linjc16/ctgov huggingface dataset:
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
This is a national, non interventional, prospective study performed in the general practice setting. The study has been designed : to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians, and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.

Detailed Description
-----------------
LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK

Official Title
-----------------
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Conditions
-----------------
Cardiovascular Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event) Usually treated by the GP Having signed the information and consent form Exclusion Criteria: Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis) Patient unable to read and complete the study documentation
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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) |  | Baseline | 
| Cardiovascular risk assessed by physicians |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet |  | Baseline | 
| Actual cardiovascular risk calculated using SCORE |  | Baseline | 
| Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR |  | Baseline | 
| Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR |  | Baseline | 
| Risk factors considered by patients in self-assessing their CVR |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular risk, SCORE, cardiovascular primary prevention, risk factors
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.

Official Title
-----------------
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Device: OrthoPulse™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of permanent dentition Eligible and scheduled for full mouth fixed orthodontic treatment Class I or Class II malocclusion (no more than ½ cusp in Class II) Non-extraction in all quadrants Non-smoker Good oral hygiene as determined by the investigator No adjunct treatment such as extra- or intra-oral appliances Exclusion Criteria: Pregnant females Patient is currently enrolled in another clinical study Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) Periodontally involved teeth Use of bisphosphonates Unerupted or partially erupted maxillary teeth Teeth blocked out of alignment and unable to engage initial arch wire Spaces present in the maxillary arch

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoPulse™<br>Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments. | Device: OrthoPulse™<br>* Patients carry out daily OrthoPulse™ treatments at home.<br>|
| No Intervention: Control<br>Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. |  | Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.

Official Title
-----------------
A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Carbamazepine
* Drug: RO4917523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, 18-65 years of age inclusive Non-smokers Body mass index (BMI) between 18 and 30 mg/m2 inclusive Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception Exclusion Criteria: Evidence of any active or chronic disease History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer History or presence of clinically significant psychiatric condition Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Period 1<br> | Drug: RO4917523<br>* Single dose of RO4917523<br>|
| Experimental: Dosing Period 2<br> | Drug: Carbamazepine<br>* Multiple doses of carbamazepine<br>Drug: RO4917523<br>* Single dose of RO4917523<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration time curve |  | Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | 6 weeks |
Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to see if the PET/CT will be able to determine the precise location of the Y-90 particles within the liver and within the tumors. We hope to use this information in order to see if these particles distribute evenly throughout large tumors or if the particles go into the tumor which is located in the portal vein. The secondary goals are threefold. First correlate the distribution of Y90 particles (as demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a difference in the Y90 particle's distribution when a low particle load (1-3 million particles) is used compared to when a high particle load (6-8 million particles) is used. Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production PET research imaging.

Official Title
-----------------
Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization With Large Hepatocellular Carcinomas or Associated Portal Vein Thrombosis

Conditions
-----------------
Carcinoma, Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UWMC patients over 18 years of age Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis. Currently undergoing treatment with Yttrium-90 Radioembolization Able to sign informed consent Exclusion Criteria: Patients who are not undergoing treatment with Yttrium-90 Radioembolization Patients unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Degree and distribution of Y90 particle uptake | To use pair production PET/CT in order to determine the degree and distribution of Y90 particle uptake in patients with large (>5cm) liver tumors or patients with tumor-associated portal vein thrombosis. | Within one year of Enrollment completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, Yttrium-90
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis

Official Title
-----------------
Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (main): Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology Established or new diagnosis Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4 Exclusion Criteria (main): Crohn's disease Toxic megacolon Present or past colorectal cancer Symptomatic gastrointestinal disease Serious secondary disease(s) Baseline stool positive for germs causing bowel disease Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline Current relapse occurred under maintenance treatment with >2g/day mesalazine Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2 Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mesalazine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical response |  |  | 
| time to resolution of symptoms |  |  | 
| rate of endoscopical remission |  |  | 
| rate of endoscopical response |  |  | 
| rate of histological remission |  |  | 
| rate of histological response |  |  | 
| PGA |  |  |
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.

