linjc16/ctgov huggingface dataset:
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales

Study Overview
=================
Brief Summary
-----------------
This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.

Official Title
-----------------
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment

Conditions
-----------------
Cerebral Venous Sinus Thrombosis, CSF Pressure Increased, Papilledema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month Exclusion Criteria: unable to complete examinations unable to complete follow-ups
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline CSF pressure | CSF pressure at baseline | baseline | 
| baseline mRS | mRS at baseline | baseline | 
| baseline papilledema grade | Frisen grade of papilledema at baseline | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline NIHSS | NIH Stroke Scale at baseline | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral venous sinus thrombosis, CSF pressure, modified Rankin Scale, papilledema, NIHSS
Trehalose Administration in Subjects With Spastic Paraplegia 11 (3AL-SPG11)

Study Overview
=================
Brief Summary
-----------------
Hereditary spastic paraparesis type 11 (SPG11) is caused by mutations in the SPG11 gene that produces spatacsin, a protein involved in lysosomal function.

Detailed Description
-----------------
Several experiments on subjects affected by neurodegenerative diseases with dysfunction of the autophagic-lysosomal system show that trehalose improves the pathological phenotype. This evidence indicates that trehalose could be used in patients with SPG11 to try to prevent the accumulation of glycosphingolipids at the lysosomal level and induce the genesis of new lysosomes. This study aims to record clinical data of 20 patients with SPG11 who take trehalose during 12 months.

Official Title
-----------------
An Observational Study in Subjects With Spastic Paraplegia Type 11 Taking Trehalose

Conditions
-----------------
Hereditary Spastic Paraplegia, Spastic Paraplegia Type 11

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of SPG11 Written signed informed consent Exclusion Criteria: Diagnosis of other concomitant neurodegenerative diseases taking other experimental drugs within 30 days of the first Study visit (T0) and during the study Refusal to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
| Changes from baseline in Spastic Paraplegia Rating Scale (SPRS) at 6 and 12 months | Assess changes in score of the Spastic Paraplegia Rating Scale (SPRS) over ± 10% | At baseline, month 6, month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glycosphingolipids and gangliosides plasmatic levels | Assess changes in glycosphingolipids and gangliosides plasmatic levels over ± 10% | At baseline, month 6, month 12 |
Evaluation of Pain Following Scoliosis Surgery.

Study Overview
=================
Brief Summary
-----------------
The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.

Official Title
-----------------
Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL

Conditions
-----------------
Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Procedure: posterior surgery for spinal arthrodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescent from 10 to 18 years of age idiopathic scoliosis posterior surgery for spinal arthrodesis non opposition children and parents Exclusion Criteria: complication following surgery needing reoperation secondary intervention anterior surgery non idiopathic scoliosis

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: posterior surgery for spinal arthrodesis|posterior surgery for spinal arthrodesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for pain (EVA) | The assessment criteria used is the numerical pain scale from 0 to 10(0 = no pain, 10 = extremely painful | 3 days after inclusion |
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fed conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fed Conditions

Conditions
-----------------
Herpes

Intervention / Treatment
-----------------
* Drug: famciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: famciclovir|500 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment of herpes
A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to determine if different dosage regimens of Sinemet® CR (Carbidopa/levodopa) are dose proportional

Official Title
-----------------
An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Sinemet® controlled release (Carbidopa/levodopa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion and exclusion criteria for healthy volunteers will be used Males and females aged 50-75

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sinemet® controlled release (Carbidopa/levodopa)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Insecticidal School Uniforms for Dengue Prevention in Thailand

Study Overview
=================
Brief Summary
-----------------
This is a randomised controlled trial that will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. A double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.

Official Title
-----------------
Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand

Conditions
-----------------
Dengue

Intervention / Treatment
-----------------
* Other: permethrin insecticide
* Other: washing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pupils in participating schools Exclusion Criteria: skin sensitivity, exema

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal school uniforms<br>washing only | Other: washing<br>* normal washing of school uniforms, without permethrin insecticide impregnation<br>|
| Experimental: insecticide-treated school uniforms<br>washing and insecticide treatment | Other: permethrin insecticide<br>* commercial permethrin insecticide impregnation of clothing before transmission season<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children | Schools are cross-over randomised to insecticide-treated or untreated (placebo) school uniforms, and so the primary outcome is the rate-ratio of dengue fever cases in school children, compared between these two groups. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dengue
Simple Preparation of Endotracheal Tube

Study Overview
=================
Brief Summary
-----------------
To observe the effect of additional E-tube angulation on intubation time and success rate.

Detailed Description
-----------------
The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.

Official Title
-----------------
Simple Preparation of Endotracheal Tube for Optimal Angulation During Intubation: A Randomized Controlled Trial

Conditions
-----------------
Endotracheal Tube

Intervention / Treatment
-----------------
* Other: Curved-tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation Exclusion Criteria: Patients with congenital or acquired upper airway lesions Patients with high risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curved-tube<br>Giving additional curve to the endotracheal tube by simple preparation. | Other: Curved-tube<br>* Connecting both ends of the endotracheal tube (O shape) for 5-min and releasing it provides additional anterior angle temporarily.<br>|
| No Intervention: Control<br>No other manipulation of the endotracheal tube is done. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful intubation on first attempt | Whether successful intubation is done on first attempt or on additional attempt | On endotracheal intubation up to 1 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubate (TIT) | The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace | On endotracheal intubation up to 1 min |
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of having a case manager help PHAs access and use health, social services and practical resources that are helpful to their needs as compared to the usual more PHA self-managed approach of deciding and using services as they see necessary. New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce Regions who consent to this study will be randomized to receive their usual self-directed supportive, educational, medical and medical care services when they seek assistance according to their needs or these usual services augmented by case management services. They will be measured before randomization and at 3, 6 and 12 months following service use for their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement in quality of life, psychological distress, risk behaviours and expenditures for the use of a range of publicly funded services.

Official Title
-----------------
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS (PHAs): The Comparative Impact on Quality of Life, Access to and Expenditures for All Health and Social Services

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Behavioral: strengths-based case managed proactive service model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive individuals living in the community setting Exclusion Criteria: cognitive impairment

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: strengths-based case managed proactive service model|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk behavior, quality of life, health and social service utilization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression, satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
people living with HIV, quality of life
Family Experience of Home Opioid Use After Pediatric Surgery

Study Overview
=================
Brief Summary
-----------------
A systematic review examining outpatient opioid use identified only three pediatric studies published between 2015 and 2016. Of these three, two studies had a short-term follow up with patients at three days after discharge; moreover, these three studies were limited by focusing on one surgical population, restriction of data to 0-12 yr old participants, and the other being a brief report. As a result, there are no pediatric studies that have examined opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after discharge.

Detailed Description
-----------------
This study is being done to learn how long children (0-18 yrs) needed to use the prescribed opioid medication for and how families can be better prepared to provide adequate and safe pain management at home. Follow up will take place 28 days after discharge from the hospital.

Official Title
-----------------
Family Experience of Home Opioid Use After Pediatric Surgery: a Pilot Study

Conditions
-----------------
Pain Management

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families are filling a prescription for opioid medications at Shoppers Drug Mart at The Hospital for Sick Children Parent has strong command of the English language (i.e., no interpreter required) Exclusion Criteria: Child has used opioid medication at home within 6 months before the date of their surgical procedure Child has history of chronic pain Child is being discharged to a rehabilitation facility anticipated

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 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 |
| --- | --- | --- |
| Questionnaire on Opioid use | Questionnaire on how families provide adequate and safe pain management at home | 28 days following discharge from hospital |
Phase 2 Study of Darbepoetin Alfa Extended Dosing

Study Overview
=================
Brief Summary
-----------------
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.

Official Title
-----------------
A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia

Conditions
-----------------
Pre-Dialysis

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 18 years of age CRI with a creatinine clearance of greater than 15 but less than 40 mL/min Stable once every other week darbepoetin alfa SC for at least 6 weeks Hb values during screening / baseline of 10.0 - 12.0 g/dL Serum B12 and folate levels above the lower limit of normal and iron replete Exclusion Criteria: Receiving renal replacement therapy Uncontrolled hypertension Hyperparathyroidism Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive Current malignancy Pregnant or breast-feeding

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: darbepoetin alfa<br> | Drug: darbepoetin alfa<br>* starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks |  | Study weeks 21 - 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks. |  | Entire study |
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study

Study Overview
=================
Brief Summary
-----------------
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?

Official Title
-----------------
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study

Conditions
-----------------
Pertrochanteric Hip Fracture

Intervention / Treatment
-----------------
* Procedure: Short versus long cephalomedullary Intramedullary nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria AO/OTA fracture classification 31(A-B) (1-3). Age greater than 18 years old. Exclusion Criteria -Less than 18 years old.

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 |
| --- | --- |
| Active Comparator: Short nail implant<br>used to treat pertrochanteric fractures | Procedure: Short versus long cephalomedullary Intramedullary nail<br>* Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.<br>|
| Active Comparator: Long nail implant<br>used to treat pertrochanteric fractures | Procedure: Short versus long cephalomedullary Intramedullary nail<br>* Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF (short form)-36 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 3 months |