or lactation recent Accutane use in the past 6 months prone to hypertrophic and keloidal scarring have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease have a history of basal-cell carcinoma have previously received autologous fibroblast treatment have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days. have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B subjects who are unable to understand the protocol or to give informed consent subjects with mental illness

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibroblast Treatment<br>The fibroblast treatment will be randomly injected into one side of the face. | Drug: Fibroblast Treatment<br> <br> |
| Placebo Comparator: Vehicle<br>The vehicle will be injected randomly to the other side of the face. | Procedure: Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of rater's comparisons at 6 months |  | Basline and 6 months |
(PROSPECTOR) Screening Study Evaluating the Prevalence of the KIT D816V Mutation in Patients With Systemic Mast Cell Activation

Study Overview
=================
Brief Summary
-----------------
This is a multi-center screening study with the primary objective to determine the prevalence of KIT D816V mutation in peripheral blood in patients with evidence of systemic mast cell activation (MCA).

Official Title
-----------------
Study Evaluating the Prevalence of the KIT D816V Mutation in Peripheral Blood of Patients With Evidence of Systemic Mast Cell Activation (MCA)

Conditions
-----------------
Systemic Mast Cell Activation, KIT D816V Mutation

Intervention / Treatment
-----------------
* Other: Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting with at least one of the three criteria below as evidence of systemic mast cell activation: Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND serum basal tryptase levels ≥8 ng/ml. One of the organ systems must be the cardiovascular system. Severe anaphylaxis (Ring and Messmer grading ≥II) due to Hymenoptera sting, regardless of serum basal tryptase levels. Severe anaphylaxis (Ring and Messmer grading ≥II), with cardiovascular involvement and documented event-related tryptase elevation fitting the formula 20% of baseline plus 2 ng/ml evaluated in at least 1 event. Exclusion Criteria: Patient previously diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: mastocytosis in the skin, indolent SM, smoldering SM, SM with associated hematological neoplasm, aggressive SM, mast cell leukemia, mast cell sarcoma

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 |
| --- |
|Other: Screening|After providing informed consent, relevant medical history data, and blood and buccal swab samples will be collected at a single visit from patients presenting with systemic mast cell activation symptoms|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with KIT D816V mutation in peripheral blood |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean KIT D816V mutated allele fraction in peripheral blood |  | Day 1 | 
| Proportion of patients with increased tryptase Alpha/ Beta 1 (TPSAB1) alpha-tryptase gene copy number (GCN) in buccal mucosa |  | Day 1 |
Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor

Study Overview
=================
Brief Summary
-----------------
Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor. The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.

Official Title
-----------------
Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms

Intervention / Treatment
-----------------
* Drug: LOXO-260


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer with RET mutant (medullary thyroid cancer [MTC] or multiple endocrine neoplasia type 2 [MEN2] tumors) or RET fusion (solid tumors) advanced/metastatic tumors that have become refractory to RET selective tyrosine kinase inhibitor (TKI) treatment, who are not eligible or able to participate in an ongoing LOXO-260 clinical trial and are medically suitable for treatment with LOXO-260. Patients tumor must have developed RET solvent front mutations (eg G810X) after RET selective treatment. Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy Have adequate organ function Patients must reside in a country where the LOXO-NGR-21001 study (NCT05241834) is not open or recruiting. Exclusion Criteria: Currently enrolled in an ongoing clinical study of LOXO-260 or another second generation RET inhibitor Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds Clinically significant malabsorption syndrome Pregnant or lactating Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4 Patients harboring known activating bypass alterations outside RET (eg. EGFR, ALK, RAS etc) that may confer resistance to LOXO-260

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LOXO-260|Oral|

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
-----------------
Solid tumors
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.

Conditions
-----------------
Li Fraumeni Syndrome

Intervention / Treatment
-----------------
* Other: whole body MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: P53 mutation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 71 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard arm<br>standard follow-up | |
| Experimental: Intensive follow-up<br>Standard follow-up plus whole body MRI at inclusion, one and two years | Other: whole body MRI<br>* whole body MRI at inclusion, one and two years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer incidence | cancer incidence during the first 3 years | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with Li Fraumeni syndrome
Comparison of Two Liraglutide Formulations in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.

Official Title
-----------------
A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments Body Mass Index (BMI) of 18-27 kg/m^2 incl. Exclusion Criteria: History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the study, as judged by the investigator Impaired renal function Uncontrolled treated/untreated hypertension Any clinically significant abnormal ECG Active hepatitis B and/or active hepatitis C Positive HIV (human immunodeficiency virus) antibodies History of alcoholism or drug abuse during the last 12 months Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

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


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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 2 formulation<br> | Drug: liraglutide<br>* Single dose administered as subcutaneous injection<br>|
| Experimental: Phase 3 formulation<br> | Drug: liraglutide<br>* Single dose administered as subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-infinity) |  |  | 
| tmax, time to maximum concentration |  |  | 
| t½, terminal half-life |  |  | 
| Terminal elimination rate constant |  |  | 
| Adverse events |  |  |
A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official Title
-----------------
A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: bevacizumab [Avastin]
* Drug: capecitabine [Xeloda]
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients, 18-65 years of age; locally recurrent and metastatic breast cancer; measurable or evaluable disease; ECOG performance status of 0-2; LVEF >=50% without clinical symptoms or signs of heart failure. Exclusion Criteria: unknown HER2 status, or known HER2-positive status; prior chemotherapy for locally recurrent or metastatic disease; prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment; clinical or radiological evidence of CNS metastases; clinically significant cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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> | Drug: bevacizumab [Avastin]<br>* 7.5mg/kg iv on day 1 of every 3 week cycle<br>Drug: capecitabine [Xeloda]<br>* 900mg/m2 po on days 1-14 of every 3 week cycle<br>Drug: docetaxel<br>* 60mg/m2 iv on day 1 of every 3 week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Every 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | Event driven | 
| Serious adverse events |  | At planned visits, till disease progression |