louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00977769: Carbetocin Versus Oxytocin and Hemodynamic Effects
Official title: Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effects of; Anesthesia, in Pregnancy
Keywords: cesarean delivery
blood pressure
cardiac output
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Detailed description: Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women for planned cesarean section

Exclusion Criteria:

* Bleeding disorders
* Placenta disorders

Primary outcomes:
measure: Cardiac Output
timeFrame: 2.5 minutes
measure: Arterial Blood Pressure
timeFrame: 2.5 min
Secondary outcomes:
measure: Bleeding
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet
city: Oslo
country: Norway
facility: Division of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: Oslo University Hospital
name: Leiv Arne Rosseland, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.
citation: Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.
Clinical trial NCT03723369: The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.
Official title: The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatologic Disease
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Androgenetic alopecia is the most common type of hair loss in men, and affects approximately 50 percent of Caucasian men by age 50. The condition is characterized by the progressive loss of terminal hairs on the scalp in a characteristic distribution. The anterior scalp, mid scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. "Male balding" and "male pattern hair loss" are additional terms used to refer to this condition.

The aim of this study is to investigate the effect of microneedling in androgenic alopecia


Eligibility criteria: Inclusion Criteria:

- androgenic alopecia patients

Exclusion Criteria:

* infection, immune disorder, other dermatosis in treating areas

Primary outcomes:
measure: hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).)
timeFrame: 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ShinKongHospital
Study officials:
References:
Clinical trial NCT00175669: Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Official title: Randomized Controlled Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Toe Walking
Keywords: Randomized control trial; placebo-control study
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of Botox and casting to placebo and casting for reducing toe walking problems in children who are idiopathic toe walkers.

Detailed description: Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking will be eligible for the study.

Eligibility criteria: Inclusion Criteria:

* Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking
* Clinical toe walkers - toe walkers as per gait lab's definition (loss of 1st ankle rocker, early heel rise \[prior to 30% of the cycle\] and A1 kinematic data)
* Aged 5 - 15 years old
* Parents and patients educated about protocol and willing to partake
* Cooperative patient with gait analysis and injection

Primary outcomes:
measure: The primary outcome will be based on gait analysis data - specifically whether post injection gait analyses show a reduction in the features that were used to determine the severity of the subjects' toe walking problem.
timeFrame: Data not known
Secondary outcomes:
measure: Ankle range of motion (dorsiflexion and plantarflexion)
timeFrame: collected at every visit
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital, Department of Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Christine Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06561269: Multifidus Plane Block Versus Caudal Block for Hypospadias
Official title: Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypospadias
Caudal Block
Keywords: Hypospadias
caudal block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 30
Sex: MALE
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

Detailed description: Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.

Eligibility criteria: Inclusion Criteria:

* ⦁ Children aged (1 -7) years old.

  * All patients will be of ASA classification I, II physical status

Exclusion Criteria:

* ⦁ Parents refusing to participate are excluded from the trial.

  * Children who had spinal anomalies, altered mental status.
  * A history of developmental delay.
  * Blood diseases: Coagulopathy or anaemia.
  * Infection at the site of injection.
  * Drug allergy.

Primary outcomes:
measure: is to measure the first time to rescue analgesia postoperative (24 hours).
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Heart rate
timeFrame: start to end of surgery
measure: Blood pressure
timeFrame: start to end of the surgery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00694369: A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Official title: A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Dental Pain
Keywords: Postoperative Dental Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 588
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 purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.


Eligibility criteria: Inclusion Criteria:

* Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
* Patients must be experiencing moderate to severe pain following the dental procedure

Exclusion Criteria:

* Previous molar extraction within the past 45 days
* Personal or family history of an inherited bleeding disorder
* Uncontrolled high blood pressure

Primary outcomes:
measure: Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
timeFrame: Over the first 6 hours post the initial Day 1 dose of the study medication
Secondary outcomes:
measure: Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
timeFrame: At 24 hours post the initial Day 1 dose of the study medication
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.
Clinical trial NCT03208569: Anticholinergic Burden - Treatment Optimization
Official title: Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticholinergics
Cognitive Function
Keywords: anticholinergic
alzheimer
cognition
MMSE
anticholinergic cognitive burden scale
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Angelholm Hospital
First posted: 2017-07-05
Enrollment: 665
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm

Brief summary: There is increasing evidence that medications with anticholinergic effects may adversely affect cognitive function. Older adults are particularly sensitive to anticholinergic effects because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking one or more medicines with anticholinergic properties is referred to as anticholinergic burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic Cognitive Burden scale (2008). The objective of this study is to measure the association between the use of medications with anticholinergic properties (identified by the ACB scale) and cognitive performance. Anticholinergic use and cognitive performance will be measured at baseline and 6-months follow-up.


Eligibility criteria: Inclusion Criteria:

* 50 years and older

Primary outcomes:
measure: Cognitive function
timeFrame: 6 months
Secondary outcomes:
measure: Anticholinergic burden
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
Other outcomes:
Locations:
city: Ängelholm
country: Sweden
facility: Specialistminnesmottagningen
Study officials:
affiliation: Region Skåne
name: Per Johansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rube T, Ecorcheville A, Londos E, Modig S, Johansson P. Development of the Swedish anticholinergic burden scale (Swe-ABS). BMC Geriatr. 2023 Aug 25;23(1):518. doi: 10.1186/s12877-023-04225-1.
Clinical trial NCT00071669: Acupuncture as a Supplemental Treatment for Bipolar Depression
Official title: Adjunctive Acupuncture as a Treatment for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Mood Disorder
Acupuncture
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of Bipolar Depression.

Detailed description: Patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication. Patients are randomly assigned to receive either acupuncture designed to relieve symptoms of depression or acupuncture designed to relieve some other legitimate physical condition. A comparison group of patients who take medication but do not receive acupuncture is assessed to evaluate the effectiveness of medication alone. Patients participate in clinical assessment each week, which includes visiting with a psychiatrist and completing symptom rating scales.

Eligibility criteria: Inclusion Criteria:

* Meet DSM-IV criteria for bipolar I disorder or bipolar II disorder
* Demonstrate symptoms of depression as determined by a minimum score of 25 on the Inventory for Depressive Symptoms-Clinician Rated Scale
* Have taken stable psychoactive medications for at least 30 days prior to study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Bipolar Disorder Clinic and Research Program
state: Texas
Study officials:
References:
citation: Dennehy EB, Schnyer R, Bernstein IH, Gonzalez R, Shivakumar G, Kelly DI, Snow DE, Sureddi S, Suppes T. The safety, acceptability, and effectiveness of acupuncture as an adjunctive treatment for acute symptoms in bipolar disorder. J Clin Psychiatry. 2009 Jun;70(6):897-905. doi: 10.4088/JCP.08m04208. Epub 2009 May 5.
Clinical trial NCT05774769: Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
Official title: Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Mitral Valve Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a degenerative mitral valve disease in whom regurgitation occurred in commissural position, hence were treated with a commisural edge to edge surgery

Brief summary: Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.


Eligibility criteria: Inclusion Criteria:

* Adult patients;
* Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
* Patients operated on with median sternotomy or left minithoracotomy;
* Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
* Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.

Exclusion Criteria:

* Patients underwent a mitral valve replacement

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of 14,5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT04368169: The Effects of an Aromatic Botanical Extract on Respiratory Health.
Official title: The Effects of an Aromatic Botanical Extract on Respiratory Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Health
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized, double blind, placebo controlled, intervention study evaluating the effect of an aromatic botanical extract on overall respiratory health among otherwise healthy adults.

Detailed description: After being informed about the study and providing informed consent, patients with respiratory complaints will be randomized into a double blind placebo controlled trial of the botanical extract.

Eligibility criteria: Inclusion Criteria:

* age: 18-60 years
* currently experiencing respiratory symptoms
* otherwise healthy

Exclusion Criteria:

* underlying respiratory conditions
* pregnant, breastfeeding, or trying to conceive
* tobacco use in the home
* allergies to any of the ingredients

Primary outcomes:
measure: Change from baseline on the 44-part Wisconsin Upper Respiratory Symptom Survey (WURSS-44) at day 3.
timeFrame: Baseline and Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin School of Integrative Health Sciences
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: Jessie H Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01336569: Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol
Official title: Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Primary Open-Angle Glaucoma
Ocular Hypertension
Pigment Dispersion Glaucoma
IOP
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 50
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 purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
* Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
* On a stable medication regimen for IOP reduction one week prior to the screening visit;
* Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
* Sign informed consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
* Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
* Infection in either eye;
* Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
* Risk for visual field or visual acuity worsening, in the opinion of the investigator;
* Women of childbearing potential;
* Pregnant or lactating women;
* Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
* Participation in another clinical study within 30 days before the screening visit;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
timeFrame: Baseline, up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Abayomi Ogundele, PharmD
role: STUDY_DIRECTOR
References: