linjc16/ctgov huggingface dataset:
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones

Study Overview
=================
Brief Summary
-----------------
Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).

Official Title
-----------------
Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones

Conditions
-----------------
Randomized Study

Intervention / Treatment
-----------------
* Device: bile duct stone removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm) endoscopic papillary balloon dilation (EPLBD) was performed. Exclusion Criteria: septic shock coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control), <platelet count 50,000 / L suspected or confirmed malignancy
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: Vortic Catch V basket catheter<br>Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter following endoscopic papillary large balloon dilation. | Device: bile duct stone removal<br>* Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.<br>|
| Active Comparator: ordinary basket catheter<br>Common bile duct stones (≧ 10 mm) are removed by using ordinary basket catheter following endoscopic papillary large balloon dilation. | Device: bile duct stone removal<br>* Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of stones cleared | Percentage of stones cleared is evaluated after the completion of procedure. | Procedure time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedural time | Total procedure time is measured. | Procedure time | 
| the number of adverse events | Adverse events are evaluated after the completion of procedure. | Procedure time | 
| the numbers of morbidities and mortality | Morbidities and mortality is evaluated within 30 days after the completion of procedure. | 30 days |
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Detailed Description
-----------------
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Official Title
-----------------
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: NVP-1603-1 (P)
* Drug: NVP-1603-2 (T)
* Drug: NVP-1603-1 and NVP-1603-2 (P+T)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 19years of age or older at screening test. BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg. Subject has signed and dated informed consent. Exclusion Criteria: Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication. History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history Current alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: NVP-1603-1 (P)<br>Drug: NVP-1603-1 1capsule, oral dosing | Drug: NVP-1603-1 (P)<br>* 1capsule, single oral dosing<br>* Other names: NVP-1603-1;|
| Experimental: NVP-1603-2(T)<br>Drug: NVP-1603-2 1Tablet, oral dosing | Drug: NVP-1603-2 (T)<br>* 1tablet, single oral dosing<br>* Other names: NVP-1603-2;|
| Experimental: NVP-1603-1and NVP-1603-2 (P+T)<br>Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing) | Drug: NVP-1603-1 and NVP-1603-2 (P+T)<br>* 1capsule and 1tablet co-administration, oral single dosing<br>* Other names: NVP-1603-1 and NVP-1603-2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic interaction | Area under the curve (AUC) | 0h - 48hrs |
Antecedents of Obesity: Fetal Measures of Adiposity

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth.

Official Title
-----------------
Antecedents of Obesity: Fetal Measures of Adiposity, A Plan for Obesity Disaster Management

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants of mothers between the ages of 18 and 45, planning child birth at the University of Utah Hospital, and willing to provide parental permission for the child to participate in the study. Exclusion Criteria: Infants of mothers under the age of 18, over the age of 45, planning child birth at another facility other than the University of Utah Hospital, or who are not willing to provide permission for the child to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 72 Hours

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 |
| --- | --- | --- |
| Infant Adiposity at 24-72 Hours Following Birth | Adiposity as measured by air displacement plethysmography | 24-72 hours following birth | 
| Fetal Abdominal Circumference | Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation. | 35 weeks gestation | 
| Estimated Fetal Weight Percentile | Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation. | 35 weeks gestation |
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with wet age-related macular degeneration.

Official Title
-----------------
A Phase 1/2, Randomized, Masked, Single and Multiple-Dose, Sequential Dose-Escalation Study of the Safety an Efficacy of AG-013958 in Subjects With Subfoveal Choroidal Neovascularization Associated With Age-related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: AG-013,958


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and/or female subjects >=55 years of age Subfoveal choroidal neovascularization complicating age-related macular degeneration Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines Exclusion Criteria: Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AG-013,958|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ocular and systemic safety of the study drug |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the visual acuity change after study treatment |  |  |
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

Official Title
-----------------
A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical DSM-IV diagnosis of schizophrenia Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required Exclusion Criteria: Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes Prisoners or subjects compulsory detained

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Improvement at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' and caregivers' medication preference |  |  |
RibFix Advantage™ Post-Market Follow-Up

Study Overview
=================
Brief Summary
-----------------
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

Detailed Description
-----------------
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021

Official Title
-----------------
Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™

