louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06233630: Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty
Official title: Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Arthritis
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty

Detailed description: Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA classification I-III,
* Aged 20-100 years,
* scheduled for knee arthroplasty under spinal anaesthesia

Exclusion Criteria:

* Patients who have a history of bleeding diathesis,
* Take anticoagulant therapy,
* have a History of chronic pain before surgery,
* have Multiple trauma,
* cannot assess their pain (dementia),
* have been operated on under general anaesthesia,
* have an infection in the area
* do not accept the procedure

Primary outcomes:
measure: Opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: first need of opiate
timeFrame: 48 hours
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 24 hours postoperatively
measure: PLR
timeFrame: 24 hours postoperatively
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznan University of Medical Science
name: Malgorzata Domagalska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501730: Use of the Quantra QPlus Sytem in Cardiac Surgery
Official title: Utilization of the Quantra QPlus System to Guide the Management of Blood Product Transfusions in Cardiac Surgery Patients: Effects on Clinical and Economic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Cardiac surgery
Quantra
Viscoelastic testing
Coagulation
QPlus
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery performed by the same surgical team.

Brief summary: Single center retrospective study evaluating the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Detailed description: Yavapai Regional Medical Center (YRMC) implemented the Quantra QPlus System to aid in their efforts to effectively reduce the transfusion rate of allogenic blood products and improve outcomes in patients undergoing cardiac surgery. Use of the Quantra to guide decisions related to the use of blood products in cardiac surgery patients began in 2019. In this retrospective study, YRMC evaluated the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Eligibility criteria: * Pre-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from January 2019 to September 2019 (n=64)
* Post-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from May 2020 to April 2021 (n=64)

Primary outcomes:
measure: Blood product utilization
timeFrame: Intraoperative - during surgery
measure: Blood product utilization
timeFrame: Postoperative - after surgery throughout the rest of the hospital stay, assessed up to 30 days
measure: Cost of blood products
timeFrame: Throughout the entire hospital stay, assessed up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Prescott
country: United States
facility: Yavapai Regional Medical Center
state: Arizona
Study officials:
affiliation: Yavapai Regional Medical Center
name: Pierre Tibi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618930: Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation
Official title: Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cleansing Prior Operation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 40
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 patients are assigned by randomisation on one of the two laxatives. After cleansing they have to fill in an evaluation form to report their findings and difficulties. Also the surgeon will be asked to fill in a score-form to report all details concerning the bowel preparation.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Older than 18
* Informed consent signed
* Mode of surgery

Exclusion Criteria:

* Renal disease
* Heart failure
* Dehydration
* Abdominal obstruction
* Abdominal perforation
* Abdominal paralysis
* Toxic megacolon

Primary outcomes:
measure: colorectal cleansing
timeFrame: prior operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT06444230: Effects of Routine Physical Therapy With and Without Neurodevelopmental Technique on GMF, Spasticity and HRQOL in Diplegic CP
Official title: Effects Of Routine Physical Therapy With And Without Neuro-Developmental Technique On Gross Motor Function, Spasticity And Health Related Quality Of Life In Diplegic Cerebral Palsy- A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
gross motor function
neurodevelopmental technique
health realted quality of life
routine physical therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of routine physical therapy with and without neurodevelopmental technique on gross motor function, spasticity and health related quality of life in diplegic cerebral palsy.

Detailed description: The neurological illness known as cerebral palsy is caused by damage to the growing brain and therefore is indicated by anomalies of muscle strength, mobility, and motor functions. Cerebral palsy affects posture, muscle tone, and movement development. Neurodevelopmental technique and routine physical therapy are considered to be effective in treatment of cerebral palsy. This study will investigate the combined effects of neurodevelopmental technique and routine physical therapy versus routine physical therapy on gross motor function, spasticity, and health related quality of life in diplegic cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Patients with an age of 8 to 18 years of both genderswith confirm diagnosis of diplegic cerebral palsy
* Patients could ambulate functionally
* Patients having limited or no prior exposure to NDT
* Individuals with mild to moderate diplegic cerebral palsy, based on established classification scales (GMFM grade I-III)

Exclusion Criteria:

* Patients with other motor or sensory dysfunctions and unable to understand and obey commands
* Patient undergone any orthopedic surgery that was ought to treatspasticity
* Patients with spasticity level 4-5 according to Modified Ashworth Scale
* Patients with Botulinum toxins type A injection within last 6 months

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 9 months
measure: Gross Motor Function Measure
timeFrame: 9 months
measure: Cerebral Palsy Quality of Life Questionnaire for Children and Adolescent
timeFrame: 9 months
Secondary outcomes:
measure: Manual Muscle Testing
timeFrame: 9 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Shehzeena Ashraf
role: STUDY_CHAIR
References:
Clinical trial NCT02124330: Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models
Official title: Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urea Cycle Disorders, Inborn
Other Metabolic Diseases
Keywords: Montmorillonite, proteic diet, in vitro and in vivo models
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
Collaborators: name: University of Trieste
First posted: 2014-04-28
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability.

The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins.

Detailed description: Montmorillonite (MONT) is a phyllosilicate layered mineral; chemically it is hydrated sodium calcium aluminium magnesium silicate hydroxide. Potassium, iron, and other cations are common substitutes and the exact ratio of cations varies with source.

Due to its unique physicochemical properties, such as swelling and cation exchange capability, as well its mechanical and thermal stability, MONT can be efficiently used as matrix for immobilization of proteins with high molecular weight (e.g. Albumin) and proteins with low molecular weight (e.g.Aflatoxines). Therefore, MONT is used for therapeutic purposes, in pharmaceutical formulations and in food preparations. In vitro assays made in our laboratory, showed that MONT absorbs, in stable manner, alimentary proteins: beta-lactoglobulins, alfa lactoalbumines and the ratio MONT-protein (w/w) 1:3, 1:5, 1:15, results in the protein capture of 50, 27, 0 % of proteins respectively.

The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake evaluated with the blood MONT- protein ratio. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins at different ratio (w/w) 1:3, 1:5, 1:15.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning

Exclusion Criteria:

* not defined

Primary outcomes:
measure: Protein uptake evaluated with the blood MONT-protein ratio
timeFrame: before administration and 30, 60, 90, 120 ,180 minutes after
Secondary outcomes:
measure: Protein absorption by MONT in vitro
timeFrame: at time of the trial
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Tarcisio Not, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439330: Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning
Official title: Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TMJ
Apical Periodontitis
Periodontal Inflammation
Retained Tooth
MRI
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
name: Dentsply Sirona Implants and Consumables
First posted: 2022-06-30
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each person has a MRI scan done following the requested radiograph. MRI and radiographs are compared for diagnostic purposes.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study is to show that the use of 0.55T MRI combined with a "dental" coil produces images of sufficient diagnostic value to assess areas of interest in dentistry, and to compare MR images to traditional, dental-oriented radiographic images for diagnostic purposes.


Eligibility criteria: Inclusion Criteria (one of the following):

* referred for CBCT imaging of at least one tooth for endodontic reasons
* referred for intra-oral and/or panoramic imaging covering at least one molar tooth for periodontal reasons
* referred for CBCT imaging of the TMJ (bilaterally)
* referred for panoramic imaging of the third molar (retained/semi-retained, uni- or bilateral), prior to treatment planning
* referred for CBCT imaging prior to implant treatment

Exclusion Criteria:

* younger than 18 years
* unable to give consent
* pregnant
* pronounced claustrophobia
* pacemakers or implanted defibrillators
* metal shrapnel injuries of the eyes or MRI incompatible metallic inclusions or implants large tatoos
* non-removable piercings

Primary outcomes:
measure: Application of a dental-dedicated MRI in the diagnosis of temporomandibular joint disorders, tissue alterations related to third molars, periapical and periodontal inflammatory diseases, and implant treatment planning
timeFrame: 2½ years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: IOOS
Study officials:
affiliation: University of Aarhus
name: Rubens Spin-Neto, ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02181530: Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of routine clinical practice.

Brief summary: This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.


Eligibility criteria: Inclusion Criteria:

* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
* Received at least one injection of OZURDEX® in the study eye

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Secondary outcomes:
measure: Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye
timeFrame: Baseline, Up to 17 Months
measure: Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye
timeFrame: Baseline, Up to 17 Months
measure: Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
measure: Time to Improvement of 2 Lines or More in BCVA in the Study Eye
timeFrame: Baseline, Up to 17 Months
measure: Time to Improvement of 3 Lines or More in BCVA in the Study Eye
timeFrame: Baseline, Up to 17 Months
measure: Time to OZURDEX® Re-Injection in the Study Eye
timeFrame: Up to 17 Months
Other outcomes:
Locations:
city: Warsaw
country: Poland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03887130: Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
Official title: Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 152
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 international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast;
* Documented metastatic disease previously untreated by chemotherapy;
* HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
* Karnofsky Performance Status 70%.

Exclusion Criteria:

* Local relapse alone after conservative treatment or contra-lateral tumor;
* Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
* Concomitant hormonal therapy for metastatic breast cancer;
* Prior chemotherapy in the metastatic setting;
* Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
* Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From Baseline to disease progression or death, up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02593630: Unicirc Adolescent 12-15 Year Old Boys
Official title: Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Circumcision, Male
Lead sponsor: Simunye Primary Health Care
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 54
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Detailed description: Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Eligibility criteria: Inclusion Criteria:

* healthy boys desiring circumcision

Exclusion Criteria:

* current illness
* bleeding disorder
* reaction to local anaesthetic
* infection
* any penile abnormality potentially complicating circumcision

Primary outcomes:
measure: Intraoperative Duration
timeFrame: Intraoperative, 10-15 minutes
Secondary outcomes:
measure: Intraoperative Pain
timeFrame: Time of surgery, approximately 10-15 minutes
measure: Healed at 4 Weeks
timeFrame: At the 4-week followup visit
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Simunye Primary Healthcare
state: Western Cape
Study officials:
affiliation: University of Stellenbosch
name: Norman Goldstuck
role: STUDY_DIRECTOR
References:
citation: Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
Clinical trial NCT02676830: Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 13
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to Evaluation of absorption, metabolism, and excretion of \[14C\]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.
* Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.

Exclusion Criteria:

* Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
* Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.

Primary outcomes:
measure: Area under the plasma-concentration time curve to last measured time point
timeFrame: 336 hours post-dose
measure: Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
timeFrame: 336 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
References: