linjc16/ctgov huggingface dataset:
The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness.

Detailed Description
-----------------
High-fidelity simulation is well recognized as an educational tool. Mr. Issenberg completed a review(2005) that determined features of high-fidelity simulation training that lead to effective learning. It this review, it is mentioned that the validity of the simulator (realism) is essential to help learners to increase their skills and sharpen their responses. It is essential to get and maintain engagement during high-fidelity simulation and it pass by an increase in realism and situation awareness. The purpose of this study is to evaluate if the use of identification badge (physical and conceptual realism) during high-fidelity simulation as an impact on situation awareness and engagement.

Official Title
-----------------
The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation

Conditions
-----------------
Patient Simulation, Awareness, Reality Testing, Residency

Intervention / Treatment
-----------------
* Other: Use of identification badge during scenarios


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthesiology residents (university of montreal) who participate to simulation course on crisis resources management Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Scenario C (control)<br>no badge | |
| Active Comparator: Scenario B (badge)<br>Use of Identification badge during scenarios (roles and places) | Other: Use of identification badge during scenarios<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Situation awareness | Subjects answer a 4 questions survey on situation awareness with 7 answers choices (1-strongly disagree... 7-strongly agree) I know where I was in the beginning of the scenario I know where I was during the scenario I know the role of each participant in the beginning of the scenario I Know the role of each participant during the scenario | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's engagement in high-fidelity simulation | Subject answer a 2 questions survey on engagement with a 7 answers choices (1- strongly disagree...7-strongly agree) I felt emotionally concerned during the scenario The scenario was enough realistic to get engaged in the clinical situation | 2 days |
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.

Official Title
-----------------
18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

Conditions
-----------------
Brain Metastases

Intervention / Treatment
-----------------
* Procedure: 18F-FCH PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient and/or guardian is able to provide written informed consent prior to study registration Age ≥ 21 years old Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology) Exclusion Criteria: Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant) Pregnant or nursing female Unable to cooperate for PET/CT

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pts with brain mets going for surgery<br>This study will enroll patients with brain metastases that are evolving after SRS who are scheduled to undergo surgical resection. Eligible patients will undergo an 18F-FCH PET study 1-to-7 days pre-operatively. Although no toxicity has been previously reported following 18F-FCH administration, patients will be contacted 1-3 days after their scan and asked whether they experienced any adverse effects. The patients who have a positive 18F-FCH PET study (in which there is visible focal hot spots (a focus of lesion/normal white matter ratio >1.4) of 18F-FCH) will undergo further evaluation and be administered a second administration oflower activity 18F-FCH at the time of surgery. The purpose of the second 18F-FCH administration in the operating room is to further elucidate the tissue distribution of 18F-FCH radioactivity with respect to the histopathology of the surgically resected tissue. | Procedure: 18F-FCH PET Scan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to distinguish radiation necrosis from progressive tumor | by comparing the PET imaging results to the surgical pathology | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, 18F-Fluorocholine (18F-FCho), Pet Scan, 13-199
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Detailed Description
-----------------
Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.

Conditions
-----------------
Stomatitis

Intervention / Treatment
-----------------
* Drug: rhEGF
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged at least 18 years Exclusion Criteria: Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential Have oral mucositis or other oral conditions at study entry

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGF<br> | Drug: rhEGF<br>* rhEGF 50 μg/ml, spray type, twice a day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, Spray type, Twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe oral mucositis (RTOG garde 3 or 4) |  | 5 weeks(at the point of receiving 50 Gy radiation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis |  | 5 weeks(at the point of receiving 50 Gy radiation) | 
| Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis |  | 5 weeks(at the point of receiving 50 Gy radiation) |
Role of Vitamin D in Innate Immunity to Tuberculosis

Study Overview
=================
Brief Summary
-----------------
The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below: To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States. To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.

