louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00318227: Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients
Official title: Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Coronary Artery Bypass Surgery
Keywords: Postoperative care
Cardiac Surgery
Blood Transfusion
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 73
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.

Two postoperative transfusion strategies:

1. Liberal - transfused when Hgb is \<100g/L
2. Restrictive - transfused when Hgb is \<70g/L


Eligibility criteria: Inclusion Criteria:

* Patients \>=70 years of age undergoing non-emergency coronary artery bypass surgery
* Initial postoperative hemoglobin level 70-90g/L

Exclusion Criteria:

* Patients who are unable to provide informed consent in English
* Patients with preoperative hemoglobin concentrations \<100g/L
* Patients who require emergency re-operation
* Patients with intraoperative or postoperative bleeding diathesis
* Patients with postoperative clinical instability (eg. low output state)
* Patients in whom insertion of an intra-aortic balloon pump is required

Primary outcomes:
measure: Distance walked during 6 minute walk test at 5 weeks postop
timeFrame: 5 weeks
Secondary outcomes:
measure: renal failure, hospital length of stay, Quality of Life questionnaire
timeFrame: during hospital stay
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
Study officials:
affiliation: London Health Sciences Centre/University of Western Ontario
name: Mary Lee Myers, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre/University of Western Ontario
name: Robin Varghese, MD MS FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01388127: Minocycline Treatment in Acute Hemorrhagic Stroke
Official title: Minocycline Treatment in Acute Hemorrhagic Stroke for Evaluation of Treatment Efficacy and Blood Brain Barrier Permeability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poor Performance Status
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 patients after acute hemorrhagic stroke. Half treated with Minocycline.

Brief summary: The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Detailed description: Minocycline, a semisynthetic second generation derivative of tetracycline, was shown to have a clear beneficial neuroprotective effect in animal models of multiple sclerosis, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Animal models provide promising evidence of minocycline's ability to improve outcomes in an animal stroke model.

In light of these findings, we will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Eligibility criteria: Inclusion Criteria:

* Patients with acute hemorrhagic stroke

  1. age \> 18
  2. NIHSS score \> 5
  3. onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

1. Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension
2. pre-existing neurological disability
3. known allergic response to tetracyclines
4. acute or chronic renal failure
5. pre-existing infectious disease requiring antibiotic therapy
6. swallowing difficulties

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Edith Wolfson Medical Center
name: Yair Lampl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04291027: Aquatic Group Exercise for People With Parkinson Disease
Official title: Comparison of Aquatic and Land-based Group Exercise for Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ithaca College
Sponsor class: OTHER
Collaborators: name: Parkinson's Foundation
First posted: 2020-03-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Participants will be randomized to participate in a land based or aquatic based group exercise program 2 times per week for 12 weeks. Prior to and after participation, balance, walking, quality of life, and balance confidence will be measured by a blinded examiner.


Eligibility criteria: Inclusion Criteria:

* adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease.
* stable dose of levadopa medication for 30 days prior to study initiation
* able to walk 20 feet without physical assistance
* a referral from a physician to participate in physical therapy

Exclusion Criteria:

individuals with:

* uncontrolled cardiovascular or pulmonary conditions
* deep vein thrombosis in the last 6 months
* the use of breathing tube or feeding tube
* those with an extreme fear of exercising in the water
* an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease
* a musculoskeletal condition that would impact their ability to participate in the exercise group
* cognitive impairment (a score of less than 24/30 on the Mini Mental Status Examination)

Primary outcomes:
measure: Change in Mini-BESTest Score
timeFrame: Prior to intervention, after 12 week intervention
measure: Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
timeFrame: Prior to intervention, after 12 week intervention
measure: Change in Gait Speed
timeFrame: Prior to intervention, after 12 week intervention
Secondary outcomes:
measure: Change in Parkinson Disease Questionnaire-39 (PDQ-39)
timeFrame: Prior to intervention, after 12 week intervention
measure: Change in Falls Efficacy Scale-International.
timeFrame: Prior to intervention, after 12 week intervention
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Ithaca College
state: New York
Study officials:
References:
Clinical trial NCT00212927: Continuity of Care and Outcomes After Discharge From Hospital
Official title: The Association of Provider Continuity and Information Continuity With Patient Outcomes After Discharge From Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 5900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 1. INTRODUCTION: Continuity of care (COC) occurs when separate elements of patient care are connected. COC is made up primarily of Continuity of Provider (COP) and Continuity of Information (COI). Many authorities believe that COC is essential to high-quality care. Previous studies have shown poor COC in varied populations. Many studies have shown that increased COC has been associated with improved intermediate outcomes. However, no study has definitively determined whether COC or either of its components is associated with important outcomes. The Ontario-Outcomes After the Hospitalization (Ontario-OAtH) study will enroll 5900 adults who are discharged to the community from medical and surgical services from 13 teaching and community hospitals in 5 regions across Ontario. Patients will be followed for 6 months to record details about all interactions with the health care system. This information will give us a detailed measure of both provider and information continuity for all patients over time. The Ontario-OAtH study will have the power to precisely determine whether COC is associated with time to urgent readmission or death after hospital discharge. Since COC is potentially modifiable, the Ontario-OAtH study will give us essential information required for designing interventions to improve outcomes for patients after they are discharged from hospital.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* discharged to the community from medical and surgical services

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute
state: Ontario
Study officials:
affiliation: OHRI
name: Carl Van Walraven, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799227: Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Vitrectomy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with diabetic macular edema
* History of vitrectomy
* Central retinal thickness ≥ 275 µm
* Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

* Known anticipated need for ocular surgery during the study period
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known allergy to the study medication
* Known steroid-responder
* Use of systemic steroids
* Female subjects that are pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Change From Baseline in Central Retinal Thickness in the Study Eye
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 26
measure: Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
timeFrame: Baseline, Week 26
measure: Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Charlotte
country: United States
state: North Carolina
city: Sydney
country: Australia
state: New South Wales
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
Clinical trial NCT06528327: Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible
Official title: Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Diabetes Mellitus, Type 2
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split Mouth Design
Primary purpose: TREATMENT

Brief summary: Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Adequate interproximal space.
* Adequate interocclusal space.
* Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.
* Both genders.
* Controlled medical condition

Exclusion Criteria:

* Presence of parafunctional dependency as bruxism.
* Adjacent pathosis near the implant site.
* Patient under radiotherapy targeting the head and neck.
* Heavy smokers.

Primary outcomes:
measure: change in implant stability
timeFrame: up to 4 months
measure: change in pain intensity
timeFrame: 1st,3rd, and 7th days
measure: Wound Healing score
timeFrame: 1st,3rd, and 7th days,14th day
Secondary outcomes:
measure: Post operative complications
timeFrame: 6 months
measure: Change in bone density
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02465827: Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty
Official title: Selective Blocks for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthroplasty, Total
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.

Detailed description: A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists' physical classification I-III
2. Age ≥ 18 years undergoing primary unilateral total knee arthroplasty

Exclusion Criteria:

1. Inability to cooperate
2. Inability to speak and understand Danish
3. Allergy to any drugs used in the study
4. Drug or alcohol abuse
5. Pregnancy or nursing
6. Opioid abusers

Primary outcomes:
measure: Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
timeFrame: 24 hours
Secondary outcomes:
measure: Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively
timeFrame: 24 hours
measure: Total opioid consumption
timeFrame: 24 hours
measure: Nausea and vomiting
timeFrame: 24 hours
measure: Time to first mobilization
timeFrame: 24 hours
measure: Length of stay in recovery and hospital
timeFrame: 72 hours
measure: Number of clinical complications
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05890027: Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
Official title: Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ptosis, Eyelid
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation.
* Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution.
* Individuals who can tolerate eye-drop medications.
* Individuals who are physically able to take a tangent screen visual field test.
* Age: Adults who can comprehend the instructions and procedures (18+ years old)

Exclusion Criteria:

- This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.

* This study will not include participants who refuse to consent.
* This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects).
* This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution.
* Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease
* This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors

Primary outcomes:
measure: Change in ptosis as measured by the tangent screen visual field test
timeFrame: Baseline, 60 minutes
measure: Change in ptosis as measured by the margin to reflex distance 1 (MRD1)
timeFrame: Baseline, 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Sara T Wester, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403527: Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
Official title: Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Puncture for Safe Atrial Fibrillation Ablation
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 1836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, prospective, randomized, interventional, multicenter trial
Primary purpose: DIAGNOSTIC

Brief summary: To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria

  1. Age ≥18 years
  2. Signed written informed consent
  3. Planned transvenous catheter ablation procedure for AF or left atrial tachycardia
  4. Willingness to participate in follow-up

Exclusion Criteria

1. Patient is unable or unwilling to provide informed consent
2. Planned/required arterial access (e.g. for blood pressure monitoring)
3. Patient has contra-indication to oral anticoagulation
4. Known coagulation disorder or Thrombocytopenia \<150.000/ul.

6. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \< 1%), 7. Patient is included in another clinical trial 8. Inability to comply with the study procedures

Primary outcomes:
measure: occurrence of venous access site complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Boris Schmidt
state: Hessen
Study officials:
affiliation: CCB
name: Neda Tarighi, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04440527: Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
Official title: Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.

Detailed description: The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Primary open angle glaucoma or pseudoexfoliation glaucoma
* medically uncontrollable intraocular pressure or intolerance of topical therapy
* negative urine/serum pregnancy test of women in childbearing age
* signed and dated informed consent

Exclusion Criteria:

* previous incisional glaucoma procedure on affected eye
* pregnancy, nursing period
* Patients in military service, training periods and civil service
* Participation in another clinical trail
* pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva

Primary outcomes:
measure: Difference in intraocular pressure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References: