linjc16/ctgov huggingface dataset:
PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)

Study Overview
=================
Brief Summary
-----------------
The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process

Detailed Description
-----------------
The aim is to explore the recent experience and views of parents in a qualitative way to assist the development of a questionnaire which can be used with a much larger group of parents. The interview guide with the topics to be covered will include: expectations, concerns and issues relating to the equipment used with their baby, any investigations, including cranial ultrasound and MR imaging and the information provided. The data collected will then inform the development of a standard instrument or questionnaire which will be used with parents participating in a trial using a randomised design to compare the influence of MR and ultrasound-based information on parental perceptions, stress and coping in association with healthcare usage and costs.

Official Title
-----------------
Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)

Conditions
-----------------
Parents of Preterm Infants Born Before 33 Weeks Gestation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of babies born before 33 weeks gestation Parents who are 16 years of age or older Parents who are able to give informed consent Parents who are able to take part in interviews which are conducted in English Exclusion Criteria: Parents who are under 16 years of age Parents who are unable to give informed consent Parents who are unable to take part in interviews which are conducted in English Parents where there are possible or know child protection issues

Ages Eligible for Study
-----------------
Maximum Age: 33 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents of babies born before 33 weeks gestation<br> | |

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
-----------------
Preterm, Perinatal, Ultrasound, Cerebral palsy, Anxiety, Parents
Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Torcetrapib/Atorvastatin
* Drug: Fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Fredrickson Type IIB dyslipidema (Mixed Hyperlipidemia) Men and women at least 18 years of age Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete 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: Torcetrapib/Atorvastatin|nan|
|Drug: Fenofibrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of lipid parameters and other biomarkers |  |  |
Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.

Study Overview
=================
Brief Summary
-----------------
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.

Official Title
-----------------
Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).

Conditions
-----------------
Subarachnoid Hemorrhage.

Intervention / Treatment
-----------------
* Procedure: Lumbar drain
* Procedure: Ventricular drain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage In need for CSF drainage based on clinical judgment Exclusion Criteria: intraventricular clots intraparenchymal clots causing midline shift 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar drain group<br>Lumbar drain | Procedure: Lumbar drain<br> <br> |
| Active Comparator: Ventricular drain<br>Ventricular drain | Procedure: Ventricular drain<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated Hb and bilirubin in CSF drainage |  | From drain placement to removal, in average 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placement of a ventriculoperitoneal shunt |  | participants will be followed for the duration of hospital stay, in average 3 weeks | 
| Lindegaard ratio (TCD) > 3 |  | the participants will be followed for the duration of hospital stay, in average 3 weeks | 
| clinical signs of vasospasms |  | The participants will be followedd for the duration of hospital stay, in average 3 weeks |
Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.

Detailed Description
-----------------
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Official Title
-----------------
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: AGT2, AGZ
* Drug: AGT2
* Drug: AGT4, AGZ
* Drug: AGT4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary hypercholesterolemia Exclusion Criteria: The subject not meet the specified LDL-C level

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGT2, AGZ<br> | Drug: AGT2, AGZ<br>* Tablet, q.d.<br>|
| Active Comparator: AGT2<br> | Drug: AGT2<br>* Tablet, q.d.<br>|
| Experimental: AGT4, AGZ<br> | Drug: AGT4, AGZ<br>* Tablet, q.d.<br>|
| Active Comparator: AGT4<br> | Drug: AGT4<br>* Tablet, q.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in LDL-C level from baseline at Week 8 | change in LDL-C level | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C level from baseline at Week 4 | change in LDL-C level | Week 4 |
Ketamine and Postoperative Analgesia in Children

Study Overview
=================
Brief Summary
-----------------
The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.

Official Title
-----------------
Ketamine and Postoperative Analgesia in Children

Conditions
-----------------
Postoperative Analgesia

Intervention / Treatment
-----------------
* Drug: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 6 months to 6 years of age American Society of Anesthesiologists (ASA) I or II Undergoing elective surgery with intraoperative caudal analgesia Exclusion Criteria: ASA III or IV Contraindication to caudal anesthesia Allergy to drugs used in the study Failure in caudal puncture Administration of morphine derivative

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of pain scores (CHEOPS) measured |  | every 2 hours during the first 24 hours after eyes open | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10 |  | at the 24th hour | 
| Number of painful episodes requiring additional boluses of nalbuphine |  |  | 
| Number of children requiring morphine after inefficiency of additional boluses of nalbuphine |  |  | 
| Percentage of children with side effects related to injection of ketamine |  |  | 
| Time to complete feeding |  |  | 
| Percentage of children with nausea or vomiting |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, ketamine, postoperative analgesia, nalbuphine, Postoperative analgesia in children
Paediatric Rural vs Urban Trauma

Study Overview
=================
Brief Summary
-----------------
Retrospective cohort study examining paediatric trauma admission over 1 year in a rural hospital vs urban centre

Detailed Description
-----------------
As above. All patient data was anonymised.

Official Title
-----------------
Comparing Paediatric Trauma Presentations in a Rural District General Hospital and an Urban Major Trauma Centre: a Retrospective Cohort Study

Conditions
-----------------
Paediatric Trauma

Intervention / Treatment
-----------------
* Other: Type of hospital (rural DGH vs Urban MTC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All paediatric trauma in each centre over the above time frame, treated operatively, seen on an acute orthopaedic take Exclusion Criteria: Adults, non-operative trauma

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Urban trauma cohort<br>All paediatric trauma admissions in an urban, MTC treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 | Other: Type of hospital (rural DGH vs Urban MTC)<br>* In this small cohort study, the hospital in which the patients were treated was the intervention. One was in a rural area and was a district general, whereas one was in an urban enviroment and was a major trauma centre.<br>|
| Rural trauma cohort<br>All paediatric trauma admissions in a rural district general, treated operatively, isolated from a departmental trauma list between 1st April 2019- 1st April 2021 | Other: Type of hospital (rural DGH vs Urban MTC)<br>* In this small cohort study, the hospital in which the patients were treated was the intervention. One was in a rural area and was a district general, whereas one was in an urban enviroment and was a major trauma centre.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of operation performed | Type of orthopaedic intervention documented | 1st April 2019- 1st April 2020 | 
| Distribution of type of paediatric trauma | Sub-types of fractures seen documented | 1st April 2019- 1st April2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seasonality of trauma | winter vs summer months trauma numbers documented | 1st April 2019- 1st April 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paediatric trauma
Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.

Official Title
-----------------
Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction

Conditions
-----------------
Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: Bivalirudin
* Drug: Unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction. Age 18 years or older. Exclusion Criteria: Inability to obtain consent Emergency cardiac catheterization for ST-segment elevation myocardial infarction.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bivalirudin<br>Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. | Drug: Bivalirudin<br> <br> |
| Active Comparator: unfractionated heparin<br>Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. | Drug: Unfractionated heparin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints) |  | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality, myocardial infarction, or unplanned revascularization for ischemia |  | 30-days | 
| Bleeding Academic Research Consortium grade III or V bleeding events |  | 30-days |
COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

Study Overview
=================
Brief Summary
-----------------
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.

Official Title
-----------------
COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 21 years of age Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII) Patients capable of providing an informed consent Exclusion Criteria: Patients with secondary hypertension Pregnant women or nursing mothers Patients with acute illnesses or psychiatric diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Compliance rate | Identify the percentage of subjects compliant to their antihypertensive treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (MINICHAL Score) | To compare and identify changes in the quality of life before and after anti-hypertensive treatment. | 6 months | 
| Type of pharmacological treatments | To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension. | 6 months | 
| Factors affecting adherence to treatment | To identify associated factors that may alter adherence to anti-hypertensive treatment. | 6 months | 
| Compliance rate by antihypertensive regimen used | To compare treatment rate for different antihypertensive regimen used | 6 months | 
| Percentage of controlled patients | To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Phase II Iressa & Carbo/Gem in NSCLC

Study Overview
=================
Brief Summary
-----------------
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Official Title
-----------------
A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Gemcitabine
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Non Small cell Lung Cell Lung cancer Never received chemotherapy Up and about 50% of waking hours Exclusion Criteria: Spread of lung cancer to the brain Low level of white blood cells Radiotherapy within 4 weeks Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gemcitabine + Carboplatin | Drug: Gemcitabine<br>* intravenous injection<br>* Other names: Gemzar;Drug: Carboplatin<br>* intravenous injection<br>* Other names: CBDCA;|
| Experimental: 2<br>Gefitinib | Drug: Gefitinib<br>* oral tablet<br>* Other names: ZD1839;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression | Date of randomization to earliest date of objective disease progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, Non-Small-Cell Lung Cancer, Lung Cancer