Conditions
-----------------
Rib Fractures

Intervention / Treatment
-----------------
* Device: RibFix Advantage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years of age, male or female Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures Minimum amount of follow-up data available, including one visit post-surgery Willing and able to sign an Informed Consent for research Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery Exclusion Criteria: Latent or active infection with positive culture at the time of implantation Documented history of metal sensitivity Documented psychiatric condition preventing the patient from following post-op care instructions Fixation of the first and/or second (true) vertebrosternal rib Bilateral rib fractures Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonary contusion requiring mechanical ventilation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| RibFix Advantage<br>Underwent surgical stabilization of rib fractures | Device: RibFix Advantage<br>* Intrathoracic rib fracture stabilization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-operation | Number of subjects who needed surgical re-intervention related to rib fracture repair | 3 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | Time spent in hospital following surgery | Day 0 (surgery) to Day 7 |
Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.

Detailed Description
-----------------
180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.

Official Title
-----------------
Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia

Conditions
-----------------
Regional Anesthesia Morbidity

Intervention / Treatment
-----------------
* Procedure: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caesarean section 18-50 years old ASA I-II risk Exclusion Criteria: heart failure patient's refusal thrombocytopenia coagulation disorder heart valve diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group sitting<br>we are performing spinal anesthesia in sitting position pregnant patients | Procedure: spinal anesthesia<br>* Investigators will perform spinal anesthesia for section<br>|
| Active Comparator: Group lateral decubitus position<br>we are performing spinal anesthesia in lateral decubitus position pregnant patients | Procedure: spinal anesthesia<br>* Investigators will perform spinal anesthesia for section<br>|
| Active Comparator: Group Modified 45-degree head-up tilt<br>we are performing spinal anesthesia in Modified 45-degree head-up tilt position pregnant patients | Procedure: spinal anesthesia<br>* Investigators will perform spinal anesthesia for section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spinal anesthesia success | The free flow of clear cerebrospinal fluid (CSF) upon first attempt was considered to be evidence of a successful LP. | spinal anesthesia success will be 15 minutes in intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sitting position, lateral decubitus position, spinal block
Effect of Bariatric Surgery on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions such as diabetes. A variety of studies showed that it cause significant weight loss, recovery from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has lower BMI than that in west country. Therefore, this research is designed to observe whether bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.

Official Title
-----------------
A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes

Conditions
-----------------
Obesity, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged between 18 and 60 years old. Type 2 Diabetes diagnosis defined according to WHO 2006 guideline. Body mass index between 25.0 and 39.9 kg/m2. Exclusion Criteria: Hypertension ≥ 180/120 mmHg; Type 1 diabetes, other types of diabetes or gestational diabetes; Acute complications of diabetes; Cerebrovascular diseases in the last 6 months. Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months. Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis. Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min. Advanced peripheral arterial disease Atrophic gastritis Alcoholism or use of illicit drugs Previous laparotomy Severe hepatic disorders Pregnancy or women not using effective contraceptive methods. Recent neoplasm (< 5 years) Immunosuppressant drugs Unable to understanding and follow the study protocol orientations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Reduction of hypertension medication prescription | Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hypertension medication prescription | Reduction of hypertension medication prescription compared to the baseline hypertension treatment at 1, 3 and 6 months. | 1 month to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Hypertension, Bariatric Surgery, Diabetes
Understanding the Effects of Intervention on the Brain in Autism

Study Overview
=================
Brief Summary
-----------------
This study examines how the PEERS (Laugeson & Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.

Official Title
-----------------
Understanding the Effects of Intervention on the Brain in Autism

Conditions
-----------------
PDD-NOS, Autism Spectrum Disorder, Asperger Disorder, Autism

Intervention / Treatment
-----------------
* Behavioral: PEERS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verbal, speaking in full sentences Meets ASD criteria Meets IQ criteria >70 Exclusion Criteria: schizophrenia or bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 28 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Immediate enrollment in the PEERS group. | Behavioral: PEERS<br>* Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.<br>* Other names: Program for the Education and Enrichment of Relational Skills;|
| No Intervention: Waitlist Group<br>Research measures while waiting for PEERS; will receive PEERS within one year. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale (SRS: Constantino, 2005) | Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used. | within two weeks of PEERS completion | 
| Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) | Questionnaire completed by participants with Autism Spectrum Disorder. Measures knowledge of the PEERS intervention concepts. Will be aggregated by group; no individual reports will be used. | within two weeks of PEERS completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
friendships, brain, PEERS