Official Title
-----------------
Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia

Conditions
-----------------
Vitamin D Deficiency, Tuberculosis

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study. Exclusion Criteria: Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br> | Dietary Supplement: Vitamin D<br>* Daily dose of 800IU of vitamin D<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Identically appearing capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum vitamin D levels |  | 6 months | 
| Tuberculin Skin Test conversion |  | 6 monhs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D deficiency, tuberculin sin test, immunity, tuberculosis
Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study

Study Overview
=================
Brief Summary
-----------------
This is a qualitative study of participants who have taken part in a randomized controlled trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose of the qualitative study is to explore participant perceptions of taking part in the RCT to further develop and improve the new treatment protocol.

Official Title
-----------------
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: A Qualitative Study

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Principal diagnosis of ADHD inattentive presentation 18 years of age or older If on medication, it needs to be well-established since three months, and Prior psycho-educational intervention Exclusion Criteria: Intellectual impairment Substance use disorder Difficulties in adherence to medical or other treatment Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or Simultaneous psychological treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral therapy<br>Cognitive-behavioral therapy, including behavioral exercises and homework assignments. | Behavioral: Cognitive-behavioral therapy<br>* Cognitive and behavioral interventions aimed at increasing behavioral activation, and reducing procrastination and inattentive symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interview data | Participant responses based on questions posed in an interview | 45-60 minutes |
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.

Official Title
-----------------
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.

Conditions
-----------------
Hypertrophic Scars, Keloids

Intervention / Treatment
-----------------
* Other: Cicatrix
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertrophic wound or keloid with no treatment for more than 1 month. Signed informed consent. Exclusion Criteria: Usage of steroids within 30 days. Malignant neoplastic conditions. Alcoholism. Handicap and/or psychiatric condition preventing treatment accomplishment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Cicatrix | Other: Cicatrix<br>* Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.<br>* Other names: Cosmetic;|
| Placebo Comparator: B<br>Placebo | Other: Placebo<br>* Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse effects at week 12 (end of the treatment) |  | 12 weeks | 
| Photographs of lesions at week 12 (end of the treatment) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
Platelet Function in Patients With Hemophilia A

Study Overview
=================
Brief Summary
-----------------
Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are classified into 3 different categories based on residual FVIII activity compared to normal: mild (6-40%), moderate (1-5%) and severe (<1%). This categorization correlates to some degree with bleeding phenotype, but does not completely define it. Some patients with hemophilia A bleed less often than others despite identical plasma FVIII levels. The cause(s) of this phenotype heterogeneity in hemophilia A remains largely unknown, despite a number of studies of possible factors. Activated platelets, in addition to their role in primary hemostasis, play a major role in secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been suggested in the past, but only a small number of studies have been performed with limitations in assays performed and numbers of patients. The purpose of the present study is to determine whether platelet reactivity in severe hemophilia A patients is associated with past bleeding frequency and/or predicts future bleeding frequency.

Official Title
-----------------
Decreased Platelet Function as a Cause of Increased Bleeding in Patients With Hemophilia A

Conditions
-----------------
Hemophilia A

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe hemophilia A who are being prophylactically treated with FVIII. Age of at least 2 years. Bleeding history of at least 6 months. IRB-approved informed consent. Exclusion Criteria: Presence of FVIII inhibitors. Greater than 7 days since active bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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 |
| --- | --- | --- |
| The percentage of coated platelets. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity. |  | 2 years | 
| The number of procoagulant platelet-derived microparticles. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coated platelets, bleeding, severe hemophilia A
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Detailed Description
-----------------
Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.

Official Title
-----------------
Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma

Conditions
-----------------
Congenital Glaucoma

Intervention / Treatment
-----------------
* Procedure: Deep Sclerectomy
* Procedure: Combined Trab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping. Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities. Within the age of (0 - 12). Exclusion Criteria: Cases of congenital glaucoma with previous intervention. Age above 12 Yrs. Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DS arm<br>Deep sclerectomy surgery will be conduct in this arm | Procedure: Deep Sclerectomy<br>* Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.<br>* Other names: Non penetrating DS;|
| Active Comparator: Trab arm<br>combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm | Procedure: Combined Trab<br>* Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.<br>* Other names: Combined Trabeculectomy Trabeculotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in IOP | decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg | 6 month |