linjc16/ctgov huggingface dataset:
Teaching Young Children Swim Survival Skills

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate whether commercially-available swim self-rescue schools are effective to teach children ages 12-35 months to stay safely alive floating in the water without adult intervention. The investigators will measure children's water self-rescue skills at baseline and then they will engage in commercially-available training over the course of several sessions. The investigators will then measure their skills again. Assessments will be conducted using a standardized protocol with a certified lifeguard always within an arm's reach of the child. Parents will also complete a short survey concerning child and family demographics and child and family swim and lifeguard training experience.

Official Title
-----------------
Teaching Young Children Swim Survival Skills

Conditions
-----------------
Drowning

Intervention / Treatment
-----------------
* Behavioral: self-rescue training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child ages 12-35 months enrolled in self-rescue course at participating swim facility Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 35 Months

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 |
| --- | --- |
| Experimental: self-rescue training<br>children will receive self-rescue training from a certified instructor | Behavioral: self-rescue training<br>* children will receive training for self-rescue if they are alone in water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| experimenter-designed standardized behavioral assessment of children's self-rescue ability | assessment of whether children can float alone, without adult assistance, for 1 minute | at completion of training intervention program, an anticipated average of 10 weeks |
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression Osteogenesis.

Study Overview
=================
Brief Summary
-----------------
The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.

Official Title
-----------------
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression.

Conditions
-----------------
Compression Osteogenesis

Intervention / Treatment
-----------------
* Procedure: Corticotomy followed by compression osteogenesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from anterior vertical maxillary excess that requires surgical intervention Exclusion Criteria: total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Other: Patients with anterior vertical maxillary excess (gummy smile)<br> | Procedure: Corticotomy followed by compression osteogenesis<br>* Surgical corticotomy supra apical in anterior maxilla then application of the compression osteogenesis concept via traction on miniscrews implanted above the corticotomy line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading | Measuring amount of linear impaction (in millimeters) to evaluate validity of compression osteogenesis in treating gummy smile of a skeletal etiology ( due to increased anterior maxilla height) after performing labia maxillary corticotomy and activating functional loading using power chain elastics anchored on transmucosal mini- screws. | 3 months |
Treatment of Anal Fistulas With Obsidian RFT®

Study Overview
=================
Brief Summary
-----------------
The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Detailed Description
-----------------
Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal passages between the anal canal and surrounding tissues. Traditional treatments, while effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence. Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. In this context, our retrospective study aims to evaluate the efficacy and safety of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its success in fistula closure and functional outcomes, thus contributing to the advancement of sphincter-preserving methods in anal fistula management. The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna. Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases. Demographic, comorbidity, fistula characteristics, and postoperative data were collected from electronic records.

Official Title
-----------------
Treatment of Anal Fistulas With Obsidian RFT® - a Retrospective Analysis

Conditions
-----------------
Anal Fistula, Minimal Invasive Surgery, Platelet-rich Fibrin Foam

Intervention / Treatment
-----------------
* Procedure: Obsidian RFP anal fistula surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna Exclusion Criteria: unclear documentation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Obsidian RFP anal fistula surgery|Anal fistula closure with instillation in the fistula tract and the inner ostium of Obsidian RTF®|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure rate anal fistula | anal fistula closure rate according to documentation in the patient administration system | 24 months |
Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients

Study Overview
=================
Brief Summary
-----------------
This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device

Official Title
-----------------
Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)

Conditions
-----------------
Unilateral Cleft Lip and Palate

Intervention / Treatment
-----------------
* Other: Nasoalveolar molding device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent Exclusion Criteria: Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 1 Month

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventionally constructed nasoalveolar molding devices (control group)<br>control group: patients receiving conventionally constructed nasoalveolar molding devices | Other: Nasoalveolar molding device<br>* comparison between using conventionally and digitally constructed nasoalveolar molding devices<br>|
| Experimental: Digitally constructed nasoalveolar molding devices (test group)<br>test group: patients receiving digitally constructed nasoalveolar molding devices | Other: Nasoalveolar molding device<br>* comparison between using conventionally and digitally constructed nasoalveolar molding devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar cleft width | measurement of width between two alveolar segments | 3 months |
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R

Study Overview
=================
Brief Summary
-----------------
A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers

Official Title
-----------------
A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers

Conditions
-----------------
Apetite Stimulants

Intervention / Treatment
-----------------
* Drug: DW5221
* Drug: DW5221-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Volunteers who are ≥19 years old Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and Exclusion Criteria: Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>cross-over | Drug: DW5221<br>* megestrol acetate<br>* Other names: Test;Drug: DW5221-R<br>* megestrol acetate<br>* Other names: Reference;|
| Experimental: Sequence B<br>cross-over | Drug: DW5221<br>* megestrol acetate<br>* Other names: Test;Drug: DW5221-R<br>* megestrol acetate<br>* Other names: Reference;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Pharmacokinetics of Megestrol Acetate | up to 120 hour | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics of Megestrol Acetate | up to 120 hour |
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

