linjc16/ctgov huggingface dataset:
Transfer Accuracy of 3D-printed Indirect Bonding Trays

Study Overview
=================
Brief Summary
-----------------
This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a method of placing orthodontic brackets on a plaster or digital model of the dentition, followed by the transfer of these brackets to the patients' teeth using a transfer tray. Various indirect bonding methods have been developed with the aim of improved bracket positioning and reduced chair time. The success of these methods ultimately depends on how reliably the precise positioning of the brackets on the model can be transferred to the patient's teeth.

Official Title
-----------------
Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets

Conditions
-----------------
Dental Bonding

Intervention / Treatment
-----------------
* Device: 3D printed tray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults and children (ages 12 years and older) who are in the permanent dentition. Exclusion Criteria: Less than 12 years of age, primary or mixed dentition, or bonded orthodontic appliances present, prosthetic restorations on the facial surfaces of teeth, craniofacial anomalies, and dental anomalies such as malformation, microdontia, or severe attrition

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printed tray<br>3D printed tray | Device: 3D printed tray<br>* 3D printed tray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfer accuracy | Transfer accuracy expressed as difference in bracket position between setup and clinical situation, as a result of the indirect bonding procedure. These differences will include both the magnitude and the direction, and will be reported in 6 dimensions; i.e. as mesial-distal, buccal-lingual, and occlusal-gingival linear differences as well as torque, tip, and rotation angular differences. Linear differences will be expressed in millimeters, angular differences will be expressed in degrees. | At time of bonding, i.e. day 1 |
A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Four-Period Crossover Study to Assess the Effects of Concomitant Administration of MK0431 and Metformin Alone and in Combination on Post-Meal Incretin Hormone Concentrations in Healthy Adult Subjects

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: metformin
* Drug: Comparator: sitagliptin and metformin
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject has been a nonsmoker for at least 6 months Subject is willing to avoid strenuous activity from the screening visit until the end of the study Subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration Exclusion Criteria: Any history of stroke or neurological disorder Subject has a history of cardiovascular, blood, endocrine or liver diseases Subject has a history of cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Sitagliptin alone | Drug: sitagliptin phosphate<br>* 100 mg sitagliptin daily for two days in one out of four treatment periods<br>|
| Active Comparator: B<br>Metformin alone | Drug: Comparator: metformin<br>* 500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.<br>|
| Experimental: C<br>Sitagliptin and metformin concomitantly | Drug: Comparator: sitagliptin and metformin<br>* 100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.<br>|
| Placebo Comparator: D<br>Placebo | Drug: Comparator: placebo<br>* Placebo only on Days 1 and 2 in one of four treatment periods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weighted average active GLP-1 (glucagonlike peptide-1) concentrations |  | 4 hours after the postdose meal |
Study Through Imaging of Visceral Lymphoid Organs in Patients With SCID Who Have Recieved Bone Marrow Allograft

Study Overview
=================
Brief Summary
-----------------
To investigate the presence of seconday of lymphoid organs in patients who underwent allogenic hematopoietic stem cell transplantation 15 to 45 years ago. The goal aims to assess the development of seconday lymphoid organs given the fact that the absence of myeloablation these patients present a split chimerism between T lymphocytes and the other leucocytes. Thus, they may not be able to generate seconday lymphoid organs. Practically, whole body MRI is being used to visualise and quantify both mediastinal and intraabdominal lymph nodes. Delta will be compared with those obtained in healthy age-matched individuals. It is scheduled to include 15 patients and 15 controls.

Official Title
-----------------
Study Through Imaging of Mediastinal and Abdominopelvic Secondary Lymphoid Organs (Lymph Nodes) in Patients With Severe Combined Immunodeficiencies (SCID) Who Have Recieved Bone Narrow Allograft

Conditions
-----------------
Severe Combined Immunodeficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with SCID transplanted 15-45 years ago Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>15 adult patients who underwent allogenic hematopoietic stem cell transplantation (HSCT) for severe combined immunodeficieny 15 to 45 years ago | |
| Control group<br>15 age-matched healthy individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of mediastinal and intraabdominal lymph nodes | analysis by MRI | 1 year |
Observational Study of Exposure to Environmental Toxicants Among Firefighters

Study Overview
=================
Brief Summary
-----------------
Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.

Official Title
-----------------
Evaluate the Exposure to Toxicants Emitted During a Structural Fire Assessed by Urinary and Buccal Cell Biomarkers Found in Firefighters.

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

Intervention / Treatment
-----------------
* Other: Sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Firefighter (career or volunteer) Over 18 years of age Able to provide written voluntary consent Exclusion Criteria: Unwilling to provide a pre and post-exposure urine sample Current cancer diagnosis Tobacco use within the last 1 year (verified by urinary TNEs)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Firefighters over 18 years old<br>This is a within subject, observational study of firefighters. This study will involve three sample collections including buccal cells and urine samples; one collection pre and two collections post-structural fire exposure. | Other: Sample collection<br>* This study will involve three sample collections including buccal cells and urine samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Studying biomarker levels in firefighters pre and post fire call. | The investigators will evaluate the differences between mean pre-exposure biomarker levels and post-exposure levels in urine and buccal samples collected within 24 hours post-exposure and 1-week post-exposure respectively using t-tests to test for statistical significance. | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAH, 1-HOP, PheT, SPMA
Cognitive Behavioral Therapy for Depression in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to depressive symptoms. This is the first time that this treatment has been used in a group setting for depression in PD. Target population is patients in the Movement Disorders Clinic at Oregon Health & Science University who have Parkinson's disease and mild to moderate depression.

Official Title
-----------------
Depression in Parkinson's Disease: A Pilot Project Using Cognitive Behavioral Therapy (CBT) to Improve Depression and Coping

Conditions
-----------------
Parkinson's Disease, Depression

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease, mild to moderate depression, seen at Oregon Health & Science University Exclusion Criteria: Suicidal Cognitive impairment with MOCA <26

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All subjects in same investigative group with same CBT intervention. | Behavioral: Cognitive Behavioral Therapy<br>* Individual interviews and group discussion/training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in CESD score |  | Baseline and 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, depression, Parkinson's disease with mild to moderate depression.
Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.

Conditions
-----------------
Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
-----------------
* Other: FFR via central venous line
* Other: FFR via peripheral venous line


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non -infarct related, patients with moderate coronary artery stenosis normal ejection fraction on echocardiogram Exclusion Criteria: infarct-related arteries or clinically unstable state collateral blood flow to the target vessel is shown atrioventricular block on electrocardiogram reduced ejection fraction(<50%) or left ventricular hypertrophy on echocardiography contraindication of adenosine
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FFR via central venous line<br> | Other: FFR via central venous line<br>* Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via Rt central femoral vein.<br>|
| Experimental: FFR via peripheral vein<br> | Other: FFR via peripheral venous line<br>* Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via continuous peripheral vein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare fractional flow reserve at maximal hyperemia |  | interval of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the time to maximal hyperemia and changes in heart rate |  | interval of 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenosine, Fractional flow reserve, Hyperemia, Fractional Flow Reserve, Myocardial
Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence)

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life. Participants will be screened with a salive swab for CMV DNA. Babies with positive results will be follow up for one year.

Detailed Description
-----------------
Cytomegalovirus (CMV) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. In most infants with congenital CMV infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. However, sensorineural hearing loss eventually develops in approximately 10 to 15% of CMV positive children. The prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). There is not any publication of the prevalence of cCMV in Buenos Aires City. We aim the study to find the prevalence in this population Screening of newborns for CMV infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development. Testing saliva via DNA detection of the virus through polymerase chain reaction testing (PCR) or rapid culture is shown to have a high sensitivity (>97%) and specificity (99%) for detecting congenital CMV infection. Our objective is to describe the prevalence of cCMV using saliva specimens for PCR detection. Secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.

Official Title
-----------------
Congenital Cytomegalovirus: Prevalence in Buenos Aires City

Conditions
-----------------
Congenital Cytomegalovirus

Intervention / Treatment
-----------------
* Diagnostic Test: CMV PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns between 1 and 21 days informed consent Exclusion Criteria: Lethal malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 21 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CMV PCR|Saliva CMV PCR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of cCMV | newborns positive for CMV | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of neurosensorial hearing loss during the 1° year of life | fail Hearing test | 1 year | 
| incidence of visual impairments detected during the 1° year of life | anormal eye exam | 1 year |
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Detailed Description
-----------------
eperisone hydrochloride(muscle relaxant)

Official Title
-----------------
A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Dietary Supplement: fasting condition
* Dietary Supplement: fed condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects age between 20 and 55 signed informed consent Exclusion Criteria: Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fasting condition<br>eperisone SR administrated under fasting condition | Dietary Supplement: fasting condition<br>* eperisone SR tablet 75mg administrated under fasting<br>|
| Active Comparator: Fed condition<br>eperisone SR administrated under fed condition | Dietary Supplement: fed condition<br>* eperisone SR tablet 75mg administrated fed condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 0-24h | 
| Cmax |  | 0-24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1/2 |  | 0-24h | 
| Tmax |  | 0-24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain
A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

Study Overview
=================
Brief Summary
-----------------
This study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.

Detailed Description
-----------------
Typically, health care providers receive inaccurate patient self- reports. This pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-EEG monitoring to serve as a comparison gold standard. More explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. In the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.

Official Title
-----------------
A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG. Exclusion Criteria: Patients with only non-convulsive events or only psychogenic non-epileptic seizures. Patients who are unable to provide consent. Patients who have developmental delay.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG) |  | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG |  | up to 7 days | 
| Frequency of movements of the watch diary interface vs vEEG |  | up to 7 days | 
| Amplitude of movements of the watch diary interface vs vEEG |  | up to 7 days | 
| Seizure semiology captured by the watch vs vEEG. |  | up to 7 days. | 
| Specificity of audio recordings of the watch vs vEEG | Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures | up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Seizures, Wrist accelerometer, Epilepsy diary, Seizure detection, Biosensor