linjc16/ctgov huggingface dataset:
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Study Overview
=================
Brief Summary
-----------------
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Detailed Description
-----------------
The minimum dataset collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The data collected include information on: Demographics of mother and infant Mother's health, labor and delivery Infant's health, medical interventions, and clinical outcomes These data are used to: provide participating hospitals with reporting for use in quality improvement; evaluate associations between baseline characteristics, treatments, and outcomes; and track trends in disease and therapy.

Official Title
-----------------
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Conditions
-----------------
Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal, Intensive Care Units, Neonatal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission; AND All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days Optional: Centers who desire to include data for NICU admissions of infants born <22 weeks' gestation may also submit these data.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Year

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registry of characteristics and outcome data for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals collected in a uniform manner |  | Longitudinal database through 1/2028 |
Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.

Official Title
-----------------
Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.

Conditions
-----------------
COVID-19, Surgery-Complications

Intervention / Treatment
-----------------
* Procedure: endoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery. Exclusion Criteria: If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic surgery|Emergency or elective surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Death up to 30-days post surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | Determine postoperative complications one month after surgery. | 30 days |
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.

Detailed Description
-----------------
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.

Official Title
-----------------
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults

Conditions
-----------------
Heart Valve Prosthesis

Intervention / Treatment
-----------------
* Device: INSPIRIS Resilia (model 11500A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022. Exclusion Criteria: Subjects that have not received the INSPIRIS Resilia device.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 64 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 |
| --- | --- |
| All Subjects<br>Subjects that have received the INSPIRIS Resilia device. | Device: INSPIRIS Resilia (model 11500A)<br>* Aortic Valve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contribute to the scarce body of literature | The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults | 5 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults | Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate | 5 years after implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Valve Replacement, Pulmonary Valve, Congenital Heart Disease, INSPIRIS Resilia
Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor & Delivery (L&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.

Official Title
-----------------
Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese and Super-obese Pregnant Women

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: ANNE One


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years old Ability and willingness to provide written informed consent Admitted for delivery at UNC Medical Center BMI of >= 40 kg/m2 Clinically indicated radial A-lines either planned or already in-situ prior to delivery Exclusion Criteria: Skin sensitivity or allergy that precludes placement of ANNE One Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation Expected delivery within <= 1 hour of arrival to L&D

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

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

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: Comparison of ANNE One system blood pressure measurements to arterial line<br> | Device: ANNE One<br>* Chest sensor for single lead ECG and finger sensor for pulse oximetry.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line | Mean absolute error and standard deviation between the non-invasive blood pressure measurement provided by the device under test and the invasive blood pressure measurement from the arterial line. | 8 hours |
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. Moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.

Official Title
-----------------
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Bone marrow sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With multiple myeloma Who receive Teclistamab Consent form signed Exclusion Criteria: Patient under legal protection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analysis of bone marrow<br>Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles | Other: Bone marrow sampling<br>* Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to teclistamab at 12 weeks | response according to International Myeloma Working Group criteria | at day 1 Cycle 4 (each cycle is 28 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Teclistamab, Resistance, Immune Cell
A Study to Evaluate the Efficacy and Safety of AD-223

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-223

Detailed Description
-----------------
Condition or disease : hypertension

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension

Conditions
-----------------
Hypertension,Essential

Intervention / Treatment
-----------------
* Drug: AD-223A
* Drug: AD-223B
* Drug: AD-223C
* Drug: AD-223A Placebo
* Drug: AD-223B Placebo
* Drug: AD-223C Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Other inclusions applied Exclusion Criteria: Orthostatic hypotension with symptom Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Test group<br>AD-223A+AD-223B+AD-223C Placebo | Drug: AD-223A<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223B<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223C Placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Active Comparator: Control group 1<br>AD-223A+AD-223B Placebo+AD-223C Placebo | Drug: AD-223A<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223B Placebo<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223C Placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Active Comparator: Control group 2<br>AD-223A Placebo+AD-223B+AD-223C Placebo | Drug: AD-223B<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223A Placebo<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223C Placebo<br>* PO, Once daily(QD), 8weeks<br>|
| Active Comparator: Control group 3<br>AD-223A Placebo+AD-223B Placebo+AD-223C | Drug: AD-223C<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223A Placebo<br>* PO, Once daily(QD), 8weeks<br>Drug: AD-223B Placebo<br>* PO, Once daily(QD), 8weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate of MSSBP | Change from baseline in mean sitting systolic blood pressure | Baseline, Week 8 |
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia

Study Overview
=================
Brief Summary
-----------------
Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep

Detailed Description
-----------------
A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.

