linjc16/ctgov huggingface dataset:
Cardiac Catheterization in the Management of Pediatric Cardiac Patients at A.U.C.H.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record the outcome in these cases.

Detailed Description
-----------------
Cardiac catheterization is of two types: diagnostic and interventional . There has been recent advances in these procedures.There is an over 10y experience at the pediatric cardiology unit in assiut University Children Hospital ( A.U.C.H ) catheterization department. The procedure usually follows other investigations used for evaluation of the pediatric cardiac patients e.g. chest X-ray , ECG and echocardiography. The role of cardiac catheterization may be in the diagnosis of congenital cardiac anomalies as well as in the follow up of repair of some cardiac anomalies . On the other hand, the indications for interventional cardiac catheterization may be repair of Atrial septal defect, Transposition of great arteries palliation with balloon septostomy ,blood vessel dilatation e.g. aortic stenosis and coarctation of the aorta . In addition Patent ductus arteriosus closure and others may be done by the interventional cardiac catheterization.

Official Title
-----------------
Cardiac Catheterization in the Management of Pediatric Cardiac Patients at Assiut University Children Hospital ( A Descriptive Study)

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Device: cardiac catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital Exclusion Criteria: cases not admitted for diagnostic or interventional cardiac catheterization

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cardiac catheterization|diagnostic and interventional cardiac catheterization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|) | duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case) |
Sedasys Post Approval Study Users Response to System Alarms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.

Official Title
-----------------
Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms

Conditions
-----------------
Conscious Sedation

Intervention / Treatment
-----------------
* Device: SEDASYS System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I and II male and female Scheduled for routine colonoscopy or EGD ≥18 years of age Able to read, speak, and understand English Exclusion Criteria: Physical or psychological condition which would impair trial participation, at the discretion of the PI BMI ≥ 35 Pregnancy or lactation Known or suspected hypersensitivity to propofol or fentanyl Use of a fentanyl patch Allergies to eggs, egg products soybeans or soy products Diagnosis of sleep apnea Gastroparesis Full stomach at the time of procedure Participation in any other investigational device or drug study within 30 days of enrollment

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 |
| --- | --- |
| SEDASYS System<br> | Device: SEDASYS System<br>* propofol sedation with the SEDASYS System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms) |  | <24 hours, i.e., for duration of study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC) |  | assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation for EGD and colonoscopy procedures
Accelerated Brain Volume Loss in People With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
To explore whether brain volume loss (BVL) in people with multiple sclerosis (MS), assessed on magnetic imaging (MRI) data obtained during routine medical follow-up (and thus outside a standardized research environment), differs from that of healthy controls and correlates with measures of physical and/or cognitive disability, the latter also gathered during regular clinical practice.

Detailed Description
-----------------
This project will not be the first study on real-world data in an existing MS cohort. A NMSC research group has already reported on the contribution of a single brain volumetric assessment to the prediction of MS-related disability10 - with distinct patterns for the Expanded Disability Status Scale (EDSS) as a measure of physical disability11, and Symbol Digit Modalities Test (SDMT) as a measure of cognitive disability12 - and found a threshold effect for the lowest brain volumes with regard to SDMT worsening over time10. Ghione and co-workers, in turn, have demonstrated a positive correlation between annualized BVL and EDSS progression based on the EDSS in a very large sample containing nearly 2,000 individuals13. The novelty of this new study lies in the fact that the investigators want to explore the correlations between BVL and changes in an expanded set of routinely collected clinical variables in our center - in addition to the EDSS score - such as Timed 25-Feet Walk Test (T25FWT)14, 9-Hole Peg Test (9HPT)15 and SDMT.

Official Title
-----------------
Accelerated Brain Volume Loss in People With Multiple Sclerosis: do Real-world Observations Align With Standardized Research Findings?

Conditions
-----------------
Retrospective Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI and volumetry performed minimum 48 and maximum 60 months apart Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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 |
| --- | --- | --- |
| The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort | the difference in annualized whole brain volume measured by Icometrix | 4 - 5 years |
Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Study Overview
=================
Brief Summary
-----------------
The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

Detailed Description
-----------------
Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes

Official Title
-----------------
Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Conditions
-----------------
Low Birth Weight

Intervention / Treatment
-----------------
* Other: Kangaroo Mother Care (KMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All newborns who are less than 2000 gm born within the study facilities during the study period. Exclusion Criteria: • Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate <20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia <32°F.

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Kangaroo Mother Care (KMC)|Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective coverage of KMC at 7 days after discharge | Effective coverage will be defined as adoption of skin-to-skin care for at least 8 hours and exclusive breastfeeding in the 24 hours prior to assessment | 7 days after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Birth weight
AZD8529 Single Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses

Official Title
-----------------
Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD8529
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential. Exclusion Criteria: Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8529<br>* Oral<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential. |  | at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD8529 in plasma and urine. |  | Blood and urine samples will be taken during the study. | 
| To asses the effect of food on the safety and pharmacokinetic profile of AZD8529. |  | Safety assessments and blood and urine samples will be taken throughout the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I
Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.

Official Title
-----------------
Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women

Conditions
-----------------
Fibromyalgia, Postural Lordosis, Postural Kyphosis, Proprioception, Postural Stability, Balance

Intervention / Treatment
-----------------
* Other: Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being women having FMS being volunteer Exclusion Criteria: have neurologic, infectious, endocrine, and other severe psychological disorders malignancy, being pregnant any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems) spinal deformities such as scoliosis, spine surgery inflammatory rheumatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromiyalgia group<br>women with FMS between 18-65 years of age and being volunteered. | Other: Evaluation<br>* Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.<br>|
| Healthy group<br>healthy women and being volunteereed | Other: Evaluation<br>* Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Position Sense | Trunk position sense will be evaluated with a digital inclinometer. | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Stability | The postural stability will be evaluated with a special balance device in eyes opened and closed position. | 20 days | 
| Spinal Posture | .The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer. | 20 days |
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Official Title
-----------------
Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Biological: G17DT Immunogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection Life expectancy of at least 3 months Functional status by Karnofsky Index of at least 70 Exclusion criteria: Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease Immunodeficiency Bone marrow transplant within past year Brain metastasis

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br>Placebo (immunogen vehicle) combined with gemcitabine. | |
| Experimental: A<br>500 µg G17DT immunogen combined with gemcitabine. | Biological: G17DT Immunogen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events | Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, G17DT, gemcitabine
Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping

Study Overview
=================
Brief Summary
-----------------
Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication.

Detailed Description
-----------------
Adolescents with ADHD who are treated with one of the methylphenidate medication that is in use in Israel(Ritalin,Ritalin SR,Concerta,Ritalin LA)will be tested by driving simulator and seat pressure mapping by 2 stages: 1.when they are taking the medication that they are taking every day to control ADHD and: 2. without medication ( after 4 day washout period).

Official Title
-----------------
Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license Exclusion Criteria: any other neurological or psychiatric problem under treatment or investment adolescents who have driving license

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum 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 |
| --- | --- |
| methylphenidate<br>30 adolescents who are treated with Methylphenidate will perform the driving simulator and seat pressure mapping tests, in 2 different days : 1. with their regular methylphenidate medication and 2: without the methylphenidate medication after a 4 days washout period. Results will be recorded and statistical test will be performed. | |
| no medication<br>30 adolescents : control group , not suffering from ADHD and without methylphenidate medication will perform the driving simulator and seat pressure mapping tests. Results will be recorded and statistical test will be performed. | |

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
-----------------
methylphenidate, ADHD, driving, simulator, pressure, adolescent