linjc16/ctgov huggingface dataset:
e-BioMatrix PostMarket Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.

Official Title
-----------------
A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patients that need a treatment with a BioMatrix™ drug-eluting stent Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents No limitation on the number of treated lesions, and vessels, and lesion length Exclusion Criteria: Inability to provide informed consent Patients needing additional stent NOT of the BioMatrix™ type Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and secondary stent thrombosis (definite and probable according to ARC definitions) |  | 30 days, 6 and 12 months, 2, 3 and 5 years | 
| Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization |  | 30 days, 6 months, 2, 3 and 5 years | 
| Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization |  | 30 days, 6 and 12 months, 2, 3 and 5 years | 
| Death and MI |  | 30 days, 6 and 12 months, 2, 3 and 5 years | 
| Total revascularization rate (clinically and non clinically driven) |  | 30 days, 6 and 12 months, 2, 3 and 5 years |
Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

Study Overview
=================
Brief Summary
-----------------
- To evaluate the feasibility of combination chemotherapies comprising of gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant non-Hodgkin lymphoma (NHL)

Detailed Description
-----------------
- The feasibility will be evaluated in terms of objective response rate, efficacy of stem cell collection, disease-free survival, and overall survival.

Official Title
-----------------
Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: GemDOx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have refractory to first-line CHOP-like regimen Patients who have first relapse after first-line CHOP-like regimen upfront autologous or allogeneic hematopoietic stem cell transplantation Age 15 years or more ECOG performance status ≤ 2 Adequate bone marrow function Adequate kidney,liver,cardiac Exclusion Criteria: Patients who have received GEM or OX

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| No Intervention: 1<br> | Drug: GemDOx<br>* gemcitabine oxliplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 10/2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT |  | 10/2009 |
Economic Burden of NAFLD

Study Overview
=================
Brief Summary
-----------------
To determine the economic burden of NAFLD (Non-Alcoholic-Fatty-Liver Disease) patients in Belgium, Flanders by means of a bottom-up approach.

Official Title
-----------------
The Economic Burden of Non-Alcoholic Fatty Liver Disease Patients in Flanders, Belgium

Conditions
-----------------
NAFLD, Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Other: Determination of the economic burden NAFLD patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having NAFLD as was diagnosed by FibroScan®, 18 years or older BMI ≥ 25 kg/m² Exclusion Criteria: unable to give informed consent >70 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: NAFLD patients<br>Non-Alcoholic Fatty Liver Disease patients | Other: Determination of the economic burden NAFLD patients<br>* Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iMTA MCQ | Healthcare cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iMTA MCQ | Patient cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services. | Baseline | 
| EuroQol-5D-5L | : Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life. | baseline |
Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

Study Overview
=================
Brief Summary
-----------------
The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.

Official Title
-----------------
Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management

Conditions
-----------------
Cerebral Oxygenation

Intervention / Treatment
-----------------
* Diagnostic Test: NIRS open


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Expected duration of Anesthesia >45 minutes Intervention/surgery in the operating room Exclusion Criteria: Impossibility to place cerebral NIRS sensor Known cerebral pathology Missing parental consent Congenial cardiac condition with right to left shunt Cardiac surgery

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS open<br>Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia | Diagnostic Test: NIRS open<br>* Treatment according to protocol in phases of cerebral hypoxia.<br>|
| No Intervention: NIRS blinded<br>NIRS monitoring applied and masked for caregiver. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral hypoxic burden | Time under 65% cerebral oxygen saturation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid administration | ml/kg | 1 day | 
| Number of participants with Vasopressor or Inotrope administered | Proportion | 1 day | 
| Number of participants with erythrocyte administration | Proportion | 1 day | 
| Fraction of inspired oxygen |  | 1 day |
Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.

Detailed Description
-----------------
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.

Official Title
-----------------
Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: midline incision or off-midline incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor size is less than 5cm No history of laparotomy No bowel obstruction by tumor Exclusion Criteria: Patients who can't respond to medical question Patients who receive steroids or insulin therapy Uncontrolled DM Severe respiratory failure(HOT)
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midline incision<br>The extraction-site incision in laparoscopic colectomy is middline | Other: midline incision or off-midline incision<br>* Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy<br>|
| Active Comparator: off-midline incision<br>The extraction-site incision in laparoscopic colectomy is off-middline | Other: midline incision or off-midline incision<br>* Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetic effect | Scar assessment score on the patient and observer scar assessment scale(POSAS) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaire on the SF-36 v2 acute | 7 days, 14 days and 30 days |
Development of a Clinical Prediction Rulefor Neck Manipulation

Study Overview
=================
Brief Summary
-----------------
Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.

