louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01118260: Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Official title: TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate
Hyperplasia
Keywords: prostata hyperplasia
transurethral resection
TIVA
spinal anaesthesia
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection

Detailed description: Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* signed informed consent
* elective transurethral prostata resection

Exclusion Criteria:

* ASA more than 3
* kidney disease, liver disease
* intolerance against bupivacaine, fentanyl, propofol og remifentanil
* chronic pulmonary disease
* dementia

Primary outcomes:
measure: patient satisfaction
timeFrame: 4 hours
Secondary outcomes:
measure: time in PACU
timeFrame: 4 hours
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Asker & Baerum Hospital
Study officials:
affiliation: Asker & Baerum Hospital
name: Vegard Dahl, MD, PhD
role: STUDY_CHAIR
affiliation: Asker & Baerum Hospital
name: Elisabet Andersson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510960: Video Gaming Improves Robotic Surgery Simulator Success
Official title: Video Gaming Improves Robotic Surgery Simulator Success: A Multi-clinic Cross-sectional Study on Robotic Skills
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic Surgery
Simulator
Keywords: robotic surgery
simulation-based learning
video game experience
surgical education
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents from general surgery, urology, and pediatric surgery clinics were included in the study. Sixty of the 64 total participants completed all the processes. Four participants were excluded from the study.

Brief summary: Investigators aimed to investigate the effects of video game habits, duration of experience, and training in different surgical clinics on the success of robotic surgery simulators.

In this prospective, observational, comparative, and multi-clinic study, all participants played the Temple Run and Piano Tiles 2™ mobile games for one month after responding to a questionnaire including their sociodemographic characteristics, surgical experience, and past and current video game experience. At the end of the study period, participants experienced four different robotic surgery simulator tasks (Camera Targeting 1, Energy Switching 1, Ring \& Rail 2, Vertical Defect Suturing) in the da Vinci® Skills Simulator™. Additionally, sociodemographic data were statistically analyzed with mobile game scores, and 13 different performance scores were obtained from the simulator.


Eligibility criteria: Inclusion Criteria:

* To be a physician trained in Surgery in the Department of General Surgery. Pediatric Surgery and Urology.
* To be an assistant and specialist of the departments with robotic surgery experience.
* To be acquainted with laparoscopic surgery.
* Having played video games.

Exclusion Criteria:

* Participation in our study is on a voluntary basis and we have no criteria other than physicians who want to leave the study voluntarily.

Primary outcomes:
measure: Robotic surgery simulator score of participants by video game experience
timeFrame: 2 months
Secondary outcomes:
measure: Determination of robotic surgery success among clinics according to simulator score
timeFrame: 2 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital
Study officials:
References:
Clinical trial NCT01436760: Genetic Contribution of Pain and Inflammation in IBS
Official title: Genetic Contribution of Pain and Inflammation in Irritable Bowel Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Generic laboratory blood bank

Brief summary: The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.

Detailed description: Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.

Eligibility criteria: Inclusion Criteria:

* Subjects with IBS and previously stored samples

Exclusion Criteria:

* Subjects without IBS and no previously stored samples

Primary outcomes:
measure: Polymorphisms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Baharak Moshiree, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03117660: Effects of Retinoids on CYP2D6 Activity During Pregnancy
Official title: Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CYP2D6 Polymorphism
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-04-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, parallel group study
Primary purpose: BASIC_SCIENCE

Brief summary: Prospective drug interaction study during pregnancy.

Detailed description: A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Extensive metabolizers

Exclusion Criteria:

* Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease
* Productive cough
* Fever
* Known kidney disease
* Known liver disease
* Diabetes
* Obesity
* Bipolar disease
* Attention deficit disorder
* Social phobia
* Allergy or history of adverse event with dextromethorphan
* Drugs, foods, beverages or dietary supplements that interact with CYP2D6 or dextromethorphan
* dextromethorphan
* Unable to give written informed consent
* Inability to fast
* Concurrent use of vitamin A supplementation

Primary outcomes:
measure: CYP2D6 activity: dextromethorphan metabolic ratio
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mary F Hebert, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somani ST, Zeigler M, Fay EE, Leahy M, Bermudez B, Totah RA, Hebert MF. Changes in erythrocyte membrane epoxyeicosatrienoic, dihydroxyeicosatrienoic, and hydroxyeicosatetraenoic acids during pregnancy. Life Sci. 2021 Jan 1;264:118590. doi: 10.1016/j.lfs.2020.118590. Epub 2020 Oct 15.
citation: Amaeze OU, Czuba LC, Yadav AS, Fay EE, LaFrance J, Shum S, Moreni SL, Mao J, Huang W, Isoherranen N, Hebert MF. Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity. J Clin Pharmacol. 2023 Mar;63(3):363-372. doi: 10.1002/jcph.2169. Epub 2022 Nov 15.
citation: Czuba LC, Fay EE, LaFrance J, Smith CK, Shum S, Moreni SL, Mao J, Isoherranen N, Hebert MF. Plasma Retinoid Concentrations Are Altered in Pregnant Women. Nutrients. 2022 Mar 25;14(7):1365. doi: 10.3390/nu14071365.
Clinical trial NCT02618460: Renal NCE-MRI in Healthy Volunteers
Official title: Non-contrast Enhanced MR Imaging of the Kidney in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Non-contrast enhanced MRI
healthy volunteers
renal diffusion
renal perfusion
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: EC-DG Research
First posted: 2015-12-01
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.

Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA), phase-contrast MRI), which could be used in combination with structural MRI in a single acquisition session, have been identified to investigate in more detail renal function and structure, opening the possibility to estimate local renal diffusion and blood perfusion, beyond providing high-resolution anatomical accuracy.

Preliminary to the identification of novel imaging biomarkers of renal disease progression, perfusion and diffusion MR sequences need to be optimized for the renal compartment. Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and diffusion changes in pathological kidneys as compared to normal and physiological condition.

The objective of this study is to provide normal control NCE-MRI sequences to be used as reference for the investigation of perfusion and diffusion changes in the kidney of patients affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal dominant polycystic kidney disease).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 and ≤59 years ;
* Healthy volunteers;
* Written informed consent.

Exclusion Criteria:

* Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment;
* Pregnancy (due to safety reasons).

Primary outcomes:
measure: Apparent Diffusion Coefficient (ADC)
timeFrame: At baseline.
measure: T2*
timeFrame: At baseline.
measure: Renal artery flow.
timeFrame: At baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII
Study officials:
References:
Clinical trial NCT05045560: Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)
Official title: Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Malformations
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

Brief summary: Objective :

Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.

The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.

The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.

Materials and methods :

In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.


Eligibility criteria: Inclusion criteria:

* fetuses and newborns born between January 2010 and September 2020 with anorectal malformations
* diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

Exclusion criteria:

* foreign-born patient
* anorectal malformation associated with an abdominal wall defect

Primary outcomes:
measure: Number of ante or post-natal diagnosispremolars
timeFrame: 1 day
Secondary outcomes:
measure: Number of with or without associated antenatal anomalies
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent Fuchs, MD; PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01646060: Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Official title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Loss
Healthy
Keywords: blood
loss
healthy
volume
To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male, 18-65 years of age
* Subject is suitable for a blood draw of a pint of blood
* Weighs at least 110 pounds

Exclusion Criteria:

* Subject has a heart condition that may interfere with the Zynex CM-1500
* Subject has unstable or untreated heart disease
* Subject has been diagnosed with chronic fatigue syndrome
* Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
* Subject donated blood within 8 weeks prior to blood draw
* Subject has high or low blood pressure on the day of blood draw
* Subject hemoglobin \< 12.5 g/dL

