linjc16/ctgov huggingface dataset:
iotaSOFT Pediatric Study

Study Overview
=================
Brief Summary
-----------------
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.

Official Title
-----------------
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

Conditions
-----------------
Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral

Intervention / Treatment
-----------------
* Device: iotaSOFT Insertion System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices Age 9 months to less than 12 years old at the time of CI surgery Willingness to participate in the study and able to comply with the follow-up visit requirements Exclusion Criteria: Prior cochlear implantation in the ear to be implanted Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations Deafness due to lesions of the acoustic nerve or central auditory pathway Diagnosis of auditory neuropathy. Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease Absence of cochlear development Additional medical concerns that would prevent participation in evaluations as determined by the investigator Planned or current participation in a clinical study of an investigational device or drug

Ages Eligible for Study
-----------------
Minimum Age: 9 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric Cochlear Implant Recipient<br>Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age. | Device: iotaSOFT Insertion System<br>* robotic assistive technology for cochlear implant electrode insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety related to adverse events | Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery | 30 days following surgery |
Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study

Study Overview
=================
Brief Summary
-----------------
Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study

Detailed Description
-----------------
Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones. This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.

Official Title
-----------------
Can Shear Wave Elastography Predict the Success of Shock-Wave Lithotripsy Used in Renal Stones Treatment: a Prospective Study

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Procedure: elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients more than 18 years With single radiopaque renal stone Ranging in size from (1-1,5 cm) for ESWL. Exclusion Criteria: Any urological abnormal anatomy Lower calyceal stone more than 1cm Impaired renal functions Uncorrected coagulopathy. Active UTI Pregnancy Single kidney Multiple stones

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESWL sucess and failed gps<br>post ESWL 50 pt large gp will be devided into sucess gp and failed gp | Procedure: elastography<br>* elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | post ESWL | 1 month |
Survey of COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
Using online questionnaires, we will obtain data regarding COVID-19 infection and treatment, including incidence rate, hospitalization rate, severity of the infection, medications, mortality rate, etc, in both hospital and communities after the change of disease control policy in China.

Official Title
-----------------
Survey of COVID-19 Infection

Conditions
-----------------
COVID-19, Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: N/A Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Infection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Quickly obtain the all-cause mortality in patients with COVID-19 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of COVID-19 infection | Incidence rate of COVID-19 infection | 6 months | 
| Medication for COVID-19 treatment | Any medication for COVID-19 treatment | 6 months | 
| Hospitalization rate due to COVID-19 infection | Hospitalization rate due to COVID-19 infection | 6 months | 
| Severity of COVID-19 infection | severity of the COVID-19 infection | 6 months |
PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

Study Overview
=================
Brief Summary
-----------------
PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.

Detailed Description
-----------------
PD Frontline is an online one-time questionnaire based study with the purpose of identifying potential candidates for gene targeted trials and observational studies. Once the questionnaire is completed, the participant is sent a saliva collection kit in the post to provide a sample for genetic testing. The genes tested for are GBA1, the most common risk factor gene for Parkinson's, and LRRK2. Once tested, the participant is informed of their results and kept up-to-date with any studies or trials for which they may be eligible.

Official Title
-----------------
PD Frontline, Part of RAPSODI GD (Remote Assessment of Parkinsonism Supporting Ongoing Development of Interventions in Gaucher's Disease) to Build an Online Trial-ready Cohort of GBA Genotyped People With Parkinson's

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Formal diagnosis of Parkinson Disease Exclusion Criteria: Confirmation that the individual carries a GBA variant (GBA positive). These individuals will be referred to sister-study, RAPSODI. History of Parkinsonism (progressive supranuclear palsy, multiple system atrophy, traumatic, manganese toxicity, postencephalitic, vascular PD; drug induced PD; corticobasal degeneration) Individuals with another neurological disorder including: dementia, movement disorders, and motor neurone disease. Individuals on drugs known to be associated with parkinsonism, including neuroleptic agents (Amisulpride, Chlorpromazine Hydrochloride, Flupenthixol, Fluphenazine Hydrochloride, Haloperidol, Methotrimeprazine, Levomepromazine, Olanzapine, Oxypertine, Pericyazine, Perphenazine, Pimozide, Pipotiazine, Prochlorperazine, Promazine Hydrochloride, Reserpine, Risperidone, Sulpiride, Thioridazine, Trifluoperazine, Zuclopenthixol acetate, Zotepine), plus Bupropion, , Lithium, Methyldopa, Metoclopramide and Sodium Valproate).

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

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 |
| --- | --- | --- |
| Genotype of participants | The primary outcome of the study is to genotype the GBA1 gene, obtained with Oxford Nanopore long read sequencing. | 20 years |
Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .

Detailed Description
-----------------
Chronic Obstructive pulmonary disease is known to escalate the consumption of Inhalation Agents in General Anesthesia. Hence the Data to Collect the Official Record

Official Title
-----------------
Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients Under General Anesthesia

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Capnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both Sex All Age Group Patient willing to give consent COPD patient Exclusion Criteria: Not willing to give consent Cancerous Lung Lung Lobectomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Patients<br>Normal patients without any Lung Pathology for General Anesthesia | Device: Capnography<br>* To know the Co2 graph in COPD and Normal patients under General Anesthesia<br>|
| COPD patients<br>Established Chronic Obstructive Pulmonary Disease for General Anesthesia | Device: Capnography<br>* To know the Co2 graph in COPD and Normal patients under General Anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of Volume consumption of Sevoflurane | The consumption is expressed in Volume ml/kg | 8 weeks |
Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this non-interventional secondary use of data study is to evaluate hematological response in patients with paroxysmal nocturnal hemoglobinuria and anemia in the 6-month period after initiation of anti-C5 antibody treatment using real-world data obtained from multiple datasets. The results will be used to contextualize results from the APPOINT-PNH (NCT04820530) trial with iptacopan.

