linjc16/ctgov huggingface dataset:
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Official Title
-----------------
An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: MIV-711


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2 Exclusion Criteria: The presence of any inflammatory arthritis Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator. Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study. Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 81 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIV-711<br>MIV-711 for a total of 26 weeks | Drug: MIV-711<br>* MIV-711 administered orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Number of Participants with Treatment Emergent Adverse Events (TEAEs) Number of Participants with Serious Adverse Events (SAEs) Number of Participants with TEAEs related to treatment Number of Participants with mild TEAEs Number of Participants with moderate TEAEs Number of Participants with severe TEAEs Number of Participants with TEAEs leading to early discontinuation | Group A: 0-56 weeks; Group B: 0-30 weeks |
Testing of Cognitive Behavioral Therapy Resource of Turkish Version

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of the 'message to dentist' (MTD) with children attending two dental settings.

Detailed Description
-----------------
Children aged 5-16 years attending a dental faculty clinic and a private dental office were invited to complete the MTD form. Children were asked to report how worried they felt, their level of pain they anticipated and the actual level of pain they experienced on a scale of 1-10 (with 1 being the best outcome).

Official Title
-----------------
Adaptation and Testing of Cognitive Behavioral Therapy Resource of Turkish Version of ''Message to Dentist'' to Reduce Dental Anxiety in Children

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy form for dental anxiety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence Without any systemical and mental diasabilities Who volunteered to participate in the study and whose parental consent was obtained. Exclusion Criteria: not have dental anxiety having any systemical or mental disability having negative experiences during dental treatment in childhood or adolescence and who did not volunteer to participate in the study and did not have parental consent for the study were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dental anxiety group<br>Children, Aged 5-15 years Having dental anxiety but not having negative experiences during dental treatment in childhood or adolescence Without any systemical and mental diasabilities Who volunteered to participate in the study and whose parental consent was obtained. | Behavioral: Cognitive Behavioral Therapy form for dental anxiety<br>* Message to Dentist form<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinic differences and dental anxiety | according to CBT form, it will be evaluated | 6 month | 
| worry type of participants | according to Cognitive Behavioral Therapy form, it will be evaluated | 6 month | 
| Gender anxiety differences | according to Cognitive Behavioral Therapy form, it will be evaluated | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental anxiety, cognitive behavioral therapy, pediatric dentistry
Oral Teleconsultation

Study Overview
=================
Brief Summary
-----------------
In this study we want to compare a dental diagnose during face to face consultation vs remote consultation with telemedicine device.

Detailed Description
-----------------
Using Soprocare® camera, videos of patients' oral cavity are recorded and analysed remotely. 200 patients have been included: 100 in Montpellier (France) and 100 in Kitakyushu (Japan). A classical face-to-face oral consultation is realized using ICDAS II classification. Then a student recorded 6 videos of patients' mouth: one video by sector, showing each face of molars and premolars in cario fluorescence mode of Soprocare® and one video of the maxillary and mandibular incisor-canine block in perio mode. In a third step, a remote dentist analysed videos and made a telediagnosis using the same classification. Dental hygiene and missing teeth are also noted in classical and tele diagnostic. The direct and the tele diagnostic are compared.

Official Title
-----------------
Validation Study of Oral Teleconsultation

Conditions
-----------------
Dental Care

Intervention / Treatment
-----------------
* Other: teleconsultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is aged at least 18 years The subject must be given free and informed consent Topics scheduled consultation from the dental center of Montpellier University Hospital and the Center Kyushu University (Japan). Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teleconsultation<br>Teleconsultation using a specific camera SoproCare®6 | Other: teleconsultation<br>* Determine the interest of teleconsultation in dentistry tool for the diagnosis of caries. Ie whether oral teleconsultations are of the same quality as conventional consultations for the diagnosis of caries ..<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic of caries | Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon .. | 1 day |
Ultrasound Features of Trigger Finger

Study Overview
=================
Brief Summary
-----------------
Our aim in this study; to compare the ultrasound findings seen in trigger finger patients with healthy volunteers. Thus, ultrasound findings associated with trigger finger development will be documented

Detailed Description
-----------------
A1 pulley thickness, flexor tendon thickness, and presence of nodules at the MCP joint level of the trigger finger patients will be recorded. The same measurements will be made in age- and sex-matched healthy volunteers, followed by comparison and analysis.

Official Title
-----------------
Ultrasound Features of Trigger Finger: A Comparative Study With Healthy Volunteers

Conditions
-----------------
Trigger Finger

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged over 18 years To have trigger finger (for patient group) Not to have trigger finger (for healthy group) Exclusion Criteria: Aged under 18 Wound or infection in the imaging area

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 |
| --- | --- |
| Trigger Finger Patients<br> | Diagnostic Test: Ultrasound<br>* Thickness of flexor tendon and A1 pulley at MCP joint level<br>|
| Healthy individuals<br> | Diagnostic Test: Ultrasound<br>* Thickness of flexor tendon and A1 pulley at MCP joint level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of flexor tendon | Thickness of flexor tendon at MCP joint level | through study completion, an average of one and a half months | 
| Thickness of A1 pulley | Thickness of A1 pulley at MCP joint level | through study completion, an average of one and a half months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of nodules | Presence of nodule in flexor tendon | through study completion, an average of one and a half months |
The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.

Official Title
-----------------
The Effects of Fractional CO2 Resurfacing Prior to Complex Wound Closure

Conditions
-----------------
Scars

Intervention / Treatment
-----------------
* Device: Lumenis fractional carbon dioxide laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing skin cancer surgery Will have a straight-line incision Fluent in English Must reside in the Los Angeles vicinity for the duration of the study Exclusion Criteria: Non-English speakers Pregnant or cognitively impaired subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Half of each subject's wound will not be treated. | |
| Experimental: Laser resurfacing<br>Half of each subject's wound will be treated with a fractional CO2 laser. | Device: Lumenis fractional carbon dioxide laser<br>* intra-operative laser resurfacing at time of wound closure<br>* Other names: Lumenis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of scar improvement as assessed by blinded-observer and patient ratings. |  | At two and six weeks following the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scar revision, intraoperative, fractional carbon dioxide laser
The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.

Official Title
-----------------
The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect. Patients with an NIH Stroke Scale score > 4 Exclusion Criteria: Age less than 19 Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy. Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before guidelines implemented<br> | |
| After guidelines implemented<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mediators of Atherosclerosis in South Asians Living in America

Study Overview
=================
Brief Summary
-----------------
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

Official Title
-----------------
Mediators of Atherosclerosis in South Asians Living in America

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka age between 40 and 84 years. Exclusion Criteria: Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin) Current atrial fibrillation Past history of cardiovascular procedures (coronary artery bypass graft (CABG) Surgery, angioplasty, valve replacement, pacemaker or defibrillator implantation, or any surgery on the heart or arteries) Active treatment for cancer Life expectancy less than 5 years due to serious medical illness Impaired cognitive ability as judged by the reviewer Plans to move out of the study region in next 5 years Weight greater than 300 pounds Living in a nursing home or on a waiting list Unable to speak/read/write English, Hindi, Urdu, or Bangla

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 84 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 |
| --- | --- | --- |
| Coronary artery calcium prevalence in South Asians |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid intima media thickness |  | Baseline | 
| Diabetes Prevalence |  | Baseline | 
| Change from baseline Coronary artery calcium prevalence in South Asians at 4 years |  | Baseline to Year 4 | 
| Incidence of type 2 diabetes after approximately 4 years of follow-up |  | Baseline to Year 4 |
Inverse Ratio Ventilation on Bariatric Operation

Study Overview
=================
Brief Summary
-----------------
for evaluating inverse ratio ventilation of laparoscopic bariatric surgery

Detailed Description
-----------------
inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.

Official Title
-----------------
Effects of a Changes in Inspiratory to Expiratory Ratio on Respiratory Mechanics and Oxygenation During Laparosopic Bariatric Surgery

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Other: inverse ratio ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA PS 1-2 obese patients(BMI>30) Exclusion Criteria: underlying cardiopulmonary diasease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inverse ratio ventilation<br>in one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1 | Other: inverse ratio ventilation<br>* change the I: E ratio 1:2-1:1-2:1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial oxygenation (PaO2) | sampling for arterial blood from arterial cannular weill be analysed 10 min after anesthetic induction, 20 min after pneurmoperitoneum (PP)with 1:2 of IE ratio, 20 min after after pneurmoperitoneum (PP)with 1:1 of IE ratio, after pneurmoperitoneum (PP)with 2:1 of IE ratio and end of operation | baseline PaO2-2hour after pneumoperitoneum |
Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack

Study Overview
=================
Brief Summary
-----------------
Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.

Conditions
-----------------
Obesity, Feeding Behaviors

Intervention / Treatment
-----------------
* Other: Cucumber snack
* Other: Pepper snack
* Other: Tomato snack
* Other: Vegetable variety snack
* Other: Apple snack
* Other: Peach snack
* Other: Pineapple snack
* Other: Fruit variety snack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attenders at the relevant child care center Exclusion Criteria: allergy or sensitivity to any test food

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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: Cucumber<br> | Other: Cucumber snack<br>* Three 300-g bowls of vegetables per table: three of cucumber slices<br>|
| Experimental: Pepper<br> | Other: Pepper snack<br>* Three 300-g bowls of vegetables per table: three of yellow pepper strips<br>|
| Experimental: Tomato<br> | Other: Tomato snack<br>* Three 300-g bowls of vegetables per table: three of grape tomatoes<br>|
| Experimental: Vegetable variety<br> | Other: Vegetable variety snack<br>* Three 300-g bowls of vegetables per table: one each of cucumber slices, pepper strips, and grape tomatoes<br>|
| Experimental: Apple<br> | Other: Apple snack<br>* Three 300-g bowls of fruits per table: three of apple wedges<br>|
| Experimental: Peach<br> | Other: Peach snack<br>* Three 300-g bowls of fruits per table: three of peach slices<br>|
| Experimental: Pineapple<br> | Other: Pineapple snack<br>* Three 300-g bowls of fruits per table: three of pineapple half-rings<br>|
| Experimental: Fruit variety<br> | Other: Fruit variety snack<br>* Three 300-g bowls of fruits per table: of each of apple wedges, peach slices, and pineapple half-rings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake of vegetables and fruit |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary variety, Vegetable intake, Fruit intake