Primary outcomes:
measure: Detect change in blood volume during blood draw
timeFrame: 15-30 minutes
Secondary outcomes:
measure: Detect insidious bleeding
timeFrame: 15-30 minutes
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Urgent Care
state: Colorado
Study officials:
affiliation: Rocky Mountain Urgent Care
name: Nathaniel Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877460: Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control
Official title: The Effects of Isovolumetric Preloads of Sodium Alginate-enriched Chocolate Milk on Glycemia, Subjective Appetite and Food Intake in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health
Appetite Regulation
Glucose Metabolism
Keywords: sodium alginate
chocolate milk
satiety
energy intake
glycemia
insulinemia
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk supplemented with sodium alginates at incremental doses on inter-meal glucose levels, appetite scores and food intake in healthy adult men. The findings of this study will illustrate whether the addition of sodium alginate to chocolate milk will improve the glycemic properties of chocolate milk and will potentiate its satiating characteristics. This study will also elucidate whether sodium alginates, incorporated into chocolate milk, will influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is hypothesized that there will be a synergy between milk and sodium alginate beyond either alone. When combined with milk components, sodium alginate is expected to improve glycemia and induce satiety more than does either milk alone or alginate alone.


Eligibility criteria: Inclusion Criteria:

* Healthy,
* non-smoking male subjects,
* aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited.

Exclusion Criteria:

* Breakfast skippers,
* smokers,
* dieters,
* individuals with lactose-intolerance or
* who are allergic to milk,
* individuals with gastrointestinal problems and
* individuals with diabetes or other metabolic diseases were excluded from the study.

Primary outcomes:
measure: Satiety Change
timeFrame: 0, 10, 20, 30, 45, 60, 75, 90 and 120 min (pre-meal) and 140, 170, 200, 230 and 260 min (post-meal) after consumption of the treatments
Secondary outcomes:
measure: Food Intake
timeFrame: 120 min
Other outcomes:
measure: Blood Glucose Change
timeFrame: 0, 10, 20, 30, 45, 60, 75, 90 and 120 min (pre-meal) and 140, 170, 200, 230 and 260 min (post-meal) after consumption of the treatments
measure: Serum Insulin Change
timeFrame: 0, 30, 60, 120 (pre-meal), and 140, 170 and 200 min (post-meal) after consumption of treatments
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences, FitzGerald Building
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018460: Anticoagulation, Vitamins, and Endothelial Function
Official title: Anticoagulation, Vitamins, and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: geriatrics
vitamin B complex
thrombomodulin
anticoagulants
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Determine whether low or high dose B vitamin therapy will lower homocysteine and thrombomodulin in patients anticoagulated with warfarin.

Detailed description: We hypothesize that 1) both high and low dose B vitamin therapy will lower homocysteine in patients anticoagulated with warfarin and 2) high dose B vitamin therapy will lower thrombomodulin in patients anticoagulated with warfarin. To accomplish these specific aims, we proposed a double- blind randomized controlled trial of 6 months duration comparing 2 different multivitamin regimens differing only in the doses of the following 3 vitamins. The multivitamin for the control group has no folic acid, B2, B6, or B 12. The multivitamin for the intervention group has 5 ing folic acid, 1.7 mg B2, 100 mg B6, and I mg B12. Participants age 50 and older, 150 in each group, are being recruited from the Anticoagulation Clinics at the Baltimore VAMC and neighboring centers. Clinical and risk factor information is being obtained through a face-to-face interview. Blood is being drawn for analyses of homocysteine and vitamin levels (University of Colorado Health Science Center) and thrombomodulin (Baltimore VAMC Hemostasis and Thrombosis Laboratory). Data analysis will be conducted according to the "intention to treat" principle using ordinary least squares regression models.

Eligibility criteria: Males and females ages 50 years or greater

On warfarin therapy for at least 3 months

No active inflammatory process

No physician prescribed B vitamins

Excluded - women of child-bearing age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References: