linjc16/ctgov huggingface dataset:
Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement. Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.

Official Title
-----------------
Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Procedure: Steroid injection into the TMJs.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with defined JIA. Exclusion Criteria: Children without defined diagnosis of JIA.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- |
| Children with JIA<br> | Procedure: Steroid injection into the TMJs.<br>* In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMJ arthritis on MRI |  | every three to six months from recruitment to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMJ arthritis on ultrasound |  | every three to six months from recruitment to end of study | 
| Action of current medication on TMJ arthritis. |  | every three to six months from recruitment to end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JIA
Tarp Assisted Cooling of Hyperthermic Individuals

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness.

Detailed Description
-----------------
This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness. 12 healthy participants (6 males, 6 females) will participate. Visit 1 will be a screening visit, consisting of informed consent followed by completion of questionnaires to determine study eligibility. Participants will have their resting vital signs (heart rate, blood pressure), height, weight, and percent body fat measured. Visits 2 and 3 will be experimental trials. Participants will complete a treadmill protocol consisting of brisk walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°C. Upon completion of exercise, participants will exit the environmental chamber and be cooled in one of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) Standard of Care. Cooling will take place for 20 minutes.

Official Title
-----------------
Tarp Assisted Cooling of Hyperthermic Individuals

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

Intervention / Treatment
-----------------
* Other: Tarp Assisted Cooling
* Other: passive cooling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Aerobic exercise at least twice weekly Exclusion Criteria: History of exertional heat illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tarp assisted cooling<br>Whole body cooling in a small amount of 20'C water. | Other: Tarp Assisted Cooling<br>* Body cooling utilizing a tarp and water<br>|
| Sham Comparator: Passive cooling<br>Supine lying | Other: passive cooling<br>* Supine rest.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cooling Rate | Internal body temperature reduction throughout cooling | 20 minutes post-exercise. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heat, Cooling
Bone Age Determined by Ultrasound (BAUS) in Brazilian Control Children

Study Overview
=================
Brief Summary
-----------------
Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children, normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in 500 children and adolescents of both genders, with chronological age varying from 6-16 years. Concordance analysis and the correlation between both BA determination methods will be performed.

Detailed Description
-----------------
Bone age is a valuable method to recognize the maturation status of development and growth. Classical analyses is performed by using the Greulich and Pyle X-Ray measurement. Such analyses have some restrictions such as intra- and inter observer variability, and variable synchronicity of bone maturation. Bone age determined by ultrasound (BAUS) has been indicated as a fast and reproducible method, allowing decimal BA determination and avoiding the need for X-Ray. Our aim is to validate the BAUS method in Brazilian normal controls. School students of both genders, with age varying from 6 to 16 years will be included.

Official Title
-----------------
Analyses of Bone Age Determined by Ultrasound in a Cohort of Brazilian Control Children and Adolescents: Comparison With Conventional Bone Age Determined by X-Ray

Conditions
-----------------
Control, Population

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of chronic illness and drug ingestion Exclusion Criteria: any chronic disease or medicine use body mass index: < -2SDS or > +2SDS stature : < -2SDS or > +2SDS

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| bone age determination by ultrasound (BAUS) | Determination of bone age in years by employing a ultrasound device | chronological ages between 6 and 16 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone age measurement, skeletal age measurement, ultrasound, x-Ray
Comparison of Two Periarticular Injection Medications for Adjunctive Pain Management Following Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with Marcaine.

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Exparel
* Drug: Marcaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital. Exclusion Criteria: American Society of Anesthesiologist (ASA) score of 4 or higher Hepatic disease (contraindication for acetaminophen) Renal disease (contraindication for NSAIDs) Any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, Tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol Fibromyalgia Any contraindication for intrathecal opioid injection History of substance abuse during the last 2 years History of allergy to amide compounds Current consumption of monoaminoxidase (MAO) inhibitors and tricyclic antidepressant (TCA) medications Allergy to metabisulfite compounds Chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia) Body weight<50 Kg, BMI>40 Kg/m2 History of hypotension Patients with any surgery related complication in the first 4-6 weeks following TKA, such as infection or mechanical failure

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 |
| --- | --- |
| Active Comparator: Exparel<br> | Drug: Exparel<br> <br> |
| Active Comparator: Marcaine<br> | Drug: Marcaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Measure pain intensity score (pre and post-operatively) by visual analogue scale (VAS) method |  | Within first 30 days post-operatively |
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.

Official Title
-----------------
A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: ARQ 501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide signed and dated informed consent prior to study-specific screening procedures. Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic. Measurable disease as defined by RECIST. Karnofsky performance status >= 70% Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501. Hemoglobin (Hgb) >= 10 g/dL. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1,500/mm3). Platelet count >= 100 x 10^9/L (>= 100,000/mm3). Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease. Creatinine less than or equal to 1.5 x ULN. Exclusion Criteria: Received three or more prior anticancer chemotherapy regimens. Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion. Have symptomatic or untreated central nervous system (CNS) involvement. Are pregnant or breastfeeding. Previous exposure to ARQ 501.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARQ 501|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41

Study Overview
=================
Brief Summary
-----------------
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Official Title
-----------------
Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients (C-02-41).

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Alcon Investigational Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alcon Investigational Agent|nan|

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
-----------------
open-angle, glaucoma, ocular, hypertension, POAG
Chinese Research Group of Gallbladder Cancer

Study Overview
=================
Brief Summary
-----------------
The Chinese Research Group of Gallbladder Cancer (CRGGC) is a retrospective multicenter registry cohort, collecting electronic medical records of patients diagnosed with gallbladder cancer from hospitals in collaboration.

Detailed Description
-----------------
The objectives of the CRGGC are as follows: To study the current diagnosis and treatment of gallbladder cancer in China. To clarify the prognostic role of debated risk factors associated with gallbladder cancer. To improve the accurate staging of gallbladder cancer. To standardize the treatment with gallbladder cancer.

Official Title
-----------------
Chinese Research Group of Gallbladder Cancer

Conditions
-----------------
Gallbladder Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least clinical diagnosis of gallbladder cancer, including C23.9 and part of C24.0 (cystic duct cancer). Patients with accessible electronic medical record Exclusion Criteria: Patients with undetermined primary site of cancer.
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 |
| --- | --- | --- |
| Overall Survival | The overall survival data were defined by (date of death) - (date of first diagnosis). The survival status of patients were retrieved from follow-up. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gallbladder neoplasms, gallbladder cancer
Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital

Study Overview
=================
Brief Summary
-----------------
Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population. it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.

Official Title
-----------------
Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital

Conditions
-----------------
Iatrogenic Drug Risk, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be affiliated or beneficiary of a health insurance Patient ≥ 65 years old Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain Available for pharmaceutical consultation about 30 minutes Exclusion Criteria: It is impossible to give information The patient objects to participating in this study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Evolution of the ADE Geriatric risk score | The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points. | 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain | The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points. | 2018 |
Evaluation of the Impact of Pancreatectomy on Systemic Immunity

Study Overview
=================
Brief Summary
-----------------
The study aims at establishing the profile of the immune reaction that occurs in the early surgical suites after pancreatectomy. Blood samples will be collected before surgery, (Day-1), at day0, and after surgery at Day 1, Day 3, Day 7 at 1 year after pancreatectomy. Mass cytometry, genomic and transcriptomic approaches will be used to evaluate the immune systemic modulation after surgery.

Official Title
-----------------
Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity

Conditions
-----------------
Pancreas Cancer, Pancreatectomy; Hyperglycemia

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an indication of pancreatectomy Signed consent form Exclusion Criteria: Neoadjuvant treatment Pregnancy

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indication for pancreatectomy<br>Blood sampling at different time points before and after pancreatectomy | Other: Blood sampling<br>* 20 mL will be collected at each time point (day-1,day 0, day 1, day 3, day 7, 1 year after pancreatectomy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of immune effectors (Tcells, NK) levels after pancreatectomy | Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatectomy, Immune system