linjc16/ctgov huggingface dataset:
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Study Overview
=================
Brief Summary
-----------------
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

Official Title
-----------------
Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)

Conditions
-----------------
Focal Onset Seizure, Focal Onset Epilepsy

Intervention / Treatment
-----------------
* Drug: NBI-921352


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Provided informed consent. Completed 11 weeks of treatment in Study NBI-921352-FOS2021. Stable treatment with at least 1 but not more than 4 antiseizure medicines. Key Exclusion Criteria: Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 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: NBI-921352 Treatment<br>Treatment for up to 107 weeks. | Drug: NBI-921352<br>* Tablets for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of serious treatment-emergent adverse events (TEAEs) |  | Through Week 111 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, antiseizure medicine, ASM, antiepileptic drug, AED, partial seizure, partial onset epilepsy
Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.

Official Title
-----------------
Pre-Approval Access With Amivantamab in Patients With Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Who Have Failed Platinum-Based Chemotherapy

Conditions
-----------------
Metastatic Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Amivantamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (NSCLC) cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins), not amenable to curative therapy Has completed prior treatment with platinum-based chemotherapy. In the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved EGFR Exon 20 targeted tyrosine kinase inhibitor [TKI], or see guidelines such as those from national comprehensive cancer network [NCCN] or European society for medical oncology [ESMO] for alternative non-platinum-based treatments) Life expectancy is projected to be greater than or equal to (>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed) Exclusion Criteria: Has medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months Has leptomeningeal disease that is active or symptomatic Symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program) Known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies Is pregnant or breastfeeding

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amivantamab|Amivantamab will be administered intravenously at the recommended doses based on weight (1050 milligram [mg] or 1400 mg) once weekly for the first 4 week cycle (1 cycle equals to 28 days), then every 2 weeks thereafter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Recurrent Events After Percutaneous Coronary INterventio for ACS

Study Overview
=================
Brief Summary
-----------------
Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk. The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Detailed Description
-----------------
Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk. The rate, predictors and outcomes of an adverse event in this population has been already investigated. However, to the best of our knowledge, only two papers took specifically in analysis rates of recurrence after a first event; the first is a recently published article by Giustino et al; it took in consideration recurrent events in a selected population of patients with ST-elevation Myocardial Infarction (STEMI) participating in the HORIZONS-AMI Trial, discharged on Aspirin and Clopidogrel, analyzing their incidence in the first year of follow-up. The second is a paper by Fanaroff et al which primarily focused on the factors leading to a DAPT intensification in patients with recurrent events. The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Official Title
-----------------
Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study

Conditions
-----------------
Coronary Artery Disease, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria in the present study was the occurrence of an adverse event (bleeding or ischemic) during DAPT therapy in the follow-up after PCI for ACS Exclusion Criteria: none

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: angioplasty|angioplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of recurrent bleeding and ischemic events after PCI for ACS | Bleedings events are defined as type 2-5 according to the Bleeding Academic Research Consortium (BARC) definition. Ischemic events are defined as myocardial infarction (MI) and definite stent thrombosis (ST). | 2018 - 2019 |
Study Evaluating Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the incidence of adverse events for patients with AS treated with Enbrel in usual care settings.

Official Title
-----------------
Observational Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ankylosing spondylitis Exclusion Criteria: Contraindications according SmPC

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed Description
-----------------
The duration of treatment is 10 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Conditions
-----------------
Hypercholesterolemia, Coronary Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: ezetimibe, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated cholesterol and coronary heart disease Exclusion Criteria: Patients who have cholesterol levels within normal ranges as identified by the study

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: MK0653, ezetimibe|nan|
|Drug: Comparator: ezetimibe, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elevated Cholesterol
MACOCHA Score Predicts Intubation Failure

Study Overview
=================
Brief Summary
-----------------
Risk factors for difficult intubation are well described in anesthesiology. But intubation in the intensive care unit (ICU) is a challenging issue, associated with severe life-threatening complications. Non-anesthesiologist trainees performing ICU intubation may not fully appreciate the potential difficulty and complications. Therefore in this retrospective analysis the MACOCHA score will be used to determine difficult intubation in the ICU and predict intubation failure.