Study Overview
=================
Brief Summary
-----------------
This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study

Official Title
-----------------
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

Conditions
-----------------
Rheumatoid Arthritis, Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of over 19 and under 75 at the time of consent Patients diagnosed with RA or AS at least 3 months prior to the study registration Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions Patients who have never received Adalloce Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study Exclusion Criteria: Patients with hypersensitivity to this drug or its components Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection Patients with moderate to severe heart failure (NYHA class III/IV) Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions Patients who are not suitable for participation in this study according to the judgment of the investigator Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 74 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 |
| --- | --- | --- |
| Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS |  | 52weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The Efficacy and Safety of Adalloce
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase

Study Overview
=================
Brief Summary
-----------------
Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6 Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.

Official Title
-----------------
Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study

Conditions
-----------------
Paancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019. Exclusion Criteria: Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels < 9.0 [Lewis antibody-negative patients] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| CA19-9<385 & FE-1>100<br> | |
| CA19-9<385 and FE-1>100<br> | |
| CA19-9>385 & FE-1>100<br> | |
| CA19-9>385 & FE-1<100<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3yr overall survival | 3-year survival rate for patients who underwent surgery for pancreatic cancer | Survival period from surgery date, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1yr disease free survival | Recurrence rate in patients who have undergone surgery for pancreatic cancer within a year | Period without recurrence from the date of surgery, one year |
School-based Group Acceptance and Commitment Therapy for Adolescents

Study Overview
=================
Brief Summary
-----------------
The objective of the investigators' mental health promotion intervention premised on the Acceptance and Commitment Therapy (ACT) framework in secondary school settings aims to enhance young people's psychological flexibility and reduce their emotional distress. ACT is an evidence-based approach that encourages individuals to act in alignment with their identified values. The investigator's team will employ an ACT protocol for adolescents developed by Louise Hayes and Joseph Ciarrochi. The study includes a single-group study design. The investigator will compare the pre- and post-intervention data to assess the feasibility and potential effectiveness of the group intervention.

Official Title
-----------------
Thriving Through the Storms: A School-based Mental Health Promotion Program for Building Psychological Flexibility and Resilience

Conditions
-----------------
Anxiety, Depressive Symptoms, Stress

Intervention / Treatment
-----------------
* Behavioral: Acceptance and commitment therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants are adolescents who reported mild to moderate severity of psychological distress, including those who report: a score of 5-19 on the Patient Health Questionnaire (PHQ-9), or a score of 5-14 on the General Anxiety Disorder-7, or a score ≥14 on the Perceived Stress Scale. Exclusion Criteria: Adolescents will be excluded if they exhibit or report: violent or aggressive behavior, or active self-injurious or suicidal thought, or active psychotic symptom.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 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: Intervention group<br> | Behavioral: Acceptance and commitment therapy<br>* Four sessions of group acceptance and commitment therapy, with each session lasting for 1.5 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance and Action Questionnaire - II |  | Baseline and 4 weeks | 
| The 14-item Resilience Scale |  | Baseline and 4 weeks | 
| Patient Health Questionnaire - 9 |  | Baseline and 4 weeks | 
| General Anxiety Disorder - 7 |  | Baseline and 4 weeks | 
| Perceived Stress Scale |  | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Life Scale |  | Baseline and 4 weeks | 
| Pittsburgh Sleep Quality Index |  | Baseline and 4 weeks |
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index

Study Overview
=================
Brief Summary
-----------------
Offering renal protection in systemic inflammatory response syndrome by atorvastatin

Official Title
-----------------
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index

Conditions
-----------------
Renal Protection

Intervention / Treatment
-----------------
* Drug: Atorvastatin 40 Mg Oral Tablet
* Drug: placebo drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ( male and female) with systemic inflammatory response ( total leucocytic count >12,000 mm3'. temperature >38 C, Heart rate >90 b/min and respiratory rate>20 cycle). Exclusion Criteria: Hemodynamic instability Pre-admission chronic kidney disease. Intra-vascular coagulopathy Patients with myopathy.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br> | Drug: placebo drug<br>* tablet resembles atorvastatin<br>|
| Active Comparator: Active ( Ator) group<br> | Drug: Atorvastatin 40 Mg Oral Tablet<br>* oral atorvastatin for renal protection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | incidence or acute kidney injury | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal resistive vascular index | renal resistive index | one week | 
| APACHE score ( acute physiology and chronic health evaluation) | acute physiology and chronic health evaluation, values below 40 are considered normal while values between 41 and 71 are considered abnormal . | one week | 
| length of ICU stay | days of ICU admission | two weeks |