Official Title
-----------------
Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening

Conditions
-----------------
Hearing Loss, Newborn Morbidity

Intervention / Treatment
-----------------
* Other: counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The parents whose infants do not pass hearing screening Exclusion Criteria: The parents whose infants have illnesses and are not ready for hearing screening The parents who decide to migrate to other areas

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counselling arm<br>Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician. | Other: counselling<br>* Educating and Counselling with personal communication for 10-15 minutes and written information about the importance of early identification and intervention for hearing loss are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.<br>|
| No Intervention: standard arm<br>The information about hearing screening results and an appointment date are provided as a routine by either nurses or nurse assistances who perform the screening test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with loss to follow-ups in all participants whose infants require follow-ups | A loss to follow-up rate which is calculated from number of participants with loss to follow-ups divided by number of all participants whose infants require follow-ups | 6 months |
Contingency Management for Attendance - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a low-cost contingency management procedure as compared to standard treatment. Using a cross-over design, CM is implemented at different community-based clinics and compared with non-CM in the same facilities. Research staff collects information regarding patients' demographic characteristics, attendance, and outcomes at the clinics. During Phase A (non-CM), standard clinical practice is in place. During Phase B (CM), all patients have the chance to win prizes by coming to treatment. Each participating clinic is randomly assigned to receive either the A or B phase first; each phase is in effect for 16 weeks.

Official Title
-----------------
Contingency Management for Attendance

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects will be patients in treatment at one of the participating clinics during the study period. There are no other inclusion or exclusion criteria because we wish to make enrollment open to increase generalizability.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Contingency management|Rewards valued $1-$100|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  | baseline and each follow-up | 
| Retention |  | baseline and each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contingency Management, Substance Abuse Treatment
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

Study Overview
=================
Brief Summary
-----------------
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.

Official Title
-----------------
Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.

Conditions
-----------------
Inguinal Hernia, Femoral Hernia

Intervention / Treatment
-----------------
* Procedure: Fibrin glue
* Procedure: Tacks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral groin hernia planned laparoscopic inguinal or femoral herniorrhaphy ASA I-III fluent Danish Exclusion Criteria: converting to open operation low compliance daily use of morphine or similar drugs daily in the last month complications to the operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrin glue<br> | Procedure: Tacks<br>* Protacks<br>|
| Active Comparator: Tacks<br> | Procedure: Fibrin glue<br>* Tissucol 2 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early pain after operation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haematoma in groin region |  | day 10 | 
| seroma in groin region |  | day 10 | 
| fatigue |  | 10 days | 
| discomfort |  | 6 month | 
| Postoperative nausea and vomiting (PONV) |  | 10 days | 
| Use of Analgesics at PACU |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
Non-Invasive EndoPAT Increases Diagnostic Yield of CAD by Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT) testing as another way of predicting potential coronary artery blockages in the heart.

Detailed Description
-----------------
We are conducting a 16 minute, non-invasive EndoPAT test on patients coming to our cath lab for a first-time angiogram. The angiogram results will be compared to the EndoPAT results to determine if the EndoPAT test, which generates a score, is successful in predicting who may have blockages in their coronary arteries.

Official Title
-----------------
Non-Invasive Peripheral Arterial Tonometry (EndoPAT) Increases Diagnostic Yield of Coronary Artery Disease by Coronary Angiography

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients without known coronary disease who are referred for coronary angiography. Adults 18 years and older. Exclusion Criteria: Patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.

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 |
| --- | --- |
| Patients having a first time angiogram<br>Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the assessment of endothelial function by non-invasive peripheral arterial tonometry improves diagnostic yield of elective coronary angiography | Will compare the score of the EndoPAT test to the outcome of the angiogram to determine if the score is predictive of coronary artery disease. | same day as the angiogram |