Official Title
-----------------
Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise

Conditions
-----------------
Mechanical Neck Pain

Intervention / Treatment
-----------------
* Procedure: Manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 60 years primary report of neck pain with or without unilateral upper extremity symptoms baseline neck disability index score of 10 points (out of 50) or greater Exclusion Criteria: any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form) bilateral upper extremity symptoms evidence of central nervous system involvement history of whiplash injury within 6 weeks of the examination pending legal action regarding their neck pain 2 or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes) any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Cervical spine manipulation<br>Subjects received cervical spine manipulation | Procedure: Manipulation<br>* Single level cervical spine joint manipulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change Scale | 15 point likert scale rating perceived recovery | 48 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Average pain scores (0 - no pain to 10 - worst imaginable pain) taken for current rating, best in last 24 hours and worst in last 24 hours | 48 hours and 96 hours post intervention | 
| Neck Disability Index | 10 item questionnaire measuring perceived disability (range 0 to 50) | 48 hours and 96 hours post intervention |
Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training

Study Overview
=================
Brief Summary
-----------------
This study looks at the comfort of interventional and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in interventional radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To measure trainee comfort performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. OUTLINE: Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device.

Official Title
-----------------
Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training Regimen

Conditions
-----------------
Malignant Vascular Neoplasm

Intervention / Treatment
-----------------
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey

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 |
| --- | --- |
| Observational (survey administration)<br>Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device. | Other: Survey Administration<br>* Complete survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trainees' feelings about using simulation to help with procedural training | Will measure how trainees feel about using simulation to help with procedural training, and how comfortable trainees feel performing various endovascular procedures after undergoing training on the Mentice simulator machine. | through study completion, an average of 1 year |
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
cross-sectional study of population who have ANSD

Detailed Description
-----------------
Cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures

Official Title
-----------------
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)

Conditions
-----------------
Auditory Neuropathy

Intervention / Treatment
-----------------
* Diagnostic Test: extratympanic electrocochleograhy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level Exclusion Criteria: proportionate ABR to PTA level Proportionate SRS to PTA level presnce ol lesions in CT or MRI

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 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 |
| --- | --- |
| case group<br>age between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT | Diagnostic Test: extratympanic electrocochleograhy<br>* electrophysiological test<br>* Other names: EchoG;|
| control group<br>age and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD | Diagnostic Test: extratympanic electrocochleograhy<br>* electrophysiological test<br>* Other names: EchoG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of site of lesion of ANSD | differentiation between presynaptic and postsynaptic types of ANSD | one and half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
auditory neuropathy
Nurse Graduateness and Patient Outcomes: a Cross Sectional Pilot Study

Study Overview
=================
Brief Summary
-----------------
This research project is relevant to the identification of the relationship, and its significance, between patient morality and a number of demographic, clinical and corporate characteristics. Two separate data sets have been compiled linking the existing intervention and employment data, one focusing on the admitting nurse and another one considering all the nurses involved in each intervention. Several statistical experiments will take place to support or reject the main hypothesis: higher nurse education, satisfaction and staffing levels result to lower patient mortality.

Detailed Description
-----------------
The primary research objective is to investigate the relationship between the education, satisfaction and staffing level of the nurses and the mortality rate across HMC. The relationship between mortality will be investigated against some additional demographic characteristics of the patient and the nurses as well as a umber of clinical parameters like the length of stay and the severity of the interventions. To achieve that data will be retrospectively collected from the Human Resources database containing the nurse education and demographic information and will combine it to the intervention data coming from the clinical information systems of all major public hospitals in Qatar excluding accident and emergency cases to avoid confounding. Rigorous statistical analysis will be conducted to obtain the significance of this relationship within expected confidence intervals. The end result of that process is to find whether there is a significant positive or negative relationship between nurse education and mortality rate. For confounding purposes Accident and Emergency data have been excluded, we have performed several adjusted and unadjusted Logistic Regression tests and taking into consideration the clustering effect of the data.

Official Title
-----------------
Nurse Graduateness and Patient Outcomes: a Cross Sectional Pilot Study

Conditions
-----------------
no Spedific Condition, All-cause In-patient Mortality

Intervention / Treatment
-----------------
* Other: all admissions except accident and emergency


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Accident and emergency patients Records with negative length of stay Records with incorrect patient demographics
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: all admissions except accident and emergency|No additional intervention, retrospective study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause In-Patient Mortality |  | 6 months |