linjc16/ctgov huggingface dataset:
Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

Study Overview
=================
Brief Summary
-----------------
Purpose: In a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.

Detailed Description
-----------------
Methods. In the developing study, three variables were found as predictors of mayor outcomes and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of daytime sleepiness as quantified by the Epworth questionnaire and the presence of current cardiovascular disease. The index (OSA-SCORE) has a value between 0 (less risk) to 5 (more risk). For each point, a significant increment in the risk of death was found. In the retrospective validation study, a number of potential variables will be recorded, all of them also predictors of major outcomes. Data will be recorded by trained personnel on-site at the respiratory Sleep Units around the country. The final cohort will include 1100 subjects aged > 18 years . The observation time will be considered since the time at diagnosis to fatal event and the patient will be censored when non-invasive ventilation was started or at the recorded time if the patient is alive. The primary outcome is all-cause death.

Official Title
-----------------
Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

Conditions
-----------------
Snoring, Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients (> 18 years) Exclusion Criteria: Under 18 years old Unable to complete sleep study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing sleep study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events |  | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
snoring, sleep apnea, sleep study, cardiovascular outcomes
Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Study Overview
=================
Brief Summary
-----------------
Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. There have been isolated case reports of patients with childhood ALL who developed LPD after ALL diagnosis, without undergoing stem cell transplantation, but data regarding such cases are limited. We propose here an international collaboration, to form a comprehensive database of children who developed LPD after diagnosis of acute lymphoblastic leukemia/lymphoma

Detailed Description
-----------------
Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. These disorders have been extensively described in the post-transplant setting, ie after hematopoietic stem cell (SCT) or solid organ (SOT) transplant. However, since the 1980's, there have been isolated case reports of patients with childhood ALL, who developed LPD after diagnosis of ALL, without undergoing SCT. Comprehensive information is unavailable regarding the prevalence, clinical manifestations, treatment, outcome and pathogenesis of such disorders in this setting. We propose here an international collaboration, to form a comprehensive database of children who developed LPD during the treatment of acute lymphoblastic leukemia/lymphoma (ALL/LBL). Information will be collected in a de-identified fashion regarding patient characteristics, leukemia and LPD characteristics, treatment and outcome. The aims of this retrospective study are: To build a database of children who developed LPD after diagnosis of ALL/LBL To investigate the characteristics and outcome of this disorder

Official Title
-----------------
Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Conditions
-----------------
Childhood Leukemia and Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed LPD after ALL/LBL diagnosis Exclusion Criteria: age>30 years

Ages Eligible for Study
-----------------
Maximum Age: 30 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 |
| --- | --- | --- |
| Probability of survival | Assess six-month probability of survival since LPD diagnosis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | Assess 5-year event-free survival since acute lymphoblastic leukemia/lymphoma diagnosis | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EBV, childhood leukemia, lymphoproliferative disorders
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

Official Title
-----------------
Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: Expedial Vascular Access Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has chronic renal failure and requires vascular access for hemodialysis Patient has given informed consent to participate in the trial and is willing to comply with the study protocol Patient is male or female, 18 years of age or older The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm) Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center Patient has a vein 4 mm or larger to which the graft can be anastomosed Exclusion Criteria: Patient is unable to comply with the study follow-up Patient has a known sensitivity to polyurethane or porcine heparin Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available Patient has an immunodeficiency syndrome Patient has a prior history of bacterial infection within 8 weeks of implantation of graft Patient has a severe coagulation disorder Patient has an elevated platelet count of greater than 1 million Patient has a history of heparin-induced thrombocytopenia syndrome (HIT) Patient is pregnant Patient has a fever greater than 100 degrees Fahrenheit

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Expedial Vascular Access Graft|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary or assisted primary patency at 1 year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency |  |  | 
| Overall adverse event rate |  |  | 
| Time to first access |  |  | 
| Time to hemostasis following needle withdrawal after dialysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular access graft, hemodialysis, dialysis, end stage renal disease
Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

Study Overview
=================
Brief Summary
-----------------
The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. A target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to 22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile RTI-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.

Official Title
-----------------
Effectiveness and Costs of Combined Influenza and Pneumococcal Vaccination in Pre-School Children With Recurrent Respiratory Tract Infections (RTI): a General Practice-Based Randomized Controlled Trial

Conditions
-----------------
Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

Intervention / Treatment
-----------------
* Biological: trivalent inactivated influenza vaccine
* Biological: combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-72 months A history of two or more episodes of general practitioner attended RTIs Exclusion Criteria: No intention to move within 12 months to another region Provision of informed consent Good mastering of the Dutch language Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.) No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 72 Months

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trivalent inactivated influenza vaccine|nan|
|Biological: combined heptavalent pneumococcal conjugate vaccine and trivalent inactivated influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of febrile RTI-episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity and length of febrile RTI-episodes as well as medical consumption |  |  |
Paracetamol Toxicity in Septic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes to look for potential toxicity.

Detailed Description
-----------------
Paracetamol is metabolized in liver using the glutathione system. This detoxification system is depressed during severe illness such as sepsis, trauma etc. The study will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. We believe that during sepsis, paracetamol metabolites are not fully detoxified and therefore are toxic to the patient. Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione (as a surrogate marker for liver glutathione), liver enzymes and various clinical data (such as length of hospitalization) to look for a potential toxicity.

Official Title
-----------------
Paracetamol-induced Liver Toxicity in Septic Patients

Conditions
-----------------
Fever, Sepsis

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: dypirone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18y hospitalized to int. med. dept. or ICU body temp>38 and one or more from the following: pulse>90 bpm resp. rate>20/min or PaCO2<32 mmHg WBC>12000 or <4000 one of the following: hypotension disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.) Exclusion Criteria: acute / chronic liver disease acute CNS disorder current isoniazid treatment alcoholism active malignancy pregnancy TPN or PPN

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol treatment<br> | Drug: paracetamol<br>* 1 gr of paracetamol PO/PZ/PR<br>* Other names: acetaminophen, acamol;|
| Active Comparator: control- dypirone treatment<br> | Drug: dypirone<br>* 1 gr PO/PZ/PR/IM<br>* Other names: optalgin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| paracetamol induced liver toxicity | defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line | every six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fever in severe sepsis
Hypertonic Saline as Therapy for Pediatric Concussion

Study Overview
=================
Brief Summary
-----------------
This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury. The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline. The null hypothesis was that there would be no difference in change of reported pain in either group.

Official Title
-----------------
Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Hypertonic Saline
* Other: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-17 years old consent obtained pain as a symptom of concussion head CT negative for intracranial pathology Exclusion Criteria: younger than 4 years or older than 17 years multi trauma cardiac, neuro, renal history of disease seizure narcotic, drug use pregnancy head CT with traumatic intracranial pathology no consent

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Normal Saline<br> | Other: Normal Saline<br>* intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour<br>* Other names: NS;|
| Experimental: Hypertonic Saline<br> | Drug: Hypertonic Saline<br>* intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour<br>* Other names: HTS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included. | Following therapy to 2-3 days post discharge |
The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.

Official Title
-----------------
Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Calcitriol
* Drug: Alfacalcidol
* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer older than 20 years Exclusion Criteria: Subjects with bone and mineral metabolism disorders Subjects with kidney or liver diseases Subjects with uncorrectable hypercalcemia or hypocalcemia Subjects with chronic gastrointestinal disorders or malabsorption Subjects taking medication related to bone loss

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control<br>Placebo control | Drug: Placebo<br> <br> |
| Active Comparator: Cholecalciferol 1000IU<br>Cholecalciferol 1000IU qd for 8 weeks | Drug: Cholecalciferol<br> <br> * Other names: DicamaxD;|
| Experimental: alfacalcidol<br>alfacalcidol 0.5ug qd for 8 weeks | Drug: Alfacalcidol<br> <br> * Other names: Onealfa;|
| Experimental: Calcitriol<br>Calcitriol 0.25ug qd for 8 weeks | Drug: Calcitriol<br> <br> * Other names: Calcio;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum sclerostin level |  | 8 weeks later | 
| Change of serum Dickkopf1 level |  | 8 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum c-telopeptide level |  | 8 weeks later | 
| Change of serum bone-specific alkaline phosphatase level |  | 8 weeks later | 
| Change of serum calcium level |  | 8 weeks later | 
| Change of serum parathyroid hormone level |  | 8 weeks later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Serum sclerostin, Serum dickkopf1
Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.

Detailed Description
-----------------
The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study

Official Title
-----------------
Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Other: CT radioraphic assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1 Informed Consent Exclusion Criteria: Hypersensitivity to i-FACTOR Bone Graft Devices Adult Spinal deformity, Spinal Cord Injury Infection Compromised renal function

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-Factor Arm<br>All patients undergoing spine fusion surgery will be treated with i-FACTOR | Other: CT radioraphic assessment<br>* CT radioraphic assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| index segment revision | Reintervention rate at index segment | 12-months post-operative |