Official Title
-----------------
Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria

Intervention / Treatment
-----------------
* Other: Anti-C5 antibody treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incident users of anti-C5 antibody treatment (i.e., first use of anti-C5 antibody with no evidence of use prior to that) Confirmed clinical diagnosis of PNH (including PNH clone size >10% in RBC percent/white blood cell (WBC) percent) Adult patients ≥18 years of age Baseline Hb <10 g/dL. Exclusion Criteria: Patients who met any of the following criteria were not eligible for inclusion. Bone marrow transplantation within one year prior to initiating anti-C5 treatment Hereditary complement deficiency Reticulocyte count <60x10^9/L. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Real-world cohort<br>The real-world cohort consists of patients with diagnosis of paroxysmal nocturnal hemoglobinuria and anemia initiating anti-C5 therapy. | Other: Anti-C5 antibody treatment<br>* Anti-C5 antibody treatment (i.e., eculizumab and ravulizumab)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase from baseline in hemoglobin | Increase from baseline in hemoglobin of ≥ 2 g/dL in the absence of transfusions occurring after Day 14 post index date | between Day 100 and Day 200 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Response | Achieving hemoglobin of ≥ 12 g/dL in the absence of blood transfusions occurring after Day 14 post index date | between Day 100 and Day 200 | 
| Transfusion avoidance | Transfusion avoidance (dichotomous endpoint) defined proportion of subjects without transfusions during the initial 6-month treatment period starting from 2 Weeks after index date (i.e., date of first anti-C5 antibody treatment for PNH). | Occurrence between Day 15 and Day 200 |
Lateral Position MRI in Preterm Infants, an Observational Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are: number of apneas during sedation Maintenance of eupnea during deep sedation

Detailed Description
-----------------
Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.

Official Title
-----------------
Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study

Conditions
-----------------
Prematurity, Magnetic Field Exposure, Sedation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 40 weeks Post Conceptional Age (PCA) Exclusion Criteria: > 50 weeks PCA previous treatment with hypothermia for neonatal asphyxia patients who received invasive positive pressure ventilation within the previous 48 h preexisting cardiac arrhythmias presence or suspicion of oncological pathology neuromuscular or metabolic diseases previous brain or abdominal surgery presence of epicranial venous accesses upper respiratory tract infections refusal of informed consent by parents or inability to express it

Ages Eligible for Study
-----------------
Maximum Age: 50 Weeks

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 |
| --- | --- | --- |
| Peripheral oxygen desaturation | Number of episodes of peripheral oxygen desaturation < 90% during deep sedation | Through study completion, an average of 7 month | 
| Apnea | Number of episodes of apnea > 20 sec during deep sedation | Through study completion, an average of 7 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of imaging quality | Subjective evaluation of images by two neuroradiologists measured as Score (1-5 points) in 5 categories | Through study completion, an average of 7 month | 
| Objective evaluation of imaging quality | Objective evaluation of image quality by measuring the Signal to Noise Ratio (SNR) | Through study completion, an average of 7 month | 
| Post-operative temperature control | Measurement of rectal core body temperature (°C) after the exam | Through study completion, an average of 7 month | 
| Time for full enteral feeding | How many hours for full enteral feeding after the preoperative fasting | Through study completion, an average of 7 month | 
| Objective evaluation of imaging quality | Objective evaluation of image quality by measuring the Contrast to Noise Ratio (CNR) | Through study completion, an average of 7 month |
Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.

Study Overview
=================
Brief Summary
-----------------
Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease morbidity and mortality

Detailed Description
-----------------
This cross sectional study will be conducted to compare between the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as a non-invasive method for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms of both conditions.

Official Title
-----------------
Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.

Conditions
-----------------
Fluid Volume Excess

Intervention / Treatment
-----------------
* Device: lung ultrasound and electrical cardiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis Exclusion Criteria: Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease. Patients with heart failure. Patients with implantable cardiac pacemaker or defibrillator

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 50 children and adolescents with end stage renal disease on regular hemodialysis<br>50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly | Device: lung ultrasound and electrical cardiometry<br>* : B-lines of lung ultrasound and the parameters of cardiometry will be measured at the mid-week HD session before starting the session by 30 min then every 30min during HD session for 180 min and then after the end of the session of HD by 30 min and then The specificity and sensitivity of both techniques will be compared to each other<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume status in pediatric patients on regular hemodialysis | detection of the fluid status in pediatric patients on regular hemodialysis | six months |
Abbott Ventricular Tachycardia PAS

Study Overview
=================
Brief Summary
-----------------
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.

Official Title
-----------------
Abbott Ventricular Tachycardia Post Approval Study

Conditions
-----------------
Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: FlexAbility SE Ablation Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure Able and willing to comply with all study requirements Exclusion Criteria: Documented or known intracardiac thrombus or myxoma Active systemic infection History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure Patients with prosthetic valves as the catheter may damage the prosthesis Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| Treatment Group<br>Single Arm Group to receive ablation. | Device: FlexAbility SE Ablation Catheter<br>* Subjects receive ablation treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. |  | 12 Month | 
| Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation |  | 12 Month |