Official Title
-----------------
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Device: Sound Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Meets DSM 5 criteria for insomnia disorder Insomnia Severity Index (ISI) of 15 - 28 Exclusion Criteria: Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets | Device: Sound Treatment<br>* Customized sound audio track delivered via standard commercially available bone conduction headset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) | Reduction in Insomnia Severity | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Reduction in Sleep Quality | 4 weeks |
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

Study Overview
=================
Brief Summary
-----------------
This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult patients with ALS, FTD, or mixed ALS/FTD phenotype with a documented mutation in the C9orf72 gene. To participate in the study, patients must have successfully completed Phase 1b/2a WVE-004-001 study.

Official Title
-----------------
A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

Conditions
-----------------
ALS, FTD

Intervention / Treatment
-----------------
* Drug: WVE-004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient successfully completed the Phase 1b/2a study with WVE-004, WVE-004-001. Exclusion Criteria: Patient has a clinically significant medical finding on the physical examination other than C9orf72-associated ALS or FTD that, in the judgment of the Investigator or Sponsor, will make the patient unsuitable for participation in and/or completion of the trial procedures. Patient received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Patient received an investigational oligonucleotide within the past 6 months or 5 half-lives of the drug, whichever is longer.
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: Experimental: WVE-004 (Dose A)<br> | Drug: WVE-004<br>* WVE-004 is a stereopure antisense oligonucleotide. It is administered via intrathecal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of patients with adverse events (AEs) |  | Day 1 to Week 120 (end of study) | 
| Safety: Number of patients with a severe AE |  | Day 1 to Week 120 (end of study) | 
| Safety: Number of patients with serious AEs (SAEs) |  | Day 1 to Week 120 (end of study) | 
| Safety: Number of patients who withdraw due to AEs |  | Day 1 to Week 120 (end of study) |
Desflurane and Sevoflurane on Remifentanil Requirement

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.

Official Title
-----------------
Comparison of Desflurane and Sevoflurane on Remifentanil Requirement Using Analgesia Nociception Index-guided Anesthesia

Conditions
-----------------
Spinal Diseases

Intervention / Treatment
-----------------
* Drug: Desflurane Inhalation Solution
* Drug: Sevoflurane Inhalation Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges Exclusion Criteria: Hyperbilirubinemia Prior chronic pain Prior opioid abuse Cardiac arrythmia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desflurane group<br> | Drug: Desflurane Inhalation Solution<br>* Keeping the anesthesia using desflurane inhalation solution as 1 minimal alveolar concentration<br>|
| Placebo Comparator: Sevoflurane group<br> | Drug: Sevoflurane Inhalation Solution<br>* Keeping the anesthesia using sevoflurane inhalation solution as 1 minimal alveolar concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remifentanil requirement | assessing the total dose of remifentanil administered from skin incision until skin suture | at time of the end of skin suture (up to 3 hours) |
Modified TIP (Snodgrass) Using Interrupted Sutures in Hypospadias

Study Overview
=================
Brief Summary
-----------------
Using interrupted sutures in TIP technique by Snodgrass in repair of hypospadias instead of continuous sutures

Official Title
-----------------
Modified TIP (Snodgrass) Using Interrupted Sutures in Hypospadias

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Other: interrupted sutures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Midshaft , distal , coronal hypospadias Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases<br>Using interrupted sutures | Other: interrupted sutures<br>* Using interrupted sutures in repair of hypospadias by Snodgrass TIP repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing complications | New technique to decrease complications of this operation | 1 year |