Official Title
-----------------
The New MACOCHA Score Predicts Intubation Failure of Non-anesthesiologist ICU Trainees

Conditions
-----------------
Intubation; Difficult, Intubation; Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients intubated in the ICU >18 years of age Exclusion Criteria: <18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Intubation complication |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, intensive care unit, MACOCHA Score
Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children

Study Overview
=================
Brief Summary
-----------------
Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.

Detailed Description
-----------------
Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.

Official Title
-----------------
Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Regional block
* Procedure: Wound infiltration
* Procedure: Caudal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Patients under 13 years of age •Inguinal hernia Exclusion Criteria: •History of allergy to any drugs used in study documented on history. •Infection at the site of regional, caudal or local infiltration, documented on clinical examination. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 12 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 |
| --- | --- |
| Experimental: Regional Block<br>Bupivacaine 0.25% | Procedure: Regional block<br>* regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline<br>|
| Active Comparator: Wound infilteration<br>Bupivacaine 0.25% | Procedure: Wound infiltration<br>* Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose<br>|
| Active Comparator: caudal block<br>Bupivacaine 0.25% | Procedure: Caudal block<br>* Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain -FLACC Pain sacle | Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10. | Within 24 hours | 
| post operative pain -Wong-Baker Faces pain scale | The scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. | Within 24 hours |
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Study Overview
=================
Brief Summary
-----------------
Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.

Detailed Description
-----------------
Patients will be recruited and sign a consent form. The patients included are patients with either uterine/cervical malignancies. Each participant undergoes radiation treatment either as primary or complementary treatment. Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points: Before the first treatment session (baseline). After the last session of laser treatment. 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Official Title
-----------------
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging

Conditions
-----------------
Radiation Injuries

Intervention / Treatment
-----------------
* Diagnostic Test: Vaginal Tactile Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy. Exclusion Criteria: Women that are not in the age range. Women with massive vaginal bleeding. Women after pelvic exenteration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing Brachytherapy<br>Women with either uterine or cervical malignancy treated primarily by brachytherapy. | Diagnostic Test: Vaginal Tactile Imaging<br>* Vaginal elasticity measurements using the Vaginal Tactile Imaging system.<br>|
| Women undergoing Pelvic Radiation<br>Women with either uterine or cervical malignancy treated primarily by pelvic radiation. | Diagnostic Test: Vaginal Tactile Imaging<br>* Vaginal elasticity measurements using the Vaginal Tactile Imaging system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal elasticity assessment | Vaginal elasticity as measured by the vaginal tactile imager. | up to 6 months from enrollment |
Quality of Life in Patients Post Radiofrequency Ablation

Study Overview
=================
Brief Summary
-----------------
Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct specific problems that cause the heart to beat faster than it should. Quality of life includes the physical as well as the emotional aspects of a patient. Doctors have always tried to take care of a medical problem with minimal physical and emotional risk. It is assumed that once the medical problem is fixed, the patient will have an improved quality of life. To know if this assumption is true, the investigators are asking children scheduled for this procedure, along with their family, to answer questions before the ablation, then answer the same questions 5-6 months after the ablation.

Detailed Description
-----------------
When a patient (age 5-18 years) is scheduled for an ablation at Children's Healthcare of Atlanta, the research coordinator contacts the family prior to the procedure and describes the study to them, details the goals, benefits versus risks, and answers any questions they may have. Written consent is obtained from the parents. Assent is obtained from the child. Both the parent and child are given the age appropriate Peds QL (tm) Pediatric Quality of Life Inventory, version 4.0. The forms are returned to the research coordinator. If the child is ablated, then 5-6 months after the ablation, the same questionnaire is sent to the child and parent. Data are entered into a database.

Official Title
-----------------
The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort

Conditions
-----------------
Radiofrequency Catheter Ablation, Quality of Life, Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5-18 years of age English is the primary language Scheduled for an ablation at Children's Healthcare of Atlanta Normally structured heart Exclusion Criteria: Congenital heart defect English is not the primary language Children with significant neurocognitive deficits as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, cardiology, Radiofrequency ablation, structurally normal heart
Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.

Official Title
-----------------
Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight regain of more than 10 kg from nadir Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass Exclusion Criteria: Formerly leak at the gastrojejunostomy Formerly open abdominal surgery Anastomotic ulcer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Weight regain / weight loss failure<br>Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass | Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)<br>* Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding<br>* Other names: A.M.I. Soft Gastric Band;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Excessive weight loss | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight regain, Weight loss failure